The combination therapy of statins and fibrates may increase the risk of hepatic dysfunction and myopathy, so this combination was contraindicated in patients with renal impairment and required careful administration even for patients with normal renal function. However, in Japan, patients with renal impairment were excluded from the relative contraindication category in 2018.
In the present study, we additionally administered 0.2 mg/day pemafibrate (PFB), a novel fibrate, for 6 months to 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 PFB monotherapy group.
In the combination group, a significant decrease in serum total cholesterol level was observed after 6 months of PFB treatment compared to baseline, along with increase in HDL-cholesterol. A significant decrease in serum triglyceride and a significant increase in HbA1c were observed in both groups. Significant decreases in serum creatinine kinase, which is an indicator of myopathy, and serum γ-GTP, a parameter of hepatic dysfunction, were observed in the combination group.
These results demonstrated that the statin-PFB combination therapy in type 2 diabetes patients with dyslipidemia improved lipid metabolism safely without increasing the risk of hepatic dysfunction and myopathy.
M. Kusunoki: Other Relationship; Self; Kaken Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd. D. Sato: None. T. Sakazaki: None. Y. Natsume: None. T. Miyata: None.