A comparison of the upper gastrointestinal mucosal effects of valdecoxib, naproxen and placebo in healthy elderly subjects
Version of Record online: 7 JUL 2003
Alimentary Pharmacology & Therapeutics
Volume 18, Issue 1, pages 125–132, July 2003
How to Cite
Goldstein, J. L., Kivitz, A. J., Verburg, K. M., Recker, D. P., Palmer, R. C. and Kent, J. D. (2003), A comparison of the upper gastrointestinal mucosal effects of valdecoxib, naproxen and placebo in healthy elderly subjects. Alimentary Pharmacology & Therapeutics, 18: 125–132. doi: 10.1046/j.1365-2036.2003.01650.x
- Issue online: 7 JUL 2003
- Version of Record online: 7 JUL 2003
- Accepted for publication 30 April 2003
Background : In long-term outcomes studies, cyclooxygenase COX-2 specific inhibitors spare COX-1 at supratherapeutic doses and therefore demonstrate improved gastrointestinal safety over nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs). However, in clinical practice, anti-inflammatory drugs are often used for short-term treatment of pain.
Aim : To compare the short-term upper gastrointestinal mucosal effects of naproxen with the new COX-2 specific inhibitor, valdecoxib, or placebo, in elderly subjects.
Methods : In this multicentre, double-blind, randomized, study, elderly subjects (65–76 years old), with a normal baseline esophagogastroduodenoscopy (EGD), received oral valdecoxib (a supratherapeutic 40 mg b.d. dosage, n = 62), naproxen (500 mg b.d., n = 62), or placebo (n = 62) for 6.5 days. Upper gastrointestinal mucosal injury was evaluated post-treatment by EGD (day 7).
Results : Subjects receiving naproxen (11/60, 18%) had significantly more gastroduodenal ulcers post-treatment than those receiving placebo (2/61, 3%; P < 0.01) or valdecoxib (0/60, 0%; P < 0.001). A similar significant finding was observed for gastric ulcer rates. All treatments had similar adverse event rates and clinical laboratory findings.
Conclusions : Valdecoxib, even at supratherapeutic doses, was associated with an ulcer rate significantly lower than naproxen but similar to placebo in healthy elderly subjects, despite the short duration of therapy (6.5 days). Naproxen and valdecoxib were as well tolerated as placebo.