Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
pantoprazole
pantoprazole 20 mg om and matching placebo nocte
干预措施: pantoprazole vs famotidine (Drug)
famotidine
Famotidine 40 mg om and nocte
干预措施: pantoprazole vs famotidine (Drug)
结局指标
主要结局
The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions.
时间窗: 48 weeks
次要结局
未报告次要终点