Eiichi Araki1, Shizuya Yamashita2,3, Hidenori Arai4, Koutaro Yokote5, Jo Satoh6, Toyoshi Inoguchi7, Jiro Nakamura8, Hiroshi Maegawa9, Narihito Yoshioka10, Yukio Tanizawa11, Hirotaka Watada12, Hideki Suganami13, Shun Ishibashi14. 1. Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan earaki@gpo.kumamoto-u.ac.jp. 2. Department of Community Medicine and Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan. 3. Rinku General Medical Center, Osaka, Japan. 4. National Center for Geriatrics and Gerontology, Aichi, Japan. 5. Department of Clinical Cell Biology and Medicine, Chiba University Graduate School of Medicine, Chiba, Japan. 6. Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Miyagi, Japan. 7. Fukuoka Health Promotion Support Center, Fukuoka, Japan. 8. Division of Diabetes, Department of Internal Medicine, Aichi Medical University, Aichi, Japan. 9. Department of Medicine, Shiga University of Medical Science, Shiga, Japan. 10. Division of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Center, NTT East Corporation, Hokkaido, Japan. 11. Division of Endocrinology, Metabolism, Hematological Science and Therapeutics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan. 12. Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. 13. Clinical Data Science Department, Kowa Company, Ltd., Tokyo, Japan. 14. Division of Endocrinology and Metabolism, Department of Medicine, Jichi Medical University, Tochigi, Japan.
Abstract
OBJECTIVE: Type 2 diabetes is frequently complicated with atherogenic dyslipidemia. This study aimed to evaluate the efficacy and safety of pemafibrate (K-877) in patients with type 2 diabetes comorbid with hypertriglyceridemia. RESEARCH DESIGN AND METHODS: Patients were randomly assigned to three groups and received placebo (n = 57), 0.2 mg/day pemafibrate (n = 54), or 0.4 mg/day pemafibrate (n = 55) for 24 weeks (treatment period 1). Subsequently, the patients received follow-up treatment for another 28 weeks (treatment period 2), in which the placebo was switched to 0.2 mg/day pemafibrate. This article presents the results of treatment period 1, which were the primary objectives. RESULTS: The pemafibrate groups showed significantly reduced fasting serum triglyceride levels by ∼45% compared with the placebo group (P < 0.001). Additionally, the pemafibrate groups displayed significant decreases in non-HDL and remnant lipoprotein cholesterol, apolipoprotein (Apo) B100, ApoB48, and ApoCIII levels and significant increases in HDL cholesterol and ApoA-I levels. LDL cholesterol levels were not considerably altered in the pemafibrate groups. Furthermore, the 0.2 mg/day pemafibrate group showed a significantly reduced HOMA-insulin resistance score compared with the placebo group; however, no significant changes compared with placebo were found in fasting plasma glucose, fasting insulin, glycoalbumin, or HbA1c levels. The pemafibrate groups also showed significantly increased fibroblast growth factor 21 levels compared with the placebo group. All groups displayed comparable rates of adverse events and drug reactions. CONCLUSIONS:Pemafibrate significantly ameliorated lipid abnormalities and was well tolerated in patients with type 2 diabetes comorbid with hypertriglyceridemia.
RCT Entities:
OBJECTIVE: Type 2 diabetes is frequently complicated with atherogenic dyslipidemia. This study aimed to evaluate the efficacy and safety of pemafibrate (K-877) in patients with type 2 diabetes comorbid with hypertriglyceridemia. RESEARCH DESIGN AND METHODS: Patients were randomly assigned to three groups and received placebo (n = 57), 0.2 mg/day pemafibrate (n = 54), or 0.4 mg/day pemafibrate (n = 55) for 24 weeks (treatment period 1). Subsequently, the patients received follow-up treatment for another 28 weeks (treatment period 2), in which the placebo was switched to 0.2 mg/day pemafibrate. This article presents the results of treatment period 1, which were the primary objectives. RESULTS: The pemafibrate groups showed significantly reduced fasting serum triglyceride levels by ∼45% compared with the placebo group (P < 0.001). Additionally, the pemafibrate groups displayed significant decreases in non-HDL and remnant lipoprotein cholesterol, apolipoprotein (Apo) B100, ApoB48, and ApoCIII levels and significant increases in HDL cholesterol and ApoA-I levels. LDL cholesterol levels were not considerably altered in the pemafibrate groups. Furthermore, the 0.2 mg/day pemafibrate group showed a significantly reduced HOMA-insulin resistance score compared with the placebo group; however, no significant changes compared with placebo were found in fasting plasma glucose, fasting insulin, glycoalbumin, or HbA1c levels. The pemafibrate groups also showed significantly increased fibroblast growth factor 21 levels compared with the placebo group. All groups displayed comparable rates of adverse events and drug reactions. CONCLUSIONS:Pemafibrate significantly ameliorated lipid abnormalities and was well tolerated in patients with type 2 diabetes comorbid with hypertriglyceridemia.
Authors: Anastasia-Stefania Alexopoulos; Ali Qamar; Kathryn Hutchins; Matthew J Crowley; Bryan C Batch; John R Guyton Journal: Curr Diab Rep Date: 2019-02-26 Impact factor: 4.810