Two closely related anti-malarial drugs championed by President Donald Trump as promising treatments for COVID-19 appear to substantially increase the risks of death and heart complications in patients hospitalized from the disease.
Thats according to the largest study yet on the topic, which involved more than 96,000 hospitalized COVID-19 patients on six continents. The peer-reviewed study, appearing Friday in The Lancet, was led by Mandeep Mehra, a professor of medicine at Harvard.
The drugs studied included chloroquine and its analogue hydroxychloroquine, which are used to treat autoimmune diseases such as lupus and rheumatoid arthritis, as well as malaria. Early laboratory work suggested that they also have potent anti-viral properties. But small clinical studies looking into potential benefits for COVID-19 patients have largely provided mixed and inconclusive results to this point.
Still, some of those small, uncontrolled studies suggesting benefits have gained traction and have led to undue optimism that the drugs can treat the pandemic disease. President Trump in particular has touted the drugs, calling them a “game changer,” even this week telling reporters that he is taking hydroxychloroquine. “A couple of weeks ago I started taking it. Because I think its good; Ive heard a lot of good stories,” he said Monday, May 18.
That revelation goes against a recent announcement by the US Food and Drug Administration that the drugs "should be limited to clinical trial settings or for treating certain hospitalized patients." The FDA made the recommendation in light of reports of potentially fatal heart rhythm problems linked to the drugs, which have been given at higher doses than those used for autoimmune and malaria patients.
The new, large study out today seems to bolster those concerns—and deflate overblown hopes.
Mehra and colleagues looked at the medical records of more than 96,000 hospitalized COVID-19 patients from 671 hospitals in various countries. Their average age was about 54, and about 54 percent were male.
Of the patients, nearly 15,000 had received one of four treatments involving one of the drugs—1,868 received chloroquine, 3,783 received chloroquine with a macrolide antibiotic (such as azithromycin), 3,016 received hydroxychloroquine, and 6,221 received hydroxychloroquine with a macrolide (a combination Trump has also promoted). Over 81,000 other hospitalized COVID-19 patients in the study did not receive any of these regimens and were considered a control group.
The researchers primarily looked at risks of in-hospital deaths and serious heart arrhythmias.
Comparing the treatment groups to controls and adjusting each patients risk factors, such as congestive heart failure, the researchers found the following:
- COVID-19 patients given hydroxychloroquine alone had a 34-percent increased risk of dying in the hospital and a 137-percent increased risk of developing a serious arrhythmia.
- Those given hydroxychloroquine with a macrolide had a 45-percent increased risk of dying in the hospital and a 411-percent increased risk of developing a serious arrhythmia.
- Those given chloroquine had a 37-percent increased risk of dying in the hospital and a 256-percent increased risk of developing a serious arrhythmia.
- Those given chloroquine and a macrolide had a 37-percent increased risk of dying in the hospital and a 301-percent increased risk of developing a serious arrhythmia.
Mehra and colleagues conclude:
In this large multinational real-world analysis, we did not observe any benefit of hydroxychloroquine or chloroquine (when used alone or in combination with a macrolide) on in-hospital outcomes, when initiated early after diagnosis of COVID-19. Each of the drug regimens of chloroquine or hydroxychloroquine alone or in combination with a macrolide was associated with an increased hazard for clinically significant occurrence of ventricular arrhythmias and increased risk of in-hospital death with COVID-19.
The study has some significant limitations, including that it is merely an observational study—not a randomized, controlled trial thoughRead More – Source