Lucke W

Relapse rates after initial ulcer healing with sucralfate and cimetidine.

The relapse rate after successful short-term therapy with sucralfate (Sc) or cimetidine (Cm) was studied in a group of 86 patients with recently healed duodenal or gastric ulcers. The patients were endoscoped on clinical relapse or, routinely, at 6 weeks, 6 months, and 1 year. Patients whose ulcers had healed with Cm relapsed earlier than did those whose ulcers had healed with Sc (p less than 0.05 at 12 weeks), but the cumulative relapse rate by the end of 1 year was of the order of 70% in both treatment groups. The mean duration of remission in patients who developed a recurrence was significantly greater in patients treated initially with Sc than in those treated initially with Cm--7.3 and 4.6 months, respectively (p less than 0.01).

Maintenance therapy with sucralfate reduces rate of gastric ulcer recurrence

Seventy-two patients with recently healed gastric ulcers were entered into a double-blind, placebo-controlled, six-month maintenance trial to assess whether sucralfate, 1 g in the morning and 2 g at night, reduces the propensity for recurrent ulceration. Patients were assessed clinically at 0, 6, 12, 18, and 24 weeks. Endoscopy was performed at the time of entry into the study and at 24 weeks, or earlier if clinical relapse occurred during this period. Eleven patients were excluded from the study because they defaulted or for other protocol violations. The other 61 patients were followed for six months or until evidence of ulcer relapse. Endoscopic recurrence was found in five of 31 patients (16 percent) randomly assigned to receive sucralfate and in 21 of 30 patients (70 percent) assigned to receive placebo. Most recurrences occurred during the first 12 weeks, with relapse rates of 10 percent and 53 percent, respectively for the sucralfate- and the placebo-treated groups. Three of the recurrences noted at 24 weeks were asymptomatic; two of these were in the sucralfate-treated group. The results indicate that a 3 g per day maintenance dose of sucralfate offers meaningful protection against recurrent gastric ulceration.

Nocturnal dosage regimen of sucralfate in maintenance treatment of gastric ulcer.

Sixty-six patients with recently healed gastric ulcers were entered into a double-blind, placebo-controlled, six-month maintenance trial to determine whether sucralfate 2 g at night reduces the liability to recurrent ulceration. Thirty-three patients were randomly assigned to treatment with sucralfate and 33 were assigned to placebo. Endoscopy was performed at the time of entry into the study and at 24 weeks, or earlier if clinical relapse occurred during this period. Of the patients available for analysis, endoscopic recurrences were found in eight of the 29 patients (28 percent) randomly assigned to sucralfate and in 15 of the 27 patients (56 percent) assigned to placebo. Eight of the recurrences noted at 24 weeks were asymptomatic and, of these, five were in the placebo-treated group. The cumulative relapse rate at 24 weeks was significantly lower in the sucralfate-treated group (p less than 0.05), and the Cox-Mantel text showed a significant difference between the cumulative relapse curves of the two treatment groups over the 24-week period (p less than 0.05). The results indicate that a single maintenance dose of sucralfate 2 g at night reduces the relapse rate in patients with recently healed gastric ulceration.

A maintenance regimen of sucralfate 2 g at night for reduced relapse rate in duodenal ulcer disease: A one-year follow-up study

One hundred seventeen patients with recently healed duodenal ulcers were entered into a one-year maintenance study. Patients were randomly assigned to treatment with sucralfate 2 g at night, cimetidine 400 mg, or placebo. The sucralfate versus placebo leg of the study was double-blind, whereas the cimetidine leg was single-blind. Endoscopy was repeated on clinical relapse and routinely at six and 12 months. Ninety-six of the 117 patients were followed up for one year or to an endoscopically proven recurrence. The remaining 21 patients were excluded from analysis because of default or protocol violation. The one-year analysis showed by endoscopy that ulcers had recurred in 17 of the 31 sucralfate-treated patients, 19 of the 32 cimetidine-treated patients, and in 28 of the 33 placebo-treated patients. These data included asymptomatic recurrences in four, four, and three patients, respectively. The relapse rate at 24 weeks was greater in patients healed initially with a histamine (H2)-blocker alone than in those healed initially with sucralfate alone, a combination of sucralfate with a H2-blocker or an antacid alone.