Effects of pemafibrate on lipid metabolism in patients with type 2 diabetes and hypertriglyceridemia: A multi-center prospective observational study, the PARM-T2D study. (October 2022)

• Record Type: Journal Article
• Authors: Kito, Kenichi; Nomoto, Hiroshi; Sakuma, Ichiro; Nakamura, Akinobu; Cho, Kyu Yong; Kameda, Hiraku; Miya, Aika; Omori, Kazuno; Yanagiya, Shingo; Handa, Takahisa; Taneda, Shinji; Takeuchi, Jun; Nagai, So; Yamashita, Kumiko; Kurihara, Yoshio; Atsumi, Tatsuya; Miyoshi, Hideaki
• Is Part Of: Diabetes research and clinical practice. Volume 192(2022)
• Publication Date: 2022-10
• Subjects: Selective PPARα modulator -- Pemafibrate -- Triglyceride -- Dyslipidemia -- Fibrate; Diabetes -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462
• DOI: 10.1016/j.diabres.2022.110091
• Languages: English
• ISSNs: 0168-8227

Abstract

Highlights: This prospective study investigated pemafibrate for patients with type 2 diabetes. Pemafibrate reduced triglycerides and increased high-density lipoprotein-cholesterol. The effects of pemafibrate on lipid profile were superior to conventional fibrates. The effects of pemafibrate on liver function were superior to conventional fibrates. The switch from a conventional fibrate to pemafibrate improved renal function. Abstract: Aims: Pemafibrate, a novel selective peroxisome proliferator-activated receptor modulator, was shown to ameliorate lipid abnormalities in a phase III clinical trial of patients with type 2 diabetes mellitus (T2DM). However, its efficacy has not been demonstrated in real-world clinical practice in patients with T2DM. Methods: We performed a multi-center prospective observational study of the use of pemafibrate in patients with T2DM and hypertriglyceridemia versus conventional therapy, with or without a fibrate. The primary outcomes were the changes from baseline in fasting serum triglyceride (TG) and high-density lipoprotein-cholesterol (HDL-C) concentrations at week 52. Results: We recruited 650 patients, and data from 504 (252 per group) were analyzed after propensity score matching. In the pemafibrate group, both TG and HDL-C showed significant improvements ( p < 0.001), and several indices reflecting TG-rich lipoproteins, low-density lipoprotein-cholesterol particle size, and liver enzyme elevations were significantly ameliorated compared with the control group, but there was no difference in glycemic control markers. One of the key secondary endpoints showed that switching from conventional fibrates to pemafibrate improved eGFR but increased uric acid concentration. Conclusions: In patients with T2DM, pemafibrate has superior effects on lipid profile as well as liver and renal dysfunction to conventional fibrates.