Adverse events following statin-fenofibrate therapy versus statin alone: a meta-analysis of randomized controlled trials.

The combination of fenofibrate with statins is a beneficial therapeutic option for patients with mixed dyslipidaemia, but concerns about adverse events (AEs) make physicians reluctant to use this combination therapy. Medline, Embase and the Cochrane Library were searched to identify 13 randomized controlled trials, involving 7712 patients, of statin-fenofibrate therapy versus statin alone for review. There were significant decreases in low-density lipoprotein-cholesterol, triglycerides and total cholesterol and increases in high-density lipoprotein-cholesterol in patients receiving combination therapy compared with statin therapy alone. The incidence of aminotransferase elevations in the fenofibrate-statin therapy group was significantly higher than in the statin monotherapy group (odds ratio (OR), 1.66; 95% confidence interval (CI) 1.17-2.37; P < 0.05). The incidence of elevated creatine kinase levels (OR 0.88; 95% CI 0.63-1.23; P > 0.05), muscle-associated AEs (OR 0.98; 95% CI 0.88-1.09; P > 0.05) and withdrawals attributed to liver and muscle dysfunction did not differ significantly between the two groups. The efficacy of fenofibrate + standard-dose statin and incidence of AEs in the fenofibrate + standard-dose statin group were almost identical to those in the fenofibrate-statin group. In conclusion, combination therapy improves the blood lipid profile of patients. Fenofibrate-statin combination therapy appears to be as well tolerated as statin monotherapy. Physicians should consider fenofibrate-statin combination therapy in patients but monitor aminotransferase levels to avoid hepatic complications.