ArticleDiabetology international2021
Real-world evidence for long-term safety and effectiveness of ipragliflozin in treatment-naïve versus non-naïve Japanese patients with type 2 diabetes mellitus: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM).
Article in Diabetology international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02479399 (Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients: LONG-TERM (STELLA-LONG TERM)
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials.Frontiers in endocrinology · 2023Pooled it
- Reasons for Discontinuing Treatment with Sodium-Glucose Cotransporter 2 Inhibitors in Patients with Diabetes in Real-World Settings: The KAMOGAWA-A Study.Journal of clinical medicine · 2023Article
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSTELLA-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. MATERIALS AND
methodsPatients 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.
resultsOf 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%;
conclusionsOver 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. CLINICAL
trial registrationClinicalTrials.gov: NCT02479399. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13340-021-00501-w.
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