Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus: final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM)

Nakamura, Ichiro; Maegawa, Hiroshi; Tobe, Kazuyuki; Uno, Satoshi

doi:10.1080/14656566.2020.1817388

Cited by 13 publications

(12 citation statements)

References 45 publications

(77 reference statements)

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“…Безопасность ипраглифлозина была в целом сопоставимой во всех подгруппах по рСКФ при одном существенном отличии частоты НРП, представляющих особый интерес, а именно частота нарушений со стороны почек и событий, связанных с гиповолемией, была выше у пациентов с умеренным или тяжелым нарушением функции почек по сравнению с участниками с нормальной функцией почек или ее незначительным нарушением. Это наблюдение согласуется с результатами основного анализа настоящего постмаркетингового исследования [27], продемонстрировавшего, что нарушение функции почек средней степени тяжести является фактором риска событий, ассоциирующихся с гиповолемией, а нарушение функции почек легкой/средней степени тяжести -фактор риска развития нарушений со стороны почек. Тем не менее, частота наиболее распространенной НРП, представляющей особый интерес, -полиурии/поллакиурии -была сходной в большинстве подгрупп рСКФ.…”

Section: Discussionunclassified

“…Целью 3-летнего наблюдательного многоцентрового постмаркетингового исследования STELLA-LONG TERM, выполненного в Японии, являлась оценка безопасности и эффективности ипраглифлозина в условиях повседневной клинической практики (идентификационный номер на ClinicalTrials.gov: NCT02479399) [27]. Подробное описание дизайна исследования было представлено ранее [18].…”

Section: пациенты и методыunclassified

“…Вкратце, к параметрам, включенным в программу наблюдения, относились демографические характеристики, подробные сведения о лечении ипраглифлозином, приеме сопутствующих препаратов, данные оценки жизненно важных функций пациента и результаты лабораторных тестов. Сбор подробных сведений о нежелательных реакциях на препарат (НРП) (MedDRA/J, версия 22.0) и НРП, представляющих особый интерес, степени тяжести НРП, времени начала НРП и их исходах осуществляли по методике, описанной ранее [27]. Под НРП подразумевали нежелательные явления (НЯ), для которых лечащий врач не мог исключить причинно-следственной взаимосвязи с лечением ипраглифлозином.…”

Section: оцениваемые параметрыunclassified

“…Параметры 11 289 пациентов были внесены в формы наблюдения; 11 051 человек был включен в популяцию анализа безопасности, а 8763 пациента -в популяцию анализа эффективности. Подробные сведения представлены в окончательной публикации результатов исследования [27]. ОРИГИНАЛЬНОЕ ИССЛЕДОВАНИЕ…”

Section: распределение пациентовunclassified

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Safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus and impaired renal function: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM)

et al. 2021

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STELLA-LONG TERM, a 3-year post-marketing surveillance study, evaluated the safety and effectiveness of the sodiumglucose cotransporter 2 inhibitor ipragliflozin in Japanese type 2 diabetes mellitus (T2DM) patients. Final results in the safety (n = 6697) and effectiveness populations (n = 5625) were analyzed by stratifying patients by baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m2) into four subgroups (≥90, 60 to <90, 45 to <60, and <45) and two subgroups (≥60 and <60). Adverse drug reaction (ADR) incidence, and changes from baseline in glycosylated hemoglobin (HbA1c), bodyweight, and eGFR were assessed. The percentage of patients experiencing ADRs and serious ADRs was similar across most eGFR subgroups. Polyuria/pollakiuria was the most common ADR. Renal disorders and volume depletion ADRs were more frequent in the subgroups with more severe renal impairment at baseline than in those with an eGFR of 60 to <90 or ≥90 mL/min/1.73 m2. Bodyweight and HbA1c decreased in all subgroups, the latter by − 0.91% to − 0.40% (P <0.05 vs. baseline). eGFR increased in the 45 to <60 mL/min/1.73 m2 subgroup (+ 1.42 ± 8.77 mL/min/1.73 m2; P = 0.006). It decreased in the ≥90 and 60 to <90 mL/min/1.73 m2 subgroups (− 8.27 ± 13.73 and − 1.22 ± 10.34 mL/min/1.73 m2; P <0.001), but not to <60 mL/min/1.73 m2. In conclusion, there were no new or unexpected safety findings in Japanese patients treated with ipragliflozin for T2DM, and long-term sustained improvements in HbA1c and bodyweight were observed regardless of the presence of renal impairment.

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Section: Discussionunclassified

Section: пациенты и методыunclassified

Section: оцениваемые параметрыunclassified

Section: распределение пациентовunclassified

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Safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus and impaired renal function: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM)

et al. 2021

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“…Results from STELLA-LONG TERM show that the most common adverse drug reactions associated with ipragliflozin use were polyuria/pollakiuria (5.5%) and volume depletion-events, including dehydration (2.2%). 72 Other potential adverse events of SGLT-2 inhibitors include falls and subsequent fractures due to volumedepletion related events. However, only two RCTs reported on the risk of bone fractures with only one event in each RCT (Figure S6).…”

Section: Other Adverse Eventsmentioning

confidence: 99%

Profile of Ipragliflozin, an Oral SGLT-2 Inhibitor for the Treatment of Type 2 Diabetes: The Evidence to Date

Alkabbani¹,

Gamble²

2021

DDDT

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Background: Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are a novel class of pharmacotherapeutics for type 2 diabetes management that work by reducing renal reabsorption of glucose. Ipragliflozin is a potent, selective SGLT-2 inhibitor used for the management of type 2 diabetes. Objective: The primary aim of this review is to summarize the available evidence on the efficacy and safety of ipragliflozin for the management of type 2 diabetes. We also review the discovery, pharmacokinetic, and pharmacodynamic profile of ipragliflozin. Methods: To inform our review, we searched MEDLINE, International Pharmaceutical Abstracts, and Embase to identify relevant papers to ipragliflozin use in type 2 diabetes. Clinical trial registries were also searched. Results: Findings from randomized clinical trials demonstrate that compared to placebo, ipragliflozin significantly reduces glucose as measured via Hemoglobin A1c and fasting plasma glucose levels. Ipragliflozin is also associated with weight reduction and an improvement in some, but not all, cardiovascular risk markers. Ipragliflozin has a favourable safety profile with a low risk of hypoglycemia and the rates of common adverse events are not significantly different than placebo. Limited data are available to assess rare and long-term adverse effects. Conclusion:Current evidence shows that ipragliflozin is an effective therapeutic option for the management of glucose control in type 2 diabetes. However, no cardiovascular outcome trials have been conducted to date. Real-world observational studies are still needed to accurately capture any possible rare or long-term adverse events.

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Real-World Safety and Effectiveness of Canagliflozin Treatment for Type 2 Diabetes Mellitus in Japan: SAPPHIRE, a Long-Term, Large-Scale Post-Marketing Surveillance

et al. 2021

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Introduction: This long-term post-marketing surveillance (SAPPHIRE) collected information on the safety and effectiveness of canagliflozin (approved dose 100 mg) prescribed to patients with type 2 diabetes mellitus (T2DM) in realworld practice in Japan. Methods: Patients with T2DM who were prescribed canagliflozin between December 2014 and September 2016 were registered and observed for up to 3 years. Safety was evaluated in terms of adverse drug reactions (ADRs). Effectiveness was assessed in terms of glycaemic control. Data were also analysed across age subgroups (\ 65, C 65 to \ 75, and C 75 years old) and the estimated glomerular filtration rate

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Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus: final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM)

Cited by 13 publications

References 45 publications

Safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus and impaired renal function: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM)

Safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus and impaired renal function: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM)

Profile of Ipragliflozin, an Oral SGLT-2 Inhibitor for the Treatment of Type 2 Diabetes: The Evidence to Date

Real-World Safety and Effectiveness of Canagliflozin Treatment for Type 2 Diabetes Mellitus in Japan: SAPPHIRE, a Long-Term, Large-Scale Post-Marketing Surveillance

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