NEW YORK (Reuters Health) – The results of a randomized multicenter trial indicate that proton pump inhibitors, such as lansoprazole, are as clinically effective as misoprostol in preventing gastric ulcers resulting from the long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs).
Writing in the January 28th issue of the Archives of Internal Medicine, Dr. David Y. Graham, from Veterans Affairs Medical Center, Houston, and associates report on 537 long-term NSAID users randomly assigned to misoprostol 200 µg four times daily, lansoprazole 15 mg or 30 mg once daily, or placebo. No patients had Helicobacter pylori infection. Eighty-two patients were excluded from the analysis.
After 12 weeks of treatment, patients receiving either dose of lansoprazole remained ulcer free longer than placebo patients (p < 0.001), but not as long as patients receiving misoprostol, the researchers found.
At the end of the trial, 93% of the patients receiving misoprostol were ulcer free, as were 80% of the patients receiving lansoprazole 15 mg, and 82% of those receiving lansoprazole 30 mg. Fifty-one percent of patients receiving placebo were free of ulcers, Dr. Graham's team reports.
Significantly more patients receiving misoprostol experienced adverse events (31%), compared with patients receiving lansoprazole 15 mg (7%), 30 mg (16%), or placebo (10%). Also, more patients receiving misoprostol withdrew early from the trial, the investigators note.
"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. Graham's team writes.
The investigators conclude that "it is apparent that despite the statistical advantage of misoprostol over proton pump inhibitors for the prevention of ulcer relapse in long-term users of NSAIDs, there is little, if any, practical advantage."