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.

目的：抗高血压药HMG-CoA还原酶抑制剂（他汀类药物）与贝特类药物联合治疗可能会增加肝功能障碍和肌病的风险，因此，这种联合治疗需要患者谨慎使用。在本研究中，评估了新出现的贝马贝特，他汀类药物和他汀类药物联合治疗的效果。

方法：对27例已经接受他汀类药物治疗6个月的血脂异常的2型糖尿病患者（联合治疗组），他汀类药物作为他汀类药物治疗的补充药物使用了6个月，并且与他汀类药物单药治疗相比，联合治疗的有效性和安全性组进行了检查。

结果：在联合治疗组中，与基线相比，皮马贝特治疗6个月后血清总胆固醇水平降低，而HDL-胆固醇升高。两组的血清甘油三酯水平降低，而HbA1c水平升高。联合治疗组降低了肌病指标的血清肌酐激酶水平。另外，在组合组中观察到肝功能障碍的参数γ-谷氨酰转肽酶的减少。

结论：他汀类药物联合纤溶酶治疗2型糖尿病血脂异常患者可以安全地改善脂质代谢，而不会增加肝功能障碍和肌病的风险。