Masataka Kusunoki*, Takahiko Sakazaki, Kazuhiko Tsutsumi, Tetsuro Miyata and Yoshiharu Oshida Pages 919 - 924 ( 6 )
Objective: The combination therapy of HMG-CoA reductase inhibitors (statins), which are anti-hyperlipidemic agents, and fibrates may increase the risk of hepatic dysfunction and myopathy, therefore, this combination required careful administration for patients. In the present study, the effects of combination therapy of pemafibrate, a novel fibrate, and statins, was evaluated.
Methods: Pemafibrate was administered for 6 months as an add-on to statin therapy in 27 type 2 diabetes patients with dyslipidemia already receiving statins for 6 months (combination group), and the efficacy and safety of the combination therapy in comparison with a pemafibrate monotherapy group was examined.
Results: In the combination group, a decrease in serum total cholesterol levels was observed after 6 months of pemafibrate treatment compared to baseline, along with an increase in HDL-cholesterol. While serum triglyceride level was reduced, HbA1c level was elevated in both the groups. Serum creatinine kinase level, which is an indicator of myopathy, was lowered in the combination group. In addition, a decrease in γ-glutamyl transpeptidase, a parameter of hepatic dysfunction, was observed in the combination group.
Conclusion: The statin-pemafibrate combination therapy in type 2 diabetes patients with dyslipidemia improved lipid metabolism safely without increasing the risk of hepatic dysfunction and myopathy.
Pemafibrate, statin, myopathy, hepatic dysfunction, type 2 diabetes, Japanese patients.
Research Center of Health, Physical Fitness and Sports, Nagoya University, Furocho, Chikusa-ku, Nagoya 464-8601, Faculty of Sports and Health Science, Fukui University of Technology, 3-6-1 Gakuen, Fukui 910-8505, Okinaka Memorial Institute for Medical Research, 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Vascular Center, Sanno Medical Center, 8-5-35 Akasaka, Minato-ku, Tokyo 107-0052, Medical Checkup Center, Minami Seikyo Hospital, 2-204 Minamiohdaka, Midori-ku, Nagoya 459-8540