Effects of dalcetrapib in patients with a recent acute coronary syndrome

Schwartz, Gregory G., Olsson, Anders G., Abt, Markus, Ballantyne, Christie M., Barter, Philip J., Brumm, Jochen, Chaitman, Bernard R., Holme, Ingar M., Kallend, David, Leiter, Lawrence A., Leitersdorf, Eran, McMurray, John J. V., Mundl, Hardi, Nicholls, Stephen J., Shah, Prediman K., Tardif, Jean-Claude, Wright, R. Scott, The dal-OUTCOMES Investigators and Colquhoun, David (2012) Effects of dalcetrapib in patients with a recent acute coronary syndrome. New England Journal of Medicine, 367 22: 2089-2099. doi:10.1056/NEJMoa1206797

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Author Schwartz, Gregory G.
Olsson, Anders G.
Abt, Markus
Ballantyne, Christie M.
Barter, Philip J.
Brumm, Jochen
Chaitman, Bernard R.
Holme, Ingar M.
Kallend, David
Leiter, Lawrence A.
Leitersdorf, Eran
McMurray, John J. V.
Mundl, Hardi
Nicholls, Stephen J.
Shah, Prediman K.
Tardif, Jean-Claude
Wright, R. Scott
The dal-OUTCOMES Investigators
Colquhoun, David
Title Effects of dalcetrapib in patients with a recent acute coronary syndrome
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2012-11-29
Sub-type Article (original research)
DOI 10.1056/NEJMoa1206797
Open Access Status File (Publisher version)
Volume 367
Issue 22
Start page 2089
End page 2099
Total pages 11
Place of publication Waltham, MA, United States
Publisher Massachusetts Medical Society
Language eng
Formatted abstract

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.


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.


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).


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 ClinicalTrials.gov number, NCT00658515.)
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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