INSPIRATION-S
Trial question
What is the role of atorvastatin in critically ill adult patients with COVID-19?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 587
587 patients (256 female, 331 male).
Inclusion criteria: adult patients with COVID-19 admitted to the ICU.
Key exclusion criteria: estimated survival < 24 hours; weight < 40 kg; major bleeding or serious bleeding diathesis within 30 days from enrollment; liver enzymes > 5 times the ULN; active liver disease; CK concentration > 500 U/L.
Interventions
N=290 atorvastatin (20 mg per oral daily for 30 days).
N=297 placebo (matching placebo).
Primary outcome
Venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or death from any cause at day 30
33%
36%
36.0 %
27.0 %
18.0 %
9.0 %
0.0 %
Atorvastatin
Placebo
No significant
difference ↔
No significant difference in venous or arterial thrombosis, treatment with ECMO, or death from any cause at day 30 (33% vs. 36%; OR 0.84, 95% CI 0.58 to 1.21).
Secondary outcomes
No significant difference in death from any cause (31% vs. 35%; OR 0.84, 95% CI 0.58 to 1.22).
No significant difference in VTE (2% vs. 3%; OR 0.71, 95% CI 0.24 to 2.06).
No significant difference in arterial thrombosis (0% vs. 0.3%; ARD -0.3, 95% CI -0.9 to 0.3).
Safety outcomes
No significant differences in elevated liver enzymes, fatal bleeding.
Conclusion
In adult patients with COVID-19 admitted to the ICU, atorvastatin was not superior to placebo with respect to venous or arterial thrombosis, treatment with ECMO, or death from any cause at day 30.
Reference
INSPIRATION-S Investigators. Atorvastatin versus placebo in patients with covid-19 in intensive care: randomized controlled trial. BMJ. 2022 Jan 7;376:e068407.
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