A controversial drug taken by Donald Trump to ward off the coronavirus may be safer than skeptics initially thought, the research suggests.
The president announced in May that he had been taking the antimalarial drug hydroxychloroquine for a week and a half, causing first-time prescription rates and online searches for the therapy to skyrocket.
Hydroxychloroquine is not approved for the prevention or treatment of COVID-19, the disease caused by the coronavirus, in the UK or the US.
The World Health Organization (WHO) stopped testing the drug after a Harvard study found that patients treated with hydroxychloroquine were more likely to develop de-novo ventricular arrhythmia, the sudden onset of abnormal beats in the lower chambers. of the heart.
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This can cause the heart to beat too fast, preventing oxygen-rich blood from reaching the brain or triggering cardiac arrest.
A team of European scientists has since discovered, however, that hydroxychloroquine was not associated with fatal heart rhythms among patients at low risk for arrhythmias.
Scientists stressed that they only looked at the safety of hydroxychloroquine. When it comes to efficacy, evidence suggests the drug is ineffective in cases of advanced COVID, however, the jury is unable to determine whether it has benefits during the early stages of ill health.
In June, the editors of the prestigious medical journal The Lancet published an “Expression of Concern to Alert Readers that Serious Scientific Issues Have Been Raised to Our Attention,” citing Harvard research.
Harvard scientists found that out of more than 96,000 coronavirus patients, those treated with hydroxychloroquine were a third (33%) more likely to die than those receiving other forms of treatment.
This increased by 44% more when hydroxychloroquine was combined with the macrolide antibiotic.
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Those taking hydroxychloroquine with macrolide were also five times more likely to develop de-novo ventricular arrhythmia than those in the control group.
The research would have a “profound impact” on WHO’s decision to stop testing the drug. This was met with criticism, with some experts questioning the robustness of Harvard’s results.
“This is completely unwarranted,” said Professor Peter Horby of the University of Oxford at the time.
“Even if the [Harvard] the results were correct, observational data like this, with its inherent weaknesses, should not be used to interrupt studies that will provide definitive and actionable answers. “
With questions about safety and efficacy still pending, a team of European scientists examined 649 coronavirus patients between March 10 and April 10.
Patients were first evaluated for risk of QT interval prolongation, a sign of arrhythmias.
Hydroxychloroquine can cause a dangerous electrical change in the heart of some patients. This is called QT interval prolongation due to the pattern it makes on an EKG.
Although the drug has been used for decades for other conditions, the coronavirus pandemic is the first time it is taken by a large number of seriously ill patients with multiple health conditions, which may also be on other drugs that cause QT prolongation. as a side effect.
The magnitude of the coronavirus outbreak increases the risk that a patient may have a pre-existing heart condition that predisposes them to arrhythmias.
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Changes in blood electrolytes – electrically charged minerals in the body that can trigger arrhythmias – can also occur in those in need of intensive care.
Once it was found that the participants’ risk of QT prolongation was low, they were given 200 mg of hydroxychloroquine twice daily.
More than half (58.6%) took a “loading dose” – a high starting dose of a medicine to ensure a rapid therapeutic response – on the first day.
Hydroxychloroquine was administered soon after symptom onset in three settings: 126 (19.4%) patients were managed at home, 495 (76.3%) in a hospital ward, and 28 (4.3%) in intensive care.
To reflect real-world conditions, about one-third (30%) of patients were taking two drugs that can cause QT interval prolongation: one was hydroxychloroquine and 13.6% were taking three of the drugs.
The results – published in the EP Europace journal – revealed a statistically significant increase in QT interval prolongation in all three settings, however, this 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 arrhythmia, which the scientists did not link to hydroxychloroquine.
“Treatment with hydroxychloroquine was associated with prolongation of the QT interval, as expected, but the change was minimal,” said study author Dr. Alessio Gasperetti of the Monzino Cardiology Center in Milan.
“There was no connection between the drug and the onset of arrhythmias.
“The study shows that administering hydroxychloroquine, alone or in combination with other drugs that potentially prolong QT, is safe for short-term treatment of COVID-19 patients at home or in the hospital, provided they are undergoing evaluation. risk and ECG [electrocardiogram] monitoring by a physician. “
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When it comes to the drug’s effectiveness, Dr Anthony Fauci – director of the US National Institute of Allergy 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 the use of hydroxychloroquine for COVID-19 outside the hospital setting or a clinical trial due to the risk of heart rhythm problems.”
The US Centers for Disease Control and Prevention also said that “current data indicates that the potential benefits of these drugs do not outweigh the risks.”
Other experts have called for more research.
“This is a widely used drug for a disease that kills hundreds of thousands of people, but based on no valid evidence,” said Professor Martin Landray of the University of Oxford previously.
“The sooner we get responses from randomized controlled trials, the better.
“If hydroxychloroquine turns out to be effective for COVID-19, let’s use it; if not, let’s abandon it. But this isn’t the time for speculation.”