SYSTEMATIC REVIEW OF THE EFFICACY/EFFECTIVENESS AND SAFETY OF FENOFIBRATE–STATIN COMBINATION THERAPY IN THE TREATMENT OF DYSLIPIDEMIA

Phạm Ngọc Viễn Linh 1 , Lê Thị Mai Sương 1 , Nguyễn Mỹ Anh Thư 2 , Lê Trần Việt An 2 , Trần Ngọc Thiên Phú 2 , Đặng Thị Kiều Nga 2 , Phạm Đình Luyến 2 ,
1 TV Pharmaceutical Trade Promotion and Investment Co., Ltd., Vietnam
2 University of Medicine and Pharmacy at Ho Chi Minh City image/svg+xml
* Corresponding author:

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DOI
10.63947/bvtn.v2i9.4
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Published
2026-10-01
Issue Vol. 2 No. 9 (2026): A Major Step Forward in Specialized Care: A Milestone Marked by the First Liver Transplant at Thong Nhat Hospital
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Review Article

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Phạm NVL, Lê TMS, Nguyễn MAT, Lê TVA, Trần NTP, Đặng TKN, Phạm ĐL. SYSTEMATIC REVIEW OF THE EFFICACY/EFFECTIVENESS AND SAFETY OF FENOFIBRATE–STATIN COMBINATION THERAPY IN THE TREATMENT OF DYSLIPIDEMIA. JHA [Internet]. Vietnam; 2026 Oct. 1 [cited 2026 Oct. 16];2(9):33–41. https://tcsuckhoelaohoa.vn/bvtn/article/view/235 doi: 10.63947/bvtn.v2i9.4
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Abstract

Dyslipidemia is a major risk factor for atherosclerotic cardiovascular disease. In patients with persistent hypertriglyceridemia or mixed dyslipidemia despite statin therapy, fenofibrate–statin combination therapy, including the fixed-dose combination (FDC) of fenofibrate/pravastatin 160/40 mg, may be considered to further improve control of non-LDL-C lipid parameters. This systematic review was conducted according to Cochrane guidance and the PRISMA 2020 checklist to evaluate the efficacy/effectiveness and safety of fenofibrate–statin combination therapy in dyslipidemia treatment. Literature was searched in PubMed and Ovid EMBASE up to July 2026; risk of bias was assessed using RoB 2 for randomized controlled trials and ROBINS-I for non-randomized studies. From 3,660 screened records and 203 full-text assessments, 10 studies (3 RCTs and 7 non-randomized studies) were included. FDC fenofibrate/pravastatin further reduced non-HDL-C by 12.9–16.3% and triglycerides by 22.6–31.6%, and increased dual lipid target attainment versus statin monotherapy, with effects sustained over 3 years in the POSE study. Large cohort studies reported that fenofibrate–statin combinations were associated with a 9.9–20.0% reduction in selected cardiovascular events and a 27.0–28.4% reduction in all-cause mortality among patients with type 2 diabetes. The combination was generally well tolerated, with no myopathy or rhabdomyolysis reported in RCTs, although some observational studies signaled increased risks of acute kidney injury, myositis, or liver injury requiring monitoring during treatment.

Keywords

fenofibrate pravastatin fixed-dose combination systematic review dyslipidemia

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