Effect of octreotide on refractory AIDS-associated diarrhea

A prospective, multicenter clinical trial

John P. Cello, James H. Grendell, Paul Basuk, Douglas Simon, Louis M. Weiss, Murray Wittner, Richard P. Rood, C. Mel Wilcox, Chris E. Forsmark, Alexandra E. Read, Julie A. Satow, Cynthia S. Weikel, Cheryl Beaumont

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)705-710
Number of pages6
JournalAnnals of Internal Medicine
Volume115
Issue number9
StatePublished - Nov 1 1991

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Octreotide
Multicenter Studies
Diarrhea
Acquired Immunodeficiency Syndrome
Clinical Trials
Inpatients
Antidiarrheals
Therapeutics
Outpatients
Randomized Controlled Trials
Placebos
HIV
Safety
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Cello, J. P., Grendell, J. H., Basuk, P., Simon, D., Weiss, L. M., Wittner, M., ... Beaumont, C. (1991). Effect of octreotide on refractory AIDS-associated diarrhea: A prospective, multicenter clinical trial. Annals of Internal Medicine, 115(9), 705-710.

Effect of octreotide on refractory AIDS-associated diarrhea : A prospective, multicenter clinical trial. / Cello, John P.; Grendell, James H.; Basuk, Paul; Simon, Douglas; Weiss, Louis M.; Wittner, Murray; Rood, Richard P.; Wilcox, C. Mel; Forsmark, Chris E.; Read, Alexandra E.; Satow, Julie A.; Weikel, Cynthia S.; Beaumont, Cheryl.

In: Annals of Internal Medicine, Vol. 115, No. 9, 01.11.1991, p. 705-710.

Research output: Contribution to journalArticle

Cello, JP, Grendell, JH, Basuk, P, Simon, D, Weiss, LM, Wittner, M, Rood, RP, Wilcox, CM, Forsmark, CE, Read, AE, Satow, JA, Weikel, CS & Beaumont, C 1991, 'Effect of octreotide on refractory AIDS-associated diarrhea: A prospective, multicenter clinical trial', Annals of Internal Medicine, vol. 115, no. 9, pp. 705-710.
Cello, John P. ; Grendell, James H. ; Basuk, Paul ; Simon, Douglas ; Weiss, Louis M. ; Wittner, Murray ; Rood, Richard P. ; Wilcox, C. Mel ; Forsmark, Chris E. ; Read, Alexandra E. ; Satow, Julie A. ; Weikel, Cynthia S. ; Beaumont, Cheryl. / Effect of octreotide on refractory AIDS-associated diarrhea : A prospective, multicenter clinical trial. In: Annals of Internal Medicine. 1991 ; Vol. 115, No. 9. pp. 705-710.
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abstract = "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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AU - Weiss, Louis M.

AU - Wittner, Murray

AU - Rood, Richard P.

AU - Wilcox, C. Mel

AU - Forsmark, Chris E.

AU - Read, Alexandra E.

AU - Satow, Julie A.

AU - Weikel, Cynthia S.

AU - Beaumont, Cheryl

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