薬理と治療

Abstract

A long-term（3-year）post-marketing prospective study of anagliptin is currently underway to examine the safety and efficacy in clinical practice in patients with type 2 diabetes mellitus. Data on the usefulness of anagliptin in 4719 patients who were observed for 1 year were reported in the“1-year Interim ReportⅠ of SWIM-JPN.”1） In the present report, we closely examined the effects of anagliptin on blood glucose and serum lipids in patients receiving anagliptin in the approved dose range between 100 and 400 mg╱day（usual-dose group）.Changes in HbA1c, fasting blood glucose and random blood glucose levels from baseline at 1 year of treatment with anagliptin were －0.75％, －19.5 mg╱dL and －31.3 mg╱dL, respectively. Thus, a sustained blood glucose-lowering effect of anagliptin during the first 1 year of treatment was demonstrated. In the examination of efficacy by patient demographic characteristic, the efficacy of anagliptin was confirmed regardless of sex, age, BMI, duration of diabetes mellitus, with or without concomitant antidiabetic drugs, with or without prior diabetes treatment, and with or without hepatic function disorder or renal impairment. The change in LDL-cholesterol（LDL-C）levels from baseline at 1 year of treatment was －7.8 mg╱dL, showing a significant decrease. In addition, a stratified analysis according to baseline LDL︱C levels revealed changes of －20.7 mg╱dL and －34.0 mg╱dL in patients with baseline LDL︱C levels of ≥120 mg╱dL and ≥140 mg╱dL, respectively. Thus, patients with higher baseline LDL-C levels showed a greater decrease in LDL-C. A similar statistical significant decrease was also observed in triglyceride（TG）levels. In addition to the blood glucose-lowering effect sustained throughout the 1-year treatment period in the usual-dose group of anagliptin, lowered LDL-C and TG levels were observed. These findings indicate that anagliptin is a potential treatment option for type 2 diabetes mellitus complicated by dyslipidemia.