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Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates
AIMS: Patients with type 2 diabetes mellitus (T2DM) have increased risk of adverse events (AEs; e.g. dehydration, hypoglycaemia) in hot weather. This analysis assessed the efficacy and safety of canagliflozin, a sodium glucose co‐transporter 2 (SGLT2) inhibitor, in patients with T2DM who live in hot...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5129493/ https://www.ncbi.nlm.nih.gov/pubmed/27600862 http://dx.doi.org/10.1111/ijcp.12868 |
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author | John, Mathew Cerdas, Sonia Violante, Rafael Deerochanawong, Chaicharn Hassanein, Mohamed Slee, April Canovatchel, William Hamilton, Gill |
author_facet | John, Mathew Cerdas, Sonia Violante, Rafael Deerochanawong, Chaicharn Hassanein, Mohamed Slee, April Canovatchel, William Hamilton, Gill |
author_sort | John, Mathew |
collection | PubMed |
description | AIMS: Patients with type 2 diabetes mellitus (T2DM) have increased risk of adverse events (AEs; e.g. dehydration, hypoglycaemia) in hot weather. This analysis assessed the efficacy and safety of canagliflozin, a sodium glucose co‐transporter 2 (SGLT2) inhibitor, in patients with T2DM who live in hot climates. METHODS: This post hoc analysis evaluated patients with T2DM using pooled data from four 26‐week, placebo‐controlled studies (N=2,313) and data from a 104‐week, active‐controlled study (add‐on to metformin vs glimepiride; N=1,450). Changes in HbA1c, fasting plasma glucose (FPG), body weight and blood pressure (BP) were assessed in subsets of patients living in hot climates (pooled, placebo‐controlled studies, n=611; active‐controlled study, n=307) and those living in other climates (i.e. other climate subset; pooled, placebo‐controlled studies, n=1,702; active‐controlled study, n=1,143). Safety was assessed based on AE reports. RESULTS: Canagliflozin 100 and 300 mg lowered HbA1c, FPG, body weight and BP vs placebo over 26 weeks and glimepiride over 104 weeks in the hot climate subsets. Canagliflozin was generally well tolerated in the hot climate subsets, with a higher incidence of AEs related to the mechanism of SGLT2 inhibition (i.e. genital mycotic infections). Volume depletion–related AEs were low across groups. CONCLUSION: Canagliflozin improved glycaemic control, lowered body weight and BP, and was generally well tolerated in patients with T2DM living in hot climates compared with placebo over 26 weeks or glimepiride over 104 weeks. Clinical Trials registration: ClinicalTrials.gov NCT01081834, NCT01106677, NCT01106625, NCT01106690, NCT00968812. |
format | Online Article Text |
id | pubmed-5129493 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-51294932016-11-30 Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates John, Mathew Cerdas, Sonia Violante, Rafael Deerochanawong, Chaicharn Hassanein, Mohamed Slee, April Canovatchel, William Hamilton, Gill Int J Clin Pract Endocrinology AIMS: Patients with type 2 diabetes mellitus (T2DM) have increased risk of adverse events (AEs; e.g. dehydration, hypoglycaemia) in hot weather. This analysis assessed the efficacy and safety of canagliflozin, a sodium glucose co‐transporter 2 (SGLT2) inhibitor, in patients with T2DM who live in hot climates. METHODS: This post hoc analysis evaluated patients with T2DM using pooled data from four 26‐week, placebo‐controlled studies (N=2,313) and data from a 104‐week, active‐controlled study (add‐on to metformin vs glimepiride; N=1,450). Changes in HbA1c, fasting plasma glucose (FPG), body weight and blood pressure (BP) were assessed in subsets of patients living in hot climates (pooled, placebo‐controlled studies, n=611; active‐controlled study, n=307) and those living in other climates (i.e. other climate subset; pooled, placebo‐controlled studies, n=1,702; active‐controlled study, n=1,143). Safety was assessed based on AE reports. RESULTS: Canagliflozin 100 and 300 mg lowered HbA1c, FPG, body weight and BP vs placebo over 26 weeks and glimepiride over 104 weeks in the hot climate subsets. Canagliflozin was generally well tolerated in the hot climate subsets, with a higher incidence of AEs related to the mechanism of SGLT2 inhibition (i.e. genital mycotic infections). Volume depletion–related AEs were low across groups. CONCLUSION: Canagliflozin improved glycaemic control, lowered body weight and BP, and was generally well tolerated in patients with T2DM living in hot climates compared with placebo over 26 weeks or glimepiride over 104 weeks. Clinical Trials registration: ClinicalTrials.gov NCT01081834, NCT01106677, NCT01106625, NCT01106690, NCT00968812. John Wiley and Sons Inc. 2016-09-06 2016-09 /pmc/articles/PMC5129493/ /pubmed/27600862 http://dx.doi.org/10.1111/ijcp.12868 Text en © 2016 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Endocrinology John, Mathew Cerdas, Sonia Violante, Rafael Deerochanawong, Chaicharn Hassanein, Mohamed Slee, April Canovatchel, William Hamilton, Gill Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates |
title | Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates |
title_full | Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates |
title_fullStr | Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates |
title_full_unstemmed | Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates |
title_short | Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates |
title_sort | efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates |
topic | Endocrinology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5129493/ https://www.ncbi.nlm.nih.gov/pubmed/27600862 http://dx.doi.org/10.1111/ijcp.12868 |
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