Continuation of low-dose aspirin therapy in peptic ulcer bleeding: a randomized trial.
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.


METHODS
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)


METHODS
A tertiary endoscopy center.


METHODS
Low-dose aspirin recipients with peptic ulcer bleeding.


METHODS
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.


METHODS
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]).


CONCLUSIONS
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.


CONCLUSIONS
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.
Sung
Joseph J Y
JJ
Institute of Digestive Disease, Chinese University of Hong Kong, Sha Tin, New Territories, Hong Kong. joesung@cuhk.edu.hk
Lau
James Y W
JY
Ching
Jessica Y L
JY
Wu
Justin C Y
JC
Lee
Yuk T
YT
Chiu
Philip W Y
PW
Leung
Vincent K S
VK
Wong
Vincent W S
VW
Chan
Francis K L
FK
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002561:Cerebrovascular Disorders / Q000517:prevention & control*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced* / Q000628:therapy; D006489:Hemostatic Techniques; D006801:Humans; D008297:Male; D000077402:Pantoprazole; D010437:Peptic Ulcer / Q000139:chemically induced* / Q000628:therapy; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D012008:Recurrence; D012307:Risk Factors
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D010975:Platelet Aggregation Inhibitors; D054328:Proton Pump Inhibitors; D000077402:Pantoprazole; D001241:Aspirin