Cargando…
Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study in Japan
AIMS/INTRODUCTION: The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial has shown the effects of canagliflozin on preventing clinically important kidney outcomes in patients with type 2 diabetes mellitus and chronic kidney disease; however,...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9720226/ https://www.ncbi.nlm.nih.gov/pubmed/35861630 http://dx.doi.org/10.1111/jdi.13888 |
_version_ | 1784843508129988608 |
---|---|
author | Wada, Takashi Mori‐Anai, Kazumi Takahashi, Akiko Matsui, Takahiro Inagaki, Masaya Iida, Mitsutaka Maruyama, Ken Tsuda, Hidetaka |
author_facet | Wada, Takashi Mori‐Anai, Kazumi Takahashi, Akiko Matsui, Takahiro Inagaki, Masaya Iida, Mitsutaka Maruyama, Ken Tsuda, Hidetaka |
author_sort | Wada, Takashi |
collection | PubMed |
description | AIMS/INTRODUCTION: The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial has shown the effects of canagliflozin on preventing clinically important kidney outcomes in patients with type 2 diabetes mellitus and chronic kidney disease; however, not many Japanese patients were included in the trial. The present study evaluated the efficacy and safety of canagliflozin in Japanese chronic kidney disease patients with type 2 diabetes mellitus. MATERIALS AND METHODS: In this multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study, chronic kidney disease patients with type 2 diabetes mellitus were randomly assigned to receive either 100 mg canagliflozin or a matching placebo once daily for 104 weeks. The primary efficacy end‐point was the incidence of a 30% decline in estimated glomerular filtration rate. RESULTS: Overall, 308 patients were randomized to the canagliflozin (n = 154) and placebo (n = 154) groups. The incidence of a 30% decline in estimated glomerular filtration rate at week 104 was 18.2% and 29.5%, respectively, and the point estimate of the intergroup difference (placebo − canagliflozin) was 11.3% (95% confidence interval 1.2–21.5, P = 0.029), which was significant. The overall incidence of adverse events was similar in the two groups. CONCLUSIONS: This study suggests that canagliflozin safely reduces the risk of end‐stage renal disease in Japanese chronic kidney disease patients with type 2 diabetes mellitus. |
format | Online Article Text |
id | pubmed-9720226 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-97202262022-12-06 Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study in Japan Wada, Takashi Mori‐Anai, Kazumi Takahashi, Akiko Matsui, Takahiro Inagaki, Masaya Iida, Mitsutaka Maruyama, Ken Tsuda, Hidetaka J Diabetes Investig Articles AIMS/INTRODUCTION: The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial has shown the effects of canagliflozin on preventing clinically important kidney outcomes in patients with type 2 diabetes mellitus and chronic kidney disease; however, not many Japanese patients were included in the trial. The present study evaluated the efficacy and safety of canagliflozin in Japanese chronic kidney disease patients with type 2 diabetes mellitus. MATERIALS AND METHODS: In this multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study, chronic kidney disease patients with type 2 diabetes mellitus were randomly assigned to receive either 100 mg canagliflozin or a matching placebo once daily for 104 weeks. The primary efficacy end‐point was the incidence of a 30% decline in estimated glomerular filtration rate. RESULTS: Overall, 308 patients were randomized to the canagliflozin (n = 154) and placebo (n = 154) groups. The incidence of a 30% decline in estimated glomerular filtration rate at week 104 was 18.2% and 29.5%, respectively, and the point estimate of the intergroup difference (placebo − canagliflozin) was 11.3% (95% confidence interval 1.2–21.5, P = 0.029), which was significant. The overall incidence of adverse events was similar in the two groups. CONCLUSIONS: This study suggests that canagliflozin safely reduces the risk of end‐stage renal disease in Japanese chronic kidney disease patients with type 2 diabetes mellitus. John Wiley and Sons Inc. 2022-08-09 2022-12 /pmc/articles/PMC9720226/ /pubmed/35861630 http://dx.doi.org/10.1111/jdi.13888 Text en © 2022 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://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 Wada, Takashi Mori‐Anai, Kazumi Takahashi, Akiko Matsui, Takahiro Inagaki, Masaya Iida, Mitsutaka Maruyama, Ken Tsuda, Hidetaka Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study in Japan |
title | Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study in Japan |
title_full | Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study in Japan |
title_fullStr | Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study in Japan |
title_full_unstemmed | Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study in Japan |
title_short | Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study in Japan |
title_sort | effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: a multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase iii study in japan |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9720226/ https://www.ncbi.nlm.nih.gov/pubmed/35861630 http://dx.doi.org/10.1111/jdi.13888 |
work_keys_str_mv | AT wadatakashi effectofcanagliflozinonthedeclineofestimatedglomerularfiltrationrateinchronickidneydiseasepatientswithtype2diabetesmellitusamulticenterrandomizeddoubleblindplacebocontrolledparallelgroupphaseiiistudyinjapan AT morianaikazumi effectofcanagliflozinonthedeclineofestimatedglomerularfiltrationrateinchronickidneydiseasepatientswithtype2diabetesmellitusamulticenterrandomizeddoubleblindplacebocontrolledparallelgroupphaseiiistudyinjapan AT takahashiakiko effectofcanagliflozinonthedeclineofestimatedglomerularfiltrationrateinchronickidneydiseasepatientswithtype2diabetesmellitusamulticenterrandomizeddoubleblindplacebocontrolledparallelgroupphaseiiistudyinjapan AT matsuitakahiro effectofcanagliflozinonthedeclineofestimatedglomerularfiltrationrateinchronickidneydiseasepatientswithtype2diabetesmellitusamulticenterrandomizeddoubleblindplacebocontrolledparallelgroupphaseiiistudyinjapan AT inagakimasaya effectofcanagliflozinonthedeclineofestimatedglomerularfiltrationrateinchronickidneydiseasepatientswithtype2diabetesmellitusamulticenterrandomizeddoubleblindplacebocontrolledparallelgroupphaseiiistudyinjapan AT iidamitsutaka effectofcanagliflozinonthedeclineofestimatedglomerularfiltrationrateinchronickidneydiseasepatientswithtype2diabetesmellitusamulticenterrandomizeddoubleblindplacebocontrolledparallelgroupphaseiiistudyinjapan AT maruyamaken effectofcanagliflozinonthedeclineofestimatedglomerularfiltrationrateinchronickidneydiseasepatientswithtype2diabetesmellitusamulticenterrandomizeddoubleblindplacebocontrolledparallelgroupphaseiiistudyinjapan AT tsudahidetaka effectofcanagliflozinonthedeclineofestimatedglomerularfiltrationrateinchronickidneydiseasepatientswithtype2diabetesmellitusamulticenterrandomizeddoubleblindplacebocontrolledparallelgroupphaseiiistudyinjapan |