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Prophylactic Fluconazole in Liver Transplant Recipients: A Randomized, Double-Blind, Placebo-Controlled Trial

Drew J. Winston, MD; Anita Pakrasi, RN; and Ronald W. Busuttil, MD, PhD
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From University of California, Los Angeles, Medical Center, Los Angeles, California.

Acknowledgments: The authors thank Dr. Marcia Levenstein, Dr. Lichen Teng, and Paul Schwartz of Pfizer, Inc., for performing statistical analyses; Dr. David Bruckner and the staff of the UCLA clinical microbiology laboratories for technical assistance; Ed Arriola and the staff of the UCLA pharmacy service for administrative assistance; and Katharine Fry for preparation of the manuscript. They also thank the UCLA liver transplant physicians and nurses for their assistance and for care of patients during the study.

Grant Support: By a research grant from Pfizer, Inc., the Joanne Barr Foundation, and the Dumont Foundation.

Requests for Reprints: Drew J. Winston, MD, Room 42-121 CHS, Department of Medicine, UCLA Medical Center, Los Angeles, CA 90095. For reprint orders in quantities exceeding 100, please contact the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints@mail.acponline.org.

Current Author Addresses: Dr. Winston: Room 42-121 CHS, Department of Medicine, UCLA Medical Center, Los Angeles, CA 90095.

Ms. Pakrasi and Dr. Busuttil: The Dumont-UCLA Transplant Center, Room 77-120 CHS, UCLA Medical Center, Los Angeles, CA 90095.

Ann Intern Med. 1999;131(10):729-737. doi:10.7326/0003-4819-131-10-199911160-00003
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Because of the relatively high incidence and severity of fungal infections (1), prophylaxis with antifungal drugs is frequently used in recipients of certain solid organ transplants. Oral prophylaxis with such agents as nystatin, clotrimazole, and amphotericin B and intravenous prophylaxis with low doses of amphotericin B have produced inconsistent results, and their beneficial effects remain largely unproved (1). Consequently, no approach for prevention of fungal infections in solid organ transplant recipients has been uniformly accepted or recommended.

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Figure 2.
Time to development of any proven fungal infection in all patients (top) and in high-risk patients (bottom).P

Survival distributions of time to development of proven superficial or invasive fungal infection in fluconazole and placebo recipients were derived by using Kaplan-Meier product-limit estimates. High-risk patients are defined as those with a United Network Organ Sharing classification of 1, baseline fungal colonization, and repeated transplantation. For the difference in time of onset of proven fungal infection between fluconazole and placebo recipients, < 0.001 in all patients and all high-risk patients.

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Summary for Patients

Preventing Fungal Infections in People Who Get Liver Transplants

The summary below is from the full report titled “Prophylactic Fluconazole in Liver Transplant Recipients. A Randomized, Double-Blind, Placebo-Controlled Trial.” It is in the 16 November 1999 issue of Annals of Internal Medicine (volume 131, pages 729-737). The authors are D.J. Winston, A. Pakrasi, and R.W. Busuttil.


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