HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Design of the DEFINE trial: determining the EFficacy and tolerability of CETP INhibition with AnacEtrapib.

AbstractBACKGROUND:
Residual cardiovascular (CV) risk often remains high despite statin therapy to lower low-density lipoprotein cholesterol (LDL-C). New therapies to raise high-density lipoprotein cholesterol (HDL-C) are currently being investigated. Anacetrapib is a cholesteryl ester transfer protein (CETP) inhibitor that raises HDL-C and reduces LDL-C when administered alone or with a statin. Adverse effects on blood pressure, electrolytes, and aldosterone levels, seen with another drug in this class, have not been noted in studies of anacetrapib to date.
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.
AuthorsChristopher 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
JournalAmerican heart journal (Am Heart J) Vol. 158 Issue 4 Pg. 513-519.e3 (Oct 2009) ISSN: 1097-6744 [Electronic] United States
PMID19781408 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Cholesterol Ester Transfer Proteins
  • Cholesterol, LDL
  • Oxazolidinones
  • anacetrapib
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

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: