ICU sedation, delirium & recovery
Simvastatin in Critically Ill Patients with Covid-19
Primary result · Organ support-free daysResult — go to the resultPosterior median adjusted OR 1.15 95% CrI 0.98–1.34Authors' conclusion
Although recruitment was stopped because cases had decreased, among critically ill patients with Covid-19, simvastatin did not meet the prespecified criteria for superiority to control.
Study context
- Population
- Critically ill patients with Covid-19 not receiving statins at baselinefinal analysis
- Participants
- 2,684 patients
- Comparison
- Simvastatin 80 mg daily vs no statin
- Primary endpoint
- Respiratory and cardiovascular organ support-free days (ordinal scale: in-hospital death = −1; days free of organ support through day 21 in survivors)
- Follow-up
- Day 21
Methodological detailsinternational, multifactorial, adaptive platform, Bayesian hierarchical ordinal model, prespecified statistical stopping criteria, Enrollment began October 28, 2020; closed January 8, 2023 on a low anticipated likelihood that prespecified stopping criteria would be met as Covid-19 cases decreased
- International
- Multifactorial
- Adaptive platform
- Bayesian hierarchical ordinal model
- Prespecified statistical stopping criteria
- Enrollment began October 28, 2020; closed January 8, 2023 on a low anticipated likelihood that prespecified stopping criteria would be met as Covid-19 cases decreased
Primary result
Organ support-free days
Posterior median adjusted OR
1.15
95% CrI 0.98–1.34
By group
Simvastatin vs Control
posterior median adjusted OR 1.15 (95% CrI 0.98–1.34)
As reported in the abstract
Further findings
| Outcome | HR for survival (95% CrI) | |
|---|---|---|
| Survival · 90 daysBayesian analysis; CrI | 1.12 (0.95–1.32) | |
| 0.512HR for survival (log scale) |
- Survival: 95% CrI; 91.9% posterior probability of superiority of simvastatin
Secondary analyses
- Results consistent with those of the primary analysis
Safety
Serious adverse events (e.g. elevated liver enzymes and creatine kinase)
- Reported more frequently with simvastatin than with control
Original publication
Simvastatin in Critically Ill Patients with Covid-19. N Engl J Med. Published 25 October 2023. doi:10. 1056/ nejmoa2309995
Composed by AI from the published abstract and checked against it. How Briefs are made →