薬理と治療

Abstract

Objectives　To compare the efficacies of extended-release exenatide （BYDUREON(R) 2 mg for subcutaneous injection; EQW）and insulin glargine（Ins）, and identify predictors╱predicting factors of the HbA1c-lowering effects of EQW in Japanese and Asian patients with type 2 diabetes. Methods　HbA1c data from two phase III trials were analyzed: GWBX（26 weeks: EQW versus Ins）and GWCK （26 weeks: EQW versus twice︱daily exenatide）. Body weight at 26 weeks of GWBX were also assessed. Changes of HbA1c and weight at 26 week in GWBX categorized into 4 groups were evaluated. HbA1c change was stratified by patient characteristics （BMI, diabetes duration, sulfonylurea use）and analyzed. Change in HbA1c at 26 weeks in EQW-treated patients in GWCK were also compared between patients with and without injection site nodules. Results　Regardless EQW and Ins, approximately 80％ of all patients in GWBX experienced reductions in HbA1c. However, weight gain occurred╱observed in 30％ in EQW arm compared to 55％ in Ins arm. EQW patients with a BMI＜20 kg╱m2 at baseline and EQW patients with shorter disease duration experienced the greatest reduction. GWBX patients with previous Sulfonylurea use showed the tendency of attenuated HbA1c reduction. Injection site nodules were not associated with the HbA1c change in EQW-treated patients in GWCK. Conclusion　These analyses confirmed the effects of EQW on glycemic control and body weight in Japanese and Asian patients with type 2 diabetes. The HbA1c-lowering effect of EQW was not associated with BMI at baseline and disease duration; however, patients with shorter disease duration and patients never used sulfonylurea indicated greater HbA1c reduction in these studies. The HbA1c-lowering effects of EQW was not associated with the injection site nodules. From aforementioned reasons, EQW demonstrated effects in diverse patients and usefulness in early intervention.