LDL-C-lowering efficacy of the ezetimibe/simvastatin single tablet compared with atorvastatin or roslivastatin in elderly patients with hype rcholesterolemia

Background: Cardiovascular disease occurs with increasing frequency with advancing age. However, despite increasing risk, the likelihood of statin use decreases with age. Co-administration of statin therapy with the cholesterol absorption inhibitor ezetimibe has been shown to increase LDL-C-lowering efficacy without requiring titration to a higher statin dose.We evaluated the LDL-C-lowering efficacy of the ezetimibe/simvastatin (E/S) single tablet vs 2 high efficacy monotherapies, atorvastatin (A) or rosuvastatin (R), in patients (pts) <65 and ≥65 yrs with hypercholesterolemia using the results from 2 clinical trials. Methods: This was a side-by-side comparison of 2 similarly-designed, randomized, double-blind, 6-week, comparator studies: E/S vs A, and E/S vs R. In E/S vs A, pts (N=1321 <65 yrs, N=581 ≥65 yrs) were randomized equally to: E/S (10/10, 10/20, 10/40, 10/80 mg) or A (10, 20, 40, 80 mg). In E/S vs R, pts (N=2369 <65 yrs, N=590 ≥65 yrs) were randomized equally to: E/S (10/20, 10/40, 10/80 mg) or R (10, 20, 40 mg).The primary endpoint in each study was % change from baseline in LDL-C for E/S vs A or E/S vs R, pooled across all doses. Safety monitoring was also conducted. Results: In both the E/S vs A and the E/S vs R comparisons, E/S produced significantly greater reduction in LDL-C in both age groups, pooled across all doses (see Table). In both studies, E/S, A, and R were well tolerated by pts in both age groups. Conclusion: E/S, through inhibition of two sources of cholesterol, offers a highly efficacious option as LDL-C-lowering therapy for the treatment of hypercholesterolemia in elderly pts.