REMAP-CAP (simvastatin)
Trial question
What is the role of simvastatin in critically ill patients with COVID-19 infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 2688
2688 patients (907 female, 1781 male)
Inclusion criteria: critically ill patients with COVID-19 infection who were not receiving statins at baseline
Key exclusion criteria: receipt of statin therapy or another medication that could not be co-administered with simvastatin; severe liver disease; a creatinine level > 2.26 mg/dL unless the patient was receiving RRT; a duration of > 48 hours since the start of organ support in an ICU
Interventions
N=1846 simvastatin (at a dose of 80 mg daily)
N=842 no statin (standard of care without any simvastatin)
Primary outcome
Median number of organ support-free days
11
7
11.0 days
8.3 days
5.5 days
2.8 days
0.0 days
Simvastatin
No
statin
No significant
difference ↔
No significant difference in median number of organ support-free days (11 days vs. 7 days; OR 1.15, 95% CI 0.98 to 1.34)
Secondary outcomes
No significant difference in in-hospital survival (73.4% vs. 70%; OR 1.04, 95% CI 0.85 to 1.27)
No significant difference in progression to invasive mechanical ventilation, ECMO, or death (37% vs. 42.5%; OR 0.81, 95% CI 0.64 to 1.02)
Borderline significant increase in median respiratory support-free days (18 days vs. 14 days; OR 1.16, 95% CI 1 to 1.35)
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In critically ill patients with COVID-19 infection who were not receiving statins at baseline, simvastatin was not superior to no statin with respect to median number of organ support-free days.
Reference
REMAP-CAP Investigators, Thomas E Hills, Elizabeth Lorenzi et al. Simvastatin in Critically Ill Patients with Covid-19. N Engl J Med. 2023 Dec 21;389(25):2341-2354.
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