Researchers from the USA investigated the prevention of ulcer recurrence among long-term users of nonsteroidal anti-inflammatory drugs (NSAIDs).
A total of 537 patients without H. pylori, who were long-term users of NSAIDs and who had a history of endoscopically documented gastric ulcer, were included in the multicenter study.
Patients were randomized to receive placebo, 200 µg of misoprostol 4 times a day, or 15 or 30 mg of lansoprazole once daily for 12 weeks.
Ulcer status was determined by endoscopy at 4, 8, and 12 weeks.
Patients receiving lansoprazole (15 or 30 mg) remained free from gastric ulcer longer than those who received placebo did but for a shorter time than those who received misoprostol.
By week 12, the percentages of gastric ulcer-free patients were as follows: placebo, 51%; misoprostol, 93%; 15-mg lansoprazole, 80%; and 30-mg lansoprazole, 82%.
|Ulcer-free patients at week 12:|
15-mg lansoprazole: 80%
30-mg lansoprazole: 82%
| Archives of Internal Medicine |
A significantly higher proportion of patients in the misoprostol group reported treatment-related adverse events and early withdrawal from the study.
When the impact of withdrawals on ulcer development was considered (as failures), therapy was successful for 69% for each of the active treatment groups and 35% for the placebo group.
Dr David Y. Graham, of the Veterans Affairs Medical Center, Houston, Texas, said on behalf of his group, "Proton pump inhibitors such as lansoprazole are superior to placebo for the prevention of NSAID-induced gastric ulcers but not superior to misoprostol, 800 µg/d."
"When the poor compliance and potential adverse effects associated with misoprostol are considered, proton pump inhibitors and full-dose misoprostol are clinically equivalent," he concluded.