gefarnate and Duodenal-Ulcer

Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain.. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively.. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event.. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Aged; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthritis; Double-Blind Method; Duodenal Ulcer; Female; Gefarnate; Humans; Kaplan-Meier Estimate; Lansoprazole; Low Back Pain; Male; Middle Aged; Prospective Studies; Secondary Prevention; Stomach Ulcer; Treatment Outcome

The efficacy of low-dose lansoprazole has not been established for the prevention of recurrent gastric or duodenal ulcers in those receiving long-term low-dose aspirin (LDA) for cardiovascular and cerebrovascular protection. This study sought to examine the efficacy of low-dose lansoprazole (15 mg once daily) for the secondary prevention of LDA-associated gastric or duodenal ulcers.. Patients were randomized to receive lansoprazole 15 mg daily (n = 226) or gefarnate 50 mg twice daily (n = 235) for 12 months or longer in a prospective, multicenter, double-blind, randomized active-controlled trial, followed by a 6-month follow-up study with open-label lansoprazole treatment. The study utilized 94 sites in Japan and 461 Japanese patients with a history of gastric or duodenal ulcers who required long-term LDA therapy for cardiovascular and cerebrovascular disease.. The primary endpoint was the development of gastric or duodenal ulcers. The cumulative incidence of gastric or duodenal ulcers on days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 1.5, 2.1, and 3.7%, respectively, in the lansoprazole group versus 15.2, 24.0, and 31.7%, respectively, in the gefarnate group. The risk of ulcer development was significantly (log-rank test, P < 0.001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.099 (95% confidence interval [CI] 0.042-0.230).. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term LDA therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Aged; Anti-Ulcer Agents; Aspirin; Double-Blind Method; Duodenal Ulcer; Female; Follow-Up Studies; Gefarnate; Humans; Incidence; Japan; Kaplan-Meier Estimate; Lansoprazole; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Secondary Prevention; Stomach Ulcer

The new H2 receptor antagonist, famotidine, has been tested in open and double-blind studies in over 2,000 acute duodenal or gastric ulcer patients as well as in the maintenance of chronic duodenal ulcer patients. In early studies, dosages of 20 mg b.i.d. were found to achieve better results than 10 mg b.i.d. and equivalent to 20 mg t.i.d. Trials comparing famotidine to cimetidine, ranitidine, and gefarnate found the new agent to be approximately equivalent to cimetidine and ranitidine and superior to gefarnate in the treatment of acute duodenal ulcer. Similar trials were conducted to compare different types of therapy in acute gastric ulcer. Famotidine 40 mg at bedtime was significantly more effective than placebo, and a 20 mg b.i.d. dosage once again proved at least as active as cimetidine 200 mg q.i.d. and considerably more effective than gefarnate. Furthermore, famotidine 20 mg at bedtime was found to effectively prevent relapses for at least 6 months. The side effect profile was extremely favorable--adverse reactions were rare and never positively associated with the drug. Although experience with this new agent is still somewhat limited, preliminary results indicate that famotidine is at least comparable with the other available H2 antagonists and can be considered an excellent choice for treatment of peptic ulcer disease.

Topics: Acute Disease; Chronic Disease; Cimetidine; Circadian Rhythm; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Duodenal Ulcer; Endoscopy; Famotidine; Gefarnate; Histamine H2 Antagonists; Humans; Ranitidine; Stomach Ulcer; Thiazoles; Time Factors

Topics: Adolescent; Adult; Aged; Aluminum Hydroxide; Anti-Ulcer Agents; Bismuth; Chronic Disease; Cimetidine; Clinical Trials as Topic; Drug Combinations; Duodenal Ulcer; Endoscopy; Female; Gefarnate; Glycyrrhiza; Humans; Magnesium Hydroxide; Male; Middle Aged; Plant Extracts; Sodium Bicarbonate

Topics: Adolescent; Adult; Aged; Benzhydryl Compounds; Clinical Trials as Topic; Duodenal Ulcer; Female; Gefarnate; Humans; Male; Middle Aged; Propylamines; Terpenes

Thirty outpatients suffering from duodenal ulcer of recent onset were given cimetidine 1 g/day or gefarnate 250 mg/day for 6 weeks in a double blind trial, randomly balances between the groups. Endoscopic assessment was carried out at 4 and 6 weeks; patients healed after 4 weeks were withdrawn from the trial. In all parameters considered, cimetidine showed a highly significant difference. The healing rate at 4--6 weeks was 67--93% after cimetidine treatment and 27--53% after gefarnate treatment. The effect of cimetidine on the disappearance of symptoms, mainly the nocturnal ulcer pain, and on antacid consumption was greater than that after medication wity gefarnate. After 4--6 weeks of a full dose cimetidine regimen, both basal and pentagastrin stimulated gastric acid secretion were reduced and peptone meal stimulated serum gastrin increased; the basal gastrinaemia remained unchanged.

Topics: Adult; Cimetidine; Clinical Trials as Topic; Double-Blind Method; Duodenal Ulcer; Female; Gastric Juice; Gastrins; Gefarnate; Guanidines; Humans; Male; Middle Aged; Terpenes; Time Factors

Topics: Adult; Alloxan; Anti-Ulcer Agents; Biological Products; Drug Combinations; Duodenal Ulcer; Gefarnate; Gluconates; Humans; Lactobacillus; Metronidazole