© Nadezhda Chipeva
The old antimalarial drug hydroxycholoroquine and its variation chloroquine, promoted as an effective drug for COVID-19 personally by leaders such as US President Trump and Brazil’s Bolsonaro, not only do they not help against the new coronavirus, but patients who take them are at significantly higher risk than those who do not. Until now, medical observations, as well as some studies have pointed in this direction, but now the conclusions are confirmed by the most massive study of the effect of the drug done so far. It covered a total of 96,000 coronavirus patients on six continents.According to him, people treated with chloroquine or hydroxychloroquine are much more likely to develop arrhythmias, which can lead to sudden cardiac death. The study, published Friday in the medical journal Lancet, is the largest analysis ever made of the risks and benefits of treating patients with antimalarial drugs. Like earlier but smaller studies, it provides disappointing news to the treatment-eager world of the new coronavirus.
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The analysis by Dr. Manip Mehra, a professor at Harvard Medical School, and her colleagues covers data from patients hospitalized in a total of 671 hospitals worldwide. Just over half of them are men (53%) and the average age is 54 years. Nearly 15,000 of the 96,000 patients in the analysis were treated with hydroxychloroquine or chloroquine alone or in combination with macrolide antibiotics such as azithromycin or clarithromycin within 48 hours of diagnosis.
The difference between patients taking the antimalarial drug together with or separately from the antibiotic and the others is more than clear. The mean mortality in the control group not treated with the antimalarial drug was 9.3%. While in those treated with hydroxychloroquine, mortality was 18%, hydroxychloroquine with antibiotic was 23.8%, chloroquine was 16.4%, and chloroquine with antibiotic was 22.2%.
So the calculations show that patients with the coronavirus treated with the drug have between 34 and 45% higher risk of death from cardiac causes.
The data on serious cardiac arrhythmias are even more pronounced – in patients treated with the drugs, they occur in between 4.3 and 8.1% of cases – depending on the combination of drugs. In the control group, arrhythmia occurred in only 0.3%. This means that the drug leads to between 137 and 411% increased risk of serious cardiac arrhythmias.
“We have not been able to confirm the benefit of hydroxychloroquine or chloroquine, either when used alone or in combination with a macrolide, in hospital outcomes for COVID-19. Each of these drug regimens is associated with reduced hospital survival and increased ventricular arrhythmias. , when used to treat COVID-19 “, is the conclusion recorded in the study summary.
The study is a retrospective analysis of medical records, not a controlled study in which patients are randomly divided into treatment groups – a method that is considered the gold standard of medicine. However, the findings of the study are largely considered convincing by many scientists because of its large scope.
There are already many voices in the scientific community calling for the US Food and Drug Administration (FDA) to revoke the emergency license for critically ill patients who are hospitalized with the new coronavirus, which issued the antimalarial drug some time ago.
FDA spokesman Michael Felberbaumquoted by the Washington Post, said Friday, that the Agency generally “does not comment on third-party studies”, but that the emergency authorization may be revised or withdrawn in certain circumstances, such as new efficacy data or changes in the risk and benefit assessment of the medicinal product. Last month, the agency warned against using the drug outside of hospital conditions or clinical trials, citing reports of “serious heart rhythm problems.”
(Hydroxy) chloroquine gained fame for helping against coronavirus in the early days of the epidemic in China, Europe and the United States. In early March, doctors in Marseille, France, began experimental treatment of patients with the drug – in some cases in combination with the antibiotic azithromycin, claiming that the results were very good.
Back in late March, US President Donald Trump revealed himself as one of the hottest fans of the antimalarial drug, promoting the combination with azithromycin as the cocktail that will “change the game” worldwide.
A few days ago, he stunned doctors in the United States by admitting that he was taking the antimalarial drug preventively, despite FDA warnings. It remains unclear whether this statement is true.
The drug is used to treat coronavirus in our country. In early May, the state-owned company Bul Bio began distributing it throughout the country. On May 14, the Minister of Health Kiril Ananiev issued an order authorizing the treatment of patients with COVID-19 in hospital with the medicinal products Hydroxychloroquine Sulfate Tablets 100 mg and Azithromycin Dispersible Tablet 250 mg.