Key result
Torcetrapib added to atorvastatin boosts HDL-C up to ~40% and lowers LDL-C vs. placebo.
Why the study?
Elevating HDL-C levels may reduce the residual cardiovascular risk seen in statin-treated patients, prompting evaluation of the efficacy and safety of the cholesteryl ester transfer protein inhibitor torcetrapib in patients with low HDL-C receiving background atorvastatin.
Does torcetrapib added to background atorvastatin improve HDL-C and LDL-C levels in statin-eligible patients with below-average HDL-C?
RCT (n=174)
Double-blind
Randomized
Yes
Does torcetrapib added to background atorvastatin improve HDL-C and LDL-C levels in statin-eligible patients with below-average HDL-C?
Adding the CETP inhibitor torcetrapib to background atorvastatin produced substantial dose-dependent increases in HDL-C and additional reductions in LDL-C over 8 weeks, though small blood pressure increases were observed in some groups.
Answers are grounded in this paper and cite their sources.
Torcetrapib augments HDL-C and LDL-C effects on atorvastatin; extends CETP inhibition data for outcomes trials.
OBJECTIVES: This study sought to evaluate the efficacy and safety of torcetrapib in patients with low high-density lipoprotein cholesterol (HDL-C) levels receiving background atorvastatin. BACKGROUND: Elevating HDL-C levels may reduce the residual cardiovascular risk that is observed in patients treated with statin therapy. Torcetrapib (a cholesteryl ester transfer protein inhibitor) increases HDL-C and decreases low-density lipoprotein cholesterol (LDL-C). METHODS: This was a multicenter, double-blind, randomized trial. Patients with below-average HDL-C (men <44 mg/dl; women <54 mg/dl) who were eligible for statin therapy according to National Cholesterol Education Program Adult Treatment Panel III guidelines or who had LDL-C >130 mg/dl at screening entered an 8-week run-in period with atorvastatin 20 mg/day before randomization (n = 174) to torcetrapib 10, 30, 60, or 90 mg/day or placebo for 8 weeks. Atorvastatin was continued during treatment with torcetrapib. RESULTS: After 8 weeks, the percent change from baseline with torcetrapib (least-squares mean difference from placebo) ranged from 8.3% to 40.2% for HDL-C (p < or = 0.0001 for 30-mg and higher doses) and from 0.6% to -18.9% for LDL-C (p < 0.01 for 60-mg and 90-mg doses). Particle size for both HDL and LDL increased with torcetrapib. The incidence of all-causality and treatment-related adverse events was similar across placebo and torcetrapib treatment groups with no evidence of a dose-related response. In some treatment groups, small increases in systolic and diastolic blood pressures were noted. CONCLUSIONS: In statin-eligible patients, torcetrapib plus background atorvastatin resulted in substantial, dose-dependent increases in HDL-C, accompanied by additional decreases in LDL-C beyond those seen with atorvastatin alone. Torcetrapib plus atorvastatin was generally well tolerated.
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McKenney et al. (2006) conducted an RCT in Below-average high-density lipoprotein cholesterol (HDL-C) levels on background atorvastatin (n=174). Torcetrapib vs. Placebo (with background atorvastatin 20 mg/day in all groups) was evaluated on Percent change from baseline in HDL-C and LDL-C after 8 weeks (least-squares mean difference from placebo) (LSM difference 8.3% to 40.2% for HDL-C; 0.6% to -18.9% for LDL-C, p=<=0.0001 for 30-mg and higher doses (HDL-C); <0.01 for 60-mg and 90-mg doses (LDL-C)). Torcetrapib added to atorvastatin increased HDL-C by 8.3% to 40.2% (p<=0.0001 for >=30 mg) and changed LDL-C by 0.6% to -18.9% (p<0.01 for >=60 mg) vs placebo at 8 weeks.
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