Adverse events of statin-fenofibric acid versus statin monotherapy: a meta-analysis of randomized controlled trials
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 2,704 participants or records.
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