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Effect of Octreotide on Refractory AIDS-associated Diarrhea: A Prospective, Multicenter Clinical Trial

John P. Cello, MD; James H. Grendell, MD; Paul Basuk, MD; Douglas Simon, MD; Louis Weiss, MD; Murray Wittner, MD; Richard P. Rood, MD; C. Mel Wilcox, MD; Chris E. Forsmark, MD; Alexandra E. Read, MD; Julie A. Satow, RN; Cynthia S. Weikel, MD; and Cheryl Beaumont, RN
[+] Article, Author, and Disclosure Information

Presented in part at Digestive Disease Week, San Antonio, TX, on 16 May 1990.

Grant Support: In part by the General Foundation for Medicine and the General Clinical Research Center (SFGH-RR-00083, UCSD-MO1-RR00827, Hopkins-RR00035/RR00722) and by the National Center for Research Resources, National Institutes of Health.

Requests for Reprints: John P. Cello, MD, 3C-21 GI Unit, San Francisco General Hospital, San Francisco, CA 94110.

Current Author Addresses: Dr. Cello and Ms. Satow: Gastroenterology Division, Medical Service, San Francisco General Hospital, San Francisco, CA 94110.

Dr. Grendell: Veterans Affairs Medical Center, Gastroenterology Unit, San Francisco, CA 94121.

Dr. Basuk: Gastroenterology Division, Box 1069, Mount Sinai Medical Center, 1 Gustave L. Levy Place, New York, NY 10029-6574.

Ms. Beaumont: University of California, San Diego Medical Center, H-811D, 225 Dickinson Street, San Diego, CA 92103.

Drs. Simon, Wittner, and Weiss: Albert Einstein College of Medicine, Room 623 Ullman Building, 1300 Morris Park Avenue, Bronx, NY 10461.

Dr. Rood: 25701 North Lakeland Boulevard, Euclid, OH 44132.

Dr. Wilcox: Gastroenterology Division, Emory University School of Medicine, 69 Butler Street, S.E., Atlanta, GA 30303.

Dr. Forsmark: Division of Gastroenterology, University of Florida Medical Center, Box J-214, Gainesville, FL 32601-0214.

Dr. Read: 1010 116th Avenue, N.E., Bellevue, WA 98004.

Dr. Weikel: Gastroenterology and Infectious Diseases Divisions, The Johns Hopkins Hospital, Hunterian 417, Baltimore, MD 21205.

©1991 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1991;115(9):705-710. doi:10.7326/0003-4819-115-9-705
Text Size: A A A

Objective: To determine the efficacy and safety of octreotide for treatment of refractory, profuse diarrhea in patients with the acquired immunodeficiency syndrome (AIDS).

Design: A prospective, open-label study.

Setting: Inpatient metabolic units of four university medical centers.

Patients: Fifty-one patients infected with human immunodeficiency virus (HIV) who had uncontrolled diarrhea (≥ 500-mL liquid stool per day) despite treatment with maximally tolerable doses of antidiarrheal medications.

Intervention: After initial baseline studies, patients received octreotide, 50 µg every 8 hours for 48 hours. If stool volume was not reduced to < 250 mL/d, the dose of octreotide was increased stepwise to 100, 250, and 500 µg.

Main Results: Fifty men and one woman (mean age, 36.3 ± 1.1 years) entered and completed the 28-day protocol (14 days of inpatient therapy and 14 days of outpatient therapy). Stool frequency and volume decreased significantly (6.5 ± 0.5 stools per day on day 0 compared with 3.8 ± 0.3 stools per day on day 21 [P < 0.001] and 1604 ± 180 mL/d on day 0 compared with 1084 ± 162 mL/d on day 14 [P < 0.001], respectively). Twenty-one patients (41.2%) were considered to be partial or complete responders (reduction in daily stool volume by ≥ 50% of initial collections or reduction to ≤ 250 mL/d). Of the 21 responders, 14 (67%) had no identifiable pathogens at initial screening compared with 9 of 30 (30%) nonresponders (P < 0.01).

Conclusion: Patients with AIDS-associated refractory watery diarrhea, especially those without identifiable pathogens, may respond favorably to subcutaneously administered octreotide. This drug deserves further study in a randomized, placebo-controlled trial.





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