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BRACE-CORONA test – the first randomized trial to address the question of whether patients with COVID-19 should continue to take angiotensin-converting-enzyme inhibitors (ACEIs) or angiotensin-receptor blockers (ARBs) – now published.
The study, which was performed in hospital patients with COVID-19 who were taking ACEIs or ARB before hospitalization, showed no significant difference in the average number of live days in and out. from the hospital for those assigned to stop vs. those assigned to follow these medications.
However, there were suggestions that continuing to take ACEIs or ARBs may be beneficial for patients with more severe COVID-19.
The study was first presented at last year’s 2020 European Society for Geology (ESC) Congress 2020 and was reported by theheart.org | Medscape Epistemology at that time. The study was published online in JAMA on 19 January 2021.
“These findings do not support consistent discontinuation of ACEIs or ARB in hospitalized patients with moderate to severe COVID-19 if there is an indication for treatment,” the authors conclude.
Led by Renato D. Lopes, MD, Duke Clinical Research Institute, Durham, North Carolina, the researchers explain that there has been controversial speculation about the effect of renin-angiotensin-aldosterone system protectors ( RAAS) on the COVID-19 course.
Conversely, observations from animal models suggest that ACEIs and ARBs upregulate ACE2 expression, a receptor involved in SARS-CoV-2 infection of host target cells. This led to suggestions that these drugs could contribute to viral binding and cell entry. Conversely, RAAS inhibitors may benefit patients with COVID-19 through effects on angiotensin II expression and subsequent increases in angiotensin 1–7 and 1–9, which have vasodilatory effects. and anti-inflammatory that may reduce lung injuries.
The BRACE-CORONA trial included 659 hospitalized patients in Brazil with moderate to severe COVID-19 who were taking ACEIs or ARB before hospitalization. The median age of the patients was 55 years. Of these patients, 57.1% were considered to have moderate cases at the time of admission to hospital, and 42.9% were considered to have moderate cases.
Results showed no significant difference in the number of live and out-of-hospital days for patients in the stop group (average, 21.9 days) compared with patients in the follow-up group (average 22.9 days). . The average ratio was 0.95 (95% CI, 0.90 – 1.01).
There was no statistically significant difference in deaths (2.7% of the stop group versus 2.8% for the follow-up group); cardiovascular mortality (0.6% vs 0.3%), or COVID-19 progression (38.3% vs 32.3%).
The most common adverse event events were respiratory failure requiring aggressive mechanical ventilation (9.6% in the stop group vs. 7.7% in the follow-up group), panic requiring vasopressors (8.4% vs 7.1%), hungry myocardial infarction (7.5% vs. 4.6%), new or worsening heart failure (4.2% vs. 4.9%), and severe renal failure requiring hemodialysis (3.3% vs 2.8%).
The authors note that hip tolerance is an important comorbidity in patients with COVID-19. Recent data suggest that immunodeficiency may contribute to adverse outcomes among patients with COVID-19 and hip intolerance.
It has been proven that when long-term use of medications is discontinued during hospitalization, the use of these medications is often not initiated, due to clinical inertia. Long-term results worsen as a result, the authors report. In the current study, all patients had hip-tolerance, and more than 50% were obese; both of these potentials increase the risk for adverse outcomes with COVID-19, they add.
They point out that a sensitivity study in which a site was considered a random effect showed a statistically significant finding for the group that followed ACEIs or ARBn. This result was similar to the treatment study. There were also statistically significant interactions between treatment effects and some subgroups, such as patients with lower oxygen absorption and more disease on admission to hospital. For these patients, continuous ACEIs or ARB may be beneficial.
“The main studies with the results are null but 95% confidence intervals indicate that the study may have been the basis for finding a statistically significant benefit from following ACEIs or ARB,” they say.
Lopes has received grant support from Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Sanofi, and Pfizer and consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, Sanofi, and Portola .
JAMA. Published online 19 January 2021. Full text
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