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Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis

Objective: To evaluate the efficacy and safety of ertugliflozin in patients with type 2 diabetes. Methods: MEDLINE, EMBASE, and Cochrane Library were searched (July 31, 2021) for phase II/III randomized clinical trials, which reported the efficacy and safety of ertugliflozin. Continuous variables we...

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Autores principales: Liu, Li, Shi, Fang-Hong, Xu, Hua, Wu, Yue, Gu, Zhi-Chun, Lin, Hou-Wen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8811446/
https://www.ncbi.nlm.nih.gov/pubmed/35126103
http://dx.doi.org/10.3389/fphar.2021.752440
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author Liu, Li
Shi, Fang-Hong
Xu, Hua
Wu, Yue
Gu, Zhi-Chun
Lin, Hou-Wen
author_facet Liu, Li
Shi, Fang-Hong
Xu, Hua
Wu, Yue
Gu, Zhi-Chun
Lin, Hou-Wen
author_sort Liu, Li
collection PubMed
description Objective: To evaluate the efficacy and safety of ertugliflozin in patients with type 2 diabetes. Methods: MEDLINE, EMBASE, and Cochrane Library were searched (July 31, 2021) for phase II/III randomized clinical trials, which reported the efficacy and safety of ertugliflozin. Continuous variables were calculated as weighted mean difference (WMD) and associated 95% confidence intervals (CIs); dichotomous data were expressed as risk ratios (RRs) with 95% CIs. Results: Nine randomized clinical trials including 5638 type 2 diabetes patients were included. For efficacy, ertugliflozin significantly reduced HbA1c (%) (WMD −0.452%; 95% CI −0.774 to −0.129), fasting plasma glucose (FPG) (WMD −0.870 mmol/L; 95% CI −1.418 to −0.322), body weight (WMD −1.774 kg; 95% CI −2.601 to −0.946), and blood pressure levels (systolic blood pressure: WMD −2.572 mmHg; 95% CI −3.573 to −1.571 and diastolic blood pressure: WMD −1.152 mmHg; 95% CI −2.002 to −0.303) compared with placebo and other hypoglycaemic agents. Compared with placebo, ertugliflozin was superior in reducing HbA1c (%) (WMD −0.641%) and FPG (WMD −1.249 mmol/L). And compared with active agents, ertugliflozin also could decrease HbA1c by 0.215% and FPG by 0.266 mmol/L. The interactive effect between different controls was significant (P (interaction) of 0.039). For safety, similar to other sodium-glucose cotransporter type-2 inhibitors, ertugliflozin mainly increased the risk of genital mycotic infection (RR: 4.004; 95% CI 2.504–6.402). There was no significant difference in the incidence of any adverse events (AEs), AEs related to study drug, serious AEs, deaths, and discontinuations due to AEs. Results were consistent with the most primary outcomes in subgroups analysis and sensitivity analysis. Conclusion: Ertugliflozin was relatively effective and tolerated in patients with type 2 diabetes compared with placebo or other hypoglycaemic agents, except for a high risk of genital mycotic infection. Systematic Review Registration: (ClinicalTrials.gov), identifier (CRD42020206356).
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spelling pubmed-88114462022-02-04 Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis Liu, Li Shi, Fang-Hong Xu, Hua Wu, Yue Gu, Zhi-Chun Lin, Hou-Wen Front Pharmacol Pharmacology Objective: To evaluate the efficacy and safety of ertugliflozin in patients with type 2 diabetes. Methods: MEDLINE, EMBASE, and Cochrane Library were searched (July 31, 2021) for phase II/III randomized clinical trials, which reported the efficacy and safety of ertugliflozin. Continuous variables were calculated as weighted mean difference (WMD) and associated 95% confidence intervals (CIs); dichotomous data were expressed as risk ratios (RRs) with 95% CIs. Results: Nine randomized clinical trials including 5638 type 2 diabetes patients were included. For efficacy, ertugliflozin significantly reduced HbA1c (%) (WMD −0.452%; 95% CI −0.774 to −0.129), fasting plasma glucose (FPG) (WMD −0.870 mmol/L; 95% CI −1.418 to −0.322), body weight (WMD −1.774 kg; 95% CI −2.601 to −0.946), and blood pressure levels (systolic blood pressure: WMD −2.572 mmHg; 95% CI −3.573 to −1.571 and diastolic blood pressure: WMD −1.152 mmHg; 95% CI −2.002 to −0.303) compared with placebo and other hypoglycaemic agents. Compared with placebo, ertugliflozin was superior in reducing HbA1c (%) (WMD −0.641%) and FPG (WMD −1.249 mmol/L). And compared with active agents, ertugliflozin also could decrease HbA1c by 0.215% and FPG by 0.266 mmol/L. The interactive effect between different controls was significant (P (interaction) of 0.039). For safety, similar to other sodium-glucose cotransporter type-2 inhibitors, ertugliflozin mainly increased the risk of genital mycotic infection (RR: 4.004; 95% CI 2.504–6.402). There was no significant difference in the incidence of any adverse events (AEs), AEs related to study drug, serious AEs, deaths, and discontinuations due to AEs. Results were consistent with the most primary outcomes in subgroups analysis and sensitivity analysis. Conclusion: Ertugliflozin was relatively effective and tolerated in patients with type 2 diabetes compared with placebo or other hypoglycaemic agents, except for a high risk of genital mycotic infection. Systematic Review Registration: (ClinicalTrials.gov), identifier (CRD42020206356). Frontiers Media S.A. 2022-01-20 /pmc/articles/PMC8811446/ /pubmed/35126103 http://dx.doi.org/10.3389/fphar.2021.752440 Text en Copyright © 2022 Liu, Shi, Xu, Wu, Gu and Lin. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Liu, Li
Shi, Fang-Hong
Xu, Hua
Wu, Yue
Gu, Zhi-Chun
Lin, Hou-Wen
Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis
title Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis
title_full Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis
title_fullStr Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis
title_full_unstemmed Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis
title_short Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis
title_sort efficacy and safety of ertugliflozin in type 2 diabetes: a systematic review and meta-analysis
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8811446/
https://www.ncbi.nlm.nih.gov/pubmed/35126103
http://dx.doi.org/10.3389/fphar.2021.752440
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