Lipid-altering efficacy of ezetimibe plus statin and statin monotherapy and identification of factors associated with treatment response: A pooled analysis of over 21,000 subjects from 27 clinical trials
Morrone D et al. – The results suggest that patient characteristics have a limited influence on response to lipid–lowering therapy and demonstrate the consistent treatment effect of ezetimibe combined with statin and statin monotherapy across a diverse patient population.Methods
- Patient–level data were combined from double–blind, placebo–controlled or active comparator studies randomizing adult subjects to ezetimibe 10mg plus statin (n=11,714) versus statin alone (n=10,517) for 6–24 weeks (mean=9 weeks).
- Association of factors with treatment response, percent change from baseline LDL–C and other lipids, and attainment of guideline–recommended lipid and lipoprotein targets were evaluated.
- Higher baseline LDL–C, diabetes mellitus, Black race, greater age, and male gender were associated with small but significantly greater percent reductions in LDL–C regardless of treatment.
- Treatment influenced efficacy, with ezetimibe plus statin producing significantly greater reductions in LDL–C, total–cholesterol, non–HDL–C, ApoB, triglycerides, lipid ratios, hs–CRP; significantly larger increases in HDL–C and ApoA1; and significantly higher achievement of LDL–C (<70mg/dl, <100mg/dl), non–HDL–C (<100mg/dl, <130mg/dl), and ApoB (<80mg/dl, <90mg/dl) targets than statin monotherapy at statin potencies compared (p<0.0001 for all).
- Differential treatment effects were seen with first–/second–line therapy and statin potency.