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  • RAS inhibitors fail to...

RAS inhibitors fail to improve outcomes in patients hospitalized with severe COVID-19: JAMA

Written By : Medha Baranwal |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2023-04-14T20:00:30+05:30  |  Updated On 14 April 2023 8:00 PM IST
RAS inhibitors fail to improve outcomes in patients hospitalized with severe COVID-19: JAMA
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USA: Initiating a renin-angiotensin system (RAS) inhibitor as a treatment for COVID-19 does not improve and likely worsens clinical outcomes in critically ill patients, according to findings from three randomized trials -- REMAP-CAP trial and two trials from the ACTIV-4 program. The trial's results were published in the Journal of the American Medical Association (JAMA).

The REMAP-CAP trial was stopped early because of safety concerns, while the other two trials were terminated at the first interim analysis after failing to demonstrate a sufficient probability of efficacy.

In the REMAP-CAP randomized clinical trial that included 779 patients (721 critically ill and 58 non–critically ill hospitalized adults), initiation of an ACE (angiotensin-converting enzyme) inhibitor or angiotensin receptor blocker, ARB (RAS inhibitors) did not improve organ support–free days (10 for those who received an ACE inhibitor, 8 for those who received an ARB and 12 in the control group). Among critically ill patients, there was a 95% probability that treatments worsened this outcome.

The key findings of the REMAP-CAP trial are as follows:

  • Among 679 critically ill patients with available primary outcome data, the median age was 56, and 35.2% were women.
  • Median organ support–free days among critically ill patients was 10 in the ACE inhibitor group (n = 231), 8 in the ARB group (n = 217), and 12 in the control group (n = 231) (median adjusted odds ratios of 0.77 for improvement for ACE inhibitor and 0.76 for ARB compared with control).
  • The posterior probabilities that ARBs and ACE inhibitors worsened organ support–free days compared with control were 95.4% and 94.9%, respectively.
  • Hospital survival occurred in 71.9% of critically ill participants in the ACE inhibitor group, 70.0% in the ARB group, and 78.8% in the control group (posterior probabilities that ARB and ACE inhibitor worsened hospital survival compared with control were 98.1% and 95.3% respectively).

"Our findings showed that initiation of an ACE inhibitor or ARB among critically ill adults with COVID-19 did not improve, and likely worsened, clinical outcomes," REMAP-CAP Investigators concluded.

In 2 placebo-controlled, randomized clinical trials, Wesley H. Self, Vanderbilt University Medical Center, Nashville, Tennessee, and colleagues determined if treatment with synthetic angiotensin (1-7) (TXA-127) or an angiotensin II type 1 receptor–biased ligand (TRV-027) improve clinical outcomes in adults hospitalized with severe COVID-19.

Dr Self and colleagues reported that the number of days alive and free from supplemental oxygen during the 28 days following trial enrollment (oxygen-free days) was not significantly different from the placebo for TXA-127 or TRV-027.

The two randomized clinical trials included adults hospitalized with acute COVID-19 and new-onset hypoxemia and were conducted at 35 sites in the US between 2021 and 2022; the last follow-up visit: was on July 26, 2022, and reported the following findings:

  • Both trials met prespecified early stopping criteria for a low probability of efficacy. Of 343 patients in the TXA-127 trial (65.9% aged 31-64 years, 58.3% men), 170 received TXA-127 and 173 received placebo.
  • Of 290 patients in the TRV-027 trial (68.6% aged 31-64 years, 57.9% men), 145 received TRV-027 and 145 received a placebo.
  • Compared with placebo, TXA-127 (unadjusted mean difference, −2.3; adjusted OR, 0.88) and TRV-027 (unadjusted mean difference, −2.4; adjusted OR, 0.74 resulted in no difference in oxygen-free days.
  • In the TXA-127 trial, 28-day all-cause mortality occurred in 13.5% of patients in the TXA-127 group vs 13.3% of patients in the placebo group (adjusted OR, 0.83).
  • In the TRV-027 trial, 28-day all-cause mortality occurred in 20.6% of patients in the TRV-027 group vs 12.9% in the placebo group (adjusted OR, 1.52).
  • The frequency of the safety outcomes was similar with either TXA-127 or TRV-027 vs placebo.

"These findings do not support the hypotheses that pharmacological interventions that selectively block the angiotensin II type 1 receptor or increase angiotensin (1-7) improve outcomes for severe COVID-19 patients," Dr Self and team concluded.

References

1) Writing Committee for the REMAP-CAP Investigators. Effect of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Initiation on Organ Support–Free Days in Patients Hospitalized With COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(14):1183–1196. doi:10.1001/jama.2023.4480

2) Self WH, Shotwell MS, Gibbs KW, et al. Renin-Angiotensin System Modulation With Synthetic Angiotensin (1-7) and Angiotensin II Type 1 Receptor–Biased Ligand in Adults With COVID-19: Two Randomized Clinical Trials. JAMA. 2023;329(14):1170–1182. doi:10.1001/jama.2023.3546


Journal of the American Medical AssociationJAMARAS inhibitorCOVID-19critically illangiotensin receptor blockerARBACE inhibitor
Source : Journal of the American Medical Association
Medha Baranwal
Medha Baranwal

    MSc. Biotechnology

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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