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Benefits and Risks of Continuing Aspirin in Patients With Peptic Ulcer Bleeding FREE

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The summary below is from the full report titled “Continuation of Low-Dose Aspirin Therapy in Peptic Ulcer Bleeding. A Randomized Trial.” It is in the 5 January 2010 issue of Annals of Internal Medicine (volume 152, pages 1-9). The authors are J.J.Y. Sung, J.Y.W. Lau, J.Y.L. Ching, J.C.Y. Wu, Y.T. Lee, P.W.Y. Chiu, V.K.S. Leung, V.W.S. Wong, and F.K.L. Chan.

Ann Intern Med. 2010;152(1):I-20. doi:10.7326/0003-4819-152-1-201001050-00178
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What is the problem and what is known about it so far?

Middle-aged and older adults often take aspirin to help prevent heart attacks and stroke. Aspirin, however, can cause potential harm, such as bleeding in the stomach or upper digestive tract (peptic ulcer bleeding). The usual treatment for peptic ulcers is endoscopic therapy to control active bleeding, drug therapy to suppress stomach acid (for example, a proton-pump inhibitor [PPI]), and discontinuation of aspirin therapy until the ulcer heals. Stopping the aspirin therapy could result in increased risk for heart attack and stroke. Whether continuing aspirin therapy while taking a PPI substantially increases risk for recurrent peptic ulcer bleeding is unclear.

Why did the researchers do this particular study?

To see whether continuing aspirin therapy in patients who receive endoscopic therapy and pantoprazole (a PPI) for peptic ulcer bleeding affects risk for recurrent bleeding.

Who was studied?

156 adults with peptic ulcer bleeding. All had a history of cardiovascular disease and were receiving aspirin to prevent heart attacks or stroke.

How was the study done?

All patients received endoscopic therapy to stop acute bleeding. After endoscopy, they were randomly assigned to receive low-dose aspirin (80 mg daily) or a matching dummy pill (placebo) for 8 weeks. Neither the patients nor their doctors knew who received which pill. All patients received pantoprazole, initially through a vein for 72 hours and then by mouth (40 mg daily). The researchers followed patients closely with telephone contacts and clinic visits to detect recurrent gastrointestinal bleeding and other adverse events, such as heart attack, stroke, or death. Patients who had symptoms or blood test findings that suggested recurrent bleeding had endoscopy to confirm that the ulcer was the bleeding site.

What did the researchers find?

About 10% and 5% of the patients assigned to low-dose aspirin and placebo, respectively, had recurrent ulcer bleeding within 30 days. At 8 weeks, fewer aspirin recipients than placebo recipients had died (1% [1 of 78 patients] vs. 13% [10 of 78 patients]). The cause of death in the patient who received aspirin was heart failure. In the placebo group, 2 patients died of acute coronary syndrome, 2 of stroke, 2 of heart failure, 3 of perforated ulcer or uncontrolled ulcer bleeding, and 2 of pneumonia.

What were the limitations of the study?

The study was small, and the follow-up duration was short. Three patients did not complete follow-up. Some deaths in the placebo group were caused by conditions that aspirin does not normally prevent.

What are the implications of the study?

Continuation of low-dose aspirin in patients with cardiovascular disease and recent peptic ulcer bleeding increases the short-term risk for recurrent bleeding, even in patients who receive PPIs. The possibility that continuation of low-dose aspirin therapy in this setting reduces risk for death needs to be confirmed in larger trials.





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