Comparison of the efficacy of administering a combination of ezetimibe plus fenofibrate versus atorvastatin monotherapy in the treatment of dyslipidemia.

Background: This trial compares the efficacy of administering a combination of ezetimibe plus fenofibrate as an alternative to statin monotherapy for the treatment of dyslipidemia. In this randomized, unblinded crossover study, 43 patients with documented hypercholesterolemia requiring pharmacotherapy were randomized to receive six weeks of either a combination of 10 mg of ezetimibe plus 160 mg of fenofibrate (combination) or 10 mg of atorvastatin monotherapy (atorvastatin). The primary endpoint was the percentage reduction of low-density lipoprotein cholesterol (LDL-C).

Results: LDL-C decreased by 34.6% with the combination therapy versus 36.7% with atorvastatin monotherapy. The difference between the two groups was not statistically significant (p = 0.46). Both study interventions provided similar improvements in total cholesterol (-25.1% with combination versus -24.6% with atorvastatin, p = 0.806) and high-density lipoproteins (+10.0% with combination versus +8.9% with atorvastatin, p = 0.778). Combination therapy showed a trend towards a greater reduction in triglycerides (-25.4% with combination versus -14.5% with atorvastatin, p = 0.079), although there was no significant difference between the two study interventions in terms of the improvement in the TC:HDL ratio (-29.0% with combination versus -28.7% with atorvastatin, p = 0.904).

Conclusions: The combination of ezetimibe plus fenofibrate appeared to produce nearly identical alterations in serum lipoprotein levels when compared to monotherapy with 10 mg of atorvastatin. Daily treatment with the combination of ezetimibe plus fenofibrate is an acceptable alternative to atorvastatin for the treatment of dyslipidemia in patients who are intolerant of statins.