Efficacy of sucralfate in the prevention of recurrence of duodenal ulcers.

Eighty-four patients who were endoscopically confirmed to have healed duodenal ulcers were entered into this 1-year, double-blind, placebo-controlled trial of sucralfate, 1g twice daily, in the prevention of duodenal ulcer recurrence. Patients remained in the study until recurrence of ulceration was endoscopically confirmed. Sixty-one patients could be evaluated for efficacy of treatment. Within 6 months, 23 of 31 placebo patients (74%) and 6 of 30 sucralfate patients (20%) had ulcer recurrence. At 12 months, 25 of 31 placebo patients (80%) and 8 of 30 receiving sucralfate (27%) had ulcer recurrence. The lower rate of ulcer recurrence in patients receiving sucralfate was significant (p = 0.0001). Survival curves also showed that sucralfate was significantly more effective in preventing relapse (p = 0.0001). Three patients were judged as experiencing drug-related side effects, two of which were in the placebo group. The results indicate that sucralfate is significantly more effective than placebo in the prevention of recurrence of duodenal ulcer disease.

In vitro and In vivo evaluations of a tableted antacid and sucralfate, a new antiulcer agent.

Sucralfate is a nonsystemic drug used in the therapy of peptic ulcer disease. It is an aluminum salt of a sulfated disaccharide which adheres to ulcerated sites and forms a cytoprotective barrier to acid peptic digestion. The purposes of this study were to determine whether sucralfate had antacid activity in humans and to test the validity of the in vitro antacid qualifying test by comparing its results for tableted products with those of in vivo studies. In the in vitro antacid qualifying test Maalox #1 (4 tablets) passes and sucralfate (1 gm.) failed. These findings were consistent with the results of in vivo tests utilizing a telemetric device, the Heidelberg capsule and tube aspirations. We conclude that sucralfate does not possess antacid properties and that the results of the standard in vitro antacid qualifying test correlated well with those of in vitro studies.

Protection of gastric mucosa by sucralfate from aspirin-induced erosions.

The protective effect of sucralfate against aspirin caused damage to the gastric mucosa was studied in healthy male volunteers (age range 18 to 44 years) with no history of gastrointestinal disease. Each was randomly assigned to placebo or sucralfate. As determined by endoscopic studies, 8 of 12 subjects on sucralfate experienced complete protection; 3 were partially protected. The question was raised whether sucralfate might have inhibited the absorption of aspirin from the gastrointestinal tract, but measurement of salicylate levels showed no statistically significant difference between salicylate levels achieved after sucralfate and after placebo.