SUMMARY
A 24-week, double-blind, randomized study at 13 centres compared the efficacy and safety of 20 mg famotidine nocte and 150 mg ranitidine h.s. for the prevention of duodenal ulcer recurrence. All participants had been successfully treated for an acute duodenal ulcer with 40 mg famotidine nocte. Patients were endoscoped at baseline and at 24 weeks, unless symptoms warranted earlier examination: of the 208 patients enrolled, 86 who received famotidine and 84 who received ranitidine met all protocol criteria and were considered evaluable.
Intention to treat and per protocol analyses showed non-significant trends in favour of famotidine (P= 0.44 and 0.16, respectively). During the 24-week observation period, 16.3% of the famotidine group and 25% of the ranitidine group had an ulcer recurrence (95% CI of percentage difference –0.22 + 0.04). At 24 weeks, relief of day and night pain was reported by 81.2% and 91.8% of the famotidine-treated patients, respectively. The corresponding figures in the ranitidine group were 73.5% and 85.5%.
No laboratory abnormalities related to the study-drugs were noted and only two drug related (possibly or probably) adverse experiences were reported, both in the famotidine group. The data from this study therefore, supports the conclusion that the efficacy of 20 mg famotidine nocte is comparable to that of ranitidine in preventing duodenal ulcer recurrence, with comparable tolerability for long-term therapy.
Last. Aki N. Nogawa(UCI: University of California, Irvine)H-Index: 7
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: We used published results from clinical trials to evaluate the efficacy of ranitidine and cimetidine as maintenance therapy following healing of acute duodenal ulcers. Only studies in which patients were treated with an evening-meal or bedtime dose of ranitidine (150 mg) or cimetidine (400 mg) over a 12-month period were used. The results from the analysis of seven clinical trials where ranitidine was directly compared to cimetidine indicated that 8.4% fewer patients experienced an ulcer recur...
In 11 duodenal ulcer patients, the antisecretory effects of bedtime famotidine 40 mg were compared to those obtained with ranitidine 300 mg and placebo by means of continuous 24-hour intragastric pH m
Abstract The efficacy and safety of famotidine, a potent new long-acting H 2 -receptor antagonist, was compared with placebo in a multicenter, double-blind, randomized, placebo-controlled study in the United States. A total of 384 patients with endoscopically proven acute duodenal ulcer disease were enrolled. Patients received either famotidine or a placebo. The patients receiving famotidine were treated with one of three dose regimens, 40 mg h.s., 40 mg b.i.d., or 20 mg b.i.d. Patients were rea...
To examine whether changes in inhibition of gastric acid secretion occur during chronic ranitidine therapy, duodenal ulcer patients in remission were studied before and after 9 months of maintenance ranitidine therapy (150 mg nocte). At each time, the effect of a bolus i.v. dose of ranitidine (50 mg) on pentagastrin-stimulated maximal acid output was measured. Oral and intravenous pharmacokinetic studies were also performed to examine whether changes in absorption or disposition occur during lon...
#1E. Clinton Texter(University of Arkansas for Medical Sciences)H-Index: 5
#2Farhad Navab(University of Arkansas for Medical Sciences)H-Index: 16
Last. Rayanne S. Berman(University of Arkansas for Medical Sciences)H-Index: 4
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Abstract The decision to treat a patient with duodenal ulcer should be based upon the following: (1) severity of disease; (2) effectiveness of treatment; and (3) risk and cost of treatment. A number of drugs are effective for this condition. When administration of the drug is discontinued, a recurrence of the ulcer occurs most often within three months, with the rate approaching 90 percent at one year. Maintenance therapy has evolved as a method of preventing recurrence. A double-blind, randomiz...
Various sections of the manuscript reviewed by: M.J.S. lAngman, Department of Therapeutics, University Hospital, Nottingham, England; D.M. McCarthy, Chief of Gastroenterology , Veterans Administration Medical Center, Albuquerque, New Mexico, USA; J.J. Misiewicz, Central Middlesex Hospital, Department of Gastroenterology and Nutrition, London, England; K. Ohe, University of Occupational and Environmental Health, School of Medicine, Yahatanishi-ku, Japan; D.W. Piper, Royal North Shore Hospital, St...
Little is known about the natural history of peptic ulcer disease. Its active phase tends to last about 15 years with a high frequency of complications (in 20-25% of cases) and recurrences after initial healing, although subsequently these problems are reduced. Until the advent of the H2 blockers, therapy (whether medical or surgical) failed to alter the course of the disease. Peptic ulcer disease, however, appears to respond positively to therapy with H: blockers, inasmuch as these drugs at rel...
The results of a randomized, single-blind, multi-clinic study comparing the therapeutic efficacy and degree of oral staining of new colloidal bismuth subcitrate (CBS) coated tablets over 4 weeks of treatment in patients suffering from duodenal ulceration are reported. The data were collected from 9 clinics in the Netherlands, Belgium, Ireland, the United Kingdom, and Italy. The results from 94 patients treated with CBS coated tablets and 95 patients treated with CBS chewing tablets were statisti...
Abstract The healing rate of duodenal ulcers may be accelerated by secretory inhibitors such as histamine H 2 -receptor antagonists and pirenzepine, by antacids, by protective drugs such as sucralfate and colloidal bismuth, and by antidepressant drugs such as trimipramine. The effect of these drugs on the rate of healing is comparable; they differ with respect to practicability of treatment, incidence and types of side effects, and suitability for long-term administration. Currently, the most ve...
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
Background and Aim: The attenuated antisecretory activity of H2 receptor antagonists (H2RA) during continuous administration is known as the tolerance phenomenon. The authors recently clarified that presence or absence of Helicobacter pylori infection influences the occurrence of the tolerance phenomenon. The aim of this study was to clarify whether tolerance to H2RA is correlated with attenuation of the inhibitory effect against gastroesophageal acid reflux in patients with gastroesophageal ref...
Summary Background : The attenuated anti-secretory activity of H2 receptor antagonists (H2RA) during continuous administration is referred to as the tolerance phenomenon. However, it is not clarified whether Helicobacter pylori infection affects the occurrence of tolerance to H2RA. It is also not clarified whether the tolerance phenomenon occurs to a new H2RA, lafutidine. Aim : To investigate the occurrence of the tolerance phenomenon in subjects with and without H. pylori infection during the c...
Background and Aim: The attenuated antisecretory activity observed during continuous administration of ranitidine has been described as tolerance. However, it remains unclear whether a similar phenomenon occurs with other histamine H2 receptor antagonists (H2RA). We investigated whether tolerance to famotidine, a stronger H2RA than ranitidine, occurs during long-term administration. Methods: Seven healthy male Japanese subjects without Helicobacter pylori infection participated in a randomized c...
Background: Helicobacter pylori eradication triple therapy with a combination of lansoprazole, amoxicillin and clarithromycin was approved in Japan in September 2000. Aim: To compare the cost-effectiveness of this eradication therapy with conventional histamine-2 receptor antagonist therapy in Japan. Methods: We established two Markov models for gastric and duodenal ulcers. The model design was based on the Japanese H. pylori eradication guideline and a specialist’s opinions, and the model input...
SUMMARY Background: Helicobacter pylori eradication triple therapy with a combination of lansoprazole, amoxicillin and clarithromycin was approved in Japan in September 2000. Aim: To compare the cost-effectiveness of this eradication therapy with conventional histamine-2 receptor antagonist therapy in Japan. Methods: We established two Markov models for gastric and duodenal ulcers. The model design was based on the Japanese H. pylori eradication guideline and a specialist’s opinions, and the mod...
In most patients duodenal ulcer is a chronicrelapsing disease. If no active maintenance treatment oreradication therapy is given after healing, around70-100% of patients have a relapse during the first year. We conducted a double-blind multicenterstudy in 472 patients with duodenal ulcer. They weretreated with omeprazole 20 mg every morning for four oreight weeks and when healed were randomly allocated to maintenance treatment with either omeprazole20 mg every morning or ranitidine 150 mg at bed...
Background: A 1994 National Institutes of Health consensus panel recommended that eradication of Helicobacter pylori should be first-line therapy for persons with duodenal ulcer. Objective: To assess the cost-effectiveness of H pylori eradication relative to alternative pharmacologic strategies in the long-term management of persons with confirmed duodenal ulcer. Methods: Decision analysis model to estimate expected costs and symptomatic ulcer recurrences during a 12-month period for three gener...