3.4. Analysis of Safety endpoints
Three studies comprising four RCTs were meta-analyzed for safety
outcomes (Supplementary File 1 ).22-24 When
compared to placebo, astodrimer gel favorably reduced the incidence of
severe AEs (RR=0.373, 95% CI [0.146, 0.950], p=0.039). Pooled
analysis was homogenous (p=0.519). However, astodrimer gel significantly
correlated with an increased incidence of vulvovaginal candidiasis
(RR=1.427, 95% CI [1.025, 1.986], p=0.035) and treatment-related
vulvovaginal candidiasis (RR=1.181, 95% CI [1.020, 3.239],
p=0.043). Pooled analyses were homogenous (p=0.910 and p=0.566,
respectively). On the hand, the overall RR presented no significant
difference between astodrimer gel and placebo groups regarding patients
with ≥1 AE (RR=1.056, 95% CI [0.947, 1.177], p=0.111), patients
with ≥1 treatment-related AE (RR=1.252, 95% CI [0.950, 1.651],
p=0.327), patients with ≥1 serious AE (RR=1.316, 95% CI [0.296,
5.854], p=0.718), patients who stopped treatment due to AE (RR=0.999,
95% CI [0.292, 3.417], p=0.999) and urinary tract infection
(RR=1.740, 95% CI [0.948, 3.193], p=0.074). Pooled analyses were
homogenous (p=0.492, p=0.780, p=0.549, p=0.444 and p=0.123).