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Int. J. Clin. Pract. · Apr 2011
Randomized Controlled TrialExtended-release niacin/laropiprant lipid-altering consistency across patient subgroups.
- H Bays, A Shah, Q Dong, C McCrary Sisk, and D Maccubbin.
- L-MARC Research Center, Louisville, KY 40213, USA. hbaysmd@aol.com
- Int. J. Clin. Pract. 2011 Apr 1;65(4):436-45.
BackgroundIn patients with primary hypercholesterolemia or mixed dyslipidemia, extended-release niacin/laropiprant (ERN/LRPT) improves key lipid parameters associated with increased atherosclerotic coronary heart disease (CHD) risk.AimThis analysis examined data from four Phase III, randomised, double-blind trials to determine the consistency of ERN/LRPT's lipid-altering efficacy among subgroups of patients.MethodsData from four Phase III, randomised, double-blind trials of ERN/LRPT were analysed to determine the consistency of ERN/LRPT's lipid-altering efficacy among subgroups of gender, race (white, non-white), region (US, ex-US), baseline age (<65, ≥65 years), use of statin therapy, CHD risk status (low, multiple, high) and type of hyperlipidemia (primary hypercholesterolemia, mixed dyslipidemia), as well as across baseline low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels. End-points included the per cent change from baseline in LDL-C, HDL-C and TG levels. Consistency of the treatment effects on LDL-C, HDL-C and TG across subgroups was evaluated by examining treatment difference estimates with 95% confidence intervals.Results Treatment with ERN/LRPT significantly improved LDL-C, HDL-C and TG levels compared with placebo/active comparator in each study cohort. These effects were generally consistent across all examined subgroups.ConclusionExtended-release niacin/laropiprant represents an effective therapeutic option for the treatment of dyslipidemia across a range of patient types.© 2011 Blackwell Publishing Ltd.
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