Simvastatin not superior to standard of care critically ill patients with COVID-19

In the treatment of critically ill patients with COVID-19, simvastatin is not necessarily better than standard of care in terms of improving organ support-free days and death outcomes, according to a study.

The study included 2,684 COVID-19 patients who were receiving respiratory organ support (high-flow nasal oxygen with a flow rate of ≥30 litres per minute and a fraction of inspired oxygen of ≥0.4 or noninvasive or invasive mechanical ventilation) or cardiovascular organ support (vasopressors or inotropes) in an intensive care unit. These patients were randomly assigned to receive simvastatin (80 mg daily) or no statin (control). All patients received care according to the standard of care at each site.

The primary endpoint was the composite of respiratory and cardiovascular organ support–free days and days free of organ support through day 21 in survivors. Researchers applied a Bayesian hierarchical ordinal model in the analysis.

Enrolment was terminated prematurely due to a low anticipated likelihood that prespecified stopping criteria would be met as COVID-19 cases decreased. The median number of organ support–free days was 11 in the simvastatin group versus 7 in the control group (odds ratio, 1.15, 95 percent credible interval [CrI], 0.98–1.34), with the 95.9 percent posterior probability of superiority failing to meet the prespecified criteria for superiority to control.

The same was true for survival at 90 days (hazard ratio, 1.12, 95 percent CrI, 0.95–1.32), with a 91.9 percent posterior probability of superiority. Death within 90 days occurred in 27.5 percent of patients in the simvastatin group and in 30.7 percent in the control group.