OBJECTIVES: To examine whether the increased risk of cardiovascular events with rofecoxib represents a class effect of cyclooxygenase-2 (COX-2) specific inhibitors. DESIGN: Systematic review and meta-analysis of randomized double-blind clinical trials of celecoxib of at least 6 weeks' duration and presented data on serious cardiovascular thromboembolic events. Data sources included six bibliographic databases, the relevant files of the United States Food and Drug Administration, and pharmaceutical company websites. MAIN OUTCOME MEASURES: Pooled fixed effects estimates of the odds ratios for risk of cardiovascular events with celecoxib compared with comparator treatment were calculated using the inverse variance weight method. The main outcome measure was myocardial infarction. RESULTS: Four placebo-controlled trials with 4422 patients were included in the primary meta-analysis comparing celecoxib with placebo. The odds ratio of myocardial infarction with celecoxib compared to placebo was 2.26 (95%confidence interval 1.0 to 5.1). For composite cardiovascular events [odd ratio 1.38 (95% CI 0.91 to 2.10)], cardiovascular deaths [OR 1.06 (95% CI 0.38 to 2.95)] and stroke [OR 1.0(95% CI 0.51 to 1.84)] there was no significant increase in risk with celecoxib. The secondary meta-analysis which included a total of six studies (with placebo, diclofenac, ibuprofen, and paracetamol as comparators) of 12 780 patients, showed similar findings with a significant increased risk with celecoxib for myocardial infarction [OR 1.88 (95% CI 1.15 to 3.08)] but not other outcome measures. CONCLUSION: The available data indicate an increased risk of myocardial infarction with celecoxib therapy, consistent with a class effect for COX-2 specific inhibitors.
OBJECTIVES: To examine whether the increased risk of cardiovascular events with rofecoxib represents a class effect of cyclooxygenase-2 (COX-2) specific inhibitors. DESIGN: Systematic review and meta-analysis of randomized double-blind clinical trials of celecoxib of at least 6 weeks' duration and presented data on serious cardiovascular thromboembolic events. Data sources included six bibliographic databases, the relevant files of the United States Food and Drug Administration, and pharmaceutical company websites. MAIN OUTCOME MEASURES: Pooled fixed effects estimates of the odds ratios for risk of cardiovascular events with celecoxib compared with comparator treatment were calculated using the inverse variance weight method. The main outcome measure was myocardial infarction. RESULTS: Four placebo-controlled trials with 4422 patients were included in the primary meta-analysis comparing celecoxib with placebo. The odds ratio of myocardial infarction with celecoxib compared to placebo was 2.26 (95%confidence interval 1.0 to 5.1). For composite cardiovascular events [odd ratio 1.38 (95% CI 0.91 to 2.10)], cardiovascular deaths [OR 1.06 (95% CI 0.38 to 2.95)] and stroke [OR 1.0(95% CI 0.51 to 1.84)] there was no significant increase in risk with celecoxib. The secondary meta-analysis which included a total of six studies (with placebo, diclofenac, ibuprofen, and paracetamol as comparators) of 12 780 patients, showed similar findings with a significant increased risk with celecoxib for myocardial infarction [OR 1.88 (95% CI 1.15 to 3.08)] but not other outcome measures. CONCLUSION: The available data indicate an increased risk of myocardial infarction with celecoxib therapy, consistent with a class effect for COX-2 specific inhibitors.
Authors: F E Silverstein; G Faich; J L Goldstein; L S Simon; T Pincus; A Whelton; R Makuch; G Eisen; N M Agrawal; W F Stenson; A M Burr; W W Zhao; J D Kent; J B Lefkowith; K M Verburg; G S Geis Journal: JAMA Date: 2000-09-13 Impact factor: 56.272
Authors: C Bombardier; L Laine; A Reicin; D Shapiro; R Burgos-Vargas; B Davis; R Day; M B Ferraz; C J Hawkey; M C Hochberg; T K Kvien; T J Schnitzer Journal: N Engl J Med Date: 2000-11-23 Impact factor: 91.245
Authors: William B White; Gerald Faich; Andrew Whelton; Clement Maurath; Nancy J Ridge; Kenneth M Verburg; G Steven Geis; James B Lefkowith Journal: Am J Cardiol Date: 2002-02-15 Impact factor: 2.778
Authors: Patricia McGettigan; Lisa F Lincz; John Attia; Patrick McElduff; Linda Bissett; Roseanne Peel; Barrie Stokes; Stephen Hancock; Kim Henderson; Michael Seldon; David Henry Journal: Br J Clin Pharmacol Date: 2011-10 Impact factor: 4.335
Authors: Luis Hermenegildo Martin Arias; Antonio Martin Gonzalez; Rosario Sanz Fadrique; Esther Salgueiro; Maria Sainz Journal: Int J Clin Pharm Date: 2018-07-31