Document Detail


Continuation of low-dose aspirin therapy in peptic ulcer bleeding: a randomized trial.
MedLine Citation:
PMID:  19949136     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Joseph J Y Sung; James Y W Lau; Jessica Y L Ching; Justin C Y Wu; Yuk T Lee; Philip W Y Chiu; Vincent K S Leung; Vincent W S Wong; Francis K L Chan
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-11-30
Journal Detail:
Title:  Annals of internal medicine     Volume:  152     ISSN:  1539-3704     ISO Abbreviation:  Ann. Intern. Med.     Publication Date:  2010 Jan 
Date Detail:
Created Date:  2010-01-05     Completed Date:  2010-01-25     Revised Date:  2013-06-25    
Medline Journal Info:
Nlm Unique ID:  0372351     Medline TA:  Ann Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1-9     Citation Subset:  AIM; IM    
Affiliation:
Institute of Digestive Disease, Chinese University of Hong Kong, Sha Tin, New Territories, Hong Kong. joesung@cuhk.edu.hk
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00153725
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MeSH Terms
Descriptor/Qualifier:
2-Pyridinylmethylsulfinylbenzimidazoles / therapeutic use
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage,  adverse effects
Anti-Ulcer Agents / therapeutic use
Aspirin / administration & dosage*,  adverse effects
Cardiovascular Diseases / prevention & control*
Cerebrovascular Disorders / prevention & control*
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Endoscopy, Gastrointestinal
Female
Gastrointestinal Hemorrhage / chemically induced*,  therapy
Hemostatic Techniques
Humans
Male
Peptic Ulcer / chemically induced*,  therapy
Platelet Aggregation Inhibitors / administration & dosage*,  adverse effects
Proton Pump Inhibitors / therapeutic use
Recurrence
Risk Factors
Chemical
Reg. No./Substance:
0/2-Pyridinylmethylsulfinylbenzimidazoles; 0/Anti-Inflammatory Agents, Non-Steroidal; 0/Anti-Ulcer Agents; 0/Platelet Aggregation Inhibitors; 0/Proton Pump Inhibitors; 50-78-2/Aspirin; D8TST4O562/pantoprazole
Comments/Corrections
Comment In:
Crit Care. 2010;14(6):331   [PMID:  21235828 ]
Ann Intern Med. 2010 Jan 5;152(1):52-3, W-12   [PMID:  19949134 ]
Endoscopy. 2011 Jan;43(1):34-7   [PMID:  21234839 ]
Gastroenterology. 2010 Aug;139(2):687-9   [PMID:  20600060 ]
Ann Intern Med. 2010 May 18;152(10):685; author reply 685   [PMID:  20479035 ]
Summary for patients in:
Ann Intern Med. 2010 Jan 5;152(1):I-20   [PMID:  19949137 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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