After adjustment for other risk factors, it appears that patients on hydroxychloroquine had double the risk of ventricular arrhythmias, and those on chloroquine had triple. About 14,000 of which received one of four drug cocktails that included chloroquine or hydroxychloroquine.
Eric Topol, director and founder of the Scripps Research Translational Institute and a cardiologist, noted the risk in a series of tweets. "It's no longer that hydroxychloroquine has no sign of efficacy", he wrote, "it is associated with an increase in mortality".
For example, one USA study published in late April found the death rate for people with COVID-19 who took hydroxychloroquine on top of usual care was actually higher than those who didn't - 28% vs. 11%, respectively.
Britain has ordered $42 million worth of hydroxychloroquine, despite numerous studies showing it is ineffective in treating Covid-19 and may even be more risky than doing nothing.
Other observational studies have made comparisons in smaller populations.
It's not the first study to highlight the potentially harmful effects of the medication, but it is by far the largest.
The US Food and Drug Administration has said hydroxychloroquine should only be used for hospitalised Covid-19 patients or those in clinical trials. "About 1 in 5 treated with chloroquine and an antibiotic died and nearly 1 in 4 treated with hydroxychloroquine and an antibiotic died".
In total, 10,698 patients died while in the hospital. He told reporters that he has been taking the drug, in combination with azithromycin, for over a week.
However, the researchers cautioned that because this was an observational study and not a randomized control trial, which is the gold standard of medical research, they could not rule out the possibility that other factors that hadn't been measured were responsible for the increased deaths. Early on in the COVID-19 pandemic, Trump labeled the drugs potential "game changers" against the disease, despite little good evidence supporting such claims. After controlling for risks such as weight, heart disease, and lung disease, the mortality rate in the control group was 9%. Last week, two studies published in the medical journal BMJ showed that patients given hydroxychloroquine did not improve significantly over those who were not. All four of the treatments were associated with a higher risk of dying in hospital. Some of them are new antibody-based drugs that can neutralize the virus and provide short-lived immunity.
Mehra said the use of hydroxychloroquine for COVID-19 is unwise.
About 15% of the patients were treated with the antimalaria drugs alone or with an antibiotic within 48 hours of diagnosis. And results are conflicting.
The authors of the new study said neither drug should be used to treat Covid-19 outside of clinical trials and said randomised clinical trials were needed.
Several more recent studies have not shown the drug to be an effective treatment for the disease.
The antimalarial drugs have been surrounded by controversy after enthusiastic remarks by US President Donald Trump earlier this year that left some epidemiologists uneasy given the well-known risks of the drugs particularly for people with heart conditions. The drug is not yet approved, but its use is being allowed on an emergency basis.
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