Adverse events of statin-fenofibric acid versus statin monotherapy: a meta-analysis of randomized controlled trials

Background: Patients with mixed dyslipidemia can benefit from the combination of fenofibric acid (FA) with statins, but concerns about adverse events make physicians reluctant to prescribe the combination therapy. Objective: In the present study, we performed a meta-analysis of randomized controlled trials (RCTs) to assess the efficacy and adverse events in patients taking statins and FA. Methods: Medline, Embase and the Cochrane Library were searched to identify studies that reported adverse events. Finally, five trials covering 2704 patients were selected in this study. Results: There were significant decreases in TG and increases in HDL-C in patients receiving combination therapy compared with statin monotherapy. The incidence of hepatic toxicity (OR, 3.57; 95% CI, 1.17-10.83; P<0.05) and increased creatinine (OR, 3.22; 95% CI, 1.28-8.11; P<0.05) was significantly higher in the FA+low-dose statin group than in the corresponding statin monotherapy. The incidence of CK elevations and muscle-associated AEs was not statistically different between the two groups. The adverse events in the FA+moderate-dose statin group were almost identical to those in the FA+low-dose statin group. Conclusions: In conclusion, combination therapy could improve the blood lipid profile. Addition of FA to statins therapy is more frequently associated with hepatic and renal toxicity than muscle-associated AEs. Therefore patients taking the combination of FA with statins should have liver enzyme and renal function monitored. However, we still need large-scale and long follow-up period RCTs to definitively confirm the adverse events of FA-statin therapy.