Atorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial.
Thromb Haemost
; 123(7): 723-733, 2023 Jul.
Article
in English
| MEDLINE | ID: covidwho-2283372
ABSTRACT
BACKGROUND:
In the INSPIRATION-S trial, atorvastatin versus placebo was associated with a nonsignificant 16% reduction in 30-day composite of venous/arterial thrombosis or death in intensive care unit (ICU) patients with COVID-19. Thrombo-inflammatory response in coronavirus disease 2019 (COVID-19) may last beyond the first 30 days.METHODS:
This article reports the effects of atorvastatin 20 mg daily versus placebo on 90-day clinical and functional outcomes from INSPIRATION-S, a double-blind multicenter randomized trial of adult ICU patients with COVID-19. The main outcome for this prespecified study was a composite of adjudicated venous/arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause mortality. Functional status was assessed with the Post-COVID-19 Functional Scale.RESULTS:
In the primary analysis, 587 patients were included (age 57 [Q1-Q3 45-68] years; 44% women). By 90-day follow-up, the main outcome occurred in 96 (33.1%) patients assigned to atorvastatin and 113 (38.0%) assigned to placebo (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.60-1.05, p = 0.11). Atorvastatin in patients who presented within 7 days of symptom onset was associated with reduced 90-day hazard for the main outcome (HR 0.60, 95% CI 0.42-0.86, p interaction = 0.02). Atorvastatin use was associated with improved 90-day functional status, although the upper bound CI crossed 1.0 (ORordinal 0.64, 95% CI 0.41-1.01, p = 0.05).CONCLUSION:
Atorvastatin 20 mg compared with placebo did not significantly reduce the 90-day composite of death, treatment with ECMO, or venous/arterial thrombosis. However, the point estimates do not exclude a potential clinically meaningful treatment effect, especially among patients who presented within 7 days of symptom onset (NCT04486508).
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Thrombosis
/
COVID-19
Type of study:
Cohort study
/
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Long Covid
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
English
Journal:
Thromb Haemost
Year:
2023
Document Type:
Article
Affiliation country:
A-2059-4844
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