The Effects of Pemafibrate in Japanese Patients with Type 2 Diabetes Receiving HMG-CoA Reductase Inhibitors

Abstract

Objective: The combination therapy of HMG-CoA reductase inhibitors (statins), which are anti-hyperlipidemia agents, and fibrates may increase the risk of hepatic dysfunction and myopathy, so this combination required careful administration for patients. In the present study, we evaluated the effects of combination therapy of pemafibrate, a novel fibrate and statins. Methods: We administered pemafibrate 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 examined the efficacy and safety of the combination therapy in comparison with a pemafibrate monotherapy group. 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.