Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion

Study Overview
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Brief Summary
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Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects. The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer or erosions by proton pump inhibitor is unclear. The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin

Detailed Description
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Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease . Its use is frequently limited by gastrointestinal side effects, ranging from dyspepsia (31%) to life-threatening bleeding or perforation of gastroduodenal ulcers (3.1%) over a period of 4 years . The best approach for the secondary prevention of low-dose aspirin induced symptomatic peptic ulcer or erosions in patients who need to continue aspirin remain uncertain. At present, eradication of Helicobacter pylori infection and long-term maintenance with proton pump inhibitor PPI appears to be the best options. The position of H2-receptor antagonists (H2RA) as a step-down therapy after healing of peptic ulcer or erosions is unclear. The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin.

Official Title
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Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study

Conditions
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Peptic Ulcer/Erosions

Intervention / Treatment
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* Drug: pantoprazole vs famotidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks 18 years old or older. Exclusion Criteria: concurrent erosive or ulcerative esophagitis pyloric stenosis previous gastric or duodenal surgery other than oversewing of a perforation thrombocytopenia renal failure with estimated creatinine clearance less than 10 ml / min active cancer known allergic to aspirin, famotidine or pantoprazole pregnancy, lactation, child-bearing potential in the absence of contraception psychosomatic disorder planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant disorders that might modify the absorption of study drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pantoprazole<br>pantoprazole 20 mg om and matching placebo nocte | Drug: pantoprazole vs famotidine<br>* pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte<br>* Other names: famotidine;|
| Active Comparator: famotidine<br>Famotidine 40 mg om and nocte | Drug: pantoprazole vs famotidine<br>* pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte<br>* Other names: famotidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions. |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pantoprazole, famotidine, aspirin, dyspepsia, gastrointestinal bleeding, peptic ulcer / erosion