1. Compared to placebo, treating patients with omeprazole bolus and infusion prior to endoscopy significantly reduces the need for endoscopic therapy, the rate of post-endoscopy active bleeding, and shortens hospital stays.
2. Treating patients with omeprazole pre-endoscopy did not significantly reduce the need for emergency surgery and did not reduce 30-day mortality as compared with placebo.
Original Date of Publication: April 2007
Study Rundown: In patients with upper gastrointestinal bleeding, it was previously showed that infusion of a high-dose proton-pump inhibitor (PPI) after hemostasis had been achieved through endoscopy reduced recurrent bleeding and improved clinical outcomes. The adjuvant use of high-dose PPIs in endoscopic therapy has also been endorsed and confirmed in two meta-analyses. Clot formation over arteries is a pH-dependent process; a gastric pH >6 is thought to be critical for platelet aggregation. In clinical practice, treatment with proton-pump inhibitors is often initiated before endoscopy in patients presenting with upper gastrointestinal bleeding. However, there is a lack of evidence in the literature to provide support for such a preemptive approach. In summary, omeprazole bolus and infusion before endoscopy accelerated the resolution of bleeding in ulcers and reduced the need for endoscopic therapy. Moreover, omeprazole treatment prior to endoscopy also resulted in less active bleeding post-endoscopy and led to shorter hospital stays. There were no significant differences between the two groups in the rate of recurrent bleeding within 30 days, need for emergency surgery, or 30-day mortality.
Lead Study Investigator, Dr. James Y.W. Lau, MBBS, MD, FHKCS, FRCS, talks to 2 Minute Medicine: The Chinese University of Hong Kong, Director, Endoscopy Centre, Prince of Wales Hospital, Professor, Department of Surgery.
“We had published an earlier study using PPI after endoscopic treatment. The use of PPI infusion became so popular that people started using it before endoscopic treatment. This was not evidence-based. We looked up the literature and found only one other study (CJ Hawkey et al. in The Lancet). We felt that there was a deficiency in the literature. We designed the trial to address the impact of early use of PPI. The study findings indicate that in those waiting for endoscopic treatment a PPI would reduce endoscopic treatment and hospitalisation. The study also reaffirms the therapeutic effect of PPI in that it stabilises clots and hastens healing. There are few remaining questions in AUGIB. They include timing of endoscopy and selected second look endoscopy with re-treatment.”
In-Depth [randomized controlled trial]: This was a double-blind, placebo-controlled, randomized trial which was originally published in NEJM in 2007. Participants in the trial were randomized to two treatment groups: 1) patients received an intravenous infusion of omeprazole or 2) a placebo. Each patient received an 80-mg intravenous bolus injection followed by continuous infusion of 8 mg per hour until endoscopic examination the following morning. Patients were eligible for the trial if they had hypotensive shock with a systolic blood pressure ≤90 mmHg or pulse ≥110 beats per minute that had been stabilized after their initial resuscitation. Exclusion criteria included long-term aspirin use, unstable condition requiring urgent endoscopy, a moribund state, and a known PPI allergy. From them, 188 of those evaluated were excluded for other reasons that were not mentioned. The primary endpoint was the need for endoscopic therapy at the first endoscopic examination. Secondary endpoints included signs of bleeding, need for urgent endoscopy, duration of hospital stay, need for transfusion, need for emergency surgery to achieve hemostasis, and rates of recurrent bleeding and death from any cause within 30 days after randomization.
A total of 638 patients underwent randomization for this trial. Compared to patients treated with placebo, patients in the omeprazole group required significantly less endoscopic treatment (RR 0.67; 95%CI 0.51-0.90). Moreover, patients treated with omeprazole also needed less endoscopic therapy for bleeding peptic ulcers (RR 0.61; 95%CI 0.44-0.84) and had less post-endoscopy active bleeding (RR 0.44; 95%CI 0.23-0.83) compared to those treated with placebo. Notably, a larger proportion of omeprazole-treated patients had hospital stays <3 days compared to those on placebo (RR 1.23; 95%CI 1.07-1.42). There were no significant differences between the two groups in the rate of recurrent bleeding within 30 days, need for emergency surgery, or 30-day mortality.
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