Hiroshi Maegawa1, Kazuyuki Tobe2, Ichiro Nakamura3, Satoshi Uno4. 1. Department of Medicine, Shiga University of Medical Science , Shiga , Japan. 2. First Department of Internal Medicine, University of Toyama , Toyama , Japan. 3. Medical Science, Medical Affairs, Astellas Pharma Inc. , Tokyo , Japan. 4. Data Science, Development, Astellas Pharma Inc. , Tokyo , Japan.
Abstract
Objective: STELLA-LONG TERM is an ongoing post-marketing surveillance study examining the safety and effectiveness of ipragliflozin in real-world clinical practice in Japan. This interim report of STELLA-LONG TERM examined the safety and effectiveness of ipragliflozin in non-elderly and elderly Japanese patients with type 2 diabetes mellitus (T2DM) using data up to 12 months. Methods: Data from T2DM patients who were first prescribed ipragliflozin between July 2014 and October 2015 and whose 12 month data were locked by January 2018 were analyzed and compared between non-elderly (<65 years) and elderly patients (≥65 years). Results: The safety and efficacy analysis sets included 11,051 and 8788 patients, respectively. Elderly patients accounted for 28.6% (n = 3157) of the study population. The mean body mass index was 29.9 kg/m2 and 26.8 kg/m2, the percentage of patients with glycated hemoglobin (HbA1c) <8.0% was 50.1% and 59.5%, and the percentage of patients with complications was 83.2% and 87.3% in the non-elderly and elderly groups, respectively. Mean HbA1c and body weight decreased significantly from baseline to 12 months in both age groups, regardless of baseline HbA1c and body weight (all p < .05). The incidence of adverse drug reactions (ADRs) was 14.8% and 14.2% and that of serious ADRs was 0.8% and 1.4% in non-elderly and elderly patients, respectively (p = .002 for serious ADRs). Conclusion: The incidence of serious ADRs was higher in elderly patients than non-elderly patients. Ipragliflozin was effective in both non-elderly and elderly patients with T2DM in the real-world clinical setting.
Objective: STELLA-LONG TERM is an ongoing post-marketing surveillance study examining the safety and effectiveness of ipragliflozin in real-world clinical practice in Japan. This interim report of STELLA-LONG TERM examined the safety and effectiveness of ipragliflozin in non-elderly and elderly Japanese patients with type 2 diabetes mellitus (T2DM) using data up to 12 months. Methods: Data from T2DM patients who were first prescribed ipragliflozin between July 2014 and October 2015 and whose 12 month data were locked by January 2018 were analyzed and compared between non-elderly (<65 years) and elderly patients (≥65 years). Results: The safety and efficacy analysis sets included 11,051 and 8788 patients, respectively. Elderly patients accounted for 28.6% (n = 3157) of the study population. The mean body mass index was 29.9 kg/m2 and 26.8 kg/m2, the percentage of patients with glycated hemoglobin (HbA1c) <8.0% was 50.1% and 59.5%, and the percentage of patients with complications was 83.2% and 87.3% in the non-elderly and elderly groups, respectively. Mean HbA1c and body weight decreased significantly from baseline to 12 months in both age groups, regardless of baseline HbA1c and body weight (all p < .05). The incidence of adverse drug reactions (ADRs) was 14.8% and 14.2% and that of serious ADRs was 0.8% and 1.4% in non-elderly and elderly patients, respectively (p = .002 for serious ADRs). Conclusion: The incidence of serious ADRs was higher in elderly patients than non-elderly patients. Ipragliflozin was effective in both non-elderly and elderly patients with T2DM in the real-world clinical setting.