This article is more than 5 years old. Information may no longer be current.
Reduced risk for recurrence of C. difficile found with fidaxomicin
Click Here to Manage Email Alerts
Fidaxomicin treatment resulted in a lower risk for recurrence of Clostridium difficile infection when compared with vancomycin treatment, according to study results published in The New England Journal of Medicine.
The rate of clinical cure after treatment with fidaxomicin (Optimer Pharmaceuticals) was also noninferior to that after treatment with vancomycin treatment, the researchers reported.
“Over the past decade, the bacterium has mutated into something much more serious that has caused epidemics worldwide,” study researcher Mark A Miller, MD, head of the division of infectious diseases at the Jewish General Hospital in Montreal, said in a press release. “It is particularly notorious for recurrences. About 20% to 30% of patients suffer relapses. Recurrent C. difficile is very difficult to treat, and this has spurred interest in newer and better treatments.”
The study included 629 adults with acute symptoms of C. difficile and a positive stool toxin test. The patients were randomly assigned 200 mg twice daily fidaxomicin or 125 mg four times daily vancomycin for a course of 10 days. The primary endpoint was rate of clinical cure, and secondary endpoints were recurrence of C. difficile and global cure.
Of the 629 adults enrolled in the study, 548 could be evaluated. The rate of clinical cure associated with fidaxomicin was 88.2%, which was noninferior to the 85.8% rate of clinical cure associated with vancomycin. Patients who received fidaxomicin also had a lower rate of relapse: 15.4% vs. 25.3% for patients who received vancomycin. In patients with the North American pulsed-field type 1 strain, the rate of recurrence was similar for both drugs. There was no difference in adverse events between the two groups.
In an accompanying editorial, Herbert L. DuPont, MD, an Infectious Disease News Editorial Board member, said because of the inadequacies of current treatments for a C. difficile infection, the search for new effective treatments is ongoing, and there is a need for antibiotics that inhibit the C. difficile while preserving colonic flora. Fidaxomicin appears to have less effect on the colonic flora than other commonly used antibiotics.
“Although therapy of C. difficile infection is fraught with challenges, fidaxomicin appears to be an important advance,” DuPont wrote. “Additional studies are needed to confirm its enhanced value in preventing the recurrence of C. difficile infection. If studies with fidaxomicin confirm a favorable clinical response and a significant decrease in the rate of recurrence after treatment, this new agent could become a recommended therapy for C. difficile infection.”
For more information:
- DuPont HL. N Engl J Med. 2011;364:473-475.
- Louie TJ. N Engl J Med. 2011;364:422-431.
Disclosure: Optimer Pharmaceuticals sponsored the study.
 |
Follow InfectiousDiseaseNews.com on Twitter. |