Discussion
VVC, diabetes mellitus, infections
DIABETES MELLITUS, INFECTIONS
By pooling the data from the two phase three VANISH studies, the study population was doubled. To our knowledge, this has yielded the largest placebo-controlled data set in the treatment of acute VVC to date. The results of the pooled analyses confirm the overall high cure rates with ibrexafungerp 300 mg BID for 1 day seen in previous studies.Similar to the VANISH 303 and VANISH 306 results,To our knowledge, this pooled analysis is also the largest data set used to analyze treatment outcomes in subgroups of patients with acute VVC. In this subgroup analysis, race, BMI, and In addition, historical comparisons of ibrexafungerp and fluconazole are difficult because of varying study methodologies. Several pivotal studies evaluating fluconazole in VVC reported 52%–65% of patients with severe VVC.In a prior In the pooled analysis, patients with baseline infections of non-Safety and tolerability results in this pooled analysis were similar to those reported in the VANISH 303 and VANISH 306 studies,Our study limitations included a very limited enrollment of patients <18 or ≥65 years of age. Although our inclusion criteria permitted females ≥12 years of age, no one <18 years of age received ibrexafungerp. Furthermore, only five patients ≥65 years of age, combined from both VANISH studies, were included in the mITT population. Future studies should continue to maintain eligibility criteria for patients ≥12 years of age to evaluate the safety and efficacy of ibrexafungerp for VVC in the younger and older patient populations.Our results are also limited by the exclusion of patients with uncontrolled diabetes mellitus (hemoglobin A1c ≥7), which resulted in ∼7% of patients with diabetes mellitus enrolled in the ibrexafungerp and placebo groups. In comparison, historical fluconazole studies have either excluded patients with diabetes mellitus