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  • 1.
    Abrahamsson, Thomas
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Paediatrics in Linköping.
    Editorial Material: Not all probiotic strains prevent necrotising enterocolitis in premature infants in LANCET, vol 387, issue 10019, pp 624-6252016In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 387, no 10019, p. 624-625Article in journal (Other academic)
    Abstract [en]

    n/a

  • 2.
    Andersson, Roland
    Linköping University, Department of Clinical and Experimental Medicine, Surgery. Linköping University, Faculty of Health Sciences.
    Antibiotics versus surgery for appendicitis2011In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 378, no 9796, p. 1067-1067Article in journal (Other academic)
    Abstract [en]

    n/a

  • 3. Bath, Philip M W
    et al.
    Lindenstrom, Ewa
    Boysen, Gudrom
    De Deyn, Peter
    Friis, Pal
    Leys, Didier
    Marttila, Reijo
    Olsson, Jan-Edvin
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Neuroscience and Locomotion. Östergötlands Läns Landsting, Local Health Care Services in Central Östergötland, Department of Neurology.
    O´Neill, Desmond
    Orgagozo, Jean-Marc
    Ringelstein, Bernd
    van der Sande, Jan-Jacob
    Turpie, Alexander G G
    Tinzaparin in acute ischaemic stroke (TAIST): A randomised aspirin-controlled trial2001In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 358, no 9283, p. 702-710Article in journal (Refereed)
    Abstract [en]

    Background: Low-molecular-weight heparins and heparinoids are superior to unfractionated heparin in the prevention and treatment of venous thromboembolism, but their safety and efficacy in acute ischaemic stroke are inadequately defined. Methods: This randomised, double-blind, aspirin-controlled trial tested the safety and efficacy of treatment with high-dose tinzaparin (175 anti-Xa IU/kg daily, 487 patients), medium-dose tinzaparin (100 anti-Xa IU/kg daily, 508 patients), or aspirin (300 mg daily, 491 patients) started within 48 h of acute ischaemic stroke and given for up to 10 days. Primary intracerebral haemorrhage was excluded by computed tomography. Outcome was assessed, with treatment allocation concealed, by the modified Rankin scale at 6 months (independence [scores 0-2] vs dependence or death [scores 3-6]). Findings: Of 1486 randomised patients, two did not receive treatment and 46 were lost to follow-up. The proportions independent at 6 months were similar in the groups assigned high-dose tinzaparin (194/468 [41.5%]), medium-dose tinzaparin (206/486 [42.4%]), or aspirin (205/482 [42.5%]). There was no difference in effect in any predefined subgroup, including patients with presumed cardioembolic stroke. Other outcome measures were similar between the treatment groups (disability, case-fatality, and neurological deterioration rates). During the in-hospital treatment period no patient assigned high-dose tinzaparin developed a symptomatic deep-vein thrombosis compared with nine assigned aspirin. Conversely, seven patients assigned high-dose tinzaparin developed symptomatic intracerebral haemorrhage compared with one in the aspirin group. Interpretation: Treatment with tinzaparin, at high or medium dose, within 48 h of acute ischaemic stroke did not improve functional outcome compared with aspirin. Although high-dose tinzaparin was superior in preventing deep-vein thrombosis, it was associated with a higher rate of symptomatic intracranial haemorrhage.

  • 4. Bergh, Jonas
    et al.
    Wiklund, Tom
    Erikstein, Björn
    Lidbrink, Elisabet
    Lindman, Henrik
    Malmström, Per
    Kellokumpu-Lehtinen, Pirkko
    Bengtsson, Nils-Olof
    Söderlund, Gustaf
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Biomedicine and Surgery, Oncology. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Anker, Gun
    Wist, Erik
    Ottosson, Susanne
    Salminen, Eeva
    Ljungman, Per
    Holte, Harald
    Nilsson, Jonas
    Blomqvist, Carl
    Wilking, Nils
    Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: A randomised trial2000In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 356, no 9239, p. 1384-1391Article in journal (Refereed)
    Abstract [en]

    Background: Chemotherapy drug distribution varies greatly among individual patients. Therefore, we developed an individualised fluorouracil, epirubicin, cyclophosphamide (FEC) regimen to improve outcomes in patients with high-risk early breast cancer. We then did a randomised trial to compare this individually tailored FEC regimen with conventional adjuvant chemotherapy followed by consolidation with high-dose chemotherapy with stem-cell support. Methods: 525 women younger than 60 years of age with high-risk primary breast cancer were randomised after surgery to receive nine cycles of tailored FEC to haematological equitoxicity with granulocyte colony-stimulating factor (G-CSF) support (n=251), or three cycles of FEC at standard doses followed by high-dose chemotherapy with cyclophosphamide, thiotepa, and carboplatin (CTCb), and peripheral-blood stem-cell or bone-marrow support (n=274). Both groups received locoregional radiation therapy and tamoxifen for 5 years. The primary outcome measure was relapse-free survival, and analysis was by intention to treat. Findings: At a median follow-up of 34.3 months, there were 81 breast-cancer relapses in the tailored FEC group versus 113 in the CTCb group (double triangular method p=0.04). 60 deaths occurred in the tailored FEC group and 82 in the CTCb group (log-rank p=0.12). Patients in the CTCb group experienced more grade 3 or 4 acute toxicity compared with the tailored FEC group (p<0.0001). Two treatment-related deaths (0.7%) occurred in the CTCb group. Six patients in the tailored FEC group developed acute myeloid leukaemia and three developed myelodysplastic syndrome. Interpretation: Tailored FEC with G-CSF support resulted in a significantly improved relapse-free survival and fewer grade 3 and 4 toxicities compared with marrow-supported high-dose chemotherapy with CTCb as adjuvant therapy of women with high-risk primary breast cancer.

  • 5.
    Björkstén, B
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Pediatrics. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Barn.
    Allergy priming early in life. 1999In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 353, p. 167-168Article in journal (Refereed)
  • 6.
    Buchbinder, Rachelle
    et al.
    Cabrini-Monash Department of Clinical Epidemiology, Cabrini Institute and Monash University, Malvern, VIC, Australia.
    van Tulder, Maurits
    Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
    Öberg, Birgitta
    Linköping University, Department of Medical and Health Sciences, Division of Physiotherapy. Linköping University, Faculty of Medicine and Health Sciences.
    Costa, Luciola Menezes
    Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.
    Woolf, Anthony
    Royal Cornwall Hospital and University of Exeter Medical School, Truro, UK.
    Schoene, Mark
    The Back Letter, Newburyport MA, USA.
    Croft, Peter
    Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
    Low back pain: a call for action2018In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 391, no 10137, p. 2384-2388Article in journal (Other academic)
    Abstract [en]

    n/a

  • 7. Cars, Otto
    et al.
    Mölstad, Sigvard
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Department of Health and Society, General Practice.
    Melander, Arne
    Variation in antibiotic use in the European Union2001In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 357, p. 1851-1853Article in journal (Refereed)
  • 8.
    Carvalho, Andre F.
    et al.
    Ctr Addict and Mental Hlth, Canada; Univ Toronto, Canada.
    Heilig, Markus
    Linköping University, Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Local Health Care Services in Central Östergötland, Psykiatriska kliniken inkl beroendekliniken.
    Perez, Augusto
    Corp Nuevos Rumbos, Colombia.
    Probst, Charlotte
    Ctr Addict and Mental Hlth, Canada.
    Rehm, Jurgen
    Ctr Addict and Mental Hlth, Canada; Univ Toronto, Canada; Univ Toronto, Canada; Univ Toronto, Canada; Ctr Addict and Mental Hlth, Canada; Tech Univ Dresden, Germany; Tech Univ Dresden, Germany; Sechenov First Moscow State Med Univ, Russia.
    Alcohol use disorders2019In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 394, no 10200, p. 781-792Article, review/survey (Refereed)
    Abstract [en]

    Alcohol use disorders consist of disorders characterised by compulsive heavy alcohol use and loss of control over alcohol intake. Alcohol use disorders are some of the most prevalent mental disorders globally, especially in high-income and upper-middle-income countries; and are associated with high mortality and burden of disease, mainly due to medical consequences, such as liver cirrhosis or injury. Despite their high prevalence, alcohol use disorders are undertreated partly because of the high stigma associated with them, but also because of insufficient systematic screening in primary health care, although effective and cost-effective psychosocial and pharmacological interventions do exist. Primary health care should be responsible for most treatment, with routine screening for alcohol use, and the provision of a staggered treatment response, from brief advice to pharmacological treatment. Clinical interventions for these disorders should be embedded in a supportive environment, which can be bolstered by the creation of alcohol control policies aimed at reducing the overall level of consumption.

  • 9.
    Cheetham, MJ
    et al.
    St Marks Hosp, Dept Surg, Harrow HA1 3UJ, Middx, England St Marks Hosp, Dept Physiol, Harrow HA1 3UJ, Middx, England John Radcliffe Hosp, Dept Colorectal Surg, Oxford OX3 9DU, England Linkoping Univ Hosp, Dept Surg, S-58185 Linkoping, Sweden.
    Mortensen, NJM
    St Marks Hosp, Dept Surg, Harrow HA1 3UJ, Middx, England St Marks Hosp, Dept Physiol, Harrow HA1 3UJ, Middx, England John Radcliffe Hosp, Dept Colorectal Surg, Oxford OX3 9DU, England Linkoping Univ Hosp, Dept Surg, S-58185 Linkoping, Sweden.
    Nyström, Per-Olof
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Surgery . Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Surgery in Östergötland.
    Kamm, MA
    St Marks Hosp, Dept Surg, Harrow HA1 3UJ, Middx, England St Marks Hosp, Dept Physiol, Harrow HA1 3UJ, Middx, England John Radcliffe Hosp, Dept Colorectal Surg, Oxford OX3 9DU, England Linkoping Univ Hosp, Dept Surg, S-58185 Linkoping, Sweden.
    Phillips, RKS
    St Marks Hosp, Dept Surg, Harrow HA1 3UJ, Middx, England St Marks Hosp, Dept Physiol, Harrow HA1 3UJ, Middx, England John Radcliffe Hosp, Dept Colorectal Surg, Oxford OX3 9DU, England Linkoping Univ Hosp, Dept Surg, S-58185 Linkoping, Sweden.
    Persistent pain and faecal urgency after stapled haemorrhoidectomy2000In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 356, no 9231, p. 730-733Article in journal (Refereed)
    Abstract [en]

    Introduction Haemorrhoidectomy usually cures haemorrhoids. Day surgery is feasible, and is associated with high patients' satisfaction and few complications, but patients take an average of 2 weeks off work after surgery. Stapled haemorrhoidectomy has the potential to decrease postoperative pain and time off work. However, data on longterm efficacy and function are lacking. Methods 22 patients underwent stapled haemorrhoidectomy: seven in a pilot study, and 15 in a randomised controlled trial to compare the new stapled operation with diathermy haemorrhoidectomy in a day-case setting. All operations were done by one consultant surgeon. Results 16 patients were followed up for longer than 6 months, five of whom (31% [95% CI 8.5-54.0%]) developed symptoms of pain and faecal urgency which persisted for up to 15 months postoperatively. The randomised trial was suspended, and patients were investigated with endoanal ultrasonography, anorectal physiology, and examination under anaesthetic. All five affected patients were reviewed by two independent surgeons experienced in the stapled operation. In one patient, a fibroepithelial polyp was found adjacent to an anodermal ulcer, in the other patients, no abnormality was found. Four of the five affected patients had some muscle incorporated into the doughnut, compared with only one of 11 of the unaffected patients (p=0.012, Fisher's exact test). No other significant differences in operative variables were identified between patients with and without symptoms, Interpretation Persistent severe pain and faecal urgency has been found in a disturbingly high proportion of patients after stapled haemorrhoidectomy. The mechanism behind this phenomenon is unclear, although muscle incorporation in the doughnut may have a role, Other groups who have studied stapled haemorrhoidectomy urgently need to audit their long-term results to assess the frequency of this problem.

  • 10.
    Cuttini, M
    et al.
    Burlo Garofolo Children's hospital, Trieste, Italy.
    Nadai, M
    Burlo Garofolo Children's hospital, Trieste, Italy.
    Kaminski, M
    Epidemiological Unit on Women's and Children's health, U149 INSERM Villejuif, France.
    Hansen, G
    Department of Pediatrics, Martin-Luther University, Halle, Germany.
    de Leeuw, R
    Department of Neonatology, Amsterdam University, Netherlands.
    Lenoir, S
    Unit of Research on Reproduction, CJF 89-08 INSERM, Toulouse, France.
    Persson, Jan
    Linköping University, Faculty of Health Sciences. Linköping University, Department of health and environment.
    Rebagliato, M
    Department of Public Health, Miguel Hernandez University, Alicante, Spain.
    Reid, M
    Department of Public Health, University of Glasgow.
    de Wonderweid, U
    Lenard, HG
    Department of Pediatrics, Heinrich Heine University, Düsseldorf, Germany.
    Orzalesi, M
    Neonatal Intensive Care Unit, Bambino Gesû Children's Hospital, Rome, Italy.
    Saracci, R
    Division of Epidemiology, IFC, National Research Council, Pisa, Italy.
    End-of-life decisions in neonatal intensive care: physicians' selfreported practices in seven European countries2000In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 355, no 9221, p. 2112-2118Article in journal (Refereed)
    Abstract [en]

    Background

    The ethical issue of foregoing life-sustaining treatment for newborn infants at high risk of death or severe disability is extensively debated, but there is little information on how physicians in different countries actually confront this issue to reach end-of-life decisions. The EURONIC project aimed to investigate practices as reported by physicians themselves.

    Methods

    The study recruited a large, representative sample of 122 neonatal intensive-care units (NICUs) by census (in Luxembourg, the Netherlands, and Sweden) or stratified random sampling (in France, Germany, the UK, Italy, and Spain) with an overall response rate of 86%. Physicians' practices of end-of-life decision-making were investigated through an anonymous, self-administered questionnaire. 1235 completed questionnaires were returned (response rate 89%).

    Findings

    In all countries, most physicians reported having been involved at least once in setting limits to intensive care because of incurable conditions (61–96%); smaller proportions reported such involvement because of a baby's poor neurological prognosis (46–90%). Practices such as continuation of current treatment without intensification and withholding of emergency manoeuvres were widespread, but withdrawal of mechanical ventilation was reported by variable proportions (28–90%). Only in France (73%) and the Netherlands (47%) was the administration of drugs with the aim of ending life reported with substantial frequency. Age, length of professional experience, and the importance of religion in the physician's life affected the likelihood of reporting of non-treatment decisions.

    Interpretation

    A vast majority of neonatologists in European NICUs have been involved in end-of-life limitation of treatments, but type of decision-making varies among countries. Cultur-related and other country-specific factors are more relevant than characteristics of individual physicians or units in explaining such variability.

  • 11.
    Dahlquist, G
    et al.
    Univ Uppsala, Childrens Hosp, Dept Women & Chil Hlth, S-75185 Uppsala, Sweden Linkoping Univ Hosp, Dept Paediat, S-58185 Linkoping, Sweden Umea Univ, Dept Paediat, Umea, Sweden Natl Board Hlth & Welf, Ctr Epidemiol, Stockholm, Sweden.
    Finnström, Orvar
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Pediatrics . Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Paediatrics in Linköping.
    Koster, M
    Univ Uppsala, Childrens Hosp, Dept Women & Chil Hlth, S-75185 Uppsala, Sweden Linkoping Univ Hosp, Dept Paediat, S-58185 Linkoping, Sweden Umea Univ, Dept Paediat, Umea, Sweden Natl Board Hlth & Welf, Ctr Epidemiol, Stockholm, Sweden.
    Stromberg, B
    Univ Uppsala, Childrens Hosp, Dept Women & Chil Hlth, S-75185 Uppsala, Sweden Linkoping Univ Hosp, Dept Paediat, S-58185 Linkoping, Sweden Umea Univ, Dept Paediat, Umea, Sweden Natl Board Hlth & Welf, Ctr Epidemiol, Stockholm, Sweden.
    Neurological sequelae in in-vitro fertilisation babies - Reply2002In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 360, no 9334, p. 719-719Other (Other academic)
  • 12.
    Frankelius, Per
    Linköping University, Department of Management and Engineering, Business Administration. Linköping University, Faculty of Arts and Sciences.
    Back to the root causes of war: food shortages2019In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 393, no 10175, p. 981-982Article in journal (Other academic)
    Abstract [en]

    n/a

  • 13. Hansson, L
    et al.
    Hedner, T
    Univ Uppsala, Dept Publ Hlth & Social Sci, S-75125 Uppsala, Sweden Sahlgrens Univ Hosp, Dept Clin Pharmacol, Gothenburg, Sweden Haukeland Univ Hosp, Dept Cardiol, N-5021 Bergen, Norway Ulleval Univ Hosp, Dept Cardiol, Oslo, Norway Umea Univ Hosp, Dept Publ Hlth & Clin Med, S-90185 Umea, Sweden Univ Lund, Dept Stat, Lund, Sweden Varna Med Ctr, Moss, Norway Karolinska Univ Hosp, Dept Med, Stockholm, Sweden Ostra Hosp, Dept Med, S-41685 Gothenburg, Sweden Linkoping Univ Hosp, Dept Endocrinol, S-58185 Linkoping, Sweden.
    Lund-Johansen, P
    Univ Uppsala, Dept Publ Hlth & Social Sci, S-75125 Uppsala, Sweden Sahlgrens Univ Hosp, Dept Clin Pharmacol, Gothenburg, Sweden Haukeland Univ Hosp, Dept Cardiol, N-5021 Bergen, Norway Ulleval Univ Hosp, Dept Cardiol, Oslo, Norway Umea Univ Hosp, Dept Publ Hlth & Clin Med, S-90185 Umea, Sweden Univ Lund, Dept Stat, Lund, Sweden Varna Med Ctr, Moss, Norway Karolinska Univ Hosp, Dept Med, Stockholm, Sweden Ostra Hosp, Dept Med, S-41685 Gothenburg, Sweden Linkoping Univ Hosp, Dept Endocrinol, S-58185 Linkoping, Sweden.
    Kjeldsen, SE
    Univ Uppsala, Dept Publ Hlth & Social Sci, S-75125 Uppsala, Sweden Sahlgrens Univ Hosp, Dept Clin Pharmacol, Gothenburg, Sweden Haukeland Univ Hosp, Dept Cardiol, N-5021 Bergen, Norway Ulleval Univ Hosp, Dept Cardiol, Oslo, Norway Umea Univ Hosp, Dept Publ Hlth & Clin Med, S-90185 Umea, Sweden Univ Lund, Dept Stat, Lund, Sweden Varna Med Ctr, Moss, Norway Karolinska Univ Hosp, Dept Med, Stockholm, Sweden Ostra Hosp, Dept Med, S-41685 Gothenburg, Sweden Linkoping Univ Hosp, Dept Endocrinol, S-58185 Linkoping, Sweden.
    Lindholm, LH
    Univ Uppsala, Dept Publ Hlth & Social Sci, S-75125 Uppsala, Sweden Sahlgrens Univ Hosp, Dept Clin Pharmacol, Gothenburg, Sweden Haukeland Univ Hosp, Dept Cardiol, N-5021 Bergen, Norway Ulleval Univ Hosp, Dept Cardiol, Oslo, Norway Umea Univ Hosp, Dept Publ Hlth & Clin Med, S-90185 Umea, Sweden Univ Lund, Dept Stat, Lund, Sweden Varna Med Ctr, Moss, Norway Karolinska Univ Hosp, Dept Med, Stockholm, Sweden Ostra Hosp, Dept Med, S-41685 Gothenburg, Sweden Linkoping Univ Hosp, Dept Endocrinol, S-58185 Linkoping, Sweden.
    Syvertsen, JO
    Univ Uppsala, Dept Publ Hlth & Social Sci, S-75125 Uppsala, Sweden Sahlgrens Univ Hosp, Dept Clin Pharmacol, Gothenburg, Sweden Haukeland Univ Hosp, Dept Cardiol, N-5021 Bergen, Norway Ulleval Univ Hosp, Dept Cardiol, Oslo, Norway Umea Univ Hosp, Dept Publ Hlth & Clin Med, S-90185 Umea, Sweden Univ Lund, Dept Stat, Lund, Sweden Varna Med Ctr, Moss, Norway Karolinska Univ Hosp, Dept Med, Stockholm, Sweden Ostra Hosp, Dept Med, S-41685 Gothenburg, Sweden Linkoping Univ Hosp, Dept Endocrinol, S-58185 Linkoping, Sweden.
    Lanke, J
    Univ Uppsala, Dept Publ Hlth & Social Sci, S-75125 Uppsala, Sweden Sahlgrens Univ Hosp, Dept Clin Pharmacol, Gothenburg, Sweden Haukeland Univ Hosp, Dept Cardiol, N-5021 Bergen, Norway Ulleval Univ Hosp, Dept Cardiol, Oslo, Norway Umea Univ Hosp, Dept Publ Hlth & Clin Med, S-90185 Umea, Sweden Univ Lund, Dept Stat, Lund, Sweden Varna Med Ctr, Moss, Norway Karolinska Univ Hosp, Dept Med, Stockholm, Sweden Ostra Hosp, Dept Med, S-41685 Gothenburg, Sweden Linkoping Univ Hosp, Dept Endocrinol, S-58185 Linkoping, Sweden.
    de Faire, U
    Univ Uppsala, Dept Publ Hlth & Social Sci, S-75125 Uppsala, Sweden Sahlgrens Univ Hosp, Dept Clin Pharmacol, Gothenburg, Sweden Haukeland Univ Hosp, Dept Cardiol, N-5021 Bergen, Norway Ulleval Univ Hosp, Dept Cardiol, Oslo, Norway Umea Univ Hosp, Dept Publ Hlth & Clin Med, S-90185 Umea, Sweden Univ Lund, Dept Stat, Lund, Sweden Varna Med Ctr, Moss, Norway Karolinska Univ Hosp, Dept Med, Stockholm, Sweden Ostra Hosp, Dept Med, S-41685 Gothenburg, Sweden Linkoping Univ Hosp, Dept Endocrinol, S-58185 Linkoping, Sweden.
    Dahlof, B
    Univ Uppsala, Dept Publ Hlth & Social Sci, S-75125 Uppsala, Sweden Sahlgrens Univ Hosp, Dept Clin Pharmacol, Gothenburg, Sweden Haukeland Univ Hosp, Dept Cardiol, N-5021 Bergen, Norway Ulleval Univ Hosp, Dept Cardiol, Oslo, Norway Umea Univ Hosp, Dept Publ Hlth & Clin Med, S-90185 Umea, Sweden Univ Lund, Dept Stat, Lund, Sweden Varna Med Ctr, Moss, Norway Karolinska Univ Hosp, Dept Med, Stockholm, Sweden Ostra Hosp, Dept Med, S-41685 Gothenburg, Sweden Linkoping Univ Hosp, Dept Endocrinol, S-58185 Linkoping, Sweden.
    Karlberg, BE
    Randomised trial of effects of calcium antagonists compared with diuretics and beta-blockers on cardiovascular morbidity and mortality in hypertension: the Nordic Diltiazem (NORDIL) study2000In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 356, no 9227, p. 359-365Article in journal (Refereed)
    Abstract [en]

    Background Calcium antagonists are a first-line treatment for hypertension. The effectiveness of diltiazem, a nondihydropyridine calcium antagonist, in reducing cardiovascular morbidity or mortality is unclear. We compared the effects of diltiazem with that of diuretics, beta-blockers, or both on cardiovascular morbidity and mortality in hypertensive patients. Methods In a prospective, randomised, open, blinded endpoint study, we enrolled 10 881 patients, aged 50-74 years, at health centres in Norway and Sweden, who had diastolic blood pressure of 100 mm Hg or more. We randomly assigned patients diltiazem, or diuretics, beta-blockers, or both. The combined primary endpoint was fatal and non-fatal stroke, myocardial infarction, and other cardiovascular death. Analysis was done by intention to treat. Findings Systolic and diastolic blood pressure were lowered effectively in the diltiazem and diuretic and beta-blocker groups (reduction 20.3/18.7 vs 23.3/18.7 mm Hg, difference in systolic reduction p<0.001). A primary endpoint occurred in 403 patients in the diltiazem group and in 400 in the diuretic and beta-blocker group (16.6 vs 16.2 events per 1000 patient-years, relative risk 1.00 [95% CI 0.87-1.15], p=0.97). Fatal and non-fatal stroke occurred in 159 patients in the diltiazem group and in 196 in the diuretic and beta-blocker group (6.4 vs 7.9 events per 1000 patient-years, 0.80 [0.65-0.99], p=0.04) and fatal and non-fatal myocardial infarction in 183 and 157 patients (7.4 vs 6.3 events per 1000 patient-years, 1.16 [0.94-1.44], p=0.17). Interpretation Diltiazem was as effective as treatment based on diuretics, beta-blockers, or both in preventing the combined primary endpoint of all stroke, myocardial infarction, and other cardiovascular death.

  • 14.
    Holdaas, H.
    et al.
    Rikshospitalet, Sognsvannsvn 20, Oslo 0072, Norway.
    Fellstrom, B.
    Fellström, B., University Hospital, Uppsala, Sweden.
    Jardine, A.G.
    University of Glasgow, Glasgow, United Kingdom.
    Holme, I.
    Preventive Medicine Clinic, Ullevaal University Hospital, Oslo, Norway.
    Nyberg, G.
    Sahlgrenska University Hospital, Göteborg, Sweden.
    Fauchald, P.
    Rikshospitalet, Sognsvannsvn 20, Oslo 0072, Norway.
    Gronhagen-Riska, C.
    Grönhagen-Riska, C., University Hospital, Helsinki, Finland.
    Madsen, S.
    Skejby Hospital, Aarhus, Denmark.
    Neumayer, H.-H.
    Univ. Klin. Charité, Berlin, Germany.
    Cole, E.
    Toronto General Hospital, Toronto, Ont., Canada.
    Maes, B.
    University Hospital, Leuven, Belgium.
    Ambuhl, P.
    Ambühl, P., University Hospital, Zürich, Switzerland.
    Olsson, Anders
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Health Sciences, Internal Medicine . Östergötlands Läns Landsting, Centre for Medicine, Department of Endocrinology and Gastroenterology UHL.
    Hartmann, A.
    Rikshospitalet, Sognsvannsvn 20, Oslo 0072, Norway.
    Solbu, D.O.
    Novartis Norge AS, Oslo, Norway.
    Pedersen, T.R.
    Preventive Medicine Clinic, Ullevaal University Hospital, Oslo, Norway.
    Effect of fluvastatin on cardiac outcomes in renal transplant recipients: A multicentre, randomised, placebo-controlled trial2003In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 361, no 9374, p. 2024-2031Article in journal (Refereed)
    Abstract [en]

    Background: Renal transplant recipients are at increased risk of premature cardiovascular disease. Although statins reduce cardiovascular risk in the general population, their efficacy and safety in renal transplant recipients have not been established. We investigated the effects of fluvastatin on cardiac and renal endpoints in this population. Methods: We did a multicentre, randomised, double-blind, placebo-controlled trial in 2102 renal transplant recipients with total cholesterol 4·0-9·0 mmol/L. We randomly assigned patients fluvastatin (n=1050) or placebo (n=1052) and follow up was for 5-6 years. The primary endpoint was the occurrence of a major adverse cardiac event, defined as cardiac death, non-fatal myocardial infarction (MI), or coronary intervention procedure. Secondary endpoints were individual cardiac events, combined cardiac death or non-fatal MI, cerebrovascular events, non-cardiovascular death, all-cause mortality, and graft loss or doubling of serum creatinine. Analysis was by intention to treat. Findings: After a mean follow-up of 5·1 years, fluvastatin lowered LDL cholesterol concentrations by 32%. Risk reduction with fluvastatin for the primary endpoint (risk ratio 0·83 [95% CI 0·64-1·06], p=0·139) was not significant, although there were fewer cardiac deaths or non-fatal MI (70 vs 104, 0·65 [0·48-0·88] p=0·005) in the fluvastatin group than in the placebo group. Coronary intervention procedures and other secondary endpoints did not differ significantly between groups. Interpretation: Although cardiac deaths and non-fatal MI seemed to be reduced, fluvastatin did not generally reduce rates of coronary intervention procedures or mortality. Overall effects of fluvastatin were similar to those of statins in other populations.

  • 15. Holmberg, L
    et al.
    Anderson, H
    Hammar, Mats
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Obstetrics and gynecology. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    steering and data monitoring committees, HABITS
    HABITS (hormonal replacement therapy after breast cancer - is it safe?), a randomised comparison: trial stopped.2004In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. on lineArticle in journal (Refereed)
  • 16.
    Home, P.D.
    et al.
    Newcastle Diabetes Centre, Newcastle University, Newcastle upon Tyne, United Kingdom.
    Pocock, S.J.
    Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London, United Kingdom.
    Beck-Nielsen, H.
    Department of Endocrinology and Metabolism, Odense, Denmark.
    Curtis, P.S.
    GlaxoSmithKline Research and Development, Greenford, United Kingdom.
    Gomis, R.
    Hospital Clinic, University of Barcelona, Barcelona, Spain.
    Hanefeld, M.
    Zentrum für Klinische Studien Forschungsbereich Endokrinologie und Stoffwechsel, Dresden, Germany.
    Jones, N.P.
    GlaxoSmithKline Research and Development, Harlow, United Kingdom.
    Komajda, M.
    Université Pierre et Marie Curie Paris 6, Hôpital Pitié-Salpêtrière, Département de Cardiologie, Paris, France.
    McMurray, J.J.
    British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
    Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial2009In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 373, no 9681, p. 2125-2135Article in journal (Refereed)
    Abstract [en]

    Background: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the combination of the two over 5-7 years of follow-up. We also assessed comparative safety. Methods: In a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A 1c (HbA 1c) of 7·9% were randomly assigned to addition of rosiglitazone (n=2220) or to a combination of metformin and sulfonylurea (active control group, n=2227). The primary endpoint was cardiovascular hospitalisation or cardiovascular death, with a hazard ratio (HR) non-inferiority margin of 1·20. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00379769. Findings: 321 people in the rosiglitazone group and 323 in the active control group experienced the primary outcome during a mean 5·5-year follow-up, meeting the criterion of non-inferiority (HR 0·99, 95% CI 0·85-1·16). HR was 0·84 (0·59-1·18) for cardiovascular death, 1·14 (0·80-1·63) for myocardial infarction, and 0·72 (0·49-1·06) for stroke. Heart failure causing admission to hospital or death occurred in 61 people in the rosiglitazone group and 29 in the active control group (HR 2·10, 1·35-3·27, risk difference per 1000 person-years 2·6, 1·1-4·1). Upper and distal lower limb fracture rates were increased mainly in women randomly assigned to rosiglitazone. Mean HbA 1c was lower in the rosiglitazone group than in the control group at 5 years. Interpretation: Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on myocardial infarction, rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs. Funding: GlaxoSmithKline plc, UK. © 2009 Elsevier Ltd. All rights reserved.

  • 17.
    Lagerqvist, Bo
    et al.
    Uppsala.
    Husted, Steen
    Århus,Danmark.
    Koontny, Fredrik
    Oslo, Norge.
    Ståhle, Elisabeth
    Uppsala.
    Swahn, Eva
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Cardiology. Östergötlands Läns Landsting, Heart Centre, Department of Cardiology.
    Wallentin, Lars
    Uppsala.
    5-year outcomes in the FRISC-II randomised trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: a follow-up study2006In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 368, no 9540, p. 998-1004Article in journal (Refereed)
    Abstract [en]

    Background: The FRISC-II invasive trial compared an early invasive with a non-invasive strategy in terms of death and myocardial infarction in non-ST-elevation acute coronary syndrome. We present 5-year follow-up results, overall and in subgroups based on recommended risk stratification criteria. Methods: In the FRISC-II trial, 2457 patients with non-ST-elevation acute coronary syndrome were randomised to early invasive strategy (coronary angiography and, if appropriate, revascularisation, within 7 days from admission) or non-invasive primarily medical strategy. Risk stratification was done on the basis of risk indicators at randomisation: age older than 65 years, male sex, diabetes mellitus, previous myocardial infarction, ST-segment depression, raised troponin concentration (>0·03 μg/L), and raised C-reactive protein or interleukin 6. Information on events after 24 months was taken from national registries. Analyses were done on an intention-to-treat basis. Findings: At 5 years the groups differed in terms of the primary composite endpoint of death, myocardial infarction, or both (invasive 217, 19·9 %, noninvasive 270, 24·5 %, risk ratio 0·81, 95% CI 0·69-0·95, p=0·009). 5-year mortality was 117 (9·7%) in the invasive group compared with 124 (10·1%) in the noninvasive group (0·95, 0·75 -1·21, p=0·693). Rates of myocardial infarction were 141 (12·9 %) in the invasive and 195 (17.7%) in the non-invasive group (0·73, 0·60-0·89, p=0·002). The benefit of the invasive strategy was confined to male patients, non-smokers, and patients with two or more risk indicators. Interpretation: The 5-year outcome of this trial indicates sustained benefit of an early invasive strategy in patients with non-ST-elevation acute coronary syndrome at moderate to high risk. © 2006 Elsevier Ltd. All rights reserved.

  • 18.
    Lennmarken, C.
    et al.
    Dept. Anaesthesia and Intensive Care, University Hospital, Linkoping, Sweden.
    Sandin, R.
    Dept. Anaesthesia and Intensive Care, County Hospital, Kalmar, Sweden, Karolinska Institute, Stockholm, Sweden.
    Neuromonitoring for awareness during surgery2004In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 363, no 9423, p. 1747-1748Other (Other academic)
    Abstract [en]

    [No abstract available]

  • 19.
    Lennmarken, Claes
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Health Sciences, Anesthesiology . Östergötlands Läns Landsting, Anaesthesiology and Surgical Centre, Department of Intensive Care UHL.
    Sandin, R
    Neuromonitoring for awareness during surgery2004In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 363, no 9423, p. 1747-1748Other (Other academic)
  • 20.
    Lennmarken, Claes
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Anaesthesiology. Östergötlands Läns Landsting, Anaesthesiology and Surgical Centre, Department of Intensive Care UHL.
    Sandin, R
    Neuromonitoring for awareness during surgery2004In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 29, p. 1747-1748Article in journal (Refereed)
  • 21. Lopman, Ben
    et al.
    Vennema, Harry
    Kohli, Evelyne
    Pothier, Pierre
    Sanchez, Alicia
    Negredo, Anabel
    Buesa, Javier
    Schreir, Eckart
    Reacher, Mark
    Brown, David
    Gray, Jim
    Iturriza, Miren
    Gallimore, Chris
    Bottiger, Blenda
    Hedlund, Kjell-Olof
    Torvén, Maria
    von Bondsdorff, Carl-Henrik
    Maunula, Leena
    Poljsak-Prijatelj, Mateja
    Zimsek, Janet
    Reuter, Gábor
    Szücs, Gyorgy
    Melegh, Béla
    Svensson, Lennart
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Molecular Virology.
    van Duijnhoven, Yvonne
    Koopmans, Marion
    Increase in viral gastroenteritis outbreaks in Europe and epidemic spread of new norovirus variant2004In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 363, no 9410, p. 682-688Article in journal (Refereed)
    Abstract [en]

    Background Highly publicised outbreaks of norovirus gastroenteritis in hospitals in the UK and Ireland and cruise ships in the USA sparked speculation about whether this reported activity was unusual. Methods We analysed data collected through a collaborative research and surveillance network of viral gastroenteritis in ten European countries (England and Wales were analysed as one region). We compiled data on total number of outbreaks by month, and compared genetic sequences from the isolated viruses. Data were compared with historic data from a systematic retrospective review of surveillance systems and with a central database of viral sequences. Findings Three regions (England and Wales, Germany, and the Netherlands) had sustained epidemiological and viral characterisation data from 1995 to 2002. In all three, we noted a striking increase in norovirus outbreaks in 2002 that coincided with the detection and emergence of a new predominant norovirus variant of genogroup II4, which had a consistent mutation in the polymerase gene. Eight of nine regions had an annual peak in 2002 and the new genogroup II4 variant was detected in nine countries. Also, the detection of the new variant preceded an atypical spring and summer peak of outbreaks in three countries. Interpretation Our data from ten European countries show a striking increase and unusual seasonal pattern of norovirus gastroenteritis in 2002 that occurred concurrently with the emergence of a novel genetic variant. In addition to showing the added value of an international network for viral gastroenteritis outbreaks, these observations raise questions about the biological properties of the variant and the mechanisms for its rapid dissemination.

  • 22.
    Ludvigsson, Johnny
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Pediatrics. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Paediatrics in Linköping.
    Endit Group, European Nicotinamide Diabetes Intervention Trial
    European Nicotinamide Diabetes Intervention Trial (ENDIT): a randomised controlled trial of intervention before the onset of type 1 diabetes.2004In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 363, p. 925-931Article in journal (Refereed)
  • 23.
    Malmqvist, Erik
    Linköping University, The Tema Institute, Technology and Social Change. Linköping University, Faculty of Arts and Sciences.
    The right to participate in high-risk research2014In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 384, no 9938, p. 128-128Article in journal (Other academic)
  • 24. Mason, SA
    et al.
    Allmark, PJ
    Euricon Study Group,
    Nelson, Nina
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Pediatrics. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Barn.
    Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study.2000In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 356, p. 2045-2051Article in journal (Refereed)
  • 25.
    Nordin, Pär
    et al.
    Department of Surgery, Östersund Hospital, Östersund, Sweden.
    Zetterström, Henrik
    Department of Anaesthetics, Östersund Hospital, Östersund, Sweden.
    Gunnarsson, Ulf
    Department of Surgery, Mora Hospital, University of Uppsala, Sweden.
    Nilsson, Erik
    Department of Surgery, Motala Hospital, Motala, Sweden.
    Local, regional, or general anaesthesia in groin hernia repair: multicentre randomised trial2003In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 362, no 9387, p. 853-858Article in journal (Refereed)
    Abstract [en]

    Background

    In specialised centres, local anaesthesia is almost always used in groin hernia surgery; whereas in routine surgical practice, regional or general anaesthesia are the methods of choice. In this three-arm multicentre randomised trial, we aimed to compare the three methods of anaesthesia and to determine the extent to which general surgeons can reproduce the excellent results obtained with local anaesthesia in specialised hernia centres.

    Methods

    Between January, 1999, and December, 2001, 616 patients at ten hospitals, were randomly assigned to have either local, regional, or general anaesthesia. Primary endpoints were early and late postoperative complications. Secondary endpoints were duration of surgery and anaesthesia, length of postoperative hospital stay, and time to normal activity. Analysis was by intention to treat.

    Findings

    Intraoperative tolerance for local anaesthesia was high. In the early postoperative period, local anaesthesia was superior to the other two types with respect to almost all endpoints. At 8 days' and 30 days' follow-up, there were no significant differences between the three groups. Although the mean duration of surgery was longer, the total anaesthesia time—ie, time from the start of anaesthesia until the patient left the operating room—was significantly shorter than it was for regional or general anaesthesia.

    Interpretation

    Local anaesthesia has substantial advantages compared with regional or general anaesthesia, such as shorter duration of admission, less postoperative pain, and fewer micturition difficulties. The favourable results obtained with local anaesthesia in specialised hernia centres can, to a great extent, be reproduced by general surgeons in routine surgical practice.

  • 26. Nyström, Lennarth
    et al.
    Andersson, Ingvar
    Bjurstam, Nils
    Frisell, Jan
    Nordenskjöld, Bo
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Biomedicine and Surgery, Oncology. Östergötlands Läns Landsting, Centre of Surgery and Oncology, Department of Oncology UHL.
    Rutqvist, Lars Erik
    Long-term effects of mammography screening: Updated overview of the Swedish randomised trials2002In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 359, no 9310, p. 909-919Article in journal (Refereed)
    Abstract [en]

    Background: There has been much debate about the value of screening mammography. Here we update the overview of the Swedish randomised controlled trials on mammography screening up to and including 1996. The Kopparberg part of the Two-County trial was not available for the overview, but the continuation of the Malm÷ trial (MMST II) has been added. The article also contains basic data from the trials that have not been presented before. Methods: The trials (n=247 010, invited group 129 750, control group 117 260) have been followed up by record linkage to the Swedish Cancer and Cause of Death Registers. The relative risks (RR) for breast cancer death and mortality were calculated for the invited and the control groups. The trial-specific as well as the age-specific effects were analysed. RRs were calculated by the density method, with total person-time experience of the cohort by time interval of follow-up as a basis for estimating mortality rates. We calculated weighted RRs and 95% CI with the Mantel-Haenszel procedure. Findings: The median trial time - the time from randomisation until the first round was completed for the control group or if the control group was not invited, until end of follow-up - was 6.5 years (range 3.0-18.1). The median follow-up time, the time from randomisation, to the end of follow-up, was 15.8 years (5.8-20.2). There were 511 breast cancer deaths in 1 864 770 women-years in the invited groups and 584 breast cancer deaths in 1 688 440 women-years in the control groups, a significant 21% reduction in breast cancer mortality (RR=0.79, 95% CI 0.70-0.89). The reduction was greatest in the age group 60-69 years at entry (33%). Looking at 5-year age groups, there were statistically significant effects in the age groups 55-59, 60-64, and 65-69 years (RR=0.76, 0.68, and 0.69, respectively). There was a small effect in women 50-54 years at randomisation (RR=0.95). The benefit in terms of cumulative breast cancer mortality started to emerge at about 4 years after randomisation and continued to increase to about 10 years. Thereafter the benefit in absolute terms was maintained throughout the period of observation. The age-adjusted relative risk for the total mortality was 0.98 (0.96-1.00). Interpretation: The advantageous effect of breast screening on breast cancer mortality persists after long-term follow-up. The recent criticism against the Swedish randomised controlled trials is misleading and scientifically unfounded.

  • 27.
    Opava, Christina H
    et al.
    Karolinska Inst, Dept Neurobiol Care Sci & Soc, Div Physiotherapy, SE-14183 Huddinge, Sweden; Karolinska Univ Hosp, Dept Rheumatol, Stockholm, Sweden .
    Björk, Mathilda
    Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Center, Rehabilitation Center. Linköping University, Department of Clinical and Experimental Medicine. Jonkoping Univ, Sch Hlth Sci, Dept Rehabil, Jonkoping, Sweden.
    Towards evidence-based hand exercises in rheumatoid arthritis.2015In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 385, no 9966, p. 396-398Article in journal (Refereed)
    Abstract [en]

    Disease-modifying biological agents and other drug regimens have substantially improved control of disease activity and joint damage in people with rheumatoid arthritis of the hand. However, commensurate changes in function and quality of life are not always noted. Tailored hand exercises might provide additional improvements, but evidence is lacking. We estimated the eff ectiveness and cost-eff ectiveness of tailored hand exercises in addition to usual care during 12 months.

  • 28.
    Raal, Frederick J.
    et al.
    University of Witwatersrand, South Africa.
    Stein, Evan A.
    Metab and Atherosclerosis Research Centre, OH USA.
    Dufour, Robert
    Institute Rech Clin Montreal, Canada.
    Turner, Traci
    Metab and Atherosclerosis Research Centre, OH USA.
    Civeira, Fernando
    University Hospital Miguel Servet, Spain.
    Burgess, Lesley
    Tygerberg Hospital, South Africa.
    Langslet, Gisle
    Oslo University Hospital, Norway.
    Scott, Russell
    University of Otago, New Zealand; Amgen Inc, CA 91320 USA.
    Olsson, Anders
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Center, Department of Endocrinology. Stockholm Heart Centre, Sweden.
    Sullivan, David
    Royal Prince Alfred Hospital, Australia.
    Kees Hovingh, G.
    University of Amsterdam, Netherlands.
    Cariou, Bertrand
    Nantes University Hospital, France.
    Gouni-Berthold, Ioanna
    University of Cologne, Germany.
    Somaratne, Ransi
    Amgen Inc, CA 91320 USA.
    Bridges, Ian
    Amgen Ltd, MA USA.
    Scott, Rob
    University of Otago, New Zealand; Amgen Inc, CA 91320 USA.
    Wasserman, Scott M.
    Amgen Inc, CA 91320 USA.
    Gaudet, Daniel
    University of Montreal, Canada.
    PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial2015In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 385, no 9965, p. 331-340Article in journal (Refereed)
    Abstract [en]

    Background Heterozygous familial hypercholesterolaemia is characterised by low cellular uptake of LDL cholesterol, increased plasma LDL cholesterol concentrations, and premature cardiovascular disease. Despite intensive statin therapy, with or without ezetimibe, many patients are unable to achieve recommended target levels of LDL cholesterol. We investigated the effect of PCSK9 inhibition with evolocumab (AMG 145) on LDL cholesterol in patients with this disorder. Methods This multicentre, randomised, double-blind, placebo-controlled trial was undertaken at 39 sites (most of which were specialised lipid clinics, mainly attached to academic institutions) in Australia, Asia, Europe, New Zealand, North America, and South Africa between Feb 7 and Dec 19,2013.331 eligible patients (18-80 years of age), who met clinical criteria for heterozygous familial hypercholesterolaemia and were on stable lipid-lowering therapy for at least 4 weeks, with a fasting LDL cholesterol concentration of 2.6 mmol/L or higher, were randomly allocated in a 2:2:1:1 ratio to receive subcutaneous evolocumab 140 mg every 2 weeks, evolocumab 420 mg monthly, or subcutaneous placebo every 2 weeks or monthly for 12 weeks. Randomisation was computer generated by the study sponsor, implemented by a computerised voice interactive system, and stratified by LDL cholesterol concentration at screening (higher or lower than 4.1 mmol/L) and by baseline ezetimibe use (yes/no). Patients, study personnel, investigators, and Amgen study staff were masked to treatment assignments within dosing frequency groups. The coprimary endpoints were percentage change from baseline in LDL cholesterol at week 12 and at the mean of weeks 10 and 12, analysed by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT01763918. Findings Of 415 screened patients, 331 were eligible and were randomly assigned to the four treatment groups: evolocumab 140 mg every 2 weeks (n=111), evolocumab 420 mg monthly (n=110), placebo every 2 weeks (n=55), or placebo monthly (n=55). 329 patients received at least one dose of study drug. Compared with placebo, evolocumab at both dosing schedules led to a significant reduction in mean LDL cholesterol at week 12 (every-2-weeks dose: 59.2% reduction [95% CI 53.4-65.1], monthly dose: 61.3% reduction [53.6-69.0]; both pless than0.0001) and at the mean of weeks 10 and 12 (60.2% reduction [95% CI 54.5-65.8] and 65.6% reduction [59.8-71.3]; both pless than0.0001). Evolocumab was well tolerated, with rates of adverse events similar to placebo. The most common adverse events occurring more frequently in the evolocumab-treated patients than in the placebo groups were nasopharyngitis (in 19 patients [9%] vs five [5%] in the placebo group) and muscle-related adverse events (ten patients [5%] vs 1 [1%]). Interpretation In patients with heterozygous familial hypercholesterolaemia, evolocumab administered either 140 mg every 2 weeks or 420 mg monthly was well tolerated and yielded similar and rapid 60% reductions in LDL cholesterol compared with placebo.

  • 29. Rampton, DS
    et al.
    Neurath, MF
    Almer, Sven
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Gastroenterology and Hepatology. Östergötlands Läns Landsting, MKC - Medicin och kirurgicentrum, GE: gastromed.
    D'Haens, G
    Petritsch, W
    Stange, EF
    Mycophenolate mofetil in Crohn's disease.2000In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 356, p. 163-164Article in journal (Refereed)
  • 30. Rasmussen, A.G.
    et al.
    Adolfsson, R.
    Karlsson, Thomas
    Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Behavioural Sciences, Cognition, Development and Disability.
    New method specific for acetylcholinesterase in cerebrospinal fluid: application to Alzheimer's disease1988In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 2, p. 571-572Article in journal (Refereed)
  • 31.
    Rewers, Marian
    et al.
    University of Colorado, CO USA.
    Ludvigsson, Johnny
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Paediatrics in Linköping.
    Environmental risk factors for type 1 diabetes2016In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 387, no 10035, p. 2340-2348Article, review/survey (Refereed)
    Abstract [en]

    The incidence of type 1 diabetes has risen considerably in the past 30 years due to changes in the environment that have been only partially identified. In this Series paper, we critically discuss candidate triggers of islet autoimmunity and factors thought to promote progression from autoimmunity to overt type 1 diabetes. We revisit previously proposed hypotheses to explain the growth in the incidence of type 1 diabetes in light of current data. Finally, we suggest a unified model in which immune tolerance to beta cells can be broken by several environmental exposures that induce generation of hybrid peptides acting as neoautoantigens.

  • 32.
    Sandin, Rolf H
    et al.
    Department of Anaesthesia and Intensive Care, Länssjukhuset, Kalmar, Sweden.
    Enlund, Gunnar
    Department of Anaesthesia and Intensive Care, Vrinnevisjukhuset, Norrköping, Sweden.
    Samuelsson, Peter
    Linköping University, Department of Medicine and Health Sciences. Linköping University, Faculty of Health Sciences.
    Lennmarken, Claees
    Department of Anaesthesia and Intensive Care, Vrinnevisjukhuset, Norrköping, Sweden.
    Awareness during anaesthesia: a prospective case study2000In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 355, no 9205, p. 707-711Article in journal (Refereed)
    Abstract [en]

    Background

    Patients who are given general anaesthesia are not guaranteed to remain unconscious during surgery. Knowledge about the effectiveness of current protective measures is scarce, as is our understanding of patients' responses to this complication. We did a prospective case study to assess conscious awareness during anaesthesia.

    Methods

    11 785 patients who had undergone general anaesthesia were interviewed for awareness on three occasions: before they left the post-anaesthesia care unit, and 1–3 days and 7–14 days after the operation.

    Findings

    We identified 18 cases of awareness and one case of inadvertent muscle blockade that had occurred before unconsciousness. Incidence of awareness was 0·18% in cases in which neuromuscular blocking drugs were used, and 0·10% in the absence of such drugs. 17 cases of awareness were identified at the final interview, but no more than 11 would have been detected if an interview had been done only when the patients left the post-anaesthesia care unit. Four non-paralysed patients recalled intraoperative events, but none had anxiety during wakefulness or had delayed neurotic symptoms. This finding contrasts with anaesthesia with muscle relaxants, during which 11 of 14 patients had pain, anxiety, or delayed neurotic symptoms. After repeated discussion and information, the delayed neurotic symptoms resolved within 3 weeks in all patients. Analysis of individual cases suggests that a reduced incidence of recall of intraoperative events would not be achieved by monitoring of end-tidal anaesthetic gas concentration or by more frequent use of benzodiazepines.

    Interpretation

    The inability to prevent awareness by conventional measures may advocate monitoring of cerebral activity by neurophysiological techniques. However, the sensitivity of such techniques is not known, and in the light of our findings, at least 861 patients would need to be monitored to avoid one patient from suffering due to awareness during relaxant anaesthesia.

  • 33.
    Sherry, Nicole
    et al.
    Massachusetts General Hospital.
    Hagopian, William
    NW Diabetes Research Institute.
    Ludvigsson, Johnny
    Linköping University, Department of Clinical and Experimental Medicine, Pediatrics. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Paediatrics in Linköping.
    Jain, Sunil M
    TOTALL Diabetes Hormone Research Institute.
    Wahlen, Jack
    Endocrine Research Specialists.
    Ferry, Robert J
    Atlanta Diabet Associates,.
    Bode, Bruce
    Atlanta Diabet Associates.
    Aronoff, Stephen
    Research Institute Dallas.
    Holland, Christopher
    MacroGenics.
    Carlin, David
    MacroGenics.
    King, Karen L
    MacroGenics.
    Wilder, Ronald L
    PAREXEL Int.
    Pillemer, Stanley
    Amer Biopharma Corp.
    Bonvini, Ezio
    MacroGenics.
    Johnson, Syd
    MacroGenics.
    Stein, Kathryn E
    MacroGenics.
    Koenig, Scott
    MacroGenics.
    Herold, Kevan C
    Yale University.
    Daifotis, Anastasia G
    MacroGenics.
    Teplizumab for treatment of type 1 diabetes (Protege study): 1-year results from a randomised, placebo-controlled trial2011In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 378, no 9790, p. 487-497Article in journal (Refereed)
    Abstract [en]

    Background Findings of small studies have suggested that short treatments with anti-CD3 monoclonal antibodies that are mutated to reduce Fc receptor binding preserve beta-cell function and decrease insulin needs in patients with recent-onset type 1 diabetes. In this phase 3 trial, we assessed the safety and efficacy of one such antibody, teplizumab. less thanbrgreater than less thanbrgreater thanMethods In this 2-year trial, patients aged 8-35 years who had been diagnosed with type 1 diabetes for 12 weeks or fewer were enrolled and treated at 83 clinical centres in North America, Europe, Israel, and India. Participants were allocated (2:1:1:1 ratio) by an interactive telephone system, according to computer-generated block randomisation, to receive one of three regimens of teplizumab infusions (14-day full dose, 14-day low dose, or 6-day full dose) or placebo at baseline and at 26 weeks. The Protege study is still underway, and patients and study staff remain masked through to study closure. The primary composite outcome was the percentage of patients with insulin use of less than 0.5 U/kg per day and glycated haemoglobin A(1c) (HbA(1c)) of less than 6-5% at 1 year. Analyses included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT00385697. less thanbrgreater than less thanbrgreater thanFindings 763 patients were screened, of whom 516 were randomised to receive 14-day full-dose teplizumab (n=209), 14-day low-dose teplizumab (n=102), 6-day full-dose teplizumab (n=106), or placebo (n=99). Two patients in the 14-day full-dose group and one patient in the placebo group did not start treatment, so 513 patients were eligible for efficacy analyses. The primary outcome did not differ between groups at 1 year: 19.8% (41/207) in the 14-day full-dose group; 13.7% (14/102) in the 14-day low-dose group; 20.8% (22/106) in the 6-day full-dose group; and 20.4% (20/98) in the placebo group. 5% (19/415) of patients in the teplizumab groups were not taking insulin at 1 year, compared with no patients in the placebo group at 1 year (p=0.03). Across the four study groups, similar proportions of patients had adverse events (414/417 [99%] in the teplizumab groups vs 98/99 [99%] in the placebo group) and serious adverse events (42/417 [10%] vs 9/99 [9%]). The most common clinical adverse event in the teplizumab groups was rash (220/417 [53%] vs 20/99 [20%] in the placebo group). less thanbrgreater than less thanbrgreater thanInterpretation Findings of exploratory analyses suggest that future studies of immunotherapeutic intervention with teplizumab might have increased success in prevention of a decline in beta-cell function (measured by C-peptide) and provision of glycaemic control at reduced doses of insulin if they target patients early after diagnosis of diabetes and children.

  • 34.
    Stenestrand, Ulf
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Cardiology. Östergötlands Läns Landsting, Heart Centre, Department of Cardiology.
    Wallentin, L
    Early revascularisation for myocardial infarction2002In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 360, p. 1603-1603Article in journal (Other (popular science, discussion, etc.))
  • 35.
    Stenestrand, Ulf
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Health Sciences, Cardiology . Östergötlands Läns Landsting, Heart Centre, Department of Cardiology.
    Wallentin, L
    Univ Hosp, Dept Cardiol, SE-58185 Linkoping, Sweden Uppsala Univ, Uppsala Clin Res Ctr, Uppsala, Sweden.
    Early revascularisation for myocardial infarction - Reply2002In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 360, no 9345, p. 1603-1603Other (Other academic)
  • 36.
    Stenestrand, Ulf
    et al.
    Linköping University, Department of Medicine and Care, Cardiology. Linköping University, Faculty of Health Sciences.
    Wallentin, Lars
    Department of Cardiology, University Hospital of Uppsala, Uppsala.
    Early revascularisation and 1-year survival in 14-day survivors of acute myocardial infarction: a prospective cohort study2002In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 359, no 9320, p. 1805-1811Article in journal (Refereed)
    Abstract [en]

    Background

    Randomised trials of early revascularisation in acute coronary syndromes have yielded conflicting results with respect to effects on survival. We assessed the association between revascularisation within 14 days after the index event and 1-year mortality in individuals who survived for at least 14 days after an acute myocardial infarction.

    Methods

    We studied a prospective cohort of patients admitted to the coronary care units of 61 Swedish hospitals between 1995 and 1998. We obtained 1-year mortality data from the Swedish National Cause of Death Register. We assessed 21 912 individuals with first registry-recorded acute myocardial infarction, who were younger than age 80 years, and alive at day 14. Relative risk of 1-year mortality in patients who had revascularisation (n=2554) or those who did not (n=19 358) within 14 days was calculated by Cox regression analysis, adjusting for multiple covariates that affect mortality and with a propensity score that adjusted for covariates that affected the likelihood of early revascularisation.

    Findings

    At 1 year, unadjusted mortality was 9·0% (1751 deaths) in the conservative group and 3·3% (84 deaths) in the early revascularisation group. In the Cox regression analysis early revascularisation was associated with a reduction in 1-year mortality (relative risk 0·47; 95% Cl 0·37–0·60; p <0·001). This relative reduction of mortality was similar in all subgroups irrespective of age, sex, baseline characteristics, previous disease manifestations, or treatment.

    Interpretation

    Early revascularisation in individuals with acute myocardial infarction is associated with substantial reduction in 1-year mortality. Our findings lend support to the use of an invasive approach early after an acute myocardial infarction.

  • 37.
    Stromberg, B.
    et al.
    Strömberg, B., Department of Women and Child Health, University Children's Hospital, 751 85 Uppsala, Sweden.
    Dahlquist, G.
    Department of Clinical Sciences, Paediatrics, Umeå University, Umeå, Sweden.
    Ericson, A.
    Centre for Epidemiology, National Board of Health and Welfare, Stockholm, Sweden.
    Finnström, Orvar
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Pediatrics . Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Paediatrics in Linköping.
    Koster, M.
    Köster, M., Centre for Epidemiology, National Board of Health and Welfare, Stockholm, Sweden.
    Stjernqvist, K.
    Department of Psychology, Lund University, Lund, Sweden.
    Neurological sequelae in children born after in-vitro fertilisation: A population-based study2002In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 359, no 9305, p. 461-465Article in journal (Refereed)
    Abstract [en]

    Background: There is an absence of population-based long-term studies on the risk of neurological sequelae in children born after in-vitro fertilisation (IVF). Our aim was to compare the frequency of such problems between IVF-born children and controls. Methods: We did a population-based retrospective cohort study in which we compared development of neurological problems in 5680 children born after IVF, with 11 360 matched controls. For 2060 twins born after IVF, a second set of controls (n=4120), all twins, were selected. We obtained data on neurological problems from the records of the Swedish habilitation centres. Findings: Children born after IVF are more likely to need habilitation services than controls (odds ratio 1.7, 95% CI 1.3-2.2). For singletons, the risk was 1.4 (1.0-2.1). The most common neurological diagnosis was cerebral palsy, for which children born after IVF had an increased risk of 3.7(2.0-6.6), and IVF singletons of 2.8 (1.3-5.8). Suspected developmental delay was increased four-fold (1.9-8.3) in children born after IVF. Twins born after IVF did not differ from control twins with respect to risk of neurological sequelae. Low-birthweight and premature infants were more likely to need habilitation than fullterm babies. Maternal age did not affect risk. Interpretation: Our study suggests that children born after IVF have an increased risk of developing neurological problems, especially cerebral palsy. These risks are largely due to the high frequency of twin pregnancies, low birthweight, and prematurity among babies born after IVF. To limit these risks, we recommend that only one embryo should be transferred during IVF.

  • 38. Strömberg, B
    et al.
    Dahlquist, G
    Ericsson, A
    Finnström, Orvar
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Pediatrics. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Barn.
    Köster, M
    Stjernquist, K
    Neurological sequelae in children born after in-vitro fertilisation.2002In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 359, p. 461-465Article in journal (Refereed)
  • 39. Tabar, L
    et al.
    Yen, MF
    Vitak, B
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Radiology. Östergötlands Läns Landsting, Centre for Medical Imaging, Department of Radiology UHL.
    Chen, HHT
    Smith, RA
    Duffy, SW
    Mammography service screening and mortality in breast cancer patients: 20-year follow-up before and after introduction of screening2003In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 361, no 9367, p. 1405-1410Article in journal (Refereed)
    Abstract [en]

    Background: The long term effect of mammographic service screening is not well established. We aimed to assess the long-term effect of mammographic screening on death from breast cancer, taking into account potential biases from self-selection, changes in breast cancer incidence, and classification of cause of death. Methods: We compared deaths from breast cancer diagnosed in the 20 years before screening was introduced (1958-77) with those from breast cancer diagnosed in the 20 years after the introduction of screening (1978-97) in two Swedish counties, in 210 000 women aged 20-69 years. We also compared deaths from all cancers and from all causes in patients diagnosed with breast cancer in the 20 years before and after screening was introduced. In the analysis, data were stratified into age-groups invited for screening (40-69 years) and not invited (20-39 years), and by whether or not the women had actually received screening. We also analysed mortality for the 40-49-year age-group separately. Findings: The unadjusted risk of death from breast cancer dropped significantly in the second screening period compared with the first in women aged 40-69 years (relative risk [RR] 0.77 [95% CI 0.7-0.85], p<0.0001). No such decline was seen in 20-39 year olds. After adjustment for age, self-selection bias, and changes in breast-cancer incidence in the 40-69 years age-group, breast-cancer mortality was reduced in women who were screened (0.56, 0.49-0.64 p<0.0001), in those who were not screened (0.84 [0.71-0.99], p=0.03), and in screened and unscreened women combined (0.59 [0.53-0.66], p<0.0001). After adjustment for age, self-selection bias, and changes in incidence in the 40-49-year age-group, deaths from breast cancer fell significantly in those who were screened (0.52 [0.4-0.67], p<0.0001), and in all women, screened and unscreened combined (0.55 [0.44-0.7] p<0.0001) but not in unscreened women (p=0.2). In both 40-69-year and 40-49-year age-groups, reductions in deaths from all cancers and from all-causes in women with breast cancer were consistent with these results. Interpretation Taking account of potential biases, changes in clinical practice and changes in the incidence of breast cancer, mammography screening is contributing to substantial reductions in breast cancer mortality in these two Swedish counties.

  • 40. Topol, EJ
    et al.
    Lincoff, AM
    Califf, RM
    Ohman, EM
    Bates, E
    Gibler, WB
    Hochman, J
    Kleiman, N
    Willerson, JT
    USA.
    Grinfeld, L
    Argentina.
    Alward, P
    Australien.
    Van de Werf, F
    Belgien.
    Armstrong, PW
    Canada.
    Heikkila, J
    Finland.
    Vahanian, A
    Steg, G
    Frankrike.
    Bode, C
    Germany.
    Adgy, AAJ
    Irland.
    Guetta, V
    Israel.
    Ardissino, D
    Savonitto, S
    Italien.
    Bär, F
    Holland.
    Simoons, M
    Holland.
    Kontny, F
    Norge.
    White, H
    Nya Zeeland.
    Sadowski, Z
    Polen.
    Seabra-Gomes, R
    Portugal.
    Dalby, A
    Syd Afrika.
    Betriu, A
    Spanien.
    Swahn, Eva
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Cardiology. Östergötlands Läns Landsting, Heart Centre, Department of Cardiology.
    Wilcox, R
    Uk.
    Reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO V randomised trial.2001In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 357, p. 1905-1914Article in journal (Refereed)
  • 41. Wallentin, Lars
    et al.
    Lagerqvist, Bo
    Husted, Steen
    Kontny, Frederic
    Ståhle, Elisabeth
    Swahn, Eva
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Cardiology. Östergötlands Läns Landsting, Heart Centre, Department of Cardiology.
    Outcome at 1 year after an invasive compared with a non-invasive strategy in unstable coronary-artery disease: The FRISC II invasive randomised trial2000In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 356, no 9223Article in journal (Refereed)
    Abstract [en]

    Background: The Fragmin and Fast Revascularisation during Instability in Coronary artery disease Il trial (FRISC II) compared an early invasive with an early non-invasive strategy in unstable coronary-artery disease. We report outcome at 1 year. Methods: 2457 patients were randomly assigned invasive or non-invasive treatment and 3 months of dalteparin or placebo. Complete information at 1 year was available for 1222 in the invasive group and 1234 in the non-invasive group. Analyses were by intention to treat. Findings: Revascularisation was done within the first 10 days in 71% of the invasive group and 9% of the non-invasive group and within the first year in 78% and 43%. During the first year, 27 (2╖2%) patients in the invasive group and 48 (3╖9%) in the non-invasive group died (risk ratio 0╖57 [95% Cl 0╖36-0╖90], p=0╖016). 105 (8╖6%) versus 143 (11╖6%) had myocardial infarction (0╖74 [0╖59-0╖94], p=0╖015). The composite of death or myocardial infarction occurred in 127 (10╖4%) versus 174 (14╖1%) patients (0╖74 [0╖60-0╖92], P=0╖005). There were also reductions in readmission (451 [37%] vs 704 [57%], 0╖67 [0╖62-0╖72]), and revascularisation after the initial admission (92 [7╖5%] vs 383 [31%], 0╖24 [0╖20╖-0╖30]). The results did not interact with the dalteparin/placebo allocation. Interpretation: After 1 year in 100 patients, an invasive strategy saves 1╖7 lives, prevents 2╖0 non-fatal myocardial infarctions and 20 readmissions, and provides earlier and better symptom relief at the cost of 15 more patients with coronary-artery bypass grafting and 21 more with percutaneous transluminal angioplasty. Therefore, an invasive approach should be the preferred strategy in patients with unstable coronary-artery disease and signs of ischaemia on electrocardiography or raised levels of biochemical markers of myocardial damage.

  • 42.
    Wallentin, Lars
    et al.
    Uppsala University, Sweden.
    Lindhagen, Lars
    Uppsala University, Sweden.
    Arnstrom, Elisabet
    Uppsala University, Sweden.
    Husted, Steen
    Hospital Unit West, Denmark.
    Janzon, Magnus
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping.
    Paaske Johnsen, Soren
    Aarhus University Hospital, Denmark.
    Kontny, Frederic
    Stavanger University Hospital, Norway; Drammen Heart Centre, Norway.
    Kempf, Tibor
    Hannover Medical Sch, Germany.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Lindahl, Bertil
    Uppsala University, Sweden.
    Stridsberg, Mats
    Uppsala University, Sweden.
    Stahle, Elisabeth
    Uppsala University, Sweden.
    Venge, Per
    Uppsala University, Sweden.
    Wollert, Kai C.
    Hannover Medical Sch, Germany.
    Swahn, Eva
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping.
    Lagerqvist, Bo
    Uppsala University, Sweden.
    Early invasive versus non-invasive treatment in patients with non-ST-elevation acute coronary syndrome (FRISC-II): 15 year follow-up of a prospective, randomised, multicentre study2016In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 388, no 10054, p. 1903-1911Article in journal (Refereed)
    Abstract [en]

    Background The FRISC-II trial was the first randomised trial to show a reduction in death or myocardial infarction with an early invasive versus a non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome. Here we provide a remaining lifetime perspective on the effects on all cardiovascular events during 15 years follow-up. Methods The FRISC-II prospective, randomised, multicentre trial was done at 58 Scandinavian centres in Sweden, Denmark, and Norway. Between June 17, 1996, and Aug 28, 1998, we randomly assigned (1:1) 2457 patients with non-ST-elevation acute coronary syndrome to an early invasive treatment strategy, aiming for revascularisation within 7 days, or a non-invasive strategy, with invasive procedures at recurrent symptoms or severe exercise-induced ischaemia. Plasma for biomarker analyses was obtained at randomisation. For long-term outcomes, we linked data with national health-care registers. The primary endpoint was a composite of death or myocardial infarction. Outcomes were compared as the average postponement of the next event, including recurrent events, calculated as the area between mean cumulative count-of-events curves. Analyses were done by intention to treat. Findings At a minimum of 15 years follow-up on Dec 31, 2014, data for survival status and death were available for 2421 (99%) of the initially recruited 2457 patients, and for other events after 2 years for 2182 (89%) patients. During follow-up, the invasive strategy postponed death or next myocardial infarction by a mean of 549 days (95% CI 204-888; p= 0.0020) compared with the non-invasive strategy. This effect was larger in non-smokers (mean gain 809 days, 95% CI 402-1175; p(interaction) = 0.0182), patients with elevated troponin T (778 days, 357-1165; p (interaction) = 0.0241), and patients with high concentrations of growth differentiation factor-15 (1356 days, 507-1650; p (interaction) = 0.0210). The difference was mainly driven by postponement of new myocardial infarction, whereas the early difference in mortality alone was not sustained over time. The invasive strategy led to a mean of 1128 days (95% CI 830-1366) postponement of death or next readmission to hospital for ischaemic heart disease, which was consistent in all subgroups (pamp;lt; 0.0001). Interpretation During 15 years of follow-up, an early invasive treatment strategy postponed the occurrence of death or next myocardial infarction by an average of 18 months, and the next readmission to hospital for ischaemic heart disease by 37 months, compared with a non-invasive strategy in patients with non-ST-elevation acute coronary syndrome. This remaining lifetime perspective supports that an early invasive treatment strategy should be the preferred option in most patients with non-ST-elevation acute coronary syndrome.

  • 43. Wallentin, Lars
    et al.
    Swahn, Eva
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Cardiology. Östergötlands Läns Landsting, Heart Centre, Department of Cardiology.
    Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC II prospective randomised multicentre study.1999In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 354, p. 708-715Article in journal (Refereed)
  • 44. Wallentin, Lars
    et al.
    Swahn, Eva
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Cardiology. Östergötlands Läns Landsting, Heart Centre, Department of Cardiology.
    Long-term low-molecular-mass heparin in unstable coronary-artery disease: FRISC II prospective randomised multicentre study.1999In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 345, p. 701-707Article in journal (Refereed)
  • 45.
    Widmark, Anders
    et al.
    Umea Univ, Sweden.
    Gunnlaugsson, Adalsteinn
    Lund Univ, Sweden.
    Beckman, Lars
    Sundsvall Hosp, Sweden.
    Thellenberg-Karlsson, Camilla
    Umea Univ, Sweden.
    Hoyer, Morten
    Aarhus Univ Hosp, Denmark.
    Lagerlund, Magnus
    Kalmar Hosp, Sweden.
    Kindblom, Jon
    Univ Gothenburg, Sweden.
    Ginman, Claes
    Karlstad Cent Hosp, Sweden.
    Johansson, Bengt
    Orebro Univ, Sweden.
    Bjornlinger, Kirsten
    Ryhov Hosp, Sweden.
    Seke, Mihajl
    Cent Lasarettet, Sweden.
    Agrup, Måns
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology.
    Fransson, Per
    Umea Univ, Sweden.
    Tavelin, Bjorn
    Umea Univ, Sweden.
    Norman, David
    Umea Univ, Sweden.
    Zackrisson, Bjorn
    Umea Univ, Sweden.
    Anderson, Harald
    Lund Univ, Sweden.
    Kjellen, Elisabeth
    Lund Univ, Sweden.
    Franzen, Lars
    Umea Univ, Sweden.
    Nilsson, Per
    Lund Univ, Sweden.
    Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial2019In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 394, no 10196, p. 385-395Article in journal (Refereed)
    Abstract [en]

    Background Hypofractionated radiotherapy for prostate cancer has gained increased attention due to its proposed high radiation-fraction sensitivity. Recent reports from studies comparing moderately hypofractionated and conventionally fractionated radiotherapy support the clinical use of moderate hypofractionation. To date, there are no published randomised studies on ultra-hypofractionated radiotherapy. Here, we report the outcomes of the Scandinavian HYPO-RTPC phase 3 trial with the aim to show non-inferiority of ultra-hypofractionation compared with conventional fractionation. Methods In this open-label, randomised, phase 3 non-inferiority trial done in 12 centres in Sweden and Denmark, we recruited men up to 75 years of age with intermediate-to-high-risk prostate cancer and a WHO performance status between 0 and 2. Patients were randomly assigned to ultra-hypofractionation (42.7 Gy in seven fractions, 3 days per week for 2.5 weeks) or conventional fractionated radiotherapy (78.0 Gy in 39 fractions, 5 days per week for 8 weeks). No androgen deprivation therapy was allowed. The primary endpoint was time to biochemical or clinical failure, analysed in the per-protocol population. The prespecified non-inferiority margin was 4% at 5 years, corresponding to a critical hazard ratio (HR) limit of 1.338. Physician-recorded toxicity was measured according to the Radiation Therapy Oncology Group (RTOG) morbidity scale and patient-reported outcome measurements with the Prostate Cancer Symptom Scale (PCSS) questionnaire. This trial is registered with the ISRCTN registry, number ISRCTN45905321. Findings Between July 1, 2005, and Nov 4, 2015, 1200 patients were randomly assigned to conventional fractionation (n=602) or ultra-hypofractionation (n=598), of whom 1180 (591 conventional fractionation and 589 ultra-hypofractionation) constituted the per-protocol population. 1054 (89%) participants were intermediate risk and 126 (11%) were high risk. Median follow-up time was 5.0 years (IQR 3.1-7.0). The estimated failure-free survival at 5 years was 84% (95% CI 80-87) in both treatment groups, with an adjusted HR of 1.002 (95% CI 0.758-1.325; log-rank p=0.99). There was weak evidence of an increased frequency of acute physician-reported RTOG grade 2 or worse urinary toxicity in the ultra-hypofractionation group at end of radiotherapy (158 [28%] of 569 patients vs 132 [23%] of 578 patients; p=0.057). There were no significant differences in grade 2 or worse urinary or bowel late toxicity between the two treatment groups at any point after radiotherapy, except for an increase in urinary toxicity in the ultra-hypofractionation group compared to the conventional fractionation group at 1-year follow-up (32 [6%] of 528 patients vs 13 [2%] of 529 patients; (p=0.0037). We observed no differences between groups in frequencies at 5 years of RTOG grade 2 or worse urinary toxicity (11 [5%] of 243 patients for the ultra-hypofractionation group vs 12 [5%] of 249 for the conventional fractionation group; p=1.00) and bowel toxicity (three [1%] of 244 patients vs nine [4%] of 249 patients; p=0.14). Patient-reported outcomes revealed significantly higher levels of acute urinary and bowel symptoms in the ultra-hypofractionation group compared with the conventional fractionation group but no significant increases in late symptoms were found, except for increased urinary symptoms at 1-year follow-up, consistent with the physician-evaluated toxicity. Interpretation Ultra-hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy for intermediate-to-high risk prostate cancer regarding failure-free survival. Early side-effects are more pronounced with ultra-hypofractionation compared with conventional fractionation whereas late toxicity is similar in both treatment groups. The results support the use of ultra-hypofractionation for radiotherapy of prostate cancer. Copyright (C) 2019 Elsevier Ltd. All rights reserved.

  • 46.
    Wijma, Barbro
    et al.
    Linköping University, Department of Molecular and Clinical Medicine. Linköping University, Faculty of Health Sciences.
    Schei, B.
    Department of Gynaecology, St Olav Hospital, Trondheim, Norway.
    Swahnberg, Katarina
    Linköping University, Department of Molecular and Clinical Medicine. Linköping University, Faculty of Health Sciences.
    Hilden, M.
    Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Glostrup; and Center for Victims of Sexual Assault, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
    Offerdal, K.
    Department of Gynaecology, St Olav Hospital, Trondheim, Norway.
    Pikarinen, U.
    Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, Helsinki, Finland.
    Sidenius, K.
    Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Glostrup; and Center for Victims of Sexual Assault, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
    Steingrimsdottir, T.
    Department of Gynaecology, Landspitalinn, Reykjavik, Iceland.
    Stoum, H.
    Department of Gynaecology, St Olav Hospital, Trondheim, Norway.
    Halmesmäki, E.
    Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, Helsinki, Finland.
    Emotional, physical, and sexual abuse in patients visiting gynaecology clinics: a Nordic cross-sectional study2003In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 361, no 9375, p. 2107-2113Article in journal (Refereed)
    Abstract [en]

    Background

    Abuse against women causes much suffering for individuals and is a major concern for society. We aimed to estimate the prevalence of three types of abuse in patients visiting gynaecology clinics in five Nordic countries, and to assess the frequency with which gynaecologists identify abuse victims.

    Methods

    We did a cross-sectional, multicentre study of women attending five departments of gynaecology in Denmark, Finland, Iceland, Norway, and Sweden. We recruited 4729 patients; 3641 (77%) responded and were included in the study. Participants completed a postal questionnaire (norvold abuse questionnaire) confidentially. Primary outcome measures were prevalences of emotional, physical, and sexual abuse, and whether abused patients had told their gynaecologist about these experiences. We assessed differences between countries with Pearson's χ2 test.

    Findings

    The ranges across the five countries of lifetime prevalence were 38–66% for physical abuse, 19–37% for emotional abuse, and 17–33% for sexual abuse. Not all abused women reported current ill-effects from the abusive experience. Most women (92–98%) had not talked to their gynaecologist about their experiences of abuse at their latest clinic visit.

    Interpretation

    Despite prevalences of emotional, physical, and sexual abuse being high in patients visiting gynaecology clinics in the Nordic countries, most victims of abuse are not identified by their gynaecologists. This lack of discussion might increase the risk of abused patients not being treated according to their needs. Gynaecologists should always consider asking their patients about abuse.

  • 47.
    Willeit, Peter
    et al.
    Med Univ Innsbruck, Austria; Univ Cambridge, England.
    Ridker, Paul M.
    Harvard Med Sch, MA USA.
    Nestel, Paul J.
    Baker Heart and Diabet Inst, Australia.
    Simes, John
    Univ Sydney, Australia.
    Tonkin, Andrew M.
    Monash Univ, Australia.
    Pedersen, Terje R.
    Oslo Univ Hosp, Norway; Univ Oslo, Norway.
    Schwartz, Gregory G.
    VA Med Ctr, CO USA; Univ Colorado, CO USA.
    Olsson, Anders
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Endocrinology.
    Colhoun, Helen M.
    MRC Inst Genet and Mol Med, Scotland.
    Kronenberg, Florian
    Med Univ Innsbruck, Austria.
    Drechsler, Christiane
    Univ Hniv Hosp Wurzburg, Germany.
    Wanner, Christoph
    Univ Hosp Wurzburg, Germany.
    Mora, Samia
    Harvard Med Sch, MA USA.
    Lesogor, Anastasia
    Novartis Pharma AG, Switzerland.
    Tsimikas, Sotirios
    Univ Calif San Diego, CA 92093 USA.
    Baseline and on-statin treatment lipoprotein(a) levels for prediction of cardiovascular events: individual patient-data meta-analysis of statin outcome trials2018In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 392, no 10155, p. 1311-1320Article in journal (Refereed)
    Abstract [en]

    Background Elevated lipoprotein(a) is a genetic risk factor for cardiovascular disease in general population studies. However, its contribution to risk for cardiovascular events in patients with established cardiovascular disease or on statin therapy is uncertain. Methods Patient-level data from seven randomised, placebo-controlled, statin outcomes trials were collated and harmonised to calculate hazard ratios (HRs) for cardiovascular events, defined as fatal or non-fatal coronary heart disease, stroke, or revascularisation procedures. HRs for cardiovascular events were estimated within each trial across predefined lipoprotein(a) groups (15 to amp;lt;30 mg/dL, 30 to amp;lt;50 mg/dL, and amp;gt;= 50 mg/dL, vs amp;lt;15 mg/dL), before pooling estimates using multivariate random-effects meta-analysis. Findings Analyses included data for 29 069 patients with repeat lipoprotein(a) measurements (mean age 62 years [SD 8]; 8064 [28%] women; 5751 events during 95 576 person-years at risk). Initiation of statin therapy reduced LDL cholesterol (mean change -39% [95% CI -43 to -35]) without a significant change in lipoprotein(a). Associations of baseline and on-statin treatment lipoprotein(a) with cardiovascular disease risk were approximately linear, with increased risk at lipoprotein(a) values of 30 mg/dL or greater for baseline lipoprotein(a) and 50 mg/dL or greater for on-statin lipoprotein(a). For baseline lipoprotein(a), HRs adjusted for age and sex (vs amp;lt;15 mg/dL) were 1.04 (95% CI 0.91-1.18) for 15 mg/dL to less than 30 mg/dL, 1.11 (1.00-1.22) for 30 mg/dL to less than 50 mg/dL, and 1.31 (1.08-1.58) for 50 mg/dL or higher; respective HRs for on-statin lipoprotein(a) were 0.94 (0.81-1.10), 1.06 (0. 94-1.21), and 1.43 (1.15-1.76). HRs were almost identical after further adjustment for previous cardiovascular disease, diabetes, smoking, systolic blood pressure, LDL cholesterol, and HDL cholesterol. The association of on-statin lipoprotein(a) with cardiovascular disease risk was stronger than for on-placebo lipoprotein(a) (interaction p=0.010) and was more pronounced at younger ages (interaction p=0.008) without effect-modification by any other patient-level or study-level characteristics. Interpretation In this individual-patient data meta-analysis of statin-treated patients, elevated baseline and on-statin lipoprotein(a) showed an independent approximately linear relation with cardiovascular disease risk. This study provides a rationale for testing the lipoprotein(a) lowering hypothesis in cardiovascular disease outcomes trials. Copyright (C) 2018 Elsevier Ltd. All rights reserved.

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