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PPIs Reduce Risk for Recurrent Ulcer Complications from Low-Dose Aspirin

PPIs reduce the risk for NSAID-associated GI complications, but it's unclear whether the benefit of PPI prophylactic therapy in average-risk patients without H. pylori infection justifies the cost for all low-dose aspirin users.

Long-term aspirin therapy is associated with increased risk for peptic-ulcer disease and ulcer complications. To date, misoprostol is the only FDA-approved therapy for prevention of nonsteroidal anti-inflammatory drug (NSAID)-associated gastrointestinal complications, but side effects and the necessity for multiple daily dosing limit its use. Proton-pump inhibitors (PPIs) have been suggested as a more acceptable alternative prophylactic therapy. However, data to support this approach are limited. Investigators in Hong Kong evaluated the efficacy of PPI therapy for preventing recurrent peptic ulcers in 123 Helicobacter pylori-infected patients who developed ulcer complications during low-dose aspirin use. After ulcers were healed and H. pylori infections were eradicated, patients were randomized to receive lansoprazole (30 mg daily) or placebo. All patients also received 100 mg of aspirin daily.

After a median follow-up of 12 months, 9 of 61 placebo recipients developed ulcer complications versus only 1 lansoprazole recipient (14.8% vs. 1.6%; hazard ratio, 9.6; 95% CI, 1.2-76.1, P=0.008). Four of the 10 patients who developed ulcer complications had recurrences of H. pylori infections. Two other patients had taken additional NSAIDs before the onset of complications. The authors concluded that lansoprazole therapy, in conjunction with H. pylori-eradication therapy, significantly reduced the risk for ulcer complications caused by low-dose aspirin use.

Comment: This is the second demonstration that PPIs reduce the risk for NSAID-associated GI complications (JW Gastroenterology Apr 17 2002). However, the results of this study should be extrapolated cautiously to populations where H. pylori infection is endemic. Recurrence of infection prior to ulcer complications in 4 patients suggests an interaction between ulcer recurrence and H. pylori infection. Patients in this study were also at high risk for complications because of their histories of ulcer complications. It's not clear whether the benefit of PPI prophylactic therapy in average-risk patients without H. pylori infection justifies the cost for all low-dose aspirin users.

— David J. Bjorkman, MD, MSPH, SM (Epid.)

Published in Journal Watch Gastroenterology August 13, 2002

Citation(s):

Lai KC et al. Lansoprazole for the prevention of recurrences of ulcer complications from long-term low-dose aspirin use. N Engl J Med 2002 Jun 27; 346:2033-8.

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