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Ulcer Prevention in Long-term Users of Nonsteroidal Anti-inflammatory Drugs
Results of a Double-blind, Randomized, Multicenter, Active- and Placebo-Controlled Study of Misoprostol vs Lansoprazole
David Y. Graham, MD;
Naurang M. Agrawal, MD;
Donald R. Campbell, MD;
Marian M. Haber, MD;
Cyndy Collis, BS;
Nancy L. Lukasik, BSN;
Bidan Huang, PhD
Arch Intern Med. 2002;162:169-175.
Background Studies that report prevention of ulcer recurrence among long-term users
of nonsteroidal anti-inflammatory drugs (NSAIDs) that do not stratify for Helicobacter pylori status may not be generalizable to
the large population of individuals without H pylori.
Methods This was a prospective, double-blind, multicenter, active- and placebo-controlled
study among 537 patients without H pylori who were
long-term users of NSAIDs and who had a history of endoscopically documented
gastric ulcer. 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.
Results Patients receiving lansoprazole (15 or 30 mg) remained free from gastric
ulcer longer than those who received placebo (P<.001)
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% (95% confidence interval [CI], 41.1%-61.3%); misoprostol, 93% (95% CI,
87.2%-97.9%); 15-mg lansoprazole, 80% (95% CI, 72.5%-87.3%); and 30-mg lansoprazole,
82% (95% CI, 75.0%-89.6%). 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.
Conclusions 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.
From the Department of Medicine, Veterans Affairs Medical Center, Houston,
Tex (Dr Graham); Department of Medicine, Duke University Medical Center, Durham,
NC (Dr Agrawal); Department of Medicine, University of Kansas School of Medicine,
University of Missouri, Kansas City, School of Medicine, Department of Veterans
Affairs Medical Center, and Saint Luke's Hospital, Kansas City (Dr Campbell);
MCP Hahnemann University, Philadelphia, Pa (Dr Haber); TAP Pharmaceutical
Products Inc, Lake Forest, Ill (Mss Collis and Lukasik); and Abbott Laboratories,
Abbott Park, Ill (Dr Huang).
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