薬理と治療

Abstract

Background　STELLA-LONG TERM is a 3-year post-marketing surveillance study in Japanese patients with type 2 diabetes mellitus（T2DM）receiving ipragliflozin in real-world clinical settings. To evaluate the influence of overweight/obesity on the long-term effectiveness and safety of ipragliflozin, a subgroup analysis of STELLA-LONG TERM was undertaken in patients stratified by body mass index（BMI）, including BMI≥35.0. Methods　Patients were divided into six categories according to their BMI（＜18.5, 18.5 to ＜22.0, 22.0 to ＜25.0, 25.0 to ＜30.0, 30.0 to ＜35.0 and ≥35.0）. The incidence of adverse drug reactions（ADRs）and changes in glycated hemoglobin（HbA1c）and body weight were evaluated over 24 months in these subgroups. Results　In the safety analysis set（n＝11,051）, the incidence of ADRs was 18.18％, 14.64％, 15.93％, 20.23％, 20.21％ and 20.70％, respectively, in the subgroups of patients with BMI＜18.5, 18.5 to ＜22.0, 22.0 to ＜25.0, 25.0 to ＜30.0, 30.0 to ＜35.0 and ≥35.0. In the efficacy analysis set（n＝8762）, HbA1c and body weight decreased significantly from baseline to 24 months in all BMI subgroups except patients with BMI＜18.5（P＜0.05）. HbA1c and body weight showed comparable changes from baseline to 24 months among patients with BMI of25.0 to ＜30.0, 30.0 to ＜35.0 and ≥35.0 groups. Conclusions　The incidence of ADRs with ipragliflozin tended to be higher in T2DM patients with BMI≥25.0 than in those with lower BMI. Ipragliflozin improved glycemic control and reduced body weight over 24 months in Japanese T2DM patients with overweight╱obesity including those with BMI≥35.0（. NCT02479399）