Effect of octreotide on refractory AIDS-associated diarrhea. A prospective, multicenter clinical trial.
OBJECTIVE
To determine the efficacy and safety of octreotide for treatment of refractory, profuse diarrhea in patients with the acquired immunodeficiency syndrome (AIDS).


METHODS
A prospective, open-label study.


METHODS
Inpatient metabolic units of four university medical centers.


METHODS
Fifty-one patients infected with human immunodeficiency virus (HIV) who had uncontrolled diarrhea (greater than or equal to 500-mL liquid stool per day) despite treatment with maximally tolerable doses of antidiarrheal medications.


METHODS
After initial baseline studies, patients received octreotide, 50 micrograms every 8 hours for 48 hours. If stool volume was not reduced to less than 250 mL/d, the dose of octreotide was increased stepwise to 100, 250, and 500 micrograms.


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 less than 0.001] and 1604 +/- 180 mL/d on day 0 compared with 1084 +/- 162 mL/d on day 14 [P less than 0.001], respectively). Twenty-one patients (41.2%) were considered to be partial or complete responders (reduction in daily stool volume by greater than or equal to 50% of initial collections or reduction to less than or equal 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 less than 0.01).


CONCLUSIONS
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.
University of California, San Francisco.
J P
JP
Cello
J H
JH
Grendell
P
P
Basuk
D
D
Simon
L
L
Weiss
M
M
Wittner
R P
RP
Rood
C M
CM
Wilcox
C E
CE
Forsmark
A E
AE
Read
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000328:Adult; D003967:Diarrhea / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D004041:Dietary Fats / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies
D004041:Dietary Fats; D015282:Octreotide