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SYSTEMATIC REVIEW article

Front. Endocrinol.

Sec. Clinical Diabetes

This article is part of the Research TopicExploring Combination Therapies for Effective Obesity and Metabolic Syndrome ManagementView all 6 articles

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

Provisionally accepted
Jiayan  HuangJiayan Huang1Kaishun  MengKaishun Meng2Huawei  QiuHuawei Qiu1*
  • 1Hainan Provincial Hospital of Traditional Chinese Medicine, Haikou, China
  • 2Sanya People's Hospital│West China (Sanya) Hospital, Sichuan University, Sanya, China

The final, formatted version of the article will be published soon.

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.

Keywords: Diabetes Mellitus, Fenofibrate, Hyperlipidemia, Meta-analysis, statin

Received: 29 Aug 2025; Accepted: 02 Feb 2026.

Copyright: © 2026 Huang, Meng and Qiu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Huawei Qiu

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