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DIFLUCAN (FLUCONAZOLE) EFFECTIVE AS PRIMARY TREATMENT OF AIDS-RELATED CRYPTOCOCCAL MENINGITIS

 DIFLUCAN (FLUCONAZOLE) EFFECTIVE AS PRIMARY TREATMENT
 OF AIDS-RELATED CRYPTOCOCCAL MENINGITIS
 NEW YORK, Jan. 9 /PRNewswire/ -- Pfizer Inc (NYSE: PFE) today issued the following statement:
 Oral Diflucan(TM) (fluconazole) has been found to be as effective as intravenous amphotericin B in the primary treatment of AIDS-related cryptococcal meningitis, with far fewer side effects, according to a study in today's New England Journal of Medicine.
 The Mycoses Study Group of the National Institute for Allergy and Infectious Diseases (NIAID) and the AIDS Clinical Trials Group studied 194 patients with AIDS-related cryptococcal meningitis in a randomized, multicenter trial. Cryptococcal meningitis is the most common life-threatening opportunistic fungal disease in patients infected with the HIV virus.
 Patients were randomized on a 2:1 ratio to receive either 200 mg of oral Diflucan a day or a standard regimen of intravenous amphotericin B. Because of the differences in the route of administration of the two drugs, the trial could not be placebo-controlled.
 Diflucan treatment resulted in clinical success, as measured by a cerebrospinal fluid culture clear of the cryptococcal pathogens, in 34 percent of patients, compared with 40 percent of the amphotericin B patients. Approximately one-fourth of the patients in each treatment group ended the 10-week study period with quiescent disease, raising the overall response rate to 60 percent in the fluconazole group versus 67 percent of the amphotericin B group. Death from progressive disease occurred in 18 percent of the fluconazole group and 14 percent of the amphotericin B group. There was no significant difference between the two treatment groups in the overall outcome of patients with cryptococcal meningitis.
 Treatment with Diflucan (fluconazole) was associated with significantly fewer side effects. Only 27 percent of fluconazole patients reported adverse effects, compared with 64 percent of amphotericin B recipients. In addition, 8 percent of the amphotericin B patients suffered severe toxicity requiring discontinuation of treatment, compared with 2 percent of fluconazole recipients.
 The study also revealed pre-treatment factors that predicted mortality during therapy and which could identify patients at the highest risk of mortality. While fluconazole and amphotericin B were shown to be effective in both low-risk and high-risk populations, further studies are ongoing to determine the optimal therapy in the high-risk population.
 Amphotericin B, either alone or in combination with flucytosine, has been widely used as primary therapy for cryptococcal meningitis. However, amphotericin B is associated with a variety of severe side effects, and must be given intravenously. The most common adverse event with fluconazole, which can be given orally, is nausea, which generally occurs in less than four percent of patients.
 Fluconazole, an oral antifungal agent discovered by Pfizer Central Research and first introduced in the United States in 1990, has been used for fungal infections due to candida and cryptococcal meningitis. Earlier studies have established fluconazole as the preferred drug for maintenance therapy of patients after treatment for acute cryptococcal infection.
 Diflucan (fluconanzole) is marketed in the U.S. by Roerig, a division of Pfizer Inc, a diversified, research-based health care company.
 Prescribing information for Diflucan (fluconazole -- 50, 100 and 200 mg tablets) is available from Roerig on request.
 -0- 1/9/92
 /CONTACT: A. A. Biesada, 212-573-2055, or Rick Honey, 212-573-2051, both of Pfizer/
 (PFE) CO: Pfizer Inc ST: New York IN: MTC SU: PDT


TS -- NY015 -- 8089 01/09/92 09:29 EST
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Date:Jan 9, 1992
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