Enprostil is a
synthetic prostaglandin E2 analogue with gastric anti-secretory, cytoprotective, and
gastrin lowering properties. The current multi-center, double-blind, placebo-controlled study was undertaken to evaluate the efficacy and safety of
enprostil (35 micrograms twice daily) for the treatment of
duodenal ulcers. The study enrolled 87 patients between the ages of 18 and 85 with an endoscopically proved
duodenal ulcer between 0.5 and 3.0 cm in its longest dimension and with no other serious medical conditions or abnormal laboratory tests results. Treatment groups were comparable in age, sex, smoking status,
ulcer history, and baseline
ulcer size. The results indicated that the healing rate for
enprostil at two weeks was 38 percent, compared with a placebo rate of 23 percent (p = 0.151). At four weeks, 70 percent of the
enprostil-treated patients had healed
ulcers, compared with 49 percent of the placebo-treated patients, a statistically significant difference (p = 0.048). Although within the
enprostil group the healing rate was higher in nonsmokers (86 percent) than in smokers (58 percent), this difference did not reach statistical significance. Side effects included
diarrhea (14 percent) and
headache (7 percent). These results indicate that 35 micrograms of
enprostil twice daily provides effective and safe
therapy for patients with
duodenal ulcer.