CHICAGO – Oral proton pump inhibitor therapy on the medical ward following endoscopic treatment of patients with a bleeding ulcer is equally effective as the current guideline-recommended practice of administering a PPI bolus followed by a 72-hour continuous intravenous infusion – and a lot less resource intensive.
That’s the highly practical message from a meta-analysis of randomized trials addressing the issue that Dr. Hamita Sachar presented at the annual Digestive Disease Week.
Dr. Hamita Sachar
Current national and international guidelines recommend an intravenous 80-mg bolus of PPI followed by a 72-hour infusion at 8 mg/hr after successful endoscopic therapy of a high-risk bleeding ulcer. These guidelines need to be revisited in light of the new data, according to Dr. Sachar, a fellow in digestive diseases at Yale University, New Haven, Conn.
"This is practice changing. Intermittent oral therapy is less expensive. Also, it’s quite easy to administer. If you can get away with twice-daily oral dosing, it’s preferred over an IV infusion by patients, it requires less nursing time, and there’s less pharmacy personnel time. As long as patients don’t have nausea and vomiting, I think it’s reasonable for them to get oral therapy because equivalent doses of IV and oral drug have exactly the same pharmacokinetic profiles," she said in an interview.
The meta-analysis, which featured a noninferiority design, included a dozen randomized trials totaling more than 1,600 patients. The primary outcome was the rate of rebleeding within 7 days. It turned out to be virtually identical in the two groups.
Moreover, there was no significant difference between patients who received intermittent oral PPI therapy at standard doses and those who got the guideline-recommended bolus, continuous-infusion regimen in terms of any of the secondary endpoints in the meta-analysis, which included rebleeding within 30 days, rebleeding within 3 days, need for blood transfusion, urgent surgical or endoscopic interventions, and length of hospital stay.
Dr. Sachar and her coinvestigators performed the meta-analysis because their physiologic model suggested that intravenous therapy was safely avoidable. They noted that several randomized trials in the literature concluded that the two treatment strategies might yield comparable outcomes; however, the individual studies were too small to allow any firm conclusions to be drawn.
The study was supported by institutional funds. Dr. Sachar reported having no financial conflicts regarding this study.