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Type: Journal article
Title: Effects of dalcetrapib in patients with a recent acute coronary syndrome
Author: Schwartz, G.
Olsson, A.
Ballantyne, C.
Abt, M.
Barter, P.
Brumm, J.
Chaitman, B.
Holme, I.
Kallend, D.
Leiter, L.
Leitersdorf, E.
McMurray, J.
Mundl, H.
Nicholls, S.
Shah, P.
Tardif, J.
Wright, R.
Citation: New England Journal of Medicine, 2012; 367(22):2089-2099
Publisher: Massachusetts Medical Soc
Issue Date: 2012
ISSN: 0028-4793
Statement of
Gregory G. Schwartz, Anders G. Olsson, Markus Abt, Christie M. Ballantyne, Philip J. Barter, Jochen Brumm, Bernard R. Chaitman, Ingar M. Holme, David Kallend, Lawrence A. Leiter, Eran Leitersdorf, John J.V. McMurray, Hardi Mundl, Stephen J. Nicholls, Prediman K. Shah, Jean-Claude Tardif and R. Scott Wright for the dal-OUTCOMES Investigators
Abstract: BACKGROUND: In 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. METHODS: We 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. RESULTS: At 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 (P<0.001 for both comparisons). CONCLUSIONS: In 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.).
Keywords: dal-OUTCOMES Investigators; Humans; Cardiovascular Diseases; Recurrence; Sulfhydryl Compounds; Triglycerides; C-Reactive Protein; Apolipoproteins; Biological Markers; Anticholesteremic Agents; Risk; Blood Pressure; Aged; Middle Aged; Female; Male; Cholesterol, LDL; Cholesterol, HDL; Cholesterol Ester Transfer Proteins; Acute Coronary Syndrome
Rights: Copyright © 2012 Massachusetts Medical Society.
RMID: 0020123156
DOI: 10.1056/NEJMoa1206797
Appears in Collections:Medicine publications

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