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Multicenter trial of octreotide in patients with refractory acquired immunodeficiency syndrome-associated diarrhea.

Abstract：

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.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Simon DM,Cello JP,Valenzuela J,Levy R,Dickerson G,Goodgame R,Brown M,Lyche K,Fessel WJ,Grendell J

doi

10.1016/0016-5085(95)90137-x

subject

Has Abstract,Author List Incomplete

pub_date

1995-06-01 00:00:00

pages

1753-60

issue

6

eissn

0016-5085

issn

1528-0012

pii

S0016508595001879

journal_volume

108

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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