BACKGROUND: In patients with primary hypercholesterolemia or mixed dyslipidemia, extended-releaseniacin/laropiprant (ERN/LRPT) improves key lipid parameters associated with increased atherosclerotic coronary heart disease (CHD) risk. AIM: This 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. METHODS: Data 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. CONCLUSION: Extended-release niacin/laropiprant represents an effective therapeutic option for the treatment of dyslipidemia across a range of patient types.
RCT Entities:
BACKGROUND: In 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. AIM: This 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. METHODS: Data 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. CONCLUSION: Extended-release niacin/laropiprant represents an effective therapeutic option for the treatment of dyslipidemia across a range of patient types.