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Reduced incidence of upper gastrointestinal ulcer complications with the COX‐2 selective inhibitor, valdecoxib
Author(s) -
Goldstein J. L.,
Eisen G. M.,
Agrawal N.,
Stenson W. F.,
Kent J. D.,
Verburg K. M.
Publication year - 2004
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2004.02118.x
Subject(s) - valdecoxib , medicine , aspirin , diclofenac , osteoarthritis , placebo , ibuprofen , rheumatoid arthritis , naproxen , randomized controlled trial , arthritis , surgery , anesthesia , gastroenterology , pharmacology , rofecoxib , cyclooxygenase , biochemistry , chemistry , alternative medicine , pathology , enzyme
Summary Aim : In a predefined analysis, data were pooled from eight blinded, randomized, controlled trials, and separately from three long‐term, open‐label trials to determine the rate of upper gastrointestinal ulcer complications with the cyclo‐oxygenase‐2 selective inhibitor, valdecoxib, vs. non‐selective non‐steroidal anti‐inflammatory drugs. Methods : In randomized, controlled trials, 7434 osteoarthritis and rheumatoid arthritis patients received placebo ( n = 973), valdecoxib 5–80 mg daily ( n =4362), or a non‐selective non‐steroidal anti‐inflammatory drug (naproxen, ibuprofen or diclofenac; n =2099) for 12–26 weeks. In long‐term, open‐label trials, 2871 patients received valdecoxib 10–80 mg daily for up to 1 year. All potential events were reviewed by a blinded, independent review committee based on a priori definitions of ulcer complications (perforations, obstructions, bleeds). Results : In randomized, controlled trials, 19 of 955 potential events were adjudicated to be ulcer complications. Valdecoxib was associated with a significantly lower ulcer complication rate than non‐selective non‐steroidal anti‐inflammatory drugs (0.68% vs. 1.96%, all patients; 0.29% vs. 2.08%, non‐aspirin users; P < 0.05). In long‐term, open‐label trials, seven of 310 potential events were adjudicated to be ulcer complications; the annualized incidence for valdecoxib was 0.39% (seven of 1791 patient‐years) for all patients and 0.2% (three of 1472 patient‐years) for non‐aspirin users. Conclusions : Valdecoxib, including above recommended doses, is associated with a significantly lower rate of upper gastrointestinal ulcer complications than therapeutic doses of non‐selective non‐steroidal anti‐inflammatory drugs.