ICU sedation, delirium & recovery

Simvastatin in Critically Ill Patients with Covid-19

N Engl J MedPublished Randomised controlled trial

Primary result · Organ support-free daysResult — go to the resultPosterior median adjusted OR 1.15 95% CrI 0.98–1.34

Authors' 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

OutcomeHR for survival (95% CrI)
Survival · 90 daysBayesian analysis; CrI1.12 (0.95–1.32)
  • 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

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