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Prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension

INTRODUCTION: Whether ACE inhibitors (ACEi) or angiotensin II receptor blocker (ARB) therapy should be continued, initiated or ceased in patients with COVID-19 is uncertain. Given the widespread use of ACEi/ARBs worldwide, guidance on the use of these drugs is urgently needed. This prospective meta-...

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Autores principales: Gnanenthiran, Sonali Rukshana, Borghi, Claudio, Burger, Dylan, Charchar, Fadi, Poulter, Neil R, Schlaich, Markus P, Steckelings, Ulrike Muscha, Stergiou, George, Tomaszewski, Maciej, Unger, Thomas, Wainford, Richard D, Williams, Bryan, Rodgers, Anthony, Schutte, Aletta E
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887864/
https://www.ncbi.nlm.nih.gov/pubmed/33593784
http://dx.doi.org/10.1136/bmjopen-2020-043625
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author Gnanenthiran, Sonali Rukshana
Borghi, Claudio
Burger, Dylan
Charchar, Fadi
Poulter, Neil R
Schlaich, Markus P
Steckelings, Ulrike Muscha
Stergiou, George
Tomaszewski, Maciej
Unger, Thomas
Wainford, Richard D
Williams, Bryan
Rodgers, Anthony
Schutte, Aletta E
author_facet Gnanenthiran, Sonali Rukshana
Borghi, Claudio
Burger, Dylan
Charchar, Fadi
Poulter, Neil R
Schlaich, Markus P
Steckelings, Ulrike Muscha
Stergiou, George
Tomaszewski, Maciej
Unger, Thomas
Wainford, Richard D
Williams, Bryan
Rodgers, Anthony
Schutte, Aletta E
author_sort Gnanenthiran, Sonali Rukshana
collection PubMed
description INTRODUCTION: Whether ACE inhibitors (ACEi) or angiotensin II receptor blocker (ARB) therapy should be continued, initiated or ceased in patients with COVID-19 is uncertain. Given the widespread use of ACEi/ARBs worldwide, guidance on the use of these drugs is urgently needed. This prospective meta-analysis aims to pool data from randomised controlled trials (RCTs) to assess the safety and efficacy of ACEi/ARB therapy in adults infected with SARS-CoV-2. METHODS AND ANALYSIS: RCTs will be eligible if they compare patients with COVID-19 randomised to ACEi/ARB continuation or commencement versuss no ACEi/ARB therapy; study duration ≥14 days; recruitment completed between March 2020 and May 2021. The primary outcome will be all-cause mortality at ≤30 days. Secondary outcomes will include mechanical ventilation, admission to intensive care or cardiovascular events at short-term follow-up (≤30 days) and all-cause mortality at longer-term follow-up (>1 month). Prespecified subgroup analyses will assess the effect of sex; age; comorbidities; smoking status; ethnicity; country of origin on all-cause mortality. A search of ClinicalTrials.gov has been performed, which will be followed by a formal search of trial registers, preprint servers, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials to identify RCTs that meet inclusion criteria. To date, a search of ClinicalTrials.gov identified 21 potentially eligible trials for this meta-analysis. We will request trial investigators/sponsors to contribute standardised grouped tabular outcome data. ETHICS AND DISSEMINATION: Ethics approval and informed consent will be the responsibility of the individual RCTs. Dissemination of results will occur by peer-reviewed publication. The results of our analysis can inform public health policy and clinical decision making regarding ACEi/ARB use in patients with COVID-19 on a global scale.
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spelling pubmed-78878642021-02-17 Prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension Gnanenthiran, Sonali Rukshana Borghi, Claudio Burger, Dylan Charchar, Fadi Poulter, Neil R Schlaich, Markus P Steckelings, Ulrike Muscha Stergiou, George Tomaszewski, Maciej Unger, Thomas Wainford, Richard D Williams, Bryan Rodgers, Anthony Schutte, Aletta E BMJ Open Cardiovascular Medicine INTRODUCTION: Whether ACE inhibitors (ACEi) or angiotensin II receptor blocker (ARB) therapy should be continued, initiated or ceased in patients with COVID-19 is uncertain. Given the widespread use of ACEi/ARBs worldwide, guidance on the use of these drugs is urgently needed. This prospective meta-analysis aims to pool data from randomised controlled trials (RCTs) to assess the safety and efficacy of ACEi/ARB therapy in adults infected with SARS-CoV-2. METHODS AND ANALYSIS: RCTs will be eligible if they compare patients with COVID-19 randomised to ACEi/ARB continuation or commencement versuss no ACEi/ARB therapy; study duration ≥14 days; recruitment completed between March 2020 and May 2021. The primary outcome will be all-cause mortality at ≤30 days. Secondary outcomes will include mechanical ventilation, admission to intensive care or cardiovascular events at short-term follow-up (≤30 days) and all-cause mortality at longer-term follow-up (>1 month). Prespecified subgroup analyses will assess the effect of sex; age; comorbidities; smoking status; ethnicity; country of origin on all-cause mortality. A search of ClinicalTrials.gov has been performed, which will be followed by a formal search of trial registers, preprint servers, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials to identify RCTs that meet inclusion criteria. To date, a search of ClinicalTrials.gov identified 21 potentially eligible trials for this meta-analysis. We will request trial investigators/sponsors to contribute standardised grouped tabular outcome data. ETHICS AND DISSEMINATION: Ethics approval and informed consent will be the responsibility of the individual RCTs. Dissemination of results will occur by peer-reviewed publication. The results of our analysis can inform public health policy and clinical decision making regarding ACEi/ARB use in patients with COVID-19 on a global scale. BMJ Publishing Group 2021-02-16 /pmc/articles/PMC7887864/ /pubmed/33593784 http://dx.doi.org/10.1136/bmjopen-2020-043625 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Cardiovascular Medicine
Gnanenthiran, Sonali Rukshana
Borghi, Claudio
Burger, Dylan
Charchar, Fadi
Poulter, Neil R
Schlaich, Markus P
Steckelings, Ulrike Muscha
Stergiou, George
Tomaszewski, Maciej
Unger, Thomas
Wainford, Richard D
Williams, Bryan
Rodgers, Anthony
Schutte, Aletta E
Prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension
title Prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension
title_full Prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension
title_fullStr Prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension
title_full_unstemmed Prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension
title_short Prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension
title_sort prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with covid-19: an initiative of the international society of hypertension
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887864/
https://www.ncbi.nlm.nih.gov/pubmed/33593784
http://dx.doi.org/10.1136/bmjopen-2020-043625
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