Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis

• Clinical rebleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]

  Clinical rebleeding defines:

  1. Hematemesis, fresh blood in the NG tube aspirate
  2. Hematochezia/melena after a normal stool
  3. Decrease in Hb >= 2 g/dL or an increase in Hb < 1 g/dL during 24 hrs, despite >=2 units of blood transfused during 24 hours
  4. SBP <= 90 mm Hg or HR >= 110 beats/min AND melena/hematemesis
  
  

• Blood transfusion [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  
• Need of surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  
• Lengths of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  
• Mortality rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  

Acute peptic ulcer bleeding remains a therapeutic challenge with significant morbidity and mortality. Endoscopic therapy using various modalities significantly reduces re-bleeding, need for surgery and mortality in patients with peptic ulcer bleeding. Endoscopic therapy achieves successful hemostasis in more than 90% of patients, and re-bleeding occurs in 10-30% of patients. Re-bleeding has an important impact on prognosis. Studies showed adjuvant treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis reduced recurrent ulcer bleeding. Two consensus documents have endorsed a high-dose PPI regimen (80 mg stat followed by an infusion of 8 mg/h for 72 h). The biologically plausible mechanism of benefit of such a high-dose regimen is to promote clot stability by sustaining the intragastric pH above 6. However, the optimal dose and administration route of proton pump inhibitors (PPI) for the prevention of peptic ulcer rebleeding remains unclear.

The use of IV PPIs adds significantly to the cost of patient care in hospital. Recent studies reported oral PPI may have similar acid suppressive effect as high dose PPI infusion. A prospective trial and a retrospective analysis have shown that oral PPI therapy may also be effective in decreasing rebleeding rates in patients with acute gastrointestinal bleeding due to high-risk peptic ulcer disease, and the magnitude of benefit appears similar to what has been demonstrated with IV PPIs. A meta-analysis reported no difference in the magnitude of risk reduction between the oral- and the intravenous-route. Given the significant cost savings over their IV counterparts, oral PPIs would be an attractive choice of therapy in this situation provided that they have a similar efficacy to IV PPIs. However, no studies have directly compared oral and IV PPI therapy in this setting.

We conducted a head-to-head study, comparing two strategies for PPI administration in the prevention of rebleeding, surgery, and death in patients with high-risk bleeding peptic ulcers in whom successful endoscopic hemostasis was achieved.