Abstract | BACKGROUND: METHODS: Determining the EFficacy and Tolerability of CETP INhibition with AnacEtrapib (DEFINE) is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety profile of anacetrapib in patients with coronary heart disease (CHD) or CHD risk equivalents (clinical trials.gov NCT00685776). Eligible patients at National Cholesterol Education Program-Adult Treatment Panel III LDL-C treatment goal on a statin, with or without other lipid-modifying medications, are treated with anacetrapib, 100 mg, or placebo for 18 months, followed by a 3-month, poststudy follow-up. The primary end points are percent change from baseline in LDL-C and the safety and tolerability of anacetrapib. Comprehensive preplanned interim safety analyses will be performed at the 6- and 12-month time points to examine treatment effects on key safety end points, including blood pressure and electrolytes. A preplanned Bayesian analysis will be performed to interpret the CV event distribution, given the limited number of events expected in this study. RESULTS: A total of 2,757 patients were screened at 153 centers in 20 countries, and 1,623 patients were randomized into the trial. Lipid results, clinical CV events, and safety outcomes from this trial are anticipated in 2010.
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Authors | Christopher P Cannon, Hayes M Dansky, Michael Davidson, Antonio M Gotto Jr, Eliot A Brinton, A Lawrence Gould, Michael Stepanavage, Sherry Xueyu Liu, Sukrut Shah, Joseph Rubino, Patrice Gibbons, Anne Hermanowski-Vosatka, Bruce Binkowitz, Yale Mitchel, Philip Barter, DEFINE investigators |
Journal | American heart journal
(Am Heart J)
Vol. 158
Issue 4
Pg. 513-519.e3
(Oct 2009)
ISSN: 1097-6744 [Electronic] United States |
PMID | 19781408
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Cholesterol Ester Transfer Proteins
- Cholesterol, LDL
- Oxazolidinones
- anacetrapib
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Cholesterol Ester Transfer Proteins
(antagonists & inhibitors, blood)
- Cholesterol, LDL
(blood, drug effects)
- Coronary Disease
(blood, drug therapy, physiopathology)
- Double-Blind Method
- Electrocardiography
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Oxazolidinones
(administration & dosage)
- Treatment Outcome
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