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薬理と治療
Abstract
Background The 3-year prospective STELLA-LONG TERM study is examining the long-term safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus (T2DM)in real-world clinical settings. This 24-month interim report also included an evaluation of the effect of ipragliflozin in patients, stratified by hepatic and renal function. Methods The incidence of adverse drug reactions (ADRs)was assessed in 11,051 patients. Change in glycosylated haemoglobin (HbA1c), fasting plasma glucose(FPG)and body weight were evaluated in the overall efficacy analysis set(n=8762), and estimated glomerular filtration rate (eGFR)was evaluated in subgroups based on baseline eGFR. The effect of ipragliflozin on hepatic enzyme level was examined in patients with or without hepatic dysfunction at baseline. Results The incidence of ADRs and serious ADRs was 17.36%(n=1919)and 1.45%(n=160)of patients, respectively. Between baseline and 24 months, ipragliflozin decreased HbA1c (-0.70%, P<0.05), FPG (-30.2 mg╱dL, P<0.05)and body weight(-3.03 kg, P<0.05). Significant reductions in hepatic enzyme levels were observed in patients with hepatic dysfunction(all P<0.05). In patients with eGFR<60 mL/min╱1.73 m2, eGFR increased significantly (P<0.05 for all timepoints between 3 and 24 months), whereas a sustained decrease in eGFR was observed during 24 months in patients with eGFR≥60 mL╱min╱1.73 m2(all P<0.05). Conclusions Ipragliflozin was well tolerated and effective in Japanese T2DM patients over 24 months in clinical practice, and improved kidney function in those with renal impairment. Significant improvements in hepatic enzyme were observed in patients with abnormal hepatic function(. NCT02479399)
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