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Effect of Discontinuing vs Continuing Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers on Days Alive and Out of the Hospital in Patients Admitted With COVID-19: A Randomized Clinical Trial.

Publication ,  Journal Article
Lopes, RD; Macedo, AVS; de Barros E Silva, PGM; Moll-Bernardes, RJ; Dos Santos, TM; Mazza, L; Feldman, A; D'Andréa Saba Arruda, G; Camiletti, AS ...
Published in: JAMA
January 19, 2021

IMPORTANCE: It is unknown whether angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) have a positive, neutral, or negative effect on clinical outcomes in patients with coronavirus disease 2019 (COVID-19). OBJECTIVE: To determine whether discontinuation compared with continuation of ACEIs or ARBs changed the number of days alive and out of the hospital through 30 days. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of 659 patients hospitalized in Brazil with mild to moderate COVID-19 who were taking ACEIs or ARBs prior to hospitalization (enrolled: April 9-June 26, 2020; final follow-up: July 26, 2020). INTERVENTIONS: Discontinuation (n = 334) or continuation (n = 325) of ACEIs or ARBs. MAIN OUTCOMES AND MEASURES: The primary outcome was the number of days alive and out of the hospital through 30 days. Secondary outcomes included death, cardiovascular death, and COVID-19 progression. RESULTS: Among 659 patients, the median age was 55.1 years (interquartile range [IQR], 46.1-65.0 years), 14.7% were aged 70 years or older, 40.4% were women, and 100% completed the trial. The median time from symptom onset to hospital admission was 6 days (IQR, 4-9 days) and 27.2% of patients had an oxygen saturation of less than 94% of room air at baseline. In terms of clinical severity, 57.1% of patients were considered mild at hospital admission and 42.9% were considered moderate. There was no significant difference in the number of days alive and out of the hospital in patients in the discontinuation group (mean, 21.9 days [SD, 8 days]) vs patients in the continuation group (mean, 22.9 days [SD, 7.1 days]) and the mean ratio was 0.95 (95% CI, 0.90-1.01). There also was no statistically significant difference in death (2.7% for the discontinuation group vs 2.8% for the continuation group; odds ratio [OR], 0.97 [95% CI, 0.38-2.52]), cardiovascular death (0.6% vs 0.3%, respectively; OR, 1.95 [95% CI, 0.19-42.12]), or COVID-19 progression (38.3% vs 32.3%; OR, 1.30 [95% CI, 0.95-1.80]). The most common adverse events were respiratory failure requiring invasive mechanical ventilation (9.6% in the discontinuation group vs 7.7% in the continuation group), shock requiring vasopressors (8.4% vs 7.1%, respectively), acute myocardial infarction (7.5% vs 4.6%), new or worsening heart failure (4.2% vs 4.9%), and acute kidney failure requiring hemodialysis (3.3% vs 2.8%). CONCLUSIONS AND RELEVANCE: Among patients hospitalized with mild to moderate COVID-19 and who were taking ACEIs or ARBs before hospital admission, there was no significant difference in the mean number of days alive and out of the hospital for those assigned to discontinue vs continue these medications. These findings do not support routinely discontinuing ACEIs or ARBs among patients hospitalized with mild to moderate COVID-19 if there is an indication for treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04364893.

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Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

January 19, 2021

Volume

325

Issue

3

Start / End Page

254 / 264

Location

United States

Related Subject Headings

  • Withholding Treatment
  • Treatment Outcome
  • Time Factors
  • Shock
  • Sample Size
  • SARS-CoV-2
  • Respiratory Insufficiency
  • Respiration, Artificial
  • Patient Discharge
  • Odds Ratio
 

Citation

APA
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Lopes, R. D., Macedo, A. V. S., de Barros E Silva, P. G. M., Moll-Bernardes, R. J., Dos Santos, T. M., Mazza, L., … BRACE CORONA Investigators, . (2021). Effect of Discontinuing vs Continuing Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers on Days Alive and Out of the Hospital in Patients Admitted With COVID-19: A Randomized Clinical Trial. JAMA, 325(3), 254–264. https://doi.org/10.1001/jama.2020.25864
Lopes, Renato D., Ariane V. S. Macedo, Pedro G. M. de Barros E Silva, Renata J. Moll-Bernardes, Tiago M. Dos Santos, Lilian Mazza, André Feldman, et al. “Effect of Discontinuing vs Continuing Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers on Days Alive and Out of the Hospital in Patients Admitted With COVID-19: A Randomized Clinical Trial.JAMA 325, no. 3 (January 19, 2021): 254–64. https://doi.org/10.1001/jama.2020.25864.
Lopes RD, Macedo AVS, de Barros E Silva PGM, Moll-Bernardes RJ, Dos Santos TM, Mazza L, Feldman A, D’Andréa Saba Arruda G, de Albuquerque DC, Camiletti AS, de Sousa AS, de Paula TC, Giusti KGD, Domiciano RAM, Noya-Rabelo MM, Hamilton AM, Loures VA, Dionísio RM, Furquim TAB, De Luca FA, Dos Santos Sousa ÍB, Bandeira BS, Zukowski CN, de Oliveira RGG, Ribeiro NB, de Moraes JL, Petriz JLF, Pimentel AM, Miranda JS, de Jesus Abufaiad BE, Gibson CM, Granger CB, Alexander JH, de Souza OF, BRACE CORONA Investigators. Effect of Discontinuing vs Continuing Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers on Days Alive and Out of the Hospital in Patients Admitted With COVID-19: A Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):254–264.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

January 19, 2021

Volume

325

Issue

3

Start / End Page

254 / 264

Location

United States

Related Subject Headings

  • Withholding Treatment
  • Treatment Outcome
  • Time Factors
  • Shock
  • Sample Size
  • SARS-CoV-2
  • Respiratory Insufficiency
  • Respiration, Artificial
  • Patient Discharge
  • Odds Ratio