VIDEO: Low risk for congestive heart failure exacerbation with Zinplava for C. difficile
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CHICAGO — In this Healio video exclusive, Paul Feuerstadt, MD, FACG, AGAF, recaps results from a real-world analysis of Zinplava for prevention of recurrent Clostridioides difficile infection in patients with congestive heart failure.
“C. difficile is a major problem in the United States,” Feuerstadt, assistant clinical professor of medicine at Yale University School of Medicine and attending gastroenterologist at PACT Gastroenterology Center, said. “It is estimated about a half a million people will be diagnosed with this infection on an annual basis.
“Importantly, of those people who are treated appropriately, up to 35% will recur and of those that recur, up to 45% will go on to recur after that and more than 60% thereafter as patients get stuck in this vicious cycle of recurrence. So, any treatment we have that can break that cycle of recurrence is welcomed for us as clinicians.”
According to Feuerstadt, one such treatment is Zimplava (bezlotoxumab, Merck), a fully humanized, monoclonal antibody designed to bind C. difficile toxin B, thus reducing surrounding inflammation in the gut and decreasing infection recurrence.
He noted that results of the pivotal MODIFY I/II phase 3 trials, which were published in 2017 in The New England Journal of Medicine, demonstrated a significant reduction in C. difficile recurrence at 90 days with bezlotoxumab compared with placebo infusion. While these results led to FDA approval, the agency warned of using bezlotoxumab in patients with congestive heart failure.
“In individuals who have congestive heart failure with reduced ejection fraction, it is important that we as clinicians think about the risks and benefits of a product like this,” Feuerstadt said.
At Digestive Disease Week, Feuerstadt and colleagues presented data from a real-world analysis of patients with congestive heart failure who received bezlotoxumab. They identified 131 individuals between 2017 and 2021, of whom 41 had congestive heart failure. Sixteen patients had reduced ejection fraction and 25 had preserved ejection fraction. Researchers monitored patients for 90 days.
“Efficacy was on par with previous studies and the safety was also on par — or even safer,” Feuerstadt noted.
According to results, two patients experienced exacerbation of congestive heart failure within 30 days of bezlotoxumab, both of whom had reduced ejection fraction. There were no cardiac-related events reported within 30 or 90 days in patients with preserved ejection fraction.
“When we treat patients with C. difficile, we have to think about recurrence and we have to think about the treatments we have to reduce recurrence — treatments like bezlotoxumab,” Feuerstadt said. “But, in a CHF population, should we give it to patients with mildly reduced ejection fraction? Yes, is certainly reasonable. If patients have moderate or severe CHF with reduced ejection fraction, that is a population we probably should shy away from.”
Reference:
- Wilcox MH, et al. N Engl J Med. 2017;doi:10.1056/NEJMoa1602615
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Chaar A, et al. Poster Su1869: Cardiac events in patients with heart failure receiving bezlotoxumab for the prevention of recurrent Clostridioides difficile infection – a multicenter study. Presented at: Digestive Disease Week; May 5-9, 2023; Chicago (hybrid meeting).
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