Similar Efficacy of Proton-Pump Inhibitors vs H2-Receptor Antagonists in Reducing Risk of Upper Gastrointestinal Bleeding or Ulcers in High-Risk Users of Low-Dose Aspirin.

Abstract

BACKGROUND & AIMS:

It is not clear whether H2-receptor antagonists (H2RAs) reduce the risk of gastrointestinal (GI) bleeding in aspirin users at high risk. We performed a double-blind randomized trial to compare the effects of a proton pump inhibitor (PPI) vs a H2RA antagonist in preventing recurrent upper GI bleeding and ulcers in high-risk aspirin users.

METHODS:

We studied 270 users of low-dose aspirin (≤325 mg/day) with a history of endoscopically confirmed ulcer bleeding at 8 sites in Hong Kong and Japan. After healing of ulcers, subjects with negative results from tests for Helicobacter pylori resumed aspirin (80 mg) daily and were assigned randomly to groups given a once-daily PPI (rabeprazole, 20 mg; n = 138) or H2RA (famotidine, 40 mg; n = 132) for up to 12 months. Subjects were evaluated every 2 months; endoscopy was repeated if they developed symptoms of upper GI bleeding or had a reduction in hemoglobin level greater than 2 g/dL and after 12 months of follow-up evaluation. The adequacy of upper GI protection was assessed by end points of recurrent upper GI bleeding and a composite of recurrent upper GI bleeding or recurrent endoscopic ulcers at month 12.

RESULTS:

During the 12-month study period, upper GI bleeding recurred in 1 patient receiving rabeprazole (0.7%; 95% confidence interval [CI], 0.1%-5.1%) and in 4 patients receiving famotidine (3.1%; 95% CI, 1.2%-8.1%) (P = .16). The composite end point of recurrent bleeding or endoscopic ulcers at month 12 was reached by 9 patients receiving rabeprazole (7.9%; 95% CI, 4.2%-14.7%) and 13 patients receiving famotidine (12.4%; 95% CI, 7.4%-20.4%) (P = .26).

CONCLUSIONS:

In a randomized controlled trial of users of low-dose aspirin at risk for recurrent GI bleeding, a slightly lower proportion of patients receiving a PPI along with aspirin developed recurrent bleeding or ulcer than of patients receiving an H2RA with the aspirin, although this difference was not statistically significant. ClincialTrials.gov no: NCT01408186.

• Authors: Francis K L Chan, Moe Kyaw, Tetsuya Tanigawa, Kazuhide Higuchi, Kazuma Fujimoto, Pui Kuan Cheong, Vivian Lee, Yoshikazu Kinoshita, Yuji Naito, Toshio Watanabe, Jessica Y L Ching, Kelvin Lam, Angeline Lo, Heyson Chan, Rashid Lui, Raymond S Y Tang, Yasuhisa Sakata, Yee Kit Tse, Toshihisa Takeuchi, Osamu Handa, Hiroko Nebiki, Justin C Y Wu, Takashi Abe, Tsuyoshi Mishiro, Siew C Ng, Tetsuo Arakawa
• Journal: Gastroenterology (Gastroenterology) Vol. 152 Issue 1 Pg. 105-110.e1 (01 2017) ISSN: 1528-0012 [Electronic] United States
• PMID: 27641510 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Hemoglobins
• Histamine H2 Antagonists
• Platelet Aggregation Inhibitors
• Proton Pump Inhibitors
• Rabeprazole
• Famotidine
• Aspirin

Topics

• Aged
• Aged, 80 and over
• Aspirin (administration & dosage, adverse effects)
• Double-Blind Method
• Famotidine (therapeutic use)
• Female
• Hemoglobins (metabolism)
• Histamine H2 Antagonists (therapeutic use)
• Humans
• Male
• Middle Aged
• Peptic Ulcer (prevention & control)
• Peptic Ulcer Hemorrhage (blood, prevention & control)
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects)
• Proton Pump Inhibitors (therapeutic use)
• Rabeprazole (therapeutic use)
• Recurrence
• Risk Factors
• Secondary Prevention