WEDNESDAY, Feb. 2 (HealthDay News) -- Fidaxomicin, a macrocyclic antibiotic, may offer greater protection than vancomycin against recurrence of Clostridium difficile (C. difficile) infection associated with non-North American Pulsed Field type 1 strains, and rates of clinical cure after fidaxomicin treatment are noninferior to those after vancomycin treatment, according to research published in the Feb. 3 issue of the New England Journal of Medicine.
Thomas J. Louie, M.D., from the University of Calgary in Canada, and colleagues randomized 629 adults with C. difficile infection to fidaxomicin or vancomycin for 10 days to compare the safety and efficacy of the two treatments.
There were 548 patients who could be evaluated for a per-protocol analysis. The researchers found that rates of clinical cure with fidaxomicin were noninferior to those with vancomycin in the per-protocol analysis (92.1 and 89.8 percent, respectively) and the modified intention-to-treat analysis (88.2 and 85.8 percent, respectively). There were significantly fewer patients with recurrences in the fidaxomicin group than the vancomycin group in the modified intention-to-treat analysis (15.4 versus 25.3 percent) and the per-protocol analysis (13.3 versus 24.0 percent). Adverse events were similar in the two groups. The lower rate of recurrence was observed in patients who had non-North American Pulsed Field type 1 strains.
"In conclusion, fidaxomicin and vancomycin have similar effectiveness with respect to the clinical resolution of acute diarrheal disease due to C. difficile infection, but more sustained or durable resolution of disease (i.e., improved global cure) is achieved with fidaxomicin -- a finding that may be attributable to lesser impairment of the intestinal microbiome during treatment of the infection," the authors write.
The study was funded in part by Optimer Pharmaceuticals; several authors disclosed financial relationships with Optimer Pharmaceuticals and/or other pharmaceutical companies. Two authors disclosed being listed on fidaxomicin patents, and one author holds a patent on lactobacillus GG probiotic and β-glucan.
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