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Atorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial

Azita H Talasaz1,2, Parham Sadeghipour3,4,5, Hooman Bakhshandeh3,4

  • 1Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.

Thrombosis and Haemostasis
|March 21, 2023
PubMed

Insights

Atorvastatin did not significantly reduce major adverse events in COVID-19 ICU patients at 90 days. However, early atorvastatin treatment showed a potential benefit for reducing thrombosis and improving function in select patients.

Area of Science:

  • Critical Care Medicine
  • Cardiovascular Pharmacology
  • Infectious Diseases

Background:

  • The INSPIRATION-S trial previously showed a non-significant 16% reduction in 30-day thrombotic events or death with atorvastatin in COVID-19 ICU patients.
  • The prolonged thrombo-inflammatory response in COVID-19 suggests potential benefits of extended atorvastatin treatment beyond 30 days.

Purpose of the Study:

  • To evaluate the 90-day clinical and functional outcomes of atorvastatin versus placebo in intensive care unit (ICU) patients with COVID-19.
  • To assess the impact of atorvastatin on composite outcomes including thrombosis, extracorporeal membrane oxygenation (ECMO) use, and all-cause mortality.

Main Methods:

  • A double-blind, multicenter, randomized trial (INSPIRATION-S) involving adult ICU patients with COVID-19.
  • Patients received either 20 mg of atorvastatin daily or a placebo.
  • Primary outcome was a composite of adjudicated venous/arterial thrombosis, ECMO treatment, or all-cause mortality at 90 days. Functional status was measured using the Post-COVID-19 Functional Scale.

Main Results:

  • The primary composite outcome occurred in 33.1% of patients on atorvastatin versus 38.0% on placebo (HR: 0.80, 95% CI: 0.60-1.05, p=0.11).
  • Atorvastatin was associated with a reduced 90-day hazard for the primary outcome in patients presenting within 7 days of symptom onset (HR: 0.60, 95% CI: 0.42-0.86, p_interaction=0.02).
  • Improved 90-day functional status was observed with atorvastatin, though the confidence interval included 1.0 (OR_ordinal: 0.64, 95% CI: 0.41-1.01, p=0.05).

Conclusions:

  • Atorvastatin 20 mg daily did not significantly reduce the composite outcome of death, ECMO, or thrombosis at 90 days compared to placebo.
  • The study suggests a potential clinically meaningful benefit of atorvastatin, particularly in patients who presented within 7 days of symptom onset.
  • Further research may be warranted to explore the specific benefits of early atorvastatin administration in COVID-19 patients.
Abstract

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