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)

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...

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Autores principales:	K. Tobe, H. Maegawa, I. Nakamura, S. Uno
Formato:	article
Lenguaje:	EN RU
Publicado:	Endocrinology Research Centre 2021
Materias:	diabetes mellitus ipragliflozin post-marketing surveillance renal impairment sodium-glucose cotransporter 2 inhibitor Nutritional diseases. Deficiency diseases RC620-627
Acceso en línea:	https://doaj.org/article/d0c41f975f364f238c654af6629cd7b2
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spelling	oai:doaj.org-article:d0c41f975f364f238c654af6629cd7b22021-11-14T09:00:23ZSafety 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)2072-03512072-037810.14341/DM12758https://doaj.org/article/d0c41f975f364f238c654af6629cd7b22021-07-01T00:00:00Zhttps://www.dia-endojournals.ru/jour/article/view/12758https://doaj.org/toc/2072-0351https://doaj.org/toc/2072-0378STELLA-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.K. TobeH. MaegawaI. NakamuraS. UnoEndocrinology Research Centrearticlediabetes mellitusipragliflozinpost-marketing surveillancerenal impairmentsodium-glucose cotransporter 2 inhibitorNutritional diseases. Deficiency diseasesRC620-627ENRUСахарный диабет, Vol 24, Iss 2, Pp 141-155 (2021)
institution	DOAJ
collection	DOAJ
language	EN RU
topic	diabetes mellitus ipragliflozin post-marketing surveillance renal impairment sodium-glucose cotransporter 2 inhibitor Nutritional diseases. Deficiency diseases RC620-627
spellingShingle	diabetes mellitus ipragliflozin post-marketing surveillance renal impairment sodium-glucose cotransporter 2 inhibitor Nutritional diseases. Deficiency diseases RC620-627 K. Tobe H. Maegawa I. Nakamura S. Uno 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)
description	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.
format	article
author	K. Tobe H. Maegawa I. Nakamura S. Uno
author_facet	K. Tobe H. Maegawa I. Nakamura S. Uno
author_sort	K. Tobe
title	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)
title_short	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)
title_full	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)
title_fullStr	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)
title_full_unstemmed	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)
title_sort	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)
publisher	Endocrinology Research Centre
publishDate	2021
url	https://doaj.org/article/d0c41f975f364f238c654af6629cd7b2
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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)

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