A randomized controlled trial comparing two different dosages of infusional pantoprazole in peptic ulcer bleeding

Abstract

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • An adjunct to endoscopy, proton pump inhibitor (PPI) is effective pharmacotherapy in high‐risk patients with peptic ulcer bleeding (PUB). • An intravenous 80‐mg bolus and 192 mg day−1 successive infusion for 3 days is the currently recommended dosing modality in administering PPI. WHAT THIS STUDY ADDS • Clinical outcomes are not different in PUB patients receiving infusional pantoprazole at either 192 mg or 160 mg day−1 for 3 days. • The effective dosage of PPI may not be as high as currently recommended. • In view of cost‐effectiveness, a lower dosage (160 mg day−1) of infusional PPI may be adopted in the management of PUB. AIM The optimal dosage of proton pump inhibitor in bleeding peptic ulcers remains controversial. The aim was to compare the clinical effectiveness of two doses of infusional pantoprazole in peptic ulcer bleeding. METHODS Peptic ulcer patients (n= 120) with bleeding stigmata were enrolled after successful endoscopic therapy. After an initial bolus injection of 80 mg pantoprazole, patients were randomized to receive continuously infused pantoprazole at either 192 mg day−1 or 40 mg every 6 h (i.e. 160 mg day−1) for 3 days. Clinical outcomes between the two groups within 14 days were compared, with 14‐day recurrent bleeding regarded as the primary end‐point. RESULTS Both groups (n= 60 each) were well matched in demographic and clinical factors upon entry. Bleeding totally recurred in 11 (9.2%) patients, with six (10%) in the 192 mg day−1 group and five (8.3%) in the 160 mg day−1 group (relative risk of bleeding recurrence between two treatments 1.2; 95% CI 0.39, 3.72). All secondary outcomes between the two groups were similar, including the amount of blood transfusion (mean 1179 ml vs. 1203 ml, P > 0.1), hospital stay (mean 9.5 days vs. 9.9 days, P > 0.1), need for surgery (n= 1 vs. n= 0, P > 0.1), and mortality (n= 1 vs. n= 0, P > 0.1). CONCLUSIONS Following endoscopic haemostasis, infusional pantoprazole at either 192 mg day−1 or 40 mg every 6 h appear similar.

High-dose vs. Low-dose Proton Pump Inhibitors post-endoscopic hemostasis in patients with bleeding peptic ulcer. A meta-analysis and meta-regression analysis

“…Ten of 859 screened RCTs were finally included (2,7,8,(11)(12)(13)(14)(15)(16)(17) with a total of 1.651 participants.…”

“…Seven studies had a score of 3 points (8,(12)(13)(14)(15)(16)(17), two studies of 2 points (2,7), and one study of 1 point (11), respectively.…”

“…All RCTs regarding low-versus high-dose PPI administration post-endoscopic hemostasis were identified (2,7,8,(11)(12)(13)(14)(15)(16)(17). In keeping with identification of suitable studies, the electronic databases Medline, Embase, PubMed, and the Cochrane Library were utilized to identify articles from 2000 to 2016 in the English language literature which included the following terms and/or amalgamations in their keyword lists, abstracts, or titles: RCT, double-blind, dexlansoprazole, omeprazole, lansoprazole, rabeprazole, esomeprazole, pantoprazole, high-dose PPI, low-dose PPI, PPI, and bleeding.…”

“…Three adequately powered randomized controlled trials (RCTs) have been released (11)(12)(13) of the aforementioned meta-analyses. This meta-analysis aims to evaluate RCTs of low-versus high-dose PPI after endoscopic bleeding arrest by additionally including the newly published RCTs and to conclude if lowdose PPI regimen can generate comparable results as the high-dose regimen after initial hemostasis by endoscopists.…”

Esomeprazole for the treatment of peptic ulcer bleeding

“…A recent study conducted in China compared iv. pantoprazole either administered continuously with 8 mg/h after a bolus of 80-or 40-mg every 6 h, and could not demonstrate any differences in outcome [85].…”