MULTICENTER TRIAL OF OCTREOTIDE IN PATIENTS WITH REFRACTORY ACQUIRED IMMUNODEFICIENCY SYNDROME-ASSOCIATED DIARRHEA

Background/Aims: Diarrhea is a significant problem in patients with ac quired immunodeficiency syndrome (AIDS). The aim of this study was to determine octreotide effectiveness in refractory AIDS-associated diarr hea. Methods: In a 3-week protocol, 129 patients with a stool weight o f >500 g/day despite standard antidiarrheal therapy were randomized to receive octreotide or placebo (3:2 ratio). Octreotide dose was increa sed 100 mu g weekly to a maximum of 300 mu g three times a day based o n weekly 72-hour stool collections. Subsequently, patients received op en-label octreotide at doses of up to 500 mu g three times a day, Resu lts: A 30% decrease in stool weight defined response. After 3 weeks, 4 8% of octreotide- and 39% of placebo-treated patients had responded (P = 0.43). At 300 mu g 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 palcebo-treat ed patients responded (P = 0.06). Response rates based on CD4 counts, diarrhea duration, body weight, human immunodeficiency virus risk fact or, and presence or absence of pathogens showed no benefit of octreoti de. Adverse events were more frequent in the octreotide-treated group. Conclusion: In the doses studied, octreotide was not more effective t han 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.