Fidaxomicin Is Superior to Vancomycin for Clostridioides difficile Infection

In this systematic review and meta-analysis, investigators searched publication databases through October 2021 for randomized controlled trials (RCTs) that compared the clinical efficacy and safety of fidaxomicin with vancomycin in patients with CDI. The primary endpoint was the rate of global cure associated with each treatment, which was calculated as the ratio of the number of patients without recurrent CDI after clinical cure achievement to the number of patients included in a modified intention-to-treat analysis. Data were analyzed using the Mantel-Haenszel random-effects model.

A total of 6 RCTs were included in the analysis. All 6 RCTs comprised patients who were a minimum age of 16 years, with sample sizes ranging from 7 to 287 and 5 to 309 among those who received fidaxomicin and vancomycin, respectively. The follow-up durations ranged from 38 to 66 days.

Compared with vancomycin, treatment with fidaxomicin was associated with significantly increased global cure rates (risk ratio [RR], 1.18; 95% CI, 1.09-1.26; P <.00001) and significantly decreased rates of recurrent CDI (RR, 0.59; 95% CI, 0.47-0.75; P <.0001).

In regard to clinical cure rates, no significant differences were found between treatment with fidaxomicin vs vancomycin (RR, 1.02; 95% CI, 0.98-1.06; P =.31).

The researchers performed additional analyses among patient subgroups stratified on the basis of CDI severity, number of previous CDI episodes, strain type, concomitant antibiotic treatment, and age (<65 vs ≥65 years). Compared with vancomycin, fidaxomicin was associated with significantly increased global cure rates in patients with nonsevere CDI (RR, 1.18; 95% CI, 95% CI, 1.07-1.29; P =.0004) and those with initial CDI (RR, 1.19; 95% CI, 1.09-1.29; P <.0001).

Subgroup analyses showed no significant differences between fidaxomicin and vancomycin in regard to clinical cure rates.

For recurrent CDI, fidaxomicin was associated with significantly decreased rates among patients with nonsevere (RR, 0.61; 95% CI, 0.45-84; P =.002) and severe (RR, 0.41; 95% CI, 0.23-0.72; P =.002) CDI compared with vancomycin.

No significant differences were observed among patients who received fidaxomicin vs vancomycin in regard to adverse events, severe adverse events, or treatment-related adverse events.

Limitations include the inability to detect significant differences between patient subgroups due to small sample sizes.

“Collectively, FDX [fidaxomicin] is superior to VCM [vancomycin] and could be the first choice for CDI treatment, especially in patients with risk factors for recurrence,” the researchers concluded.

Disclosure: Multiple authors declared affiliations with industry. Please see the original reference for a full list of disclosures.