Arbaprostil [15(R)-15-methyl prostaglandin E2] in a single nighttime dose of either 50 or 100 micrograms in acute duodenal ulcer.
To determine the efficacy of single nighttime doses of arbaprostil [15(R)-15-methyl prostaglandin E2], 50 or 100 micrograms for 4 wk, a double-blind randomized placebo-controlled multiclinic trial was undertaken. Success was defined as complete healing of the ulcer documented by endoscopy. Fifty-one of 64 patients enrolled were considered evaluable. Ulcer healing was documented in 64.3%, 85.7%, and 31.2% of the 100-micrograms arbaprostil, 50-micrograms arbaprostil, and placebo treatment groups (p value vs. placebo = 0.003 and 0.002, respectively). No difference in side effects or changes in laboratory parameters were found between the treatment groups except that diarrhea, usually mild, was found more often in the 100-micrograms arbaprostil group (60.0%) than in the 50-micrograms arbaprostil (31.8%) or placebo groups (23.5%) (p value 100 micrograms arbaprostil vs. placebo = 0.02). A single nighttime administration of arbaprostil seems to be a safe and efficacious agent for the treatment of acute duodenal ulcer.
Euler
A R
AR
Upjohn Company, Kalamazoo, Michigan.
Bailey
R J
RJ
Zinny
M A
MA
Brandon
M L
ML
Rousseau
B
B
Ferguson
J P
JP
Wood
D R
DR
Le
V H
VH
D000328:Adult; D001101:Arbaprostil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy*; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D011459:Prostaglandins E, Synthetic / Q000627:therapeutic use*; D011897:Random Allocation
D011459:Prostaglandins E, Synthetic; D001101:Arbaprostil