Lansoprazole for the Prevention of Recurrences of Ulcer Complications
Abstract & Commentary
Synopsis: Even low-dose aspirin leads to a significant risk of recurrent ulceration and bleeding, and this risk can be lowered with concomitant lansoprazole therapy.
Source: Lai KC, et al. N Engl J Med. 2002;346:2033-2038.
A group of 123 patients with ulcer complications were on low-dose aspirin for prophylaxis of CVA or ischemic heart disease. Ulcers were healed and patients had Helicobacter pylori eradicated. Aspirin 100 mg/d was resumed and patients were then randomized to receive 30 mg of lansoprazole daily or placebo. Over 12 months, 9 of 61 patients on placebo had recurrent ulcer complications vs. 1 of 62 patients on lansoprazole. Although a larger study had been planned, the trial was aborted due to these findings with an adjusted hazard ratio of 9.6. The interpretation of study results were complicated by NSAID use in 2 patients and 4 recurrences of H pylori infection. Nevertheless, it seems clear that patients who have had ulcer complications such as bleeding or obstruction on low-dose aspirin remain at risk for recurrent complications if they continue on aspirin. This risk can be substantially eliminated by coadministration of an effective dose of a proton pump inhibitor (PPI).
Comment by Malcolm Robinson MD, FACP, FACG
Although it is well known that PPIs can block NSAID-related damage and that bleeding with aspirin also can be reduced with PPI therapy, some have assumed that it should be safe to resume low-dose aspirin in H pylori-positive patients with ulcer complications once the H pylori infection has been eradicated. This study from Hong Kong clearly demonstrates that patients with ulcer complications while on low-dose aspirin remain at substantial risk with resumption of aspirin, even if the H pylori has been eradicated and the ulcer healed. More important is the fact that this risk can be largely eliminated by the coadministration of lansoprazole 30 mg (and presumably by comparable doses of alternative PPIs). The clinician should strongly consider PPI prophylaxis of patients at high risk of ulcer complications.
Dr. Robinson, Medical Director, Oklahoma Foundation for Digestive Research; Clinical Professor of Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK, is Associate Editor of Internal Medicine Alert.
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