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Lopes, Renato D; Macedo, Ariane V S; de Barros E Silva, Pedro G M; Moll-Bernardes, Renata J; Dos Santos, Tiago M; Mazza, Lilian; Feldman, André; D'Andréa Saba Arruda, Guilherme; de Albuquerque, Denílson C; Camiletti, Angelina S; de Sousa, Andréa S; de Paula, Thiago C; Giusti, Karla G D; Domiciano, Rafael A M; Noya-Rabelo, Márcia M; Hamilton, Alan M; Loures, Vitor A; Dionísio, Rodrigo M; Furquim, Thyago A B; De Luca, Fábio A; Dos Santos Sousa, Ítalo B; Bandeira, Bruno S; Zukowski, Cleverson N; de Oliveira, Ricardo G G; Ribeiro, Noara B; de Moraes, Jeffer L; Petriz, João L F; Pimentel, Adriana M; Miranda, Jacqueline S; de Jesus Abufaiad, Bárbara E; Gibson, C Michael; Granger, Christopher B; Alexander, John H; de Souza, Olga F
JAMA : the journal of the American Medical Association, 01/2021, Volume: 325, Issue: 3Journal Article
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). 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. 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). Discontinuation (n = 334) or continuation (n = 325) of ACEIs or ARBs. 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. 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%). 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. ClinicalTrials.gov Identifier: NCT04364893.
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