Maegawa Hiroshi, Tobe Kazuyuki, Nakamura Ichiro, Uno Satoshi
Department of Medicine, Shiga University of Medical Science, Seta-tsukinowa-cho, Otsu, Shiga 520-2192 Japan.
First Department of Internal Medicine, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama, Japan.
Diabetol Int. 2021 Mar 24;12(4):430-444. doi: 10.1007/s13340-021-00501-w. eCollection 2021 Oct.
STELLA-LONG TERM was a 3-year post-marketing surveillance study that evaluated the long-term safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus (T2DM). This subgroup analysis examined the safety and effectiveness of ipragliflozin in treatment-naïve and non-naïve patients.
Patients were stratified into two subgroups: treatment-naïve (patients who had not received any antidiabetic drugs before starting ipragliflozin monotherapy) and non-naïve (all other patients). Patients who had added or switched antidiabetic drugs during follow-up were excluded from the analysis from that point. The incidence of adverse drug reactions (ADRs) and changes from baseline in glycosylated hemoglobin (HbA1c), body weight, fasting plasma glucose (FPG) and laboratory parameters were assessed.
Of the 11,051 patients in the safety analysis set, 1980 patients (17.92%) were treatment-naïve and 9071 (82.08%) were non-naïve. In the safety analysis set, treatment-naïve patients reported significantly lower incidences of ADRs (10.81% vs 20.87%; < 0.001) and serious ADRs (0.86% vs 2.09%; < 0.001) compared with non-naïve patients, as well as significantly lower incidences of polyuria/pollakiuria, volume depletion-related events, skin complications and renal disorders. In the effectiveness analysis, sustained and significant reductions from baseline to 36 months were observed in HbA1c, FPG and body weight in both treatment-naïve and non-naïve patients (all < 0.001 vs baseline).
Over 3 years, ipragliflozin was better tolerated in treatment-naive than in non-naive Japanese patients with T2DM and had similar efficacy in these populations. Therefore, ipragliflozin is a useful first-line treatment option for patients with T2DM.
ClinicalTrials.gov: NCT02479399.
The online version contains supplementary material available at 10.1007/s13340-021-00501-w.
STELLA-LONG TERM是一项为期3年的上市后监测研究，评估了依帕列净在日本2型糖尿病（T2DM）患者中的长期安全性和有效性。该亚组分析研究了依帕列净在初治和非初治患者中的安全性和有效性。
患者被分为两个亚组：初治患者（在开始依帕列净单药治疗前未接受过任何抗糖尿病药物治疗的患者）和非初治患者（所有其他患者）。在随访期间添加或更换抗糖尿病药物的患者从该时间点起被排除在分析之外。评估药物不良反应（ADR）的发生率以及糖化血红蛋白（HbA1c）、体重、空腹血糖（FPG）和实验室参数相对于基线的变化。
在安全性分析集的11051例患者中，1980例患者（17.92%）为初治患者，9071例（82.08%）为非初治患者。在安全性分析集中，与非初治患者相比，初治患者报告的ADR发生率显著更低（10.81%对20.87%；P<0.001），严重ADR发生率也显著更低（0.86%对2.09%；P<0.001），多尿/尿频、容量耗竭相关事件、皮肤并发症和肾脏疾病的发生率也显著更低。在有效性分析中，初治和非初治患者的HbA1c、FPG和体重从基线到36个月均持续且显著降低（与基线相比均P<0.001）。
在3年多的时间里，依帕列净在初治的日本T2DM患者中耐受性优于非初治患者，且在这些人群中具有相似的疗效。因此，依帕列净是T2DM患者有用的一线治疗选择。
ClinicalTrials.gov：NCT02479399。
在线版本包含可在10.1007/s13340-021-00501-w获取的补充材料。
