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- Title
Effect of octreotide on refractory AIDS-associated diarrhea. A prospective, multicenter clinical trial.
- Authors
Cello, John P.; Grendell, James H.; Basuk, Paul; Simon, Douglas; Weiss, Louis; Wittner, Murray; Rood, Richard P.; Wilcox, C. Mel; Forsmark, Chris E.; Read, Alexandra E.; Satow, Julie A.; Weikel, Cynthia S.; Beaumont, Cheryl; Cello, J P; Grendell, J H; Basuk, P; Simon, D; Weiss, L; Wittner, M; Rood, R P
- Abstract
<bold>Objective: </bold>To determine the efficacy and safety of octreotide for treatment of refractory, profuse diarrhea in patients with the acquired immunodeficiency syndrome (AIDS).<bold>Design: </bold>A prospective, open-label study.<bold>Setting: </bold>Inpatient metabolic units of four university medical centers.<bold>Patients: </bold>Fifty-one patients infected with human immunodeficiency virus (HIV) who had uncontrolled diarrhea (greater than or equal to 500-mL liquid stool per day) despite treatment with maximally tolerable doses of antidiarrheal medications.<bold>Intervention: </bold>After initial baseline studies, patients received octreotide, 50 micrograms every 8 hours for 48 hours. If stool volume was not reduced to less than 250 mL/d, the dose of octreotide was increased stepwise to 100, 250, and 500 micrograms.<bold>Main Results: </bold>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 less than 0.001] and 1604 +/- 180 mL/d on day 0 compared with 1084 +/- 162 mL/d on day 14 [P less than 0.001], respectively). Twenty-one patients (41.2%) were considered to be partial or complete responders (reduction in daily stool volume by greater than or equal to 50% of initial collections or reduction to less than or equal 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 less than 0.01).<bold>Conclusion: </bold>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.
- Subjects
UNITED States; PEPTIDES; DIARRHEA; THERAPEUTICS; AIDS patients
- Publication
Annals of Internal Medicine, 1991, Vol 115, Issue 9, p705
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-115-9-705