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  • 1.
    Amundstuen Reppe, Linda
    et al.
    Nordic University, Norway; Norwegian University of Science and Technology, Norway; St Olays Hospital, Norway.
    Lydersen, Stian
    Norwegian University of Science and Technology, Norway.
    Schjott, Jan
    Haukeland Hospital, Norway; University of Bergen, Norway; Haukeland Hospital, Norway.
    Damkier, Per
    Odense University Hospital, Denmark.
    Rolighed Christensen, Hanne
    Bispebjerg and Frederiksberg University Hospital, Denmark.
    Peter Kampmann, Jens
    Bispebjerg and Frederiksberg University Hospital, Denmark.
    Böttiger, Ylva
    Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Pharmacology.
    Spigset, Olav
    Norwegian University of Science and Technology, Norway; St Olays Hospital, Norway.
    Relationship Between Time Consumption and Quality of Responses to Drug-related Queries: A Study From Seven Drug Information Centers in Scandinavia2016In: Clinical Therapeutics, ISSN 0149-2918, E-ISSN 1879-114X, Vol. 38, no 7, p. 1738-1749Article in journal (Refereed)
    Abstract [en]

    Purpose: The aims of this study were to assess the quality of responses produced by drug information centers (DICs) in Scandinavia, and to study the association between time consumption processing queries and the quality of the responses. Methods: We posed six identical drug-related queries to seven DICs in Scandinavia, and the time consumption required for processing them was estimated. Clinical pharmacologists (internal experts) and general practitioners (external experts) reviewed responses individually. We used mixed model linear regression analyses to study the associations between time consumption on one hand and the summarized quality scores and the overall impression of the responses on the other hand. Findings: Both expert groups generally assessed the quality of the responses as "satisfactory" to "good." A few responses were criticized for being poorly synthesized and less relevant, of which none were quality-assured using co-signatures. For external experts, an increase in time consumption was statistically significantly associated with a decrease in common quality score (change in score, -0.20 per hour of work; 95% CI, -0.33 to -0.06; P = 0.004), and overall impression (change in score, -0.05 per hour of work; 95% CI, -0.08 to -0.01; P = 0.005). No such associations were found for the internal experts assessment. Implications: To our knowledge, this is the first study of the association between time consumption and quality of responses to drug-related queries in DICs. The quality of responses were in general good, but time consumption and quality were only weakly associated in this setting. (C) 2016 The Authors. Published by Elsevier HS Journals, Inc.

  • 2.
    Jacobsson, F.
    et al.
    Sahlgrenska University Hospital/Östra, Göteborg, Sweden, Clinical Experimental Research Laboratory, Department of Medicine, Sahlgrenska University Hospital/Östra, 416 85 Göteborg, Sweden.
    Swahn, Eva
    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.
    Akademiska Hospital, Uppsala, Sweden.
    Dellborg, M.
    Sahlgrenska University Hospital/Östra, Göteborg, Sweden.
    Safety profile and tolerability of intravenous AR-C69931MX, a new antiplatelet drug, in unstable angina pectoris and non-Q-wave myocardial infarction2002In: Clinical Therapeutics, ISSN 0149-2918, E-ISSN 1879-114X, Vol. 24, no 5, p. 752-765Article in journal (Refereed)
    Abstract [en]

    Background: Thrombin generation and platelet aggregation in the disrupted atherosclerotic plaque are the major reasons for thrombus formation associated with acute coronary events. AR-C69931MX is a new agent that inhibits adenosine diphosphate-induced platelet aggregation by antagonism of the P2T purinoceptor. Objective: This study assessed the safety profile, tolerability, and plasma concentrations at steady state of intravenous AR-C69931MX in patients with unstable angina pectoris or non-Q-wave myocardial infarction (MI). Methods: This was a Phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients with unstable angina or non-Q-wave MI were randomized to a 72-hour infusion of AR-C69931MX or placebo as adjunctive therapy to aspirin and low-molecular-weight heparin. Other treatment was at the discretion of the local investigator. Outcomes were assessed at 30 days. Results: Ninety-four patients were randomized and 91 received treatment (45 AR-C69931MX, 46 placebo). Plasma concentrations of AR-C69931MX were within the expected range, there were no signs of accumulation, and interindividual variability in clearance was low. Four patients receiving AR-C69931MX discontinued treatment due to minor bleeding events, and 5 patients receiving placebo discontinued treatment due to other adverse events or deterioration in their condition. No serious bleeding events were seen during treatment. The incidence of =1 episode of minor bleeding was slightly higher in patients receiving AR-C69931MX compared with those receiving placebo (38% vs 26%, respectively). The drug was well tolerated hemodynamically, and there were no significant changes in other laboratory values between groups. Conclusions: As adjunctive therapy to aspirin and low-molecular-weight heparin in patients with unstable angina or non-Q-wave MI, intravenous AR-C69931MX was well tolerated, with no difference in the incidence of serious adverse events compared with placebo.

  • 3. Lindgren, Peter
    et al.
    Stenestrand, Ulf
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Cardiology. Östergötlands Läns Landsting, Heart Centre, Department of Cardiology.
    Malmberg, Klas
    Jönsson, Bengt
    The long-term cost-effectiveness of clopidogrel plus aspirin in patients undergoing percutaneous coronary intervention in Sweden2005In: Clinical Therapeutics, ISSN 0149-2918, E-ISSN 1879-114X, Vol. 27, no 1, p. 100-110Article in journal (Refereed)
    Abstract [en]

    Background: The Percutaneous CoronaryIntervention-Clopidogrel in Unstable Angina to Prevent Recurrent Events (PCI-CURE) study, which examined the effect of adding clopidogrel to aspirin versus aspirin alone in patients with unstable coronary artery disease (CAD) undergoing PCI, found a relative risk reduction in cardiovascular deaths and myocardial infarction among those treated with clopidogrel. In addition, a within-trial cost-effectiveness analysis showed favorable costs per event avoided. However, to estimate the long-term effects, a modeling approach is necessary. Objectives: The purpose of this study was to estimatethe long-term cost-effectiveness of treating patients undergoing PCI with clopidogrel plus aspirin in Sweden. Methods: A Markov model was developed. Transitionprobabilities were estimated based on a register of patients treated in the coronary care units at 74 (out of 78) hospitals throughout Sweden. Patients were assumed to be treated for 1 year with an effect based on data from the PCI-CURE study. Costs were collected from published sources and recalculated to year-2004 euros (1.00 = US $1.24). Life-years gained were used as the measure of effectiveness. The perspective was that of the Swedish society, with a separate analysis using a health care cost perspective. Results: After inclusion and exclusion criteria were applied, 3474 patients were included in the model analysis. The model predicted a net gain in survival of 0.04 year per patient when adding clopidogrel. This yielded a net increase of 449 if only direct costs were included, with indirect costs, the net increase was 332. The resulting cost-effectiveness ratios were €10,993 and 8127 per life-year gained. Conclusions: The predicted cost-effectiveness ratios were well below the threshold values generally considered cost-effective. Adding clopidogrel to aspirin appeared to be cost-effective in this model analysis of patients with unstable CAD undergoing PCI in Sweden. Copyright © 2005 Excerpta Medica, Inc.

  • 4.
    Olsson, Anders
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Internal Medicine. Östergötlands Läns Landsting, MKC - Medicin och kirurgicentrum, EMK-endokrin.
    Eriksson, M
    Johnson, O
    Kjellström, T
    Lanke, J
    Lytken Larsen, M
    Pedersen, T
    Tikkanen, MJ
    Wiklund, O
    A 52-week, multicenter, randomized, parallel-group, double-blind, double-dummy study to assess the efficacy of atorvastatin and simvastatin in reaching low-density lipoprotein cholesterol and triglyceride targets: The Treat-to-Target (3T) Study2003In: Clinical Therapeutics, ISSN 0149-2918, E-ISSN 1879-114X, Vol. 25, no 1, p. 119-138Article in journal (Refereed)
    Abstract [en]

    Background: Guidelines for the prevention of coronary heart disease call for low-density lipoprotein cholesterol (LDL-C) reduction as the primary target of treatment and reduction of triglycerides (TG) as an additional target. Objective: The purpose of this study was to investigate the ability of atorvastatin and simvastatin to reduce LDL-C and TG concentrations and to meet 3 target lipid levels: LDL-C =2.6 mmol/L, TG =1.5 mmol/L, and both LDL-C =2.6 mmol/L and TG =1.5 mmol/L. Methods: The Treat-to-Target (3T) Study was a 52-week, multicenter, randomized, parallel-group study. Using the double-blind, double-dummy technique, adult patients aged 35 to 75 years with cardiovascular disease and dyslipidemia, defined as LDL-C concentration =4.0 mmol/L (=155 mg/dL), were randomized in a 1:1 ratio to receive once-daily oral treatment with 20 mg atorvastatin or 20 mg simvastatin. Fasting (12-hour) blood samples for the estimation of lipid levels and clinical laboratory values were collected after 4, 8, 12, 26, and 52 weeks. The dose was doubled after 12 weeks if the target National Cholesterol Education Program level of LDL-C (=2.6 mmol/L [100 mg/dL]) was not reached at 8 weeks. Results: The intent-to-treat analysis included 552 patients (418 men, 134 women) randomized to receive atorvastatin and 535 (404 men, 131 women) randomized to receive simvastatin. The number of patients enrolled in the study allowed the evaluation of the drugs' effects on YG. Patient demographic characteristics were similar for the 2 treatment groups, and there were no differences in baseline lipid values. Compared with simvastatin, atorvastatin produced significantly greater reductions in LDL-C (8 weeks: -46% vs -40%, P < 0.001, 52 weeks: -49% vs -44%, P < 0.001) and in YG (8 weeks: -23% vs -14%, P < 0.001, 52 weeks: -24% vs -16%, P < 0.001). Compared with simvastatin-treated patients, a significantly greater number of atorvastatin-treated patients reached the LDL-C target after 8 weeks (45% vs 24%, P < 0.001). Fewer atorvastatin patients needed to have their dose doubled, nevertheless more atorvastatin patients reached the LDL-C target after 52 weeks (61% vs 41%, P < 0.001). Both statins were well tolerated. Muscular symptoms occurred in 12 patients (2.2%) in the atorvastatin group and in 13 patients (2.4%) in the simvastatin group. Conclusions: Atorvastatin 20 or 40 mg/d for up to 1 year of treatment was significantly more effective than simvastatin 20 or 40 mg/d m reducing LDL-C and YG levels and at achieving recommended lipid targets in this selected patient population with cardiovascular disease and dyslipidemia. Both statins were well tolerated.

  • 5.
    Olsson, Anders G.
    Linköping University, Department of Medicine and Health Sciences, Internal Medicine . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Medicine, Department of Endocrinology and Gastroenterology UHL.
    Expanding options with a wider range of rosuvastatin doses2006In: Clinical Therapeutics, ISSN 0149-2918, E-ISSN 1879-114X, Vol. 28, no 11, p. 1747-1763Article in journal (Refereed)
    Abstract [en]

    Background: The dose range for rosuvastatin in Europe has recently been expanded to 5 to 40 mg and is now in line with the dose range currently available in the United States. Objective: The goal of this article was to review the efficacy and safety data available for the rosuvastatin 5-mg dose and discuss these data in the context of the full 5- to 40-mg dose range. Methods: Articles referring to clinical efficacy or safety data for the 5-mg dose of rosuvastatin were identified and reviewed after a search of the MEDLINE database (2000-August 2006, English language only) using the search term rosuvastatin. Proceedings from major cardiology congresses (2000-2006) were also searched for additional information. Results: Rosuvastatin 5 mg is significantly (P < 0.001) more effective at reducing low-density lipoprotein cholesterol (LDL-C) and total cholesterol (42% and 30%) levels compared with atorvastatin 10 mg (36% and 27%), simvastatin 20 mg (36% and 25%), and pravastatin 20 mg (27% and 19%). Rosuvastatin 5 mg allows significantly more patients to reach their LDL-C goals as recommended by the 2003 European guidelines and the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) (49%-52% and 67%-71%) than atorvastatin 10 mg (36%, P < 0.001, 53%, P < 0.01), simvastatin 20 mg (37%, P < 0.001, 64%, P < 0.05), and pravastatin 20 mg (12%, P < 0.001, 49%, P < 0.001). Rosuvastatin is well tolerated across the 5- to 40-mg dose range, with a type and incidence of adverse events similar to the other commonly available, but less effective, statins. The introduction of a 5-mg dose offers greater flexibility to prescribing physicians in that it provides an additional dosing option for those patients who are at a lower cardiovascular risk or who have an increased potential for developing myopathy with statin therapy. Conclusions: Rosuvastatin 5 mg is well tolerated and has beneficial effects across the atherogenic lipid profile by reducing LDL-C and total cholesterol, raising high-density lipoprotein cholesterol, and helping a greater proportion of patients reach their LDL-C goals. © 2006 Excerpta Medica, Inc.

  • 6.
    Olsson, Anders
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Internal Medicine. Östergötlands Läns Landsting, MKC-2, GE: endomed.
    Pauciullo, P
    Soska, V
    Luley, C
    Pieters, RE
    Broda, G
    Palacios, B
    Comparison of the efficacy and tolerability of fluvastatin extended-release and immediate-release formulations in the treatment of primary hypercholesterolemia: A randomized trial2001In: Clinical Therapeutics, ISSN 0149-2918, E-ISSN 1879-114X, Vol. 23, no 1, p. 45-61Article in journal (Refereed)
    Abstract [en]

    Background: A new extended-release (ER) formulation of fluvastatin 80 mg has been developed for once-daily treatment of primary hypercholesterolemia. Objective: The purpose of this study was to compare the lipid-lowering efficacy and tolerability of fluvastatin ER (80 mg once daily) versus fluvastatin immediate-release (IR) (40 mg once or twice daily). Methods: Following a 4-week placebo/dietary run-in period, patients with primary hypercholesterolemia type IIa or IIb (low-density lipoprotein cholesterol [LDL-C] =160 mg/dL and triglycerides [TG] =400 mg/dL) were randomized (2:1:1) to receive fluvastatin ER 80 mg once daily at bedtime (QPM), fluvastatin IR 40 mg QPM, or fluvastatin IR 40 mg BID for 24 weeks. Patients who had homozygous familial hypercholesterolemia, type I, III, IV, V, or secondary hyperlipoproteinemia, diabetes, or evidence of liver or renal impairment were excluded. At weeks 0, 2, 4, 8, 12, 16, 20, and 24 of the active-treatment period, levels of LDL-C, high-density lipoprotein cholesterol (HDL-C), TG, and total cholesterol (TC) were measured. Results: Of the 1183 patients enrolled, 695 were randomly assigned to treatment, 346 to fluvastatin ER 80 mg QPM, 174 to fluvastatin IR 40 mg QPM, and 175 to fluvastatin IR 40 mg BID. Patients were well matched between groups, with a mean age of-56 years and body mass index of 27 kg/m2, 56.0% of patients (389/695) were female and 97.7% (679/695) were white. Fluvastatin ER 80 mg QPM lowered LDL-C levels significantly more than did fluvastatin IR 40 mg QPM (33.7% vs 24.4%, P < 0.001) and as effectively as fluvastatin IR 40 mg BID (33.9%). More than half of the patients administered fluvastatin ER 80 mg QPM and IR 40 mg BID achieved reductions in LDL-C levels of =35%, more than half of those administered fluvastatin IR 40 mg QPM experienced reductions in LDL-C levels of =25%. The mean reductions in LDL:HDL ratio, TC, and apolipoprotein B levels in the fluvastatin ER 80 mg QPM group were significantly greater than the reductions in the IR 40 mg QPM group (P < 0.001). In patients with mixed dyslipidemia, fluvastatin ER 80 mg reduced triglycerides by 21.8% (median 28%) and increased HDL-C by 14.5%. Fluvastatin ER 80 mg QPM was well tolerated, with incidences of clinically notable elevations in alanine aminotransferase, aspartate aminotransferase, and creatine kinase levels and musculoskeletal adverse events comparable to those in the IR 40 mg QPM group. Conclusion: The ER 80-mg formulation of fluvastatin is effective and well tolerated as a once-daily starting and maintenance treatment for primary hypercholesterolemia.

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