Cargando…

Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study)

AIMS/INTRODUCTION: Although sodium‐glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1‐year post‐marketing study of tofogliflozin, a novel agent in this class, in Japane...

Descripción completa

Detalles Bibliográficos
Autores principales: Utsunomiya, Kazunori, Shimmoto, Naoki, Senda, Masayuki, Kurihara, Yuji, Gunji, Ryoji, Fujii, Shoko, Kakiuchi, Seigo, Fujiwara, Hisataka, Kameda, Hiroyuki, Tamura, Masahiro, Kaku, Kohei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5668483/
https://www.ncbi.nlm.nih.gov/pubmed/28107773
http://dx.doi.org/10.1111/jdi.12626
_version_ 1783275681365360640
author Utsunomiya, Kazunori
Shimmoto, Naoki
Senda, Masayuki
Kurihara, Yuji
Gunji, Ryoji
Fujii, Shoko
Kakiuchi, Seigo
Fujiwara, Hisataka
Kameda, Hiroyuki
Tamura, Masahiro
Kaku, Kohei
author_facet Utsunomiya, Kazunori
Shimmoto, Naoki
Senda, Masayuki
Kurihara, Yuji
Gunji, Ryoji
Fujii, Shoko
Kakiuchi, Seigo
Fujiwara, Hisataka
Kameda, Hiroyuki
Tamura, Masahiro
Kaku, Kohei
author_sort Utsunomiya, Kazunori
collection PubMed
description AIMS/INTRODUCTION: Although sodium‐glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1‐year post‐marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This was a prospective, observational and multicenter post‐marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014. RESULTS: Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow‐up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion‐related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was −0.46% (P < 0.0001) and −2.71 kg (P < 0.0001), respectively. CONCLUSIONS: The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels.
format Online
Article
Text
id pubmed-5668483
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-56684832017-11-08 Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study) Utsunomiya, Kazunori Shimmoto, Naoki Senda, Masayuki Kurihara, Yuji Gunji, Ryoji Fujii, Shoko Kakiuchi, Seigo Fujiwara, Hisataka Kameda, Hiroyuki Tamura, Masahiro Kaku, Kohei J Diabetes Investig Articles AIMS/INTRODUCTION: Although sodium‐glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1‐year post‐marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This was a prospective, observational and multicenter post‐marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014. RESULTS: Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow‐up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion‐related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was −0.46% (P < 0.0001) and −2.71 kg (P < 0.0001), respectively. CONCLUSIONS: The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels. John Wiley and Sons Inc. 2017-03-06 2017-11 /pmc/articles/PMC5668483/ /pubmed/28107773 http://dx.doi.org/10.1111/jdi.12626 Text en © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Articles
Utsunomiya, Kazunori
Shimmoto, Naoki
Senda, Masayuki
Kurihara, Yuji
Gunji, Ryoji
Fujii, Shoko
Kakiuchi, Seigo
Fujiwara, Hisataka
Kameda, Hiroyuki
Tamura, Masahiro
Kaku, Kohei
Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study)
title Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study)
title_full Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study)
title_fullStr Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study)
title_full_unstemmed Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study)
title_short Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study)
title_sort safety and effectiveness of tofogliflozin in elderly japanese patients with type 2 diabetes mellitus: a post‐marketing study (j‐step/el study)
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5668483/
https://www.ncbi.nlm.nih.gov/pubmed/28107773
http://dx.doi.org/10.1111/jdi.12626
work_keys_str_mv AT utsunomiyakazunori safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT shimmotonaoki safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT sendamasayuki safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT kuriharayuji safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT gunjiryoji safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT fujiishoko safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT kakiuchiseigo safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT fujiwarahisataka safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT kamedahiroyuki safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT tamuramasahiro safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy
AT kakukohei safetyandeffectivenessoftofogliflozininelderlyjapanesepatientswithtype2diabetesmellitusapostmarketingstudyjstepelstudy