Objectives Although fenofibrate-statin combination therapy could improve the lipid parameters in patients with mixed dyslipidemia, the coadministration is still underutilised because of safety of the combination therapy.
Methods Randomised, controlled trials were searched from 1976 to 2012 in MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. The following terms were used: atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin, statins, hydroxymethylglutaryl-CoA reductase inhibitors and fenofibrate. Finally, 13 studies were selected in the analysis.
Results The risk of aminotransferase elevation in the combination therapy was significantly higher than in the statin monotherapy group [odds ratio (OR), 1.69; 95% confidence interval (CI), 1.19-2.40; P < 0.05]. As compared with the statin monotherapy, the combination of fenofibrate with statins could not increase the risk of creatine kinase (CK) elevations (OR, 0.88; 95% CI, 0.88-1.23; P > 0.05) and muscle-associated adverse events (OR, 0.98; 95% CI, 0.88-1.09; P > 0.05). There was no liver failure and rhabdomyolysis.
Conclusions In summary, the combination therapy was generally well tolerated. For patients with mixed dyslipidemia, addition of fenofibrate to statins may be of benefit, as long as aminotransferase levels are monitored.