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Aerosol Pentamidine for Secondary Prophylaxis of AIDS-related Pneumocystis carinii Pneumonia: A Randomized, Placebo-Controlled Study

Julio S. G. Montaner, MD; Lindsay M. Lawson, MD; André Gervais, MD; Robert H. Hyland, MD; Charles K. Chan, MD; Julian M. Falutz, MD; Paolo M. Renzi, MD; Douglas MacFadden, MD; Anita R. Rachlis, MD; I. W. Fong, MD; Gary E. Garber, MD; Andrew Simor, MD; Norbert Gilmore, MD; Mary Fanning, MD; Geoffrey D. Taylor, MD; Alain Y. Martel, MD; Walter F. Schlech, MD; and Martin T. Schechter, MD, PhD
[+] Article, Author, and Disclosure Information

Grant Support: In part by Fisons Company. Drs. Schechter and Montaner are supported by a National Health Research Scholar Award from the National Health Research Development Program, Health and Welfare, Canada.

Requests for Reprints: Julio S. G. Montaner, MD, National Health Research Scholar, Director, AIDS Research Programme, St. Paul's Hospital/University of British Columbia, Suite 210, 1033 Davie Street, Vancouver, British Columbia V6E 1M7.

Current Author Addresses: Dr. Montaner: St. Paul's Hospital-University of British Columbia, Suite 210, 1033 Davie Street, Vancouver, British Columbia V6E 1M7.

Dr. Lawson: St. Paul's Hospital, 1081 Burrard Street, Vancouver, British Columbia V6E 1M7.

Dr. Gervais: Notre Dame Hospital, 1560 rue Sherbrooke Est, Montreal, Quebec H2L 4M1.

Drs. Hyland and Chan: Wellesley Hospital, E. K. Jones Building, 160 Wellesley Street East, Toronto, Ontario M4Y 1J3.

Dr. Falutz: Montreal General Hospital, Room 7112, 1650 Cedar Avenue, Montreal, Quebec H3G 1A4.

Dr. Renzi: St. Luke's Hospital, 1058 rue St. Dennis, Montreal, Quebec H2X 3J4.

Dr. MacFadden: Toronto Western Hospital, Suite 4006, Edith Cavell Wing, 399 Bathurst Street, Toronto, Ontario M5T 2S8.

Dr. Rachlis: Sunnybrook Medical Centre, 2075 Bayview, Room 2026, Toronto, Ontario M4N 3M5.

Dr. Fong: St. Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8.

Dr. Garber: Department of Infectious Disease, Ottawa General Hospital, 501 Smyth Road, Ottawa, Ontario K1H 8L6.

Dr. Simor: Department of Microbiology, Room 602, Mount Sinai Hospital, 600 University Avenue, Toronto, Ontario M5G 1X5.

Dr. Gilmore: Royal Victoria Hospital, Room Ml 122, Division of Clinical Immunology, 687 Pine Avenue, Montreal, Quebec H3A 1A1.

Dr. Fanning: Division of Infectious Diseases, Toronto General Hospital, Eaton Wing North, G-222, 200 Elizabeth Street, Toronto, Ontario M5G 2C4.

Dr. Taylor: Infectious Unit, University of Alberta Hospital, 2E4 11 W. C. Mackenzie HSC, Edmonton, Alberta T6G 2B7.

Dr. Martel: Centre Hôpital de l'Université Laval, 2705 boulevard Laurier, St. Foy, Quebec GlV 4G2.

Dr. Schlech: ACC-4089, Victoria General Hospital, 1278 Tower Road, Halifax, Nova Scotia B3H 2Y9.

Dr. Schechter: Department of Health Care and Epidemiology, University of British Columbia, Mather Building, 5804 Fairview Avenue, Vancouver, British Columbia V6T 1W5.

©1991 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1991;114(11):948-953. doi:10.7326/0003-4819-114-11-948
Text Size: A A A

Objective: To assess the safety and efficacy of aerosol pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome (AIDS).

Participants: Patients recovering from a first confirmed episode of AIDS-related P. carinii pneumonia who had no evidence of either another active AIDS-defining opportunistic infection or another pulmonary abnormality were considered eligible for the study but were included only if they had received no immunomodulators or antiretroviral agents other than zidovudine within 30 days of entry. One hundred sixty-two patients were randomized and started on the study drug.

Intervention: Patients were randomly assigned to receive aerosol pentamidine, 60 mg per dose, or placebo, delivered using a hand-held, patient-triggered, ultrasonic nebulizer. The induction phase of treatment consisted of S doses over 14 days, followed by a maintenance phase beginning on day 21 and consisting of one dose every 2 weeks.

Results: Thirty-two cases of P. carinii pneumonia were diagnosed before the termination of the trial; 27 cases occurred among 78 patients receiving placebo and S occurred among 84 patients receiving aerosol pentamidine. Estimates of the cumulative relapse rate of P. carinii pneumonia by 24 weeks were 50% and 9% for the placebo and pentamidine groups, respectively (P < 0.001). Adverse reactions attributed to the study drug occurred in 15 of 78 patients receiving placebo and in 28 of 84 patients receiving pentamidine (P = 0.04). These were all mild or moderate in severity and did not preclude continued administration of the study drug.

Conclusion: Intermittent therapy with aerosol pentamidine is highly effective and well tolerated as secondary prophylaxis for AIDS-related P. carinii pneumonia.





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