Document 0839
 DOCN  M9590839
 TI    Multicenter trial of octreotide in patients with refractory acquired
       immunodeficiency syndrome-associated diarrhea [see comments]
 DT    9509
 AU    Simon DM; Cello JP; Valenzuela J; Levy R; Dickerson G; Goodgame R; Brown
       M; Lyche K; Fessel WJ; Grendell J; et al; Department of Medicine, Albert
       Einstein College of Medicine,; Bronx, New York, USA.
 SO    Gastroenterology. 1995 Jun;108(6):1753-60. Unique Identifier : AIDSLINE
       MED/95285990
 CM    Comment in: Gastroenterology 1995 Jun;108(6):1939-41
 AB    BACKGROUND/AIMS: 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. METHODS: 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 micrograms weekly to a maximum of 300 micrograms three
       times a day based on weekly 72-hour stool collections. Subsequently,
       patients received open-label octreotide at doses of up to 500 micrograms
       three times a day. RESULTS: 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 micrograms 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. CONCLUSION: 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.
 DE    Acquired Immunodeficiency Syndrome/*COMPLICATIONS  Adult  CD4 Lymphocyte
       Count  Diarrhea/*DRUG THERAPY  Double-Blind Method  Female  Human  Male
       Octreotide/ADVERSE EFFECTS/*THERAPEUTIC USE  Support, Non-U.S. Gov't
       CLINICAL TRIAL  JOURNAL ARTICLE  MULTICENTER STUDY  RANDOMIZED
       CONTROLLED TRIAL

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