December 1, 2009 — Continuous low-dose aspirin therapy may increase the risk for recurrent peptic ulcer bleeding but potentially lowers mortality rates, according to the results of a parallel, randomized, placebo-controlled, noninferiority trial reported in the November 30 Online First issue of the Annals of Internal Medicine.
"Aspirin has been increasingly used as a treatment of cardiovascular and cerebrovascular diseases, especially in the aging population, yet it causes a 2- to 3-fold increase in the risk for dose-related peptic ulcer bleeding," write Joseph J.Y. Sung, MD, PhD, from the Chinese University of Hong Kong, Sha Tin, New Territories, Hong Kong, and colleagues. "It is uncertain whether aspirin therapy should be continued after endoscopic hemostatic therapy in patients who develop peptic ulcer bleeding while receiving low-dose aspirin."
The goal of the study was to determine if continuing aspirin therapy with proton-pump inhibitors after endoscopic control of ulcer bleeding in adults with cardiovascular or cerebrovascular diseases was not inferior to stopping aspirin therapy, in terms of recurrent ulcer bleeding.
From 2003 to 2006 at a tertiary endoscopy center, low-dose aspirin recipients with peptic ulcer bleeding were randomly assigned by use of computer-generated numbers in concealed envelopes. Patients and clinicians were both blinded to the treatment assignment. Immediately after endoscopic therapy, 78 patients received aspirin (80 mg/day), 78 received placebo for 8 weeks, and all received 72-hour infusion of pantoprazole followed by oral pantoprazole.
The main study outcome was endoscopically confirmed recurrent ulcer bleeding within 30 days, and secondary outcomes were all-cause and specific-cause mortality in 8 weeks. Intent-to-treat analysis included 156 patients; 3 patients withdrew from the trial before completing follow-up.
The main endpoint of recurrent ulcer bleeding within 30 days occurred in 10.3% in the aspirin group and 5.4% in the placebo group (difference, 4.9 percentage points; 95% confidence interval [CI], –3.6 - 13.4 percentage points). Compared with patients who received placebo, patients who received aspirin had lower all-cause mortality rates (1.3% vs 12.9%; difference, 11.6 percentage points; 95% CI, 3.7 - 19.5 percentage points). In addition, patients in the aspirin group had lower mortality rates resulting from cardiovascular, cerebrovascular, or gastrointestinal tract complications vs patients in the placebo group (1.3% vs 10.3%; difference, 9 percentage points; 95% CI, 1.7 - 16.3 percentage points).
"Among low-dose aspirin recipients who had peptic ulcer bleeding, continuous aspirin therapy may increase the risk for recurrent bleeding but potentially reduces mortality rates," the study authors write. "Larger trials are needed to confirm these findings."
Limitations of this study include relatively small sample size and use of only low-dose aspirin (80 mg). In addition, further endoscopy was not performed in 2 patients with recurrent bleeding in the placebo group.
"Early resumption of low-dose aspirin therapy with proton-pump inhibitors in patients with bleeding ulcers and cardiovascular diseases should be considered," the study authors conclude.
The Institute of Digestive Disease, Chinese University of Hong Kong, supported this study. Altana Pharma, Hong Kong, provided pantoprazole. Some of the study authors have disclosed various financial relationships with Pfizer, Otsuka, Takeda, AstraZeneca, Nycomed, and/or Condor.
Annals Intern Med. Published online November 30, 2009.
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Cite this: Continuous Aspirin May Lower Mortality Despite Increased Risk for Recurrent Peptic Ulcer Bleeding - Medscape - Dec 01, 2009.