Efficacy and safety of pemafibrate in people with type 2 diabetes and elevated triglyceride levels: 52-week data from the PROVIDE study.

Eiichi Araki, Shizuya Yamashita, Hidenori Arai, Koutaro Yokote, Jo Satoh, Toyoshi Inoguchi, Jiro Nakamura, Hiroshi Maegawa, Narihito Yoshioka, Yukio Tanizawa, Hirotaka Watada, Hideki Suganami, Shun Ishibashi

Journal: Diabetes, obesity & metabolism 2020;21(7):1737-1744

PMID: 30830727

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Abstract

The aim of this study was to evaluate the efficacy and safety of pemafibrate in people with type 2 diabetes and hypertriglyceridaemia over a 52-week period. Participants were randomly assigned to receive treatment with placebo or pemafibrate at a dose of 0.2 or 0.4 mg/d for 24 weeks (treatment period 1). The main results from treatment period 1 have been reported previously. The assigned treatment was continued up to week 52, except that the placebo was changed to pemafibrate 0.2 mg/d after week 24 (treatment period 2). The percentage changes in fasting serum triglyceride (TG) levels at week 52 (last observation carried forward) were -48.2%, -42.3%, and -46.4% in the placebo/pemafibrate 0.2 mg/d (n = 57), pemafibrate 0.2 mg/d (n = 54), and pemafibrate 0.4 mg/d (n = 55) groups, respectively. Levels of TG, non-HDL cholesterol and total cholesterol stably decreased, whereas levels of HDL cholesterol increased with pemafibrate treatments over 52 weeks. Pemafibrate was well tolerated throughout the study period. The present study is the first to show that pemafibrate treatment substantially ameliorated lipid abnormalities and was well tolerated for 52 weeks in people with type 2 diabetes and hypertriglyceridaemia.

Address: Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.; Department of Community Medicine and Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.; Rinku General Medical Centre, Osaka, Japan.; National Centre for Geriatrics and Gerontology, Aichi, Japan.; Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.; Department of Endocrinology, Haematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.; Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Miyagi, Japan.; Fukuoka Health Promotion Support Centre, Fukuoka, Japan.; Division of Diabetes, Department of Internal Medicine, Aichi Medical University, Aichi, Japan.; Department of Medicine, Shiga University of Medical Science, Shiga, Japan.; Division of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Centre, NTT East Corporation, Hokkaido, Japan.; Division of Endocrinology, Metabolism, Haematological Science and Therapeutics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.; Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.; Clinical Data Science Department, Kowa Company, Ltd, Tokyo, Japan.; Division of Endocrinology and Metabolism, Department of Medicine, Jichi Medical University, Tochigi, Japan.

DOI: 10.1111/dom.13686

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MeSH Terms: Benzoxazoles, Butyrates, Diabetes Mellitus, Type 2, Humans, Hypertriglyceridemia, Hypolipidemic Agents, Triglycerides