Multicenter trial of octreotide in patients with refractory acquired immunodeficiency syndrome-associated diarrhea |
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| Authors: | Douglas M. Simon John P. Cello Jorge Valenzuela Richard Levy Gordon Dickerson Richard Goodgame Michael Brown Kip Lyche W.Jeffrey Fessel James Grendell C.Mel Wilcox Nezam Afdhal Ronald Fogel Vonda Reeves-Darby John Stern Owen Smith Frank Graziano Douglas Pleakow Timothy Flanigan Timothy Schubert Mark Loveless Larry Eron Paul Basuk Maurizio Bonacini Jan Orenstein |
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| Affiliation: | ∗Department of Medicine, Albert Einstein College of Medicine, Bronx, New York, USA;‡Department of Medicine, University of California, San Francisco, California, USA;§Department of Medicine, University of Southern California Medical School, Los Angeles, California, USA;¶Department of Medicine, University of Miami Medical School, Miami, Florida, USA;∥∥Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA;#Department of Medicine, Baylor College of Medicine, Houston, Texas, USA;‡‡Department of Medicine, University of California, San Diego, California, USA;¶¶Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA;∗∗∗Department of Medicine, University of Texas at Galveston, Galveston, Texas, USA;‡‡‡Department of Medicine, University of Pennsylvania Medical School, Philadelphia, Pennsylvania, USA;§§§§Department of Medicine, Mount Sinai School of Medicine, New York, New York, USA;∗∗Department of Medicine, Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, USA;##Department of Medicine, Henry Ford Hospital, Detroit, Michigan, USA;§§Department of Medicine, Kaiser Permanente Medical Center of San Francisco, San Francisco, California, USA;∥∥∥Department of Medicine, University of Wisconsin Medical School, Madison, Wisconsin, USA;§§§Department of Medicine, University of Missouri Medical School, Kansas, City, Missouri, USA;¶¶¶Department of Medicine, New England Deaconess Hospital-Harvard Medical School, Boston, Massachusetts, USA;###Department of Medicine, Brown University, Providence, Rhode Island, USA;∗∗∗∗Department of Medicine, Oregon Health Sciences University, Portland, Oregon, USA;‡‡‡‡Department of Medicine, Fairfax Hospital, Fairfax, Virginia, USA;∥∥∥∥Department of Pathology, George Washington University, Washington, D.C., USA;∥Sandoz Research Institute, East Hanover, New Jersey, USA |
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| Abstract: |  Diarrhea is a significant problem in patients with acquired immunodeficiency syndrome (AIDS). The aim of this study was to determine octreotide effectiveness in refractory AIDS-associated diarrhea.  In a 3-week protocol, 129 patients with a stool weight of >500 g/day despite standard antidiarrheal therapy were randomized to receive octreotide or placebo (3:2 ratio). Octreotide dose was increased 100 μg weekly to a maximum of 300 μg three times a day based on weekly 72-hour stool collections. Subsequently, patients received open-label octreotide at doses of up to 500 μg three times a day.  A 30% decrease in stool weight defined response. After 3 weeks, 48% of octreotide- and 39% of placebo-treated patients had responded (P = 0.43). At 300 μg three times a day, 50% of octreotide- and 30.1% of placebo-treated patients responded (P = 0.12). At a baseline stool weight of 1000–2000 g/day, 57% of octreotide- and 25% of placebo-treated patients responded (P = 0.06). Response rates based on CD4 counts, diarrhea duration, body weight, human immunodeficiency virus risk factor, and presence or absence of pathogens showed no benefit of octreotide. Adverse events were more frequent in the octreotide-treated group.  In the doses studied, octreotide was not more effective than placebo in patients with refractory AIDS-associated diarrhea. This lack of effectiveness may be attributable to inadequate sample size, doses, and duration of study treatment. |
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| Keywords: | Abbreviations: AIDS, acquired immunodeficiency syndrome HIV, human immunodeficiency virus |
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