42009
document
Design of the DEFINE trial : determining the EFficacy and tolerability of CETP INhibition with AnacEtrapib . BACKGROUND 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 .
42010
Intervention_Pharmacological
AnacEtrapib
42011
Intervention_Pharmacological
Anacetrapib
42012
Intervention_Pharmacological
anacetrapib
42013
Intervention_Pharmacological
AnacEtrapib
42014
Intervention_Control
placebo-controlled
42015
Intervention_Pharmacological
anacetrapib
42016
Intervention_Pharmacological
anacetrapib
42017
Intervention_Control
placebo
42018
Intervention_Pharmacological
anacetrapib
42019
Outcome_Other
EFficacy and tolerability
42020
Outcome_Physical
low-density lipoprotein cholesterol ( LDL-C )
42021
Outcome_Physical
high-density lipoprotein cholesterol ( HDL-C )
42022
Outcome_Physical
LDL-C
42023
Outcome_Other
efficacy and safety profile
42024
Outcome_Physical
LDL-C
42025
Outcome_Physical
baseline in LDL-C
42026
Outcome_Other
safety and tolerability
42027
Outcome_Physical
blood pressure
42028
Outcome_Physical
electrolytes
42029
Outcome_Physical
Lipid results
42030
Outcome_Physical
clinical CV events
42031
Outcome_Other
safety outcomes