Prevention of adverse gastrointestinal events of nonsteroidal anti-inflammatory drugs with proton pump inhibitors. Results of the epidemiologic study GREAT

Authors: Š. Forejtová;  K. Pavelka;  Z. Mareš
Authors‘ workplace: Revmatologický ústav Praha
Published in: Čes. Revmatol., 19, 2011, No. 3, p. 104-110.
Category: Original Papers


The aim of our study
was to survey the forms of gastroprotective therapy used in the Czech Republic during the treatment with nonsteroidal anti-rheumatic drugs (NSAIDs) in patients with chronic rheumatic diseases with different risk factors for NSAID-induced gastropathy.

We conducted a multicentric study with data collected directly by rheumatologists. Administration of NSAIDs for at least 4 days a week in the last 3 months was considered as chronic use. The study had two parts: the first part was a cross-sectional study with a one-time record of use of gastroprotective therapy at the time of questionnaire completion; the second part was a retrospective observation of adverse effects in the last 3 months.

90 rheumatologists participated in our survey. Records were collected for a total of 869 patients: 275 men (31.65%) and 594 women (68.35%). A total of 789 patients (90.79%) were at risk of NSAID-induced gastropathy; with 397 (45.68%) at high-risk and 392 patients (45.10%) at low risk. At least one gastroprotective drug was used in 648 (74.57%) individuals (coxibs, H2-blockers or proton pump inhibitors), with omeprazole being the most commonly used gastroprotective agent (94.41%). The relationship between risk of NSAID-induced gastropathy and gastroprotective agent used reached statistical significance (p<0.01, r = 0.349); ie gastroprotective drugs were used in 83.88% patients at high risk of gastropathy, in 73.72% patients with low risk, and in 32.50% patients with no risk. No gastroprotective drugs were used in 16.18% high-risk patients and in 26.27% patients with low risk of gastropathy. 672 (77.33%) out of all monitored individuals experienced no difficulties during the NSAIDs treatment, whereas 197 (22.66%) individuals had some ailments under the treatment with NSAIDs.

We have found a significant correlation between the GI risk and use of gastroprotective drug. The most commonly used agent was omeprazole (94.41%). However 19.22% of all monitored individuals with at least one risk factor for NSAID-induced gastropathy were not treated with any gastroprotective drug.

Key words:
NSAID-induced gastropathy, gastroprotective therapy, proton pump inhibitors, omeprazole


1. Laine L. Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient. Gastroenterology 2001;120(3):594-606.

2. Pirmohamed M, James S, Meakin S et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004;329:15-19.

3. Laine L, Bombardier C, Hawkey CJ, Davis B, Shapiro D, Brett C, Reicin A. Stratifying the risk of NSA-related upper gastrointestinal clinical events: result of a double-blind outcomes study in patients with rheumatoid arthritis. Gastroenterology 2002;123(4):1006-1012.

4. Bombardier C, Laine L, Reicin A et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000;343(21):1520-1528.

5. Fries JF, Williams Ca, Bloch DA et al. Nonsteroidal anti-inflammatory drugs associated gastropathy: incidence and risk factor model. Am J Med 1991:91:213-222.

6. Griffin MR, Piper JM, Daugherty JR et al. Nonsteriodal anti-inflammatory drug use and increased risk for peptic ulcer in elderly persons. Ann Intern Med 1991;114:257-263.

7. Piper JM, Ray WA, Daugherty JR et al. Corticosteroid use and peptic ulcer disease. Role of non-steroidal anti-inflammatory drugs. Ann Intern Med 1991;114:735-740.

8. Shorr RJ, Ray WA, Daugherty JR et al. Concurent use of nonsteroidal anti-inflammatory drugs and oral anticoagulants places elderly persons at high risk for hemorrhagic peptic ulcer diseases. Arch Intern Med 1993;153:1665-1670.

9. Silverstein FE, Graham DY, Senior JR et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomised, double blind, placebo controlled trial. Ann Intern Med 1995;123:241-249.

10. Chan FKL, Hung LCT, Suen BY et al. Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: Result of a randomised double blind trial. Gastroenterology 2004;127:1038-1043.

11. Rostom A, Dube C, Wells GA, Tugwell P, Welch V, Jolicoeur E, McGowan J, Lanas A. Prevention of NSAID-induced gastroduodenal ulcers (Review). Cochrane Database Syst Rev. 2002;(4):CD002296.

12. Silverstein FE, Faich G, Goldstein JL et al. Gastointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib long-therm artrhritis safety study. JAMA 2000;284(10): 1247-1255.

13. Schnitzer T, Burmester GR, Mysler E et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet 2004;364:665-674

14. Hawkey CJ, Gitton X, Hoexter E, Richard D, Einstein WM. Gastrointestinal tolerability of lumiracoxib in patients with osteoarthritis and rheumatoid arthritis. Clin Gastroenterol Hepatol 2006;4:57-66.

15. Hunt RH, Harper S, Watson DJ et al. The gastrointestinal safety of the COX-2 selective inhibitor etoricoxib assessed by both endoscopy and analysis of upper gastrointestinal events. Am J Gastroenterol 2003;98:1725-1733.

16. Fries JF, Murtagh KN, Bennett M, Zatarain E, Lingala B, Bruce B. The rise and decline of nonsteroidal antiinflammatory drug-associated gastropathy in rheumatoid arthritis. Arthritis Rheum 2004;50:2433-40.

17. Steen KSS, Nurmohamed MT, Visman I, Heijerman M, Boers M, Dijkmans BAC, Lems WF. Decreasing incidence of symptomatic gastrointestinal ulcer complications in patients with rheumatoid arthritis. Ann Rheum Dis 2008;67:256-259.

18. Roux C, Briot K, Gossec L et al. Increase of fracture risk in postmenopausal women using omeprazol. Calcif Tissue Int 2009;24:100-103.

Dermatology & STDs Paediatric rheumatology Rheumatology
Forgotten password

Don‘t have an account?  Create new account

Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.


Don‘t have an account?  Create new account