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Atorvastatin for reduction of 28-day mortality in severe and critical COVID-19 patients: a randomized controlled
Naglaa Hamdi Eltahan1, Neamat Hamdy Elsawy2,3, Kholoud M Abdelaaty4
1Sherbin Central Hospital, Ministry of Health and Population, Sherbin, Egypt.
Insights
Atorvastatin did not significantly reduce mortality in severe COVID-19 patients. This study found no benefit in 28-day or 6-month survival rates for atorvastatin users compared to placebo.
Area of Science:
- Cardiology
- Infectious Diseases
- Critical Care Medicine
Background:
- COVID-19 involves abnormal host response, endothelial dysfunction, and multi-organ failure.
- Atorvastatin, a statin, has been investigated for its potential to mitigate COVID-19 severity.
- Previous hypotheses suggested atorvastatin might reduce COVID-19 severity and mortality.
Purpose of the Study:
- To evaluate the efficacy of atorvastatin in reducing mortality among severe COVID-19 patients.
- To assess the impact of atorvastatin on clinical improvement and hospital stay duration.
- To investigate the effect of atorvastatin on secondary outcomes like acute kidney injury and need for mechanical ventilation.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 220 COVID-19 patients.
- Patients received either 40 mg of atorvastatin daily or a placebo for 28 days.
- Primary outcome was 28-day all-cause mortality; secondary outcomes included 6-month mortality, clinical improvement, and length of stay.
Main Results:
- No statistically significant difference in 28-day all-cause mortality between atorvastatin (50%) and placebo (52.4%) groups (P=0.727).
- Six-month mortality also showed no significant difference (52% vs. 60.8%, P=0.208).
- Atorvastatin did not shorten time to clinical improvement or reduce hospital stay duration.
Conclusions:
- Atorvastatin did not demonstrate a significant benefit in reducing mortality for severe or critical COVID-19 patients.
- The drug did not improve clinical recovery times or reduce hospital length of stay.
- Further research may be needed to explore potential benefits in specific patient subgroups or at different stages of the disease.
Background:
COVID-19 is an abnormal host response to the SARS-CoV-2 infection, which is associated with endothelial dysfunction and multi-organ failure. Atorvastatin has been proposed to reduce COVID-19 severity and mortality in chronic and de-novo users.
Methods:
This randomized double-blind trial included 220 COVID-19 patients admitted to Mansoura University's isolation hospital in Egypt. One hundred and ten cases were given 40 mg of atorvastatin once daily for 28 days (group A), while 110 received a placebo (group B). All patients received treatment as per hospital protocol. The primary outcome is all-cause mortality at 28 days. We also tracked 6-month mortality, time to clinical improvement, the risk of invasive mechanical ventilation, acute kidney injury, potential adverse events, and hospital and intensive care length of stay.
Results:
The 28-day all-cause mortality was 52/104 (50%) in group A vs. 54/103 (52.4%) in group B, odds ratio (OR) = 0.907 (0.526, 1.565), P = 0.727; adjusted OR = 0.773 (0.407, 1.47), P = 0.433. Six-month mortality occurred in 53/102 (52%) and 59/79 (60.8%) in group A vs. B, respectively, P = 0.208. Among hospital survivors in group A vs. group B, the median time to clinical improvement was 10 days (7-14) vs. 10 (7-15), P = 0.715; the duration of hospital stay was 10 days (7-14) vs. 10 (8-17), P = 0.378. Discontinuation was higher in group B (four vs. one), but statistically insignificant, P = 0.369.
Conclusions:
In adults with severe or critical COVID-19, atorvastatin did not reduce the risk of 28-day or 6-month mortality and did not shorten the length of hospital stay or time to clinical improvement. Trial registration Clinical Trial Registry (NCT04952350) on July 1st, 2021. https://clinicaltrials.gov/ct2/show/NCT04952350.
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