Malaria drug, President Donald Trump, has aggressively promoted to treat Covid-19 without any benefit and has been linked to higher mortality rates for Veterans Affairs patients hospitalized with the new coronavirus, study finds, raising new questions about the safety and efficacy of a treatment that has been widely used in the pandemic.
The study by AV and university researchers analyzed the results of 368 male patients in the country, 97 receiving hydroxychloroquine, 113 receiving hydroxychloroquine in combination with the antibiotic azithromycin and 158 not receiving any hydroxychloroquine.
The study found that death rates in the drug-treated groups were worse than those who did not. The rates of patients on respirators were about equal, with no benefit demonstrated by the drugs.
More than 27% of patients treated with hydroxychloroquine died and 22% of those treated with combination therapy died, compared with a death rate of 11.4% in those who were not treated with the drugs, according to the study. The results came from an observational study of the results and were not part of a randomized, placebo-controlled clinical trial, which is the gold standard for testing drugs.
The study has been published on medrxiv.org, which is a clearinghouse for university studies on the coronavirus that have not yet been peer reviewed or published in academic journals.
“An association of increased overall mortality has been identified in patients treated with hydroxychloroquine alone,” wrote the authors, affiliated with the University of Virginia, the University of South Carolina and the VA system. Columbia, South Carolina. “These results underscore the importance of waiting for the results of prospective, randomized, controlled studies before the widespread adoption of these drugs. “
The coronavirus pandemic has invaded the world faster than science can respond. There is no vaccine or approved treatment to stop its spread or alleviate the severe respiratory symptoms that have claimed the lives of more than 175,000 people worldwide.
In some cases, hope has overshadowed the evidence in the global race to find countermeasures. Hospitals and doctors around the world have prescribed chloroquine and hydroxychloroquine, often in combination with azithromycin, based on the belief that it might help, despite the lack of solid evidence that drugs improve them. patients or clear the virus from the body.
Interest in drugs peaked after Trump began to repeatedly increase their use in White House press conferences. He tweeted a reference to a French study in March which has since been reviewed for its lean test size and questionable methods. In a decision that cited no evidence of benefit, the Food and Drug Administration issued an emergency use authorization authorizing the administration of the drug in hospitals.
But the dangers of these drugs for treating certain patients with coronaviruses become apparent, especially when hydroxychloroquine is used in combination with azithromycin. The low risk of cardiac death for patients treated with these drugs comes from a well-known side effect: they extend the fraction of a second it takes for the heart to recharge between beats, a condition called prolonged interval QT.
Citing the phenomenon, a panel of the Infectious Diseases Society of America, citing the risks, strongly advised its member physicians that the combination of drugs should only be given as part of a clinical trial. He cited the lack of clear evidence of any benefit. Her treatment guidelines indicated that “the overall certainty of the evidence was very low.”
The French national drug safety agency reported that 43 patients taking hydroxychloroquine or a combination of the drug and azithromycin experienced cardiac side effects and between one and four deaths. The agency said the drugs should only be given to hospital patients with covid-19, the disease caused by the coronavirus. Brazilian researchers have terminated part of a clinical trial testing high doses of chloroquine in covid-19 patients after developing heart problems and higher mortality rates.
A team of researchers from the Langone Medical Center at New York University found that, out of 84 patients treated with the combination of hydroxychloroquine and azithromycin, 11% had a prolongation of the QT interval beyond 500 milliseconds – the danger zone for sudden cardiac death. Overall, 30% of patients saw their QT interval increase significantly.
Lior Jankelson, a lead researcher in the Langone study, said the danger makes it very inadvisable for people to take the drug as a preventive measure or without a positive coronavirus test, which would have happened around the world.
“If the patient is not proven to be ill, I think there is no doubt that the risk associated with this therapy is not reasonable,” he said in an interview.
“This is a really extreme situation … where hundreds of thousands, if not more, of people are taking a known combination that prolongs the QT interval in a high risk situation,” he said.
In hospitals, managing the risk of fatal side effects is EKG monitoring, specialists say. But even advanced ECG screening may not reduce the risk.
NYU Langone’s study found that increasing the existing QT does not predict a subsequent increase in QT due to drug use. Kidney failure was a higher risk factor, indicating that the sickest patients are the most exposed to the dangerous side effects of the drugs.