The therapeutic cure rate, defined as a complete resolution of signs and symptoms of vaginal candidiasis (clinical cure), along with a negative KOH examination and negative culture for Candida (microbiologic eradication), was 55% in both the fluconazole group and the vaginal products group.

 Fluconazole PO 150 mg tablet Vaginal Product qhs × 7 days
Enrolled 448 422
eva luable at Late Follow-up 347 (77%) 327 (77%)
Clinical cure 239/347 (69%) 235/327 (72%)
Mycologic eradication 213/347 (61%) 196/327 (60%)
Therapeutic cure 190/347 (55%) 179/327 (55%)

Approximately three-fourths of the enrolled patients had acute vaginitis (<4 episodes/12 months) and achieved 80% clinical cure, 67% mycologic eradication, and 59% therapeutic cure when treated with a 150 mg DIFLUCAN tablet administered orally. These rates were comparable to control products. The remaining one-fourth of enrolled patients had recurrent vaginitis (≥4 episodes/12 months) and achieved 57% clinical cure, 47% mycologic eradication, and 40% therapeutic cure. The numbers are too small to make meaningful clinical or statistical comparisons with vaginal products in the treatment of patients with recurrent vaginitis.

Substantially more gastrointestinal events were reported in the fluconazole group compared to the vaginal product group. Most of the events were mild to moderate. Because fluconazole was given as a single dose, no discontinuations occurred.

Parameter Fluconazole PO Vaginal Products
eva luable patients 448 422
With any adverse event 141 (31%) 112 (27%)
  Nervous System   90 (20%)   69 (16%)
  Gastrointestinal   73 (16%)   18 (4%)
With drug-related event 117 (26%)   67 (16%)
  Nervous System   61 (14%)   29 (7%)
    Headache   58 (13%)   28 (7%)
  Gastrointestinal   68 (15%)   13 (3%)
    Abdominal pain   25 (6%)     7 (2%)
    Nausea   30 (7%)     3 (1%)
    Diarrhea   12 (3%)     2 (<1%)
  Application site event     0 (0%)   19 (5%)
  Taste Perversion     6 (1%)     0 (0%)

Pediatric Studies

Oropharyngeal candidiasis
An open-label, comparative study of the efficacy and safety of DIFLUCAN (2–3 mg/kg/day) and oral nystatin (400,000 I.U. 4 times daily) in immunocompromised children with oropharyngeal candidiasis was conducted. Clinical and mycological response rates were higher in the children treated with fluconazole.

Clinical cure at the end of treatment was reported for 86% of fluconazole treated patients compared to 46% of nystatin treated patients. Mycologically, 76% of fluconazole treated patients had the infecting organism eradicated compared to 11% for nystatin treated patients.

 Fluconazole Nystatin
*
Subjects without follow-up cultures for any reason were