Many patients with type 2 diabetes mellitus have dyslipidemia, often both hypercholesterolemia and hypertriglyceridemia. Conventionally, statins in combination with fibrates have been relatively contraindicated in patients with abnormal renal function and are carefully administered in those with normal renal function. In this study, pemafibrate (PFB), a new fibrate, was additionally administered to type 2 diabetic patients with both hypercholesterolemia and hypertriglyceridemia who were already receiving statins, to evaluate the efficacy and safety of the coadministration.
Fourteen patients receiving pitavastatin (1, 2, or 4 mg/day) or rosuvastatin (2.5 or 5 mg/day) for 6 months were additionally administered PFB (0.1 mg, twice daily) for 1 month. Eleven patients receiving lipid-lowering drugs other than statins also additionally received PFB for 1 month. Blood samples were collected before and after the administration of PFB to measure the serum levels of biochemical parameters.
In patients who received PFB in addition to statins, significant improvement was seen in the following lipid parameters: total cholesterol (195 ± 44 deceasing to 177 ± 37 mg/dL, P < 0.05), HDL cholesterol (54 ± 16 to 58 ± 16 mg/dL, P < 0.05), the LDL cholesterol/HDL cholesterol ratio (2.08 ± 0.45 to 1.76 ± 0.57, P<0.05), and triglyceride (246 ± 150 to 137 ± 47 mg/dL, P < 0.05). The drug did not affect hepatic function. In patients who received PFB in addition to lipid-lowering drugs other than statins, only significant decrease of the serum triglyceride was noted. Additional administration of PFB had no effect on body weight, BMI or serum creatinine kinase (CK).
PFB administered with statins yielded a marked improvement of blood lipid profile than PFB administered with lipid-lowering drugs other than statins. No effects were noted on the hepatic function parameters or serum CK. The results suggest the efficacy and safety of PFB in combination with statins.
M. Kusunoki: Other Relationship; Self; Kaken Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd. Y. Natsume: Other Relationship; Self; Kaken Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd. Y. Oshida: None. T. Miyata: Research Support; Self; Bayer AG, Daiichi Sankyo Company, Limited.