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.