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For COVID-19 patients attending intensive care, administration of atorvastatin 20 mg / d did not result in a significant reduction in the risk of intravenous or arterial thrombosis. Endogenous membrane oxygenation (ECMO) or all-cause mortality compared to Placebo in the study INSPIRATION-S
However, there are suggested benefits in a subgroup of patients treated within 7 days of the onset of COVID-19.
The study was presented by Behnood Bikdeli, MD, Brigham and Women’s Hospital, Boston, Massachusetts on May 16 in the Virtual American College of Cardiology (ACC) 2021Scientific Session.
He explained that COVID-19 is characterized by a prolific immune response and a potential for thromboembolism due to increased endothelial stimulation and thromboembolic status.
In this context, it is interesting to think that statins are potent studied in COVID-19 because they have lipid-lowering effects as well. They are also thought to have anti-inflammatory and anti-inflammatory effects. A blood clot occurred too, “he said
In the HARP-2 trial of simvastatin in acute respiratory syndrome (ARDS), published a few years ago, the main results were neutral. But in a subgroup of patients with hyperinflammatory ARDS, mortality was reduced with simvastatin compared to placebo, Bikdeli noted.
Moreover, in an observational study of COVID-19 patients, use of statins was associated with a reduced mortality in hospitalized patients. However, there is limited high-quality data available to guide clinical practice, he said.
The INSPIRATION study, conducted in 11 Iranian hospitals, designed a two-to-one factorial to examine different anticoagulant strategies and the use of atorvastatin for COVID-19 patients in the ward. Severe Illness (ICU)
In the anticoagulant section of the trial, published in JAMA Last month, there were no differences in the main endpoints of the medium and standard enoxaparin doses.
For the statin part of the experiment (INSPIRATION-S) 605 patients were randomized to receive atorvastatin 20 mg per day or placebo. Patients who have previously taken statins are exempt. The baseline characteristics were similar for both groups, with approximately a quarter of the patients taking aspirin and more than 90% who took the steroid.
The results showed that atorvastatin was not associated with a significant decrease in the primary outcome, a component of intravenous or arterial thrombosis, ECMO treatment, or death within 30 days that occurred. In 32.7% of the statins group, compared with 36.3% of the placebo group (odds [OR], 0.84; A = .35)
Atorvastatin was not associated with significant differences in any component of the primary composite endpoint. In addition, there were no significant differences in any safety endpoint, including major hemorrhage and liver enzyme levels.
Most subgroup analyzes were consistent with the core findings, with one exception.
In a subgroup of patients showing symptoms within the first 7 days of onset of COVID-19, there is indication of a potential protective effect of atorvastatin.
In this cohort of 171 patients, the primary endpoint occurred in 30.9% of those taking atorvastatin, compared to 40.3% of those who received a placebo (OR, 0.60; A = .055)
“This is an interesting and possible observation because these patients may be in other stages of COVID-19, but we need to be aware of the diversity of the comparisons and will need further investigation in studies. Next time, ”Bikdeli said.
The higher the dosage in the less ill patients, the better strategy?
Commenting on the study, Binita Shah, MD, in the ACC presentation, said the importance of enrolling COVID-19 patients into clinical trials is paramount. But these patients in the ICU may not be suitable populations for statin testing.
“Perhaps for these critically ill patients it is too late, trying to control the inflammatory cytokine storm and interacting with thrombosis at this point is very difficult,” comments Shah.
She suggested it might be appropriate to try statins earlier in the disease to prevent the inflammatory process rather than try to stop it after it has begun.
Shah also raised questions about the use of low-dose atorvastatin for these patients. “In the cardiovascular literature – at least in the ACS. [acute coronary syndrome] – Take high doses of statin drugs for short-term benefits. In this extremely inflammatory environment, I was wondering if a high-intensity regimen would be more useful, ”she guesses.
Bikdeli responded that a low dose of atorvastatin was chosen because initially several antiretroviral drugs such as ritonavir were used for COVID-19 patients and that these drugs were associated with increased liver enzyme levels.
“We do not want to aggravate the use of high statins,” he said. Higher may be better. “
The INSPIRATION study was funded by Rajaie Cardiovascular Medical and Research Center, Tehran, Iran.Bikdeli has not disclosed any relevant financial ties.
American College of Cardiology (ACC) 2021 Scientific Session: Presented May 16, 2021.
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