Efficacy of ezetimibe 2.5 mg with a novel tablet-splitting strategy

Objective: To determine the lipid-lowering effect of ezetimibe 2.5 mg delivered as a ezetimibe/simvastatin 10/80 tablet, which contains 10 mg of ezetimibe and 80 mg of simvastatin, split into 4 parts. Study Design: Prospective randomized study. Methods: Thirty-three subjects were randomized to receive either simvastatin 20 mg or an ezetimibe/simvastatin 10/80 tablet divided into 4 parts to yield an estimated daily dose of ezetimibe 2.5 mg and simvastatin 20 mg. Lipid panels were collected at baseline and after 6 weeks of therapy. Results: Twentynine subjects successfully completed the study. Low-density lipoprotein cholesterol (LDL-C) was lowered 27.1% with simvastatin 20 mg and 44.7% with one quarter tablet of ezetimibe/simvastatin, providing an additional 17.7% reduction in LDL (P=.03). The ezetimibe 2.5-mg component reduced total cholesterol, non-high- density lipoprotein cholesterol, and triglycerides by an additional 14.3%(P=.001), 16.5% (P=.02), and 11.4% (P=.18), respectively. High-density lipoprotein cholesterol decreased by 0.7% and 5.1% in the simvastatin and ezetimibe/simvastatin groups, respectively (P=.17). Conclusion: From a comparative-effectiveness perspective, ezetimibe 2.5 mg, delivered by splitting an ezetimibe/ simvastatin 10/80 tablet into 4 parts, provides the greatest value. It is comparable to full-dose ezetimibe 10 mg with respect to its ability to lower LDL-C. This novel tablet-splitting strategy may be applicable to other medications and provide signif cant additional cost reduction.