The following is a summary of “Simvastatin in Critically Ill Patients with COVID-19,” published in the October 2023 issue of Critical Care by Michael et al.
Researchers started a retrospective study to assess the efficacy of simvastatin in critically ill patients with coronavirus disease 2019 (COVID-19).
They conducted an international, multifactorial, adaptive platform, randomized, controlled trial that assessed simvastatin (80 mg daily) compared to no statin (control) in critically ill patients with COVID-19 who did not receive statins at baseline. The primary outcome measured organ support-free days, combining in-hospital death (-1) and days without support up to day 21 for survivors. The analysis employed a Bayesian hierarchical ordinal model. The adaptive design featured predefined statistical stopping criteria for superiority (with a >99% posterior probability that the odds ratio exceeded 1) and futility (with a >95% posterior probability that the odds ratio was less than 1.2).
The results showed that enrollment was terminated on October 28, 2020, and on January 8, 2023, due to a low anticipated likelihood of meeting the predefined stopping criteria as COVID-19 cases decreased. The final analysis encompassed 2,684 critically ill patients. In the simvastatin group, the median number of organ–support–free days stood at 11 (IR, -1 to 17), while in the control group, it was 7 (IR, -1 to 16). The posterior median adjusted odds ratio for simvastatin versus control was 1.15 (95%CIl, 0.98 to 1.34), resulting in a 95.9% posterior probability of superiority. At 90 days, the hazard ratio for survival equaled 1.12 (95%CIl, 0.95 to 1.32), yielding a 91.9% posterior probability of simvastatin’s superiority. The findings of secondary analyses aligned with the primary analysis. Serious adverse events, such as elevated liver enzymes and creatine kinase, were more familiar with simvastatin.
They concluded that simvastatin was inferior to control in critically ill COVID-19 patients.