Infectious Disease

“Premature, preventable deaths” renew plea to end prescribing hydroxychloroquine for COVID-19

07.09.2021

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Disclosure:
Hennekens reports as chair of data monitoring committees for Amgen, the British Heart Foundation, Cadila, the Canadian Institutes of Health Research, DalCor and Regeneron, and the Collaborative Institutional Training Initiative (CITI), legal counsel for Pfizer, the FDA and UpToDate; Royalties for the authorship or editing of three textbooks and co-inventing inflammatory marker and cardiovascular disease patents owned by Brigham and Women’s Hospital; and an investment management relationship with the West Bacon Group within SunTrust Investment Services. Please refer to the study for all relevant financial information from the other authors.

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Updated evidence “strongly supports” ending the use of hydroxychloroquine for either the prevention or treatment of COVID-19 due to its lack of benefits combined with potentially fatal cardiovascular complications, according to a meta-analysis.

“In 2021, there were more than 560,000 prescriptions of hydroxychloroquine for the prevention, post-exposure, and treatment of COVID-19 in the United States alone.” Charles H. Hennekens, MD, Dr PH, from Schmidt College of Medicine at Florida Atlantic University in Boca Raton, said Healio Rheumatology.

“Premature and preventable deaths will continue to occur if subjects take hydroxychloroquine and avoid public health strategies with proven benefits,” Charles H. Hennekens, MD, DrPH, told Healio Rheumatology. “This includes vaccinations and masking, social distancing, avoiding crowds, and frequent hand and face washing.” Source: Adobe Stock

“As of February 2020, the United States has been the epicenter of the pandemic and remains the world leader in cases and deaths,” he added. “Last year, the 890,000 prescriptions for hydroxychloroquine were nine times higher than in the previous year, which led to major bottlenecks in the approved indications for autoimmune diseases, especially among younger women.”

In the American Journal of Medicine, Hennekens and colleagues wrote, “When the body of evidence is incomplete, it is appropriate for healthcare providers to remain unsure.”

Charles H. Hennekens

“Still, regulators are sometimes forced to act on incomplete evidence,” they wrote. “On March 28, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for hydroxychloroquine for COVID-19. By April 24, 2020, the FDA issued a drug safety warning of potentially fatal QTc interval extensions detectable on 12-lead electrocardiograms and the risks of other serious cardiac arrhythmias. “

To provide an updated overview of the benefits and risks of hydroxychloroquine in COVID-19, Hennekens and colleagues reviewed the most recent major publications of randomized, double-blind, placebo-controlled studies investigating the drug in post-exposure prophylaxis and in hospitalized patients. Endpoint of SARS- CoV-2 infections and their meta-analyzes.

In total, the authors reviewed three studies of hydroxychloroquine for post-exposure prophylaxis and two that examined the drug in hospitalized patients, and eventually performed their own meta-analysis of the evidence.

In their meta-analysis of hydroxychloroquine in post-exposure prophylaxis, Hennekens and colleagues found a nonsignificant relative risk of 0.9 and a statistically nonsignificant estimated 10% reduction in COVID-19 infection in those treated with the drug. Meanwhile, their meta-analysis of hydroxychloroquine in hospitalized patients with COVID-19 found a nonsignificant relative risk of 1.1 (95% CI 0.99-1.23) and a statistically nonsignificant estimated 10% increase in mortality but with sufficient precision to make a statement only a 1% reduction.

Additionally, while the data suggests equality, the point estimate tends to tend toward small harm to mortality, the authors wrote.

According to Hennekens and colleagues, the previous, calming safety profile of hydroxychloroquine applied only to patients with lupus and rheumatoid arthritis, both of which are more common in younger and medium-sized women. In these populations, the risks of fatal heart disease from hydroxychloroquine are “reassuringly very low,” according to a Florida Atlantic University press release.

In contrast, the risks associated with hydroxychloroquine in patients with COVID-19 associated with fatal cardiovascular complications are significantly higher, as these conditions are much more common in elderly patients and those with pre-existing heart disease or its risk factors, both of which are more common, predominantly in men According to the press release.

“The recent large randomized, double-blind, placebo-controlled trials of hydroxychloroquine in post-exposure prophylaxis and in patients hospitalized with COVID-19 are even more supportive of stopping prescribing hydroxychloroquine,” said Hennekens. “In addition to the lack of a significant benefit, the new randomized evidence shows some indications of harm.”

“The previous reassuring safety profile of hydroxychloroquine applies to patients with lupus and rheumatoid arthritis, both of which are more common in younger and medium-sized women whose risks of fatal heart disease from hydroxychloroquine are reassuringly very low,” he added. “In contrast, the risks of hydroxychloroquine for patients with COVID-19 are significantly higher because fatal cardiovascular complications from these drugs are much higher in elderly patients and those with existing heart disease or their risk factors, which are both more prevalent in men.”

Hennekens later warned that continued use of hydroxychloroquine will result in persistent preventable deaths at the expense of established health measures.

“Premature and preventable deaths will continue to occur if subjects take hydroxychloroquine and avoid public health strategies with proven benefits,” he said. “This includes vaccinations and masking, social distancing, avoiding crowds, and frequent hand and face washing.”

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COVID-19 and rheumatology

COVID-19 and rheumatology

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