Nakamura Ichiro, Maegawa Hiroshi, Tobe Kazuyuki, Uno Satoshi
Operational Excellence, Medical Affairs Japan, Astellas Pharma Inc., Tokyo, Japan.
Department of Medicine, Shiga University of Medical Science, Shiga, Japan.
Diabetes Ther. 2021 May;12(5):1359-1378. doi: 10.1007/s13300-021-01042-w. Epub 2021 Mar 17.
STELLA-LONG TERM is a post-marketing surveillance study evaluating the safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus.
Patients were classified by age at ipragliflozin initiation (< 65 and ≥ 65 years), and elderly patients were subclassified by baseline body mass index (BMI) < 25.0 or ≥ 25.0 kg/m. Incidence of adverse drug reactions (ADRs) and effectiveness were evaluated over 3 years.
Among 11,051 patients, 7894 (71.4%) were aged < 65 years and 3157 (28.6%) ≥ 65 years. The 3-year ADR incidence was similar in patients aged ≥ 65 (19.04%) and < 65 years (19.36%; P = 0.701). Serious ADRs were more frequent in the subgroup ≥ 65 years (2.79% vs 1.55%; P < 0.001). In terms of ADRs of special interest, a significantly greater proportion of elderly patients had skin complications (2.22% vs 1.62%, P = 0.033), renal disorders (2.28% vs 1.51%, P = 0.005), hypoglycemia (0.73% vs 0.43%, P = 0.048), or malignant tumors (1.01% vs 0.24%, P < 0.001), while the incidence of polyuria/pollakiuria (5.97% vs 4.47%, P = 0.002) and hepatic disorders (1.39% vs 0.73%, P = 0.004) was significantly higher in non-elderly than elderly patients. In patients aged ≥ 65 years, the incidence of ADRs was higher when baseline BMI was ≥ 25 kg/m versus < 25 kg/m (24.40% vs 17.68%; P < 0.001). Glycosylated hemoglobin, fasting blood glucose, and body weight significantly decreased from baseline in both age groups at each evaluation up to 3 years (all P < 0.001).
Ipragliflozin was well tolerated and effective for 3 years in routine clinical use in elderly and non-elderly patients, although elderly patients had a higher rate of serious ADRs. No new safety concerns were identified.
ClinicalTrials.gov identifier NCT02479399.
STELLA-LONG TERM是一项上市后监测研究，旨在评估依帕列净在日本2型糖尿病患者中的安全性和有效性。
根据开始使用依帕列净时的年龄（<65岁和≥65岁）对患者进行分类，老年患者再根据基线体重指数（BMI）<25.0或≥25.0kg/m²进行亚分类。在3年时间里评估药物不良反应（ADR）的发生率和有效性。
在11051例患者中，7894例（71.4%）年龄<65岁，3157例（28.6%）≥65岁。≥65岁患者的3年ADR发生率（19.04%）与<65岁患者（19.36%；P=0.701）相似。严重ADR在≥65岁亚组中更常见（2.79%对1.55%；P<0.001）。在特别关注的ADR方面，老年患者出现皮肤并发症（2.22%对1.62%，P=0.033）、肾脏疾病（2.28%对1.51%，P=0.005）、低血糖（0.73%对0.43%，P=0.048）或恶性肿瘤（1.01%对0.24%，P<0.001）的比例显著更高，而多尿/尿频（5.97%对4.47%，P=0.002）和肝脏疾病（1.39%对0.73%，P=0.004）的发生率在非老年患者中显著高于老年患者。在≥65岁的患者中，基线BMI≥25kg/m²时的ADR发生率高于<25kg/m²时（24.40%对17.68%；P<0.001）。在各次评估直至3年时，两个年龄组的糖化血红蛋白、空腹血糖和体重均较基线显著下降（所有P<0.001）。
在老年和非老年患者的常规临床使用中，依帕列净3年耐受性良好且有效，尽管老年患者严重ADR的发生率较高。未发现新 的安全问题。
ClinicalTrials.gov标识符NCT02479399。
