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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2022
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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). |
format | Online Article Text |
id | pubmed-8811446 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
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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