An evaluation of arbaprostil at multiple doses for the treatment of acute duodenal ulcer: a randomized double-blind placebo-controlled international trial.
Six hundred and thirty patients were enrolled in a randomized double-blind placebo-controlled trial evaluating two arbaprostil dosages (25 micrograms and 50 micrograms) qid for 4 wk for the treatment of acute duodenal ulcers. The healing rates in the placebo, 25-micrograms, and 50-micrograms treatment groups were 39%, 51%, and 60%, respectively. Smoking was found to adversely affect the healing rates in all the treatment groups. Pain severity was less with either arbaprostil treatment. The only side effect found was diarrhea: 10%, 14%, and 32% in the placebo, 25-micrograms, and 50-micrograms treatment groups, respectively. Severe diarrhea occurred in 1% of those patients who received the 50-micrograms dosage regimen, but in none of the other two groups. Arbaprostil at these two dosage levels, when given for 4 wk, appears to be a safe and efficacious agent for the treatment of acute duodenal ulcers.
Euler
A R
AR
Upjohn Company, Kalamazoo, MI 49001.
Krawiec
J
J
Odes
H
H
Gilat
T
T
Garcia
L
L
Rachmilewitz
D
D
Gabryelewicz
A
A
Gibinski
K
K
Bass
D
D
Barbara
L
L
D000208:Acute Disease; D001101:Arbaprostil / Q000008:administration & dosage* / Q000009:adverse effects; D002214:Capsules; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004384:Duodenoscopy; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D010919:Placebos; D011459:Prostaglandins E, Synthetic / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors; D014945:Wound Healing / Q000187:drug effects
D002214:Capsules; D010919:Placebos; D011459:Prostaglandins E, Synthetic; D001101:Arbaprostil