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Reduced incidence of upper gastrointestinal ulcer complications with the COX-2 selective inhibitor, valdecoxib.
Aliment Pharmacol Ther. 2004 Sep 01; 20(5):527-38.AP

Abstract

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.

Authors+Show Affiliations

University of Illinois at Chicago, Chicago, IL 60612, USA. jlgoldst@uic.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15339324

Citation

Goldstein, J L., et al. "Reduced Incidence of Upper Gastrointestinal Ulcer Complications With the COX-2 Selective Inhibitor, Valdecoxib." Alimentary Pharmacology & Therapeutics, vol. 20, no. 5, 2004, pp. 527-38.
Goldstein JL, Eisen GM, Agrawal N, et al. Reduced incidence of upper gastrointestinal ulcer complications with the COX-2 selective inhibitor, valdecoxib. Aliment Pharmacol Ther. 2004;20(5):527-38.
Goldstein, J. L., Eisen, G. M., Agrawal, N., Stenson, W. F., Kent, J. D., & Verburg, K. M. (2004). Reduced incidence of upper gastrointestinal ulcer complications with the COX-2 selective inhibitor, valdecoxib. Alimentary Pharmacology & Therapeutics, 20(5), 527-38.
Goldstein JL, et al. Reduced Incidence of Upper Gastrointestinal Ulcer Complications With the COX-2 Selective Inhibitor, Valdecoxib. Aliment Pharmacol Ther. 2004 Sep 1;20(5):527-38. PubMed PMID: 15339324.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reduced incidence of upper gastrointestinal ulcer complications with the COX-2 selective inhibitor, valdecoxib. AU - Goldstein,J L, AU - Eisen,G M, AU - Agrawal,N, AU - Stenson,W F, AU - Kent,J D, AU - Verburg,K M, PY - 2004/9/2/pubmed PY - 2004/12/18/medline PY - 2004/9/2/entrez SP - 527 EP - 38 JF - Alimentary pharmacology & therapeutics JO - Aliment Pharmacol Ther VL - 20 IS - 5 N2 - 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. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/15339324/Reduced_incidence_of_upper_gastrointestinal_ulcer_complications_with_the_COX_2_selective_inhibitor_valdecoxib_ L2 - https://doi.org/10.1111/j.1365-2036.2004.02118.x DB - PRIME DP - Unbound Medicine ER -