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Continuation of low-dose aspirin therapy in peptic ulcer bleeding: a randomized trial
Joseph J Y Sung1, James Y W Lau, Jessica Y L Ching
1Institute of Digestive Disease, Chinese University of Hong Kong, Sha Tin, New Territories, Hong Kong. joesung@cuhk.edu.hk
Insights
Continuing low-dose aspirin therapy after peptic ulcer bleeding may increase re-bleeding risk but potentially lowers mortality rates. Further large-scale trials are necessary to confirm these findings in patients with cardiovascular or cerebrovascular diseases.
Area of Science:
- Gastroenterology
- Cardiology
- Clinical Trials
Background:
- Uncertainty exists regarding the continuation of aspirin therapy post-endoscopic hemostasis for peptic ulcer bleeding.
- Patients on low-dose aspirin with peptic ulcer bleeding require clear management guidelines.
Purpose of the Study:
- To evaluate if continuing aspirin therapy with proton-pump inhibitors is non-inferior to stopping aspirin in preventing recurrent ulcer bleeding.
- To assess the impact of continuous aspirin therapy on mortality rates in patients with cardiovascular or cerebrovascular diseases.
Main Methods:
- A parallel, randomized, placebo-controlled, double-blind noninferiority trial.
- Involved 156 patients with peptic ulcer bleeding receiving low-dose aspirin.
- Compared 8-week aspirin (80 mg/d) plus proton-pump inhibitors versus placebo plus proton-pump inhibitors.
Main Results:
- Recurrent ulcer bleeding within 30 days occurred in 10.3% of the aspirin group versus 5.4% in the placebo group.
- All-cause mortality was significantly lower in the aspirin group (1.3% vs. 12.9%).
- Mortality from cardiovascular, cerebrovascular, or gastrointestinal complications was also reduced in the aspirin group (1.3% vs. 10.3%).
Conclusions:
- Continuous low-dose aspirin therapy post-peptic ulcer bleeding may increase recurrent bleeding risk.
- Continuous aspirin therapy potentially reduces mortality rates in this patient population.
- Larger trials are needed to validate these findings and refine clinical recommendations.
Background:
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.
Objective:
To test that continuing aspirin therapy with proton-pump inhibitors after endoscopic control of ulcer bleeding was not inferior to stopping aspirin therapy, in terms of recurrent ulcer bleeding in adults with cardiovascular or cerebrovascular diseases.
Design:
A parallel randomized, placebo-controlled noninferiority trial, in which both patients and clinicians were blinded to treatment assignment, was conducted from 2003 to 2006 by using computer-generated numbers in concealed envelopes. (ClinicalTrials.gov registration number: NCT00153725)
Setting:
A tertiary endoscopy center.
Patients:
Low-dose aspirin recipients with peptic ulcer bleeding.
Intervention:
78 patients received aspirin, 80 mg/d, and 78 received placebo for 8 weeks immediately after endoscopic therapy. All patients received a 72-hour infusion of pantoprazole followed by oral pantoprazole. All patients completed follow-up.
Measurements:
The primary end point was recurrent ulcer bleeding within 30 days confirmed by endoscopy. Secondary end points were all-cause and specific-cause mortality in 8 weeks.
Results:
156 patients were included in an intention-to-treat analysis. Three patients withdrew from the trial before finishing follow-up. Recurrent ulcer bleeding within 30 days was 10.3% in the aspirin group and 5.4% in the placebo group (difference, 4.9 percentage points [95% CI, -3.6 to 13.4 percentage points]). Patients who received aspirin had lower all-cause mortality rates than patients who received placebo (1.3% vs. 12.9%; difference, 11.6 percentage points [CI, 3.7 to 19.5 percentage points]). Patients in the aspirin group had lower mortality rates attributable to cardiovascular, cerebrovascular, or gastrointestinal complications than patients in the placebo group (1.3% vs. 10.3%; difference, 9 percentage points [CI, 1.7 to 16.3 percentage points]).
Limitations:
The sample size is relatively small, and only low-dose aspirin, 80 mg, was used. Two patients with recurrent bleeding in the placebo group did not have further endoscopy.
Conclusion:
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. Larger trials are needed to confirm these findings.
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