The most extensive study of the antimalarial drug revealed that those who received the drug had a significantly higher risk of dying than those who did not. The analysis was published on Friday in the medical journal Lancet involved 96,000 hospitalized coronavirus patients in six continents.
According to the Washington Post, the study concluded that people treated with hydroxychloroquine, or the closely related drug chloroquine, were more likely to develop irregular heart rhythm that can lead to sudden cardiac death.
Eric Topol, a cardiologist, and Director of the Scripps Research Translational Institute said that having no benefit at all is one thing, but this new research clearly shows the harm it can cause. "If there was ever hope for this drug, this is the death of it," Topol added.
A Hard Lesson Learned: First, Do No Harm
The Lancet analysis by Harvard Medical School professor and physician at Brigham and Women's Hospital, Mandeep Mehra and his colleagues provide absolutely no reason for optimism that the drug might be useful in treating COVID-19 patients, said David Maron, director of preventive cardiology at the Stanford University School of Medicine.
The study included COVID-19 patients admitted to the hospital since December 20, 2019, and April 14, 2020, at 671 medical facilities worldwide. The mean age of the participants was 54 years, while 53% of them are men. Patients who received Gilead Sciences remdesivir antiviral drug was excluded in the study.
According to Mehra, the widespread use of hydroxychloroquine for COVID-19 patients stemmed from the idea that "a desperate disease demands desperate measures" in which people have now learned a hard lesson from experience about the importance of first not harm.
In hindsight, Mehra said that using the drug with no systematic testing was unwise, for there has been potential harm caused to the patients. Out of the 96,000 patients in the analysis, 15,000 were treated with the antimalarial drug alone or in combination with a type of antibiotics.
The study is a retrospective analysis of the patients' medical records rather than a controlled study in which patients were divided into different treatment groups. The difference between those who received the antimalarial drug and who did not was striking.
Another Nail in the Coffin for Hydroxychloroquine
The results showed that patients who received the drug alone are 34% more likely to die and a 137% increased risk of a severe heart arrhythmia. For patients who received hydroxychloroquine with an antibiotic, revealed a 45% increased risk of death and 411% increased risk of severe heart arrhythmias.
While patients given chloroquine had a 37% increased risk of death and 256% increased risk of severe heart arrhythmias. For those taking both chloroquine and antibiotics, there was a 37% increased risk of death, and a 301% increased risk of severe heart arrhythmias.
FDA officials called the report "very concerning." Although it was an observational study rather than experimental, it showed a correlation between the drugs and the specific outcomes rather than a clear cause and effect.
Furthermore, Peter Lurie, a former FDA official, called the report "another nail in the coffin for hydroxychloroquine." He said it is time to revoke the emergency use authorization by the FDA.
Previous researches have also shown the adverse side effects of the antimalarial drug, particularly in the increased risk of adverse cardiac reactions.
