Clinical efficacy of combining fenofibrate with statins in patients with diabetes and hyperlipidemia: a meta-analysis

Objective To systematically assess the clinical effectiveness of combining fenofibrate with statins in treating patients with diabetes mellitus and hyperlipidemia. Methods Clinical randomized controlled trials assessing the efficacy of fenofibrate and statins in patients with diabetes mellitus and hyperlipidemia were identified from both Chinese and international databases. The experimental group received fenofibrate combined with statins, while the control group received either statins or fenofibrate alone, statins or fenofibrate with placebo, placebo alone, or lifestyle interventions. Results The analysis incorporated 18 randomized controlled trials with a combined participant count of 2113. The analysis showed that patients in the experimental group had a higher overall efficacy rate than those in the control group (OR = 5.42, 95% CI = 3.11 to 9.45, P < 0. 00001). Furthermore, levels of total cholesterol (SMD = -1.01, 95% CI = -1.60 to -0.41, P = 0.0009), high-density lipoprotein cholesterol (SMD = 1.31, 95% CI = 0.86 to 1.76, P < 0.00001), triglycerides (SMD = -0.94, 95% CI = -1.59 to - 0.30, P = 0. 004), low-density lipoprotein cholesterol (SMD = -2.26, 95% CI = -3.05 to -1.47, P < 0. 00001), fasting plasma glucose (SMD = -0.37, 95% CI = -0.51∼-0.23, P<0. 00001), and postchallenge plasma glucose (SMD =-0.88, 95% CI =-1.19∼-0.57, P<0. 00001) showed significant improvements compared to those in the control group. All of the above differences were statistically significant. Conclusion This meta-analysis shows that the combination of fenofibrate and statins is superior to statin monotherapy in improving lipid and glycemic profiles (surrogate markers) in patients with diabetes and hyperlipidemia. However, its long-term benefits on cardiovascular hard endpoints need further confirmation, and combination therapy may increase the risk of adverse reactions such as muscular and hepatic events. Clinical application requires balancing benefits and risks, accompanied by enhanced monitoring.