Gefarnate Could Help Reduce Triglycerides in Statin-Treated Adults

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Data from a randomized controlled trial suggests use of gefarnate, an anti-ulcer drug, could help improve the lipid profile in older adults using statins with residual hypertriglyceridemia.

A prospective, open-label trial of adults with coronary artery disease receiving statin therapy, results of the trial indicate use of gefarnate was associated with significant reductions in triglycerides as well as LDL-C cholesterol, with notable improvement also observed for HDL-C during the study.¹

"We performed a carefully randomized controlled study to investigate the protective lipid-lowering effects of gefarnate in [coronary artery disease[ patients on statin therapy with residual [hypertriglyceridemia] and observe its safety,” wrote investigators.¹ “Our results showed that gefarnate could effectively reduce the plasma [triglycerides] and increase the plasma HDL-C.”

For decades, statin therapy has remained a cornerstone in the management of hyperlipidemia. However, some patients with atherosclerotic cardiovascular disease risk prescribed statins still fail to achieve recommended target goals for LDL-C even and, for others, statins may not adequately address other forms of dyslipidemia contributing to cardiovascular risk, such as hypertriglyceridemia. Citing evidence purporting a potential lipid-lowering effect of gefarnate, a team of investigators led by Yue Li, MD, of Heilongjiang Academy of Medical Science, designed the current study to evaluate the effects of gefarnate treatment on the lipid profile of patients with coronary artery disease and residual hypertriglyceridemia already receiving statin therapy.^1,2

To do so, investigators designed their study as a prospective, open-label, randomized, controlled trial to be conducted among patients recruited from the First Affiliated Hospital of Harbin Medical University in China. In total, 84 patients underwent screening and 76 underwent randomization in a 1:1 ratio to either gefarnate 100 mg 3 times daily combined with statin therapy or statin therapy alone for 1 month.¹

Overall, the 76-patient cohort was 60.87% men, had a mean age of 58.23 years, and 69 patients completed the study. Inclusion criteria required patients to be 18 to 75 years of age, have stable corner artery disease and treated with an antiplatelet drug, be receiving maximally tolerated statin therapy for at least 1 month, and have a plasma triglyceride level of 1.7 mmol/L or greater.¹

The primary outcome of interest for the trial was the mean change in triglycerides after treatment. The trial also included multiple secondary outcomes of interest, such as mean change in LDL-C, HDL-C and TC after treatment.¹

Upon analysis, results of the trial suggested use of gefarnate was associated with a significant reduction in level of triglycerides from baseline (mean, 2.64 [SD, 0.84] mmol/L) to 1 month (mean, 2.12 [SD, 0.95] mmol/L) (P = .0018). In contrast, there was no statistical difference in mean triglyceride level among the control group from baseline to 1 month (P = .5046). According to investigators, these results indicate gefarnate combined with statin can significantly reduce the plasma triglyceride level (P = .0148).¹

Analysis of secondary outcomes revealed statistically significant improvements in LDL-C (P = .0004) and HDL-C (P = .0004) with gefarnate treatment at 1 month. However, there was no statistically significant change in total cholesterol level at this point (P = .3165).¹

Investigators called attention to several limitations within their study. These limitations included the open-label design, a small sample size, being conducted at a single center, short follow-up duration, and not examining the effect of gefarnate on cardiovascular risk.¹

“We expect the current study to provide valuable insights into the role of gefarnate as dyslipidemia treatment drugs or reduce the cardiovascular residual risk,” investigators added.¹

References:

1. Shi J, Xu ML, He MJ, et al. Lipid-lowering effects of gefarnate in statin-treated patients with residual hypertriglyceridemia: a randomized controlled study. J Geriatr Cardiol. 2024;21(8):791-798. doi:10.26599/1671-5411.2024.08.001
2. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines [published correction appears in Circulation. 2019 Jun 18;139(25):e1182-e1186. doi: 10.1161/CIR.0000000000000698] [published correction appears in Circulation. 2023 Aug 15;148(7):e5. doi: 10.1161/CIR.0000000000001172]. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625