{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T19:45:11Z","timestamp":1770061511856,"version":"3.49.0"},"reference-count":34,"publisher":"BMJ","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Gut"],"accepted":{"date-parts":[[2002,12,17]]},"published-print":{"date-parts":[[2003,6]]},"abstract":"<jats:p>\n                  <jats:bold>Background:<\/jats:bold> 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.<\/jats:p>\n               <jats:p>\n                  <jats:bold>Methods:<\/jats:bold> 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 \u22653 mm. Gastric or duodenal ulcers \u22655 mm and erosions were also evaluated as secondary end points. Tolerability was assessed by adverse events.<\/jats:p>\n               <jats:p>\n                  <jats:bold>Results:<\/jats:bold> The cumulative incidence of ulcers \u22653 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&lt;0.001) or placebo (2.9%; difference 22.6% (95% CI 16.1%, 29.1%); p&lt;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 \u22655 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).<\/jats:p>\n               <jats:p>\n                  <jats:bold>Conclusions:<\/jats:bold> 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.<\/jats:p>","DOI":"10.1136\/gut.52.6.820","type":"journal-article","created":{"date-parts":[[2003,5,9]],"date-time":"2003-05-09T16:21:23Z","timestamp":1052497283000},"page":"820-826","source":"Crossref","is-referenced-by-count":55,"title":["Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study"],"prefix":"10.1136","volume":"52","author":[{"given":"C J","family":"Hawkey","sequence":"first","affiliation":[{"name":"University Hospital, Nottingham, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L","family":"Laine","sequence":"additional","affiliation":[{"name":"USC School of Medicine, Los Angeles, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T","family":"Simon","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, West Point, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H","family":"Quan","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, West Point, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S","family":"Shingo","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, West Point, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J","family":"Evans","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, West Point, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2003,6,1]]},"reference":[{"key":"2025090713032324000_52.6.820.1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199906173402407"},{"key":"2025090713032324000_52.6.820.2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1977.03270370048021"},{"key":"2025090713032324000_52.6.820.3","first-page":"1","volume":"15","year":"2001","journal-title":"Aliment Pharmacol Ther"},{"key":"2025090713032324000_52.6.820.4","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(200005)43:5<978::AID-ANR4>3.0.CO;2-0"},{"key":"2025090713032324000_52.6.820.5","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.160.12.1781"},{"key":"2025090713032324000_52.6.820.6","doi-asserted-by":"publisher","DOI":"10.1016\/S0009-9236(99)70113-X"},{"key":"2025090713032324000_52.6.820.7","unstructured":"Merck & Co., Inc. 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