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Effects of the cyclooxygenase-2 specific inhibitor valdecoxib versus nonsteroidal antiinflammatory agents and placebo on cardiovascular thrombotic events in patients with arthritis.
Am J Ther. 2004 Jul-Aug; 11(4):244-50.AJ

Abstract

There have been concerns that the risk of cardiovascular thrombotic events may be higher with cyclooxygenase (COX)-2-specific inhibitors than nonselective nonsteroidal antiinflammatory drugs (NSAIDs). We evaluated cardiovascular event data for valdecoxib, a new COX-2-specific inhibitor in approximately 8000 patients with osteoarthritis and rheumatoid arthritis treated with this agent in randomized clinical trials. The incidence of cardiovascular thrombotic events (cardiac, cerebrovascular and peripheral vascular, or arterial thrombotic) was determined by analyzing pooled valdecoxib (10-80 mg daily), nonselective NSAID (diclofenac 75 mg bid, ibuprofen 800 mg tid, or naproxen 500 mg bid) and placebo data from 10 randomized osteoarthritis and rheumatoid arthritis trials that were 6-52 weeks in duration. The incidence rates of events were determined in all patients (n = 7934) and in users of low-dose (< or =325 mg daily) aspirin (n = 1051) and nonusers of aspirin (n = 6883). Crude and exposure-adjusted incidences of thrombotic events were similar for valdecoxib, NSAIDs, and placebo. The risk of serious thrombotic events was also similar for each valdecoxib dose. Thrombotic risk was consistently higher for users of aspirin users than nonusers of aspirin (placebo, 1.4% vs. 0%; valdecoxib, 1.7% vs. 0.2%; NSAIDs, 1.9% vs. 0.5%). The rates of events in users of aspirin were similar for all 3 treatment groups and across valdecoxib doses. Short- and intermediate-term treatment with therapeutic (10 or 20 mg daily) and supratherapeutic (40 or 80 mg daily) valdecoxib doses was not associated with an increased incidence of thrombotic events relative to nonselective NSAIDs or placebo in osteoarthritis and rheumatoid arthritis patients in controlled clinical trials.

Authors+Show Affiliations

Division of Hypertension and Clinical Pharmacology, Department of Medicine, University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, CT 06030-3940, USA. wwhite@nso1.uchc.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15266215

Citation

White, William B., et al. "Effects of the Cyclooxygenase-2 Specific Inhibitor Valdecoxib Versus Nonsteroidal Antiinflammatory Agents and Placebo On Cardiovascular Thrombotic Events in Patients With Arthritis." American Journal of Therapeutics, vol. 11, no. 4, 2004, pp. 244-50.
White WB, Strand V, Roberts R, et al. Effects of the cyclooxygenase-2 specific inhibitor valdecoxib versus nonsteroidal antiinflammatory agents and placebo on cardiovascular thrombotic events in patients with arthritis. Am J Ther. 2004;11(4):244-50.
White, W. B., Strand, V., Roberts, R., & Whelton, A. (2004). Effects of the cyclooxygenase-2 specific inhibitor valdecoxib versus nonsteroidal antiinflammatory agents and placebo on cardiovascular thrombotic events in patients with arthritis. American Journal of Therapeutics, 11(4), 244-50.
White WB, et al. Effects of the Cyclooxygenase-2 Specific Inhibitor Valdecoxib Versus Nonsteroidal Antiinflammatory Agents and Placebo On Cardiovascular Thrombotic Events in Patients With Arthritis. Am J Ther. 2004 Jul-Aug;11(4):244-50. PubMed PMID: 15266215.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of the cyclooxygenase-2 specific inhibitor valdecoxib versus nonsteroidal antiinflammatory agents and placebo on cardiovascular thrombotic events in patients with arthritis. AU - White,William B, AU - Strand,Vibeke, AU - Roberts,Richard, AU - Whelton,Andrew, PY - 2004/7/22/pubmed PY - 2004/10/23/medline PY - 2004/7/22/entrez SP - 244 EP - 50 JF - American journal of therapeutics JO - Am J Ther VL - 11 IS - 4 N2 - There have been concerns that the risk of cardiovascular thrombotic events may be higher with cyclooxygenase (COX)-2-specific inhibitors than nonselective nonsteroidal antiinflammatory drugs (NSAIDs). We evaluated cardiovascular event data for valdecoxib, a new COX-2-specific inhibitor in approximately 8000 patients with osteoarthritis and rheumatoid arthritis treated with this agent in randomized clinical trials. The incidence of cardiovascular thrombotic events (cardiac, cerebrovascular and peripheral vascular, or arterial thrombotic) was determined by analyzing pooled valdecoxib (10-80 mg daily), nonselective NSAID (diclofenac 75 mg bid, ibuprofen 800 mg tid, or naproxen 500 mg bid) and placebo data from 10 randomized osteoarthritis and rheumatoid arthritis trials that were 6-52 weeks in duration. The incidence rates of events were determined in all patients (n = 7934) and in users of low-dose (< or =325 mg daily) aspirin (n = 1051) and nonusers of aspirin (n = 6883). Crude and exposure-adjusted incidences of thrombotic events were similar for valdecoxib, NSAIDs, and placebo. The risk of serious thrombotic events was also similar for each valdecoxib dose. Thrombotic risk was consistently higher for users of aspirin users than nonusers of aspirin (placebo, 1.4% vs. 0%; valdecoxib, 1.7% vs. 0.2%; NSAIDs, 1.9% vs. 0.5%). The rates of events in users of aspirin were similar for all 3 treatment groups and across valdecoxib doses. Short- and intermediate-term treatment with therapeutic (10 or 20 mg daily) and supratherapeutic (40 or 80 mg daily) valdecoxib doses was not associated with an increased incidence of thrombotic events relative to nonselective NSAIDs or placebo in osteoarthritis and rheumatoid arthritis patients in controlled clinical trials. SN - 1075-2765 UR - https://www.unboundmedicine.com/medline/citation/15266215/Effects_of_the_cyclooxygenase_2_specific_inhibitor_valdecoxib_versus_nonsteroidal_antiinflammatory_agents_and_placebo_on_cardiovascular_thrombotic_events_in_patients_with_arthritis_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=15266215.ui DB - PRIME DP - Unbound Medicine ER -