How well does DIFICID(Fidaxomicin) work?
Fidaxomicin is indicated for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults and children aged 6 months and above. It has achieved significant clinical results. The efficacy of fidaxomicin can be further understood through the following two studies on adults and children:
Efficacy of fidaxomicin in the treatment of Clostridium difficile-associated diarrhea
1. Clinical study of fidaxomicin in adult patients with Clostridium difficile-associated diarrhea
(1) Trial design
The efficacy of fidaxomicin and vancomycin in adult patients with Clostridium difficile-associated diarrhea was demonstrated in two randomized, double-blind trials. The demographic characteristics and baseline Clostridium difficile-associated diarrhea characteristics of the enrolled subjects were similar, and the average age of the patients was 64 years old.
(2) Setting of trial results
The primary efficacy endpoint was the clinical remission rate at the end of treatment, and the other efficacy endpoint was the sustained remission rate 25 days after the end of treatment.
(3) Trial results
At the end of treatment, the clinical remission rate of adult patients using fidaxomicin was 88%, and the clinical remission rate of vancomycin was 86%-87%. After 25 days of treatment, the sustained remission rate of fidaxomicin was 70%-72%, while the sustained remission rate of the vancomycin group was only 57%, which was 13%-15% higher than that of vancomycin. However, compared with vancomycin, fidaxomicin did not show superiority in terms of adverse reactions.
2. Clinical study of fidaxomicin in children with Clostridium difficile-associated diarrhea
(1) Trial design
In a phase 3, multicenter, investigator-blind, randomized, comparative trial, the safety and efficacy of fidaxomicin in children aged 6 months to less than 18 years were studied, and 148 patients were randomly divided into groups.
(2) Setting of trial results
The primary efficacy endpoint was the clinical remission rate at the end of treatment, and another efficacy endpoint was the sustained remission rate 30 days after the end of treatment.
(3) Trial results
At the end of treatment, the overall clinical remission rate of children using fidaxomicin was 77.6%, and the clinical remission rate using vancomycin was 70.5%. After 30 days of treatment, the sustained remission rate of fidaxomicin was 68.4%, while the sustained remission rate of the vancomycin group was only 50%, and fidaxomicin increased it by 18.4%.
