tetano
Editor, Senior Moderator
Respir Res
. 2024 Feb 22;25(1):97.
doi: 10.1186/s12931-024-02732-2. Atorvastatin for reduction of 28-day mortality in severe and critical COVID-19 patients: a randomized controlled trial
Naglaa Hamdi Eltahan[SUP] #[/SUP][SUP] 1 [/SUP], Neamat Hamdy Elsawy[SUP] #[/SUP][SUP] 2 3 [/SUP], Kholoud M Abdelaaty[SUP] #[/SUP][SUP] 4 [/SUP], Amal Salah Elhamaky[SUP] 5 [/SUP], Ahmed H Hassan[SUP] 6 [/SUP], Moataz Maher Emara[SUP] 7 [/SUP]
Affiliations
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.
Keywords: Atorvastatin; COVID-19; Coronavirus; Mortality; SARS-CoV-2; Statins, hmg coa.
. 2024 Feb 22;25(1):97.
doi: 10.1186/s12931-024-02732-2. Atorvastatin for reduction of 28-day mortality in severe and critical COVID-19 patients: a randomized controlled trial
Naglaa Hamdi Eltahan[SUP] #[/SUP][SUP] 1 [/SUP], Neamat Hamdy Elsawy[SUP] #[/SUP][SUP] 2 3 [/SUP], Kholoud M Abdelaaty[SUP] #[/SUP][SUP] 4 [/SUP], Amal Salah Elhamaky[SUP] 5 [/SUP], Ahmed H Hassan[SUP] 6 [/SUP], Moataz Maher Emara[SUP] 7 [/SUP]
Affiliations
- PMID: 38389078
- PMCID: PMC10885389
- DOI: 10.1186/s12931-024-02732-2
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.
Keywords: Atorvastatin; COVID-19; Coronavirus; Mortality; SARS-CoV-2; Statins, hmg coa.