triletide and Duodenal-Ulcer

A study was carried out in 30 out-patients with endoscopically confirmed active, benign gastric or duodenal ulceration to assess the comparative effectiveness and tolerance of treatment with triletide, a new synthetic tripeptide with anti-ulcer properties, with that of conventional antacids. Patients were allocated at random to receive treatment with either 1.6 g aluminium hydroxide and 1.6 g magnesium hydroxide per day or the antacids plus 1.5 g triletide per day over a period of 8 weeks. Heartburn and epigastric pain, monitored every other week, were significantly relieved by both treatments, but to a significantly greater extent (70% vs 20% on average, p less than 0.01) and significantly faster (p less than 0.01) in the presence of triletide. Endoscopic control showed that the patients who had triletide experienced complete healing in a significantly greater proportion (73% vs 27%, p less than 0.02) than those who had antacids only. The efficacy of treatments was the same, regardless of the actual ulcer location. Routine haematology and haematochemistry findings were unaffected by either treatment, and subjective possible side-reactions were limited to constipation (9 complaints overall) which is a well-known side-effect of antacid treatment. It would appear, therefore, that triletide is at least as well tolerated as antacids, while promoting the healing of peptic ulcers in a significantly greater proportion of patients and easing symptoms significantly faster and to a greater extent than antacids alone, regardless of the ulcer location.

Topics: Adult; Antacids; Anti-Ulcer Agents; Clinical Trials as Topic; Drug Tolerance; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Oligopeptides; Random Allocation; Stomach Ulcer; Time Factors

A controlled study was carried out in 20 out-patients with endoscopically confirmed active duodenal ulcer to compare the effectiveness and tolerance of a new cytoprotective agent, triletide, with an established antisecretory agent, cimetidine. Patients were allocated at random to receive 8-weeks' treatment with either 1.5 g triletide per day or 1.2 g cimetidine per day. The results showed that all patients experienced improvement of the ulcer condition by the end of treatment, the vast majority being found endoscopically healed. There was no statistically significant difference between the groups. At the same time, the intensity of heartburn and epigastric pain, as well as the mean antacid intake, decreased significantly with both drugs, almost to the same extent. A significant relief of symptoms was already apparent by the end of 2 weeks of treatment, except for heartburn in the cimetidine group which did not show improvement until the fourth week. There were no complaints of possible side-effects with either treatment and no evidence of any significant changes in blood pressure, heart rate or routine haematology and haematochemistry investigations.

Topics: Adult; Antacids; Anti-Ulcer Agents; Blood Pressure; Cimetidine; Clinical Trials as Topic; Duodenal Ulcer; Female; Heart Rate; Humans; Male; Middle Aged; Oligopeptides; Random Allocation; Time Factors

Twenty out-patients with active, chronic duodenal ulcer were treated over a period of 6 weeks with either 0.6 g ranitidine per day or 2 g triletide per day, a new synthetic tripeptide shown to be effective in healing ulcers by increasing the mucosal defence mechanisms. Efficacy was assessed by scoring the intensity of day and night pain before, after 2 and after 6 weeks of treatment, and by endoscopy before and after. Tolerance was assessed by routine laboratory tests, physical examination and a survey of any accessory symptoms. Both drugs significantly relieved pain almost at the same rate and to the same extent, whereas endoscopy showed a not significantly greater improvement in the ranitidine group. It was found, however, that the patients in the triletide group had, on average, a significantly greater intensity of intractable factors on entry than those in the ranitidine group (+75%; p less than 0.02). After stratifying the intractability factor intensity, the 5 patients in the triletide sub-group comparable with those in the ranitidine group exhibited exactly the same behavior on pain relief and a very similar one on endoscopy findings (2 healed, 2 improved and 1 unchanged, compared with 7 healed and 3 improved, respectively). The sub-group with greater severity also showed improvements, both symptomatic and endoscopic, but to a lesser extent, indicating the need for prolonged treatment. Tolerance was good with both drugs. Two patients on triletide reported adverse effects; 1 of increased intensity of previous constipation and the other 1 of mild headache and dizziness, but these could not be related definitely to treatment.

Topics: Adult; Aged; Anti-Ulcer Agents; Blood Pressure; Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Duodenal Ulcer; Female; Heart Rate; Humans; Male; Middle Aged; Oligopeptides; Random Allocation; Ranitidine; Time Factors

Thirty out-patients with endoscopically assessed, active duodenal ulcer of mild to moderate intensity were randomly assigned to 8-weeks' treatment with either antacids (0.8 g/day each of aluminium hydroxide and magnesium hydroxide), triletide (1.5 g/day) or a combination of the two treatments. Every other week, the intensity of subjective symptoms and of objective signs was scored and recorded, and the endoscopic outcome assessed at the 8th week. Three patients on antacids alone and 1 on triletide alone were withdrawn at the 4th week because of therapeutic failure. Symptoms and signs improved in the three groups significantly faster, to a significantly greater extent, and in more patients with triletide, alone or in combination, than with antacids. Endoscopic evidence of therapeutic response was detected in significantly more patients given triletide, alone or in combination, in comparison with the group who had antacids. A significant influence on promoting ulcer healing could be attributed to triletide (p less than 0.05, multiple linear regression) and not to antacids. Tolerance was complete in all patients. It is concluded that triletide appears to be equally well tolerated as, but significantly more effective than, antacids in relieving symptoms and promoting healing in patients with mild to moderate duodenal ulcer.

Topics: Adult; Aged; Ambulatory Care; Antacids; Anti-Ulcer Agents; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Oligopeptides; Random Allocation; Time Factors

Three groups of 15 patients with endoscopically confirmed active gastric or duodenal ulcer were treated over a period of 8 weeks with daily doses of 1, 1.5 or 2 g triletide, an anti-ulcer agent which acts by enhancing the mucosal defence capacity. Intensity of epigastric pain and of heartburn and weekly consumption of standard antacid tablets, as well as possible accessory symptoms, were recorded every other week, endoscopy was repeated at the end of treatment and routine haematology and haematochemistry performed before and after treatment. The proportion of patients found to be endoscopically healed was significantly correlated to the log of the dose used, giving an ED50, under the test conditions, of 1.2 g/day (86.7% healed at 2 g/day). The improvement in each assessed symptom was significantly correlated with time according to an exponential regression. The computed exponent indicated that each higher dose resulted in a significantly faster regression of symptoms than each lower dose (mean time to decrease symptoms by 50%; 4.3 weeks at 2 g/day; 7.4 weeks at 1.5 g/day; and 20.8 weeks at 1 g/day). Moreover, two-ways analysis of variance indicated a significant dose-time interaction (p less than 0.01); thus, the improvement provided at any given time was more than proportional to the used dose. Tolerance was good at all three dose levels and no variations in haematology and haematochemistry could be detected. It is concluded that triletide, at a dose of between 1.5 and 2 g/day according to the patient's condition, appears to be an effective and well-tolerated means of promoting healing and controlling symptoms in peptic ulcer patients.

Topics: Adult; Aged; Antacids; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Oligopeptides; Stomach Ulcer; Time Factors

A study was carried out in 15 patients with gastric or duodenal ulcer to assess whether the efficacy of the antisecretory agent cimetidine might be improved by the addition of a cyto-protective agent, triletide, to the treatment regimen. The patients were treated for an average of 11 +/- 5 days with 0.2 g parenteral cimetidine per day plus 1.5 g oral triletide per day. Endoscopy was performed before and after treatment, as well as routine haematology and haematochemistry. Intensity of symptoms and signs of the illness was scored and recorded daily during the first 5 days of treatment, as well as the extent of antacid intake. Collected data were compared with those of a series of 15 superimposable patients who had shortly before been treated with 0.2 g/day of cimetidine alone. A greater proportion of patients given the combination was found to be endoscopically healed after treatment in comparison with those who had cimetidine alone (53% vs 40%). Intensity of symptoms decreased significantly faster and to a significantly greater extent in the same patients, as did antacid intake. The intensity of objective signs (tenderness, melaena) showed a similar but not significantly different trend. Total symptom intensity decreased twice as fast with the combination in comparison with cimetidine alone (time to decrease by 50%: 4.2 days vs 8.2, respectively). There was no evidence of side-effects or intolerance during treatment.

Topics: Adult; Aged; Anti-Ulcer Agents; Cimetidine; Drug Therapy, Combination; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Oligopeptides; Retrospective Studies; Stomach Ulcer; Time Factors