Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed
Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed
Despite recommendations from clinical practice guidelines to discharge patients from the
 hospital on once daily proton pump inhibitors after acute management of UGIB, clinical
 practice is to use twice daily proton pump inhibitor therapy. The objective of this study
 will be to assess whether or not once daily pantoprazole is non-inferior to twice daily
 pantoprazole in ulcer healing with a dose of once daily versus twice daily proton-pump
 inhibitor following an upper gastrointestinal bleed. Additionally, this study will observe
 for any potential difference in safety for once daily versus twice daily proton pump
 inhibitors.
There are few clinical practice guidelines for the management of a non-variceal, upper
 gastrointestinal bleed (UGIB). The 2012 guidelines released by the American College of
 Gastroenterology (ACG) indicate that for active bleeding or non-bleeding visible vessels or
 adherent clot, a bolus of 80 mg proton pump inhibitor followed by continuous infusion of 8
 mg/hr infusion is to be used. Following 72 hours of infusion therapy, an oral proton pump
 inhibitor (PPI) may be used. If the clot is a flat pigmented spot or a clean ulcer base, an
 oral proton pump inhibitor may be used for management (without infusion) (Laine 2012). There
 are no recommendations made on once versus twice daily proton pump inhibitor. The 2010
 American College of Physicians guideline recommends following the 72-hour infusion with
 once-daily proton pump inhibitors for duration as dictated by underlying etiology following
 upper gastrointestinal bleeding (UGIB) (Barkun 2012). This recommendation is graded 1C, with
 the decision to support once-daily over twice-daily dosing due to demonstrated effective
 ulcer healing for patients with peptic ulcer disease with once-daily dosing, and insufficient
 data to suggest twice-daily is superior to once-daily. There have been no head-to-head trials
 to evaluate once-daily versus twice-daily proton pump inhibitor following acute management of
 an endoscopic bleed. Additionally, studies suggest about 50% to 60% of proton pump inhibitors
 are being used without appropriate indications or at inappropriate dosages (Ali 2009).Safety
 concerns such as increased risk for Clostridium difficile infection , community acquired
 pneumonia, electrolyte abnormalities (hypomagnesemia), and fractures are becoming more
 prevalent warranting improved risk versus benefit examination of proton pump inhibitors
 including ascertainment of least effective dosing (Ali 2009, Sheen 2011). Despite
 recommendations to discharge patients after acute management of UGIB on once daily PPI
 therapy, clinical practice is to use twice daily proton pump inhibitor therapy. The objective
 of this study will be to examine if once daily pantoprazole is non-inferior to twice daily
 pantoprazole with regards to ulcer healing after acute management of an UGIB. In addition,
 because more evidence is emerging regarding safety concerns with proton pump inhibitors, the
 study will seek to examine if once daily versus twice daily therapy results in difference in
 safety or adverse reactions such as occurrence of rebleed, C. difficile diarrhea, or
 pneumonia.
Inclusion Criteria:

 -  Adult, 18 years and older; Upper GI bleed confirmed by endoscopy

 Exclusion Criteria:

 -  Intensive Care Unit admission, Emergency endoscopic intervention required to control
 bleeding, Malignant appearing ulcers as determined by endoscopy, Previous documented
 treatment with twice daily PPI for other indication, Receiving twice daily PPI therapy
 prior to admission