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Critical Care Reviews Podcast

REMAP-CAP Statin Domain

Oct 25, 2023
Scott Berry and Danny McAuley discuss the results of the statin domain of the REMAP-CAP trial, investigating the effectiveness of simvastatin in treating severe COVID-19. They explore the rationale behind using statins as an intervention, the trial's design and eligibility criteria, and the decision to stop the trial early. The primary outcome and results are presented, highlighting the potential benefits for clinicians. They also discuss response adaptive randomization, the inflammatory phenotype of patients, and the challenges of conducting mechanistic work alongside clinical trials during a pandemic.
36:10

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Quick takeaways

  • The REMAP-CAP trial found that Simvastatin did not meet the predefined stopping endpoint for critically ill COVID-19 patients, but demonstrated a posterior median adjusted odds ratio of 1.15 and a 95.9% posterior probability of survival, suggesting potential benefits in terms of in-hospital survival and reduced need for invasive mechanical ventilation.
  • The REMAP-CAP trial incorporated response adaptive randomization, allowing for a focus on interventions showing positive effects, and took into account the evolving treatment landscape of COVID-19, including the introduction of dexamethasone and other immunosuppressants. Subgroup analyses indicated that Simvastatin had a larger treatment effect in patients not receiving invasive mechanical ventilation at baseline and in those with higher systemic inflammation levels.

Deep dives

Effectiveness of Simvastatin in Severe COVID-19

The podcast episode discusses the results of the statin domain from the remap cap trial, focusing on the efficacy of Simvastatin in severe COVID-19. The trial used a platform design that allows for the investigation of multiple therapies simultaneously. Simvastatin was chosen based on evidence suggesting its pleiotropic effects, including reducing inflammation. The trial enrolled hospitalized patients with COVID-19, with inclusion criteria and exclusion criteria related to the severity of the patients' condition and pre-existing use of statins. The trial did not use a placebo, as per the standard practice in remap cap. The primary outcome measured was organ support three days up to day 21, which included mortality and days on organ support for survivors. The results showed that Simvastatin did not meet the predefined stopping endpoint, but demonstrated a posterior median adjusted odds ratio of 1.15 and a 95.9% posterior probability of survival. Secondary analyses were consistent with the primary analysis, showing potential benefits in terms of in-hospital survival, decreased need for invasive mechanical ventilation, and shorter ICU and hospital stays.

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