There’s a strong likelihood that the antidepressant fluvoxamine (Luvox) may moderately lower rates of hospitalization due to COVID-19 in unvaccinated patients, a new systematic review and meta-analysis has found. But outside experts differ over whether the evidence from just three studies is strong enough to warrant adding the drug to the COVID-19 armamentarium.
The report, published online April 6 in JAMA Network Open, looked at three studies and estimated that the drug could reduce the relative risk of hospitalization by around 25% (likelihood of moderate effect = 81.6%-91.8%), depending on the type of analysis used.
“This research might be valuable, but the jury remains out until several other adequately powered and designed trials are completed,” said infectious disease specialist Carl J. Fichtenbaum, MD, of the University of Cincinnati, Ohio, who’s familiar with the findings. “I’m not sure how useful this is given we have several antiviral agents available. Why would we choose this over Paxlovid, remdesivir, or molnupiravir?”
According to Fichtenbaum, researchers began focusing on fluvoxamine after case reports about patients improving while on the medication. This led to further interest, he said, boosted by the drug’s known ability to dampen the immune system.
A Silicon Valley investor and antivaccine activist named Steve Kirsch has been pushing the drug along with the debunked treatment hydroxychloroquine. He’s accused the government of a cover-up of fluvoxamine’s worth, according to MIT Technology Review, and he wrote a commentary that referred to the drug as “the fast, easy, safe, simple, low-cost solution to COVID that works 100% of the time that nobody wants to talk about.”
For the new analysis, researchers examined three randomized clinical trials with a total of 2196 participants. The most extensive trial, the TOGETHER STUDY in Brazil (n = 1497), focused on an unusual outcome: It linked the drug to a 32% reduction in relative risk of patients with COVID-19 being hospitalized in an emergency room for fewer than 6 hours or transferred to a tertiary hospital due to the disease.
Another study, the STOP COVID 2 TRIAL in the United States and Canada (N = 547), was stopped because too few patients could be recruited to provide useful results. The initial phase of this trial, STOP COVID 1 (n = 152), was also included in the analysis.
All participants in the three studies were unvaccinated. Their median age was 46-50 years, 55%-72% were women, and 44%-56% were obese. Most were multiracial due to the high number of participants from Brazil.
“In the Bayesian analyses, the pooled risk ratio in favor of fluvoxamine was 0.78 (95% CI, 0.58 – 1.08) for the weakly neutral prior and 0.73 (95% CI, 0.53 – 1.01) for the moderately optimistic prior,” the researchers reported, referring to a reduction in risk of hospitalization. “In the frequentist meta-analysis, the pooled risk ratio in favor of fluvoxamine was 0.75 (95% CI, 0.58 – 0.97; I2 , 0.2%).”
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