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Effects of Dalcetrapib in Patients with a Recent Acute Coronary Syndrome
University of Colorado, CO USA Vet Affairs Medical Centre, CO USA .
Linköping University, Department of Medical and Health Sciences, Internal Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Centre, Department of Endocrinology and Gastroenterology UHL.
F Hoffmann La Roche, Switzerland .
Baylor Coll Med, TX 77030 USA Methodist DeBakey Heart and Vasc Centre, TX 77030 USA .
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2012 (English)In: New England Journal of Medicine, ISSN 0028-4793, Vol. 367, no 22, 2089-2099 p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND less thanbrgreater than less thanbrgreater thanIn observational analyses, higher levels of high-density lipoprotein (HDL) cholesterol have been associated with a lower risk of coronary heart disease events. However, whether raising HDL cholesterol levels therapeutically reduces cardiovascular risk remains uncertain. Inhibition of cholesteryl ester transfer protein (CETP) raises HDL cholesterol levels and might therefore improve cardiovascular outcomes. less thanbrgreater than less thanbrgreater thanMETHODS less thanbrgreater than less thanbrgreater thanWe randomly assigned 15,871 patients who had had a recent acute coronary syndrome to receive the CETP inhibitor dalcetrapib, at a dose of 600 mg daily, or placebo, in addition to the best available evidence-based care. The primary efficacy end point was a composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, unstable angina, or cardiac arrest with resuscitation. less thanbrgreater than less thanbrgreater thanRESULTS less thanbrgreater than less thanbrgreater thanAt the time of randomization, the mean HDL cholesterol level was 42 mg per deciliter (1.1 mmol per liter), and the mean low-density lipoprotein (LDL) cholesterol level was 76 mg per deciliter (2.0 mmol per liter). Over the course of the trial, HDL cholesterol levels increased from baseline by 4 to 11% in the placebo group and by 31 to 40% in the dalcetrapib group. Dalcetrapib had a minimal effect on LDL cholesterol levels. Patients were followed for a median of 31 months. At a prespecified interim analysis that included 1135 primary end-point events (71% of the projected total number), the independent data and safety monitoring board recommended termination of the trial for futility. As compared with placebo, dalcetrapib did not alter the risk of the primary end point (cumulative event rate, 8.0% and 8.3%, respectively; hazard ratio with dalcetrapib, 1.04; 95% confidence interval, 0.93 to 1.16; P = 0.52) and did not have a significant effect on any component of the primary end point or total mortality. The median C-reactive protein level was 0.2 mg per liter higher and the mean systolic blood pressure was 0.6 mm Hg higher with dalcetrapib as compared with placebo (Pandlt;0.001 for both comparisons). less thanbrgreater than less thanbrgreater thanCONCLUSIONS less thanbrgreater than less thanbrgreater thanIn patients who had had a recent acute coronary syndrome, dalcetrapib increased HDL cholesterol levels but did not reduce the risk of recurrent cardiovascular events. (Funded by F. Hoffmann-La Roche; dal-OUTCOMES number, NCT00658515.)

Place, publisher, year, edition, pages
Massachusetts Medical Society , 2012. Vol. 367, no 22, 2089-2099 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-86373DOI: 10.1056/NEJMoa1206797ISI: 000311624400006OAI: diva2:576901

Funding Agencies|F. Hoffmann-La Roche||Anthera Pharmaceuticals||Resverlogix||Roche||Sanofi||AstraZeneca||Abbott||Adnexus||Amarin||Amylin||Bristol-Myers Squibb||Esperion Therapeutics||Genentech||GlaxoSmithKline||Idera Pharmaceuticals||Kowa Pharmaceuticals||Merck||Novartis||Omthera Pharmaceuticals||Pfizer||Takeda Pharmaceuticals||CSL Behring||Eli Lilly||Boehringer Ingelheim||Servier||Cerenis Therapeutics||

Available from: 2012-12-14 Created: 2012-12-14 Last updated: 2012-12-14

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Olsson, Anders
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Internal MedicineFaculty of Health SciencesDepartment of Endocrinology and Gastroenterology UHL
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