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Omeprazole Before Endoscopy in Patients with Gastrointestinal Bleeding
Abstract & Commentary
By Malcolm Robinson, MD, FACP, FACG, Emeritus Clinical Professor of Medicine, University of Oklahoma College of Medicine, Oklahoma City. Dr. Robinson reports no financial relationship to this field of study.
Synopsis: High dose PPI infusion prior to endoscopy accelerated resolution of the signs of ulcer bleeding and significantly reduced the need for endoscopic hemostasis therapy.
Source: James Y Lau, et al. The New England Journal of Medicine. 2007;356:1631-1640.
These highly experienced Hong Kong investigators have been major contributors to the literature on GI bleeding and its management. In the present study extending over 17 months, 631 stabilized patients who presented with acute upper GI hemorrhage (hematemesis and/or melena) were randomly assigned to receive either high dose intravenous omeprazole or placebo. This particular study excluded most chronic aspirin recipients due to a parallel study of these patients also underway. Study patients on warfarin received vitamin K or fresh frozen plasma. Heparin was continued in patients with prosthetic heart valves or histories of pulmonary embolism within 6 months. If NSAIDs had been received by patients prior to admission (22-23%), they were discontinued. Patients with hypotension and evidence of acutely continuing bleeding underwent emergency endoscopy and were not included in the study population nor were patients who bled again in the period prior to scheduled endoscopy the day after admission.
Study patients received omeprazole 80 mg as a bolus on admission, followed by continuous infusion of 8 mg per hour until endoscopy the next morning. When scheduled endoscopy was done, study patients with endoscopic evidence of spurting hemorrhage or visible vessels were treated with injected epinephrine using a sclerotherapy needle followed by coaptive thermocoagulation with a 3.2 mm heater probe. Overlying clots were snared away, and underlying vessels were also treated. Duration of omeprazole or placebo infusion was about 15 hours prior to scheduled endoscopy. Ulcers were present in about 60% of patients with a variety of lesions accounting for bleeding in the remainder (including erosions, Mallory-Weiss tears, and some cancers). Of 314 patients who received omeprazole, 60 (19.1%) required endoscopic therapy vs 90 (28.4%) of the 317 patients on placebo (CI 0.51 to 0.90; p = 0.007). This was mirrored in the large subgroup of peptic ulcer patients who also had fewer bleeding ulcers seen at endoscopy. There were no differences between groups in requirements for emergency endoscopy or in deaths within 30 days of study entry. There were no medication-related adverse events.
This excellent study provides strong evidence for the utility of aggressive acid suppression in patients who present with acute upper gastrointestinal hemorrhage. Its limitations (mentioned by the authors) include the lack of chronic aspirin users and the high rate of ulcer disease that continues to be present in Asian countries. There is wide international agreement regarding the value of early endoscopy in patients with UGI hemorrhage, but this study probably can be interpreted to validate the immediate use of intravenous PPIs in patients presenting with upper GI hemorrhage. Such therapy is safe and can be expected to be beneficial in the subgroup of patients with acid-peptic etiologies for GI hemorrhage. Ideally, a similar study should be done in the setting of patient populations expected to have a higher proportion of variceal bleeding (where results might well be different). Although no formal cost analysis was done by these authors, the results are almost certainly consistent with a cost effective intervention.