Lansoprazole for the prevention of recurrences of ulcer complications from long-term low-dose aspirin use

N Engl J Med. 2002 Jun 27;346(26):2033-8. doi: 10.1056/NEJMoa012877.


Background: The role of gastric acid suppression in preventing the recurrence of ulcer complications after the eradication of Helicobacter pylori infection in patients taking long-term low-dose aspirin is uncertain.

Methods: We enrolled 123 patients who had ulcer complications after using low-dose aspirin continuously for more than one month and who had H. pylori infection. After the ulcers had healed and the H. pylori infection was eradicated, the patients were randomly assigned to treatment with 30 mg of lansoprazole daily or placebo, in addition to 100 mg of aspirin daily, for 12 months. The primary end point was the recurrence of ulcer complications.

Results: During a median follow-up of 12 months, 9 of the 61 patients in the placebo group (14.8 percent), as compared with 1 of the 62 patients in the lansoprazole group (1.6 percent), had a recurrence of ulcer complications (adjusted hazard ratio, 9.6; 95 percent confidence interval, 1.2 to 76.1). Of these 10 patients, 4 had evidence of a recurrence of H. pylori infection and 2 had taken nonsteroidal antiinflammatory drugs before the onset of complications. Patients in the lansoprazole group were significantly less likely to have a recurrence of ulcer complications than patients in the placebo group (P=0.008). There was no significant difference in mortality between the two groups.

Conclusions: In patients who had ulcer complications related to the long-term use of low-dose aspirin, treatment with lansoprazole in addition to the eradication of H. pylori infection significantly reduced the rate of recurrence of ulcer complications.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Anti-Ulcer Agents / therapeutic use*
  • Aspirin / adverse effects*
  • Enzyme Inhibitors / therapeutic use*
  • Female
  • Helicobacter Infections / drug therapy
  • Helicobacter pylori
  • Humans
  • Lansoprazole
  • Male
  • Middle Aged
  • Omeprazole / analogs & derivatives*
  • Omeprazole / therapeutic use*
  • Peptic Ulcer / chemically induced
  • Peptic Ulcer / microbiology
  • Peptic Ulcer / prevention & control*
  • Peptic Ulcer Hemorrhage / chemically induced
  • Peptic Ulcer Hemorrhage / microbiology
  • Peptic Ulcer Hemorrhage / prevention & control
  • Platelet Aggregation Inhibitors / adverse effects*
  • Proportional Hazards Models
  • Prospective Studies
  • Proton Pump Inhibitors*
  • Recurrence
  • Statistics, Nonparametric


  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Inflammatory Agents, Non-Steroidal
  • Anti-Ulcer Agents
  • Enzyme Inhibitors
  • Platelet Aggregation Inhibitors
  • Proton Pump Inhibitors
  • Lansoprazole
  • Omeprazole
  • Aspirin