ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2021
Safety and Effectiveness of Ipragliflozin in Elderly Versus Non-elderly Japanese Patients with Type 2 Diabetes: Subgroup Analysis of STELLA-LONG TERM.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02479399 (Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients), which is not on this map. Not yet cited in PubMed.
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Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients: LONG-TERM (STELLA-LONG TERM)
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Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSTELLA-LONG TERM is a post-marketing surveillance study evaluating the safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus.
methodsPatients 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
resultsAmong 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
conclusionsIpragliflozin 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. CLINICAL
trial registrationClinicalTrials.gov identifier NCT02479399.
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