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

Ruttonjee Hospital

Status and phase: Completed; Phase 4

Conditions: Peptic Ulcer/Erosions

Treatments: Drug: pantoprazole vs famotidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00843063

HKEC 2004-016

Details and patient eligibility

About

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

Full description

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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161 participants in 2 patient groups

pantoprazole

Active Comparator group

Description:

pantoprazole 20 mg om and matching placebo nocte

Treatment:

Drug: pantoprazole vs famotidine

famotidine

Active Comparator group

Description:

Famotidine 40 mg om and nocte

Treatment:

Drug: pantoprazole vs famotidine