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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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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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 |
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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 |
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