A controversial drug Donald Trump took to ward off the coronavirus may be safer than initially thought by skeptics.
The president announced in May that he had been taking the malaria drug hydroxychloroquine for a week and a half, leading to a surge in first-time prescription rates and online searches for therapy.
Hydroxychloroquine is not approved in the UK or US for the prevention or treatment of COVID-19, the disease caused by the coronavirus.
The World Health Organization (WHO) stopped testing the drug after a Harvard study found that patients taking hydroxychloroquine were more likely to develop a de novo ventricular arrhythmia, which causes sudden abnormal beats in the lower chambers of the heart.
Continue reading: In England, coronavirus cases double every seven to eight days
This can cause the heart to beat too fast, preventing oxygen-rich blood from reaching the brain or causing cardiac arrest.
A team of European scientists has now found that hydroxychloroquine is not associated with fatal heart rhythms in patients with a low risk of arrhythmias.
The scientists emphasized that they were only studying the safety of hydroxychloroquine. In terms of effectiveness, the data suggest that the drug is ineffective in advanced COVID cases. However, the jury isn’t sure if it has any benefits in the early stages of the disease.
In June, citing the Harvard study, the editors of the prestigious medical journal The Lancet published “an expression of concern to alert readers to the fact that serious scientific questions have been brought to our attention”.
Harvard researchers found that of more than 96,000 coronavirus patients, those given hydroxychloroquine had a third (33%) more deaths than those given other forms of treatment.
This resulted in a 44% higher risk when hydroxychloroquine was combined with the antibiotic macrolide.
Continue reading: The coronavirus risk is highest among detergents in an NHS trust
Those who received hydroxychloroquine with macrolide also developed de novo ventricular arrhythmia more than five times more often than those in the control group.
The research is said to have a “profound influence” on the WHO’s decision to stop testing the drug. This has been criticized, with some experts questioning the robustness of the Harvard results.
“That is totally unjustified,” said Professor Peter Horby of Oxford University at the time.
“Even if the [Harvard] The results were correct. Observational data like this, with its inherent weaknesses, should not be used to stop attempts that provide definitive and actionable answers. “
With questions about safety and efficacy still open, a team of European scientists examined 649 coronavirus patients between March 10 and April 10.
Patients were initially assessed for their risk of QT prolongation, a sign of arrhythmias.
Hydroxychloroquine can cause dangerous electrical changes in the heart in some patients. This is called QT prolongation because of the pattern it creates on an electrocardiogram.
Although the drug has been used for other medical conditions for decades, the coronavirus pandemic marks the first time it has been taken by large numbers of acutely ill patients with multiple health conditions who may also be taking other drugs that cause QT prolongation as a side effect .
The magnitude of the coronavirus outbreak increases the risk that a patient will have pre-existing heart disease that predisposes them to arrhythmias.
Continue reading: One in 100 COVID patients hospitalized in the UK has a lung puncture
Changes in blood electrolytes – electrically charged minerals in the body that can cause arrhythmias – can also occur in intensive care staff.
Once the participants’ QT prolongation risk was found to be low, they were given hydroxychloroquine 200 mg twice daily.
More than half (58.6%) took a “loading dose” on the first day – an initial large dose of a drug to ensure a rapid therapeutic response.
Hydroxychloroquine was administered in three situations shortly after symptoms appeared: 126 (19.4%) patients were treated at home, 495 (76.3%) were in the hospital ward, and 28 (4.3%) were in the intensive care unit .
To reflect real-world conditions, around a third (30%) of patients were given two drugs that may cause QT prolongation – one is hydroxychloroquine, and 13.6% were taking three of the drugs.
The results – published in the journal EP Europace – showed a statistically significant increase in QT prolongation in all three settings, but it was modest and similar regardless of where the patient was treated.
About 16 days after taking hydroxychloroquine, none of the arrhythmias that occurred were fatal.
Seven (1.1%) of the participants had severe ventricular arrhythmias that the scientists did not associate with hydroxychloroquine.
“Treatment with hydroxychloroquine was associated with QT prolongation as expected, but the change was small,” said study author Dr. Alessio Gasperetti from the Monzino Cardiology Center in Milan.
“There was no association between the drug and the occurrence of arrhythmias.
“The study shows that administration of hydroxychloroquine alone or in combination with other potentially QT-prolonging drugs for the short-term treatment of COVID-19 patients at home or in the hospital is safe, provided they are subjected to a risk assessment and an EKG [electrocardiogram] Monitoring by a doctor. “
Continue reading: The doctor’s “bone-deep fatigue” of working in the midst of a pandemic
Regarding the effectiveness of the drug, Dr. Anthony Fauci, director of the US National Institute for Allergies and Infectious Diseases, told the BBC in July: “Every single good study has shown that hydroxychloroquine is not effective in treating COVID-19.”
The US Food and Drug Administration “warns against using hydroxychloroquine for COVID-19 outside of the hospital setting or clinical trial due to the risk of cardiac arrhythmia.”
The US Centers for Disease Control and Prevention also said, “Current data shows that the potential benefits of these drugs do not outweigh their risks.”
Other experts have called for further research.
“This is a drug that is very widely used for a disease that kills hundreds of thousands, but based on poor evidence,” said Professor Martin Landray of Oxford University earlier.
“The sooner we get answers from randomized controlled trials, the better.
“If hydroxychloroquine is found to be effective for COVID-19, we’ll use it. If not, let’s give it up. However, this is no time for speculation. “