| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS | REGISTER |
|
|
|
|
|||||||||||||
|
|
|||||||||||||||
STOMACH |
1 University Hospital, Nottingham, United Kingdom
2 USC School of Medicine, Los Angeles, CA, USA
3 Merck Research Laboratories, West Point, PA, USA
Correspondence to:
Correspondence to:
Professor C J Hawkey, School of Medical and Surgical Sciences, Division of Gastroenterology, University Hospital, Nottingham NG7 2UH, UK;
cj.hawkey{at}nottingham.ac.uk
ABSTRACT
Background: Previous studies in patients with osteoarthritis have suggested that the selective cyclooxygenase (COX)-2 inhibitor rofecoxib results in less gastrointestinal damage than non-selective non-steroidal antiinflammatory drugs (NSAIDs). This study compared the incidence of endoscopically detected gastroduodenal ulcers in rheumatoid arthritis patients treated with rofecoxib or a non-selective NSAID.
Methods: In this multicentre, randomised, double blind, 12 week study, patients with rheumatoid arthritis were allocated to rofecoxib 50 mg once daily (n=219), naproxen 500 mg twice daily (n=220), or placebo (n=221). Endoscopy was performed at baseline and at six and 12 weeks. Lifetable analysis and log rank tests were used to analyse the incidence of gastroduodenal ulcers 
3 mm. Gastric or duodenal ulcers 5 mm and erosions were also evaluated as secondary end points. Tolerability was assessed by adverse events.
Results: The cumulative incidence of ulcers 3 mm at 12 weeks was significantly higher in patients on naproxen (25.5%) than in patients receiving rofecoxib (6.8%; difference 18.7% (95% confidence interval (CI) 11.7%, 25.7%); p<0.001) or placebo (2.9%; difference 22.6% (95% CI 16.1%, 29.1%); p<0.001). The difference between rofecoxib (6.8%) and placebo (2.9%) did not reach statistical significance (p=0.066). Results were similar for ulcers 5 mm and for mean changes from baseline in the number of gastroduodenal erosions. The overall incidence of clinical adverse events was similar among treatment groups (61% of patients on placebo, 62% in patients on rofecoxib, and 66% in patients on naproxen).
Conclusions: Rofecoxib 50 mg daily (twice the dose recommended for this patient population) resulted in a lower incidence of endoscopically detected gastroduodenal ulcers and erosions than treatment with naproxen 500 mg twice daily.
Keywords: cyclooxygenase-2 inhibitor; rheumatoid arthritis; gastrointestinal tolerability; coxib; rofecoxib; non-steroidal anti-inflammatory drugs
Abbreviations: COX, cyclooxygenase; NSAIDs, non-steroidal anti-inflammatory drugs; OA, osteoarthritis; PUBs, gastrointestinal perforations, ulcers, or bleeding episodes; RA, rheumatoid arthritis
This article has been cited by other articles:
|
|
 |
|
  U. Kiltz, J. Zochling, W. E. Schmidt, and J. Braun Use of NSAIDs and infection with Helicobacter pylori--what does the rheumatologist need to know? Rheumatology, May 13, 2008; (2008) ken123v1. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. S. Ross, K. P. Hill, D. S. Egilman, and H. M. Krumholz Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation JAMA, April 16, 2008; 299(15): 1800 - 1812. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. O. Bingham III, A. I. Sebba, B. R. Rubin, G. E. Ruoff, J. Kremer, S. Bird, S. S. Smugar, B. J. Fitzgerald, K. O'Brien, and A. M. Tershakovec Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies Rheumatology, March 1, 2007; 46(3): 496 - 507. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Zhang, E. L. Ding, and Y. Song Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials JAMA, October 4, 2006; 296(13): 1619 - 1632. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 T.-J. Aw, S. J. Haas, D. Liew, and H. Krum Meta-analysis of Cyclooxygenase-2 Inhibitors and Their Effects on Blood Pressure Arch Intern Med, March 14, 2005; 165(5): 490 - 496. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S.S. Chua and T. Paraidathathu Utilisation of Non-steroidal Anti-inflammatory Drugs (NSAIDs) through Community Pharmacies in Malaysia Asia Pac J Public Health, January 1, 2005; 17(2): 117 - 123. [Abstract] [PDF]
|
|
|
|
 |
|
 U K Misra, M Jose, and J Kalita Rofecoxib versus ibuprofen for acute treatment of migraine: a randomised placebo controlled trial Postgrad. Med. J., December 1, 2004; 80(950): 720 - 723. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Miura, A. Tatsuguchi, K. Wada, H. Takeyama, Y. Shinji, T. Hiratsuka, S. Futagami, K. Miyake, K. Gudis, Y. Mizokami, et al. Cyclooxygenase-2-regulated vascular endothelial growth factor release in gastric fibroblasts Am J Physiol Gastrointest Liver Physiol, August 1, 2004; 287(2): G444 - G451. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 Rofecoxib v naproxen v placebo in rheumatoid arthritis: gastroduodenal ulcer incidence Ann Rheum Dis, February 1, 2004; 63(2): 155 - 155. [Full Text] [PDF]
|
|
|
|
 |
|
 B J R Whittle New dogmas or old? Gut, September 1, 2003; 52(9): 1379 - 1381. [Abstract] [Full Text]
|
|
|
|
 |
|
 Minerva BMJ, June 5, 2003; 326(7401): 1274 - 1274. [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS | REGISTER |
