In a multicenter study comparing DIFLUCAN (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal meningitis in patients with AIDS, a multivariate analysis revealed three pretreatment factors that predicted death during the course of therapy: abnormal mental status, cerebrospinal fluid cryptococcal antigen titer greater than 1:1024, and cerebrospinal fluid white blood cell count of less than 20 cells/mm3. Mortality among high risk patients was 33% and 40% for amphotericin B and DIFLUCAN patients, respectively (p=0.58), with overall deaths 14% (9 of 63 subjects) and 18% (24 of 131 subjects) for the 2 arms of the study (p=0.48). Optimal doses and regimens for patients with acute cryptococcal meningitis and at high risk for treatment failure remain to be determined. (Saag, et al. N Engl J Med 1992; 326:83-9.)
Two adequate and well-controlled studies were conducted in the U.S. using the 150 mg tablet. In both, the results of the fluconazole regimen were comparable to the control regimen (clotrimazole or miconazole intravaginally for 7 days) both clinically and statistically at the one month post-treatment evaluation.
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 |
Evaluable 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 |
|---|---|---|
Evaluable 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%) |
An open-label, comparative study of the efficacy and safety of DIFLUCAN (2 to 3 mg/kg/day) and oral nystatin (400,000 I.U. 4 times daily) was conducted in immunocompromised pediatric patients from 6 months to 13 years of age with oropharyngeal candidiasis. Clinical and mycological response rates were higher in pediatric patients 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 | |
|---|---|---|
| ||
Enrolled | 96 | 90 |
Clinical Cure | 76/88 (86%) | 36/78 (46%) |
Mycological eradication* | 55/72 (76%) | 6/54 (11%) |
The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving DIFLUCAN and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment, the percentages of patients with clinical relapse were 22% for DIFLUCAN and 23% for nystatin.
In a multicenter study comparing DIFLUCAN (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal meningitis in patients with AIDS, a multivariate analysis revealed three pretreatment factors that predicted death during the course of therapy: abnormal mental status, cerebrospinal fluid cryptococcal antigen titer greater than 1:1024, and cerebrospinal fluid white blood cell count of less than 20 cells/mm3. Mortality among high risk patients was 33% and 40% for amphotericin B and DIFLUCAN patients, respectively (p=0.58), with overall deaths 14% (9 of 63 subjects) and 18% (24 of 131 subjects) for the 2 arms of the study (p=0.48). Optimal doses and regimens for patients with acute cryptococcal meningitis and at high risk for treatment failure remain to be determined. (Saag, et al. N Engl J Med 1992; 326:83-9.)
Two adequate and well-controlled studies were conducted in the U.S. using the 150 mg tablet. In both, the results of the fluconazole regimen were comparable to the control regimen (clotrimazole or miconazole intravaginally for 7 days) both clinically and statistically at the one month post-treatment evaluation.
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 |
Evaluable 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 |
|---|---|---|
Evaluable 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%) |
An open-label, comparative study of the efficacy and safety of DIFLUCAN (2 to 3 mg/kg/day) and oral nystatin (400,000 I.U. 4 times daily) was conducted in immunocompromised pediatric patients from 6 months to 13 years of age with oropharyngeal candidiasis. Clinical and mycological response rates were higher in pediatric patients 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 | |
|---|---|---|
| ||
Enrolled | 96 | 90 |
Clinical Cure | 76/88 (86%) | 36/78 (46%) |
Mycological eradication* | 55/72 (76%) | 6/54 (11%) |
The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving DIFLUCAN and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment, the percentages of patients with clinical relapse were 22% for DIFLUCAN and 23% for nystatin.
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