Vancomycin, fidaxomicin use increases following revised C. difficile practice guidelines
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Revised clinical practice guidelines for Clostridioides difficile that were published in February 2018 led to immediate, significant increases in oral vancomycin and fidaxomicin use in the United States, as well as a significant decrease in oral metronidazole use, according to findings published in Clinical Infectious Diseases.
“Shortly before this study, the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America published their updated treatment guidelines for Clostridioides difficile infection (CDI), which strengthened recommendations for use of oral vancomycin over oral metronidazole. The guidelines also endorsed use of oral fidaxomicin, an agent that was FDA approved 1 year after the previous version of the guidelines was published,” Cornelius (Neil) J. Clancy, MD, associate professor of medicine and director of the extensively drug-resistant pathogen lab and mycology program at the University of Pittsburgh, told Healio.
“Since the previous guidelines, randomized clinical trial data had shown that vancomycin was superior to metronidazole against CDI and that fidaxomicin was at least comparable to vancomycin,” Clancy said. “We were curious about how the new guidelines had impacted use of oral vancomycin, fidaxomicin and metronidazole against CDI and compared changes in drug use after the revised guidelines to those seen after publication of the respective clinical trials.”
Clancy and colleagues collected U.S. antibiotic prescription data from 2006 through 2019. Vancomycin, fidaxomicin and metronidazole dosing regimens that are recommended for CDI were used to estimate monthly numbers of 10-day treatment courses for each drug. Interrupted time-series analyses were adjusted by month for possible seasonality and linear trends were compared for monthly numbers of treatment courses in different time periods.
The results demonstrated that “guidelines matter,” according to Clancy.
“We found that the revised practice guidelines had a significant impact on CDI treatment in the United States,” he said. “Use of oral vancomycin and fidaxomicin increased immediately and dramatically after publication of the guidelines in February 2018. Use of metronidazole decreased significantly.”
According to the study, cumulative treatment courses of oral vancomycin and fidaxomicin increased by 54% (n = 226,166) and 48% (n = 18,518), respectively, in the 18 months after the guidelines were published compared with the 18 months before, whereas oral metronidazole decreased by 3% (n = 238,372). Monthly vancomycin and fidaxomicin use significantly increased throughout the period following the revised guidelines (P < .0001 and P = .0002, respectively), whereas that of metronidazole decreased significantly (P < .0001).
“One message here is that professional societies need to offer more timely treatment recommendations and updates to existing guidelines for various infections as new data become available,” Clancy said. “However, another message of both our carbapenem-resistant Enterobacteriaceae study and this one is that clinicians should not wait for formal guidelines to change how they treat infections if there are clinical trial data offering evidence that new treatments are more effective. A failure to use newer treatments, in at least some instances, is what I call ‘hiding behind the guidelines.’”
The results raise questions the infectious disease field “must consider,” he added.
“An important question for the field is how much cost considerations, rather than clinical considerations, drive stewardship and formulary decisions in hospitals and health plans,” Clancy said. “How much evidence and what type of clinical data are sufficient to make a drug the standard of care, even if not formally endorsed as yet in professional guidelines? These are questions the infectious disease field must consider.” – by Caitlyn Stulpin
Disclosures: Clancy reports receiving investigator-initiated research grants from Astellas, Cidara, Melinta and Merck for studies unrelated to this project, serving on advisory boards or consulting for Astellas, Cidara, Merck, Needham & Company, Qpex, Scynexis, Shionogi and The Medicines Company, and speaking at symposia sponsored by Merck and T2Biosystems. Please see the study for all other authors’ relevant financial disclosures.
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