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Erschienen in: Rheumatology International 5/2007

01.03.2007 | Original Article

Adjusted indirect comparison of celecoxib versus rofecoxib on cardiovascular risk

verfasst von: Young Ho Lee, Jong Dae Ji, Gwan Gyu Song

Erschienen in: Rheumatology International | Ausgabe 5/2007

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Abstract

To compare the magnitude of celecoxib versus rofecoxib on the cardiovascular risk. We performed adjusted indirect comparison of celecoxib versus rofecoxib for cardiovascular events using two data on The Adenomatous Polyp Prevention on Vioxx (APPROVe) trial and Adenoma Prevention with Celecoxib (APC) trial. Baseline characteristics of the patients and placebos were comparable in both trials, in terms of age, sex, hypertension, diabetes mellitus, smoking, and hypercholesterolemia. The overall incidence of cardiovascular events was similar in both groups (rofecoxib 48/1,287 versus celecoxib 48/1,356, p = 0.79). The relative risks (RRs) of all myocardial infarction or sudden death from cardiac causes were increased in both rofecoxib and celecoxib groups [rofecoxib versus placebo; RR 1.35, 95% confidence interval (CI) 1.07–1.69, p = 0.03, celecoxib versus placebo; RR 1.35, 95% CI 1.14–1.51, p = 0.01]. The RRs for cardiovascular events derived from the adjusted indirect comparisons of the two coxibs did not significantly differ from unity (celecoxib versus rofecoxib; RR 0.95, 95% CI 0.76–1.19, p = 0.67). The adjusted indirect comparison analysis shows that celecoxib and rofecoxib may have similarly effect of cardiovascular events when used for 3 years.
Literatur
1.
Zurück zum Zitat Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B et al (2000) Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 343:1520–1528PubMedCrossRef Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B et al (2000) Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 343:1520–1528PubMedCrossRef
2.
Zurück zum Zitat Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K et al (2005) Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 352:1092–1102PubMedCrossRef Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K et al (2005) Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 352:1092–1102PubMedCrossRef
3.
Zurück zum Zitat Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A et al (2000) Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 284:1247–1255PubMedCrossRef Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A et al (2000) Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 284:1247–1255PubMedCrossRef
4.
Zurück zum Zitat Kimmel SE, Berlin JA, Reilly M, Jaskowiak J, Kishel L, Chittams J et al (2005) Patients exposed to rofecoxib and celecoxib have different odds of nonfatal myocardial infarction. Ann Intern Med 142:157–164PubMed Kimmel SE, Berlin JA, Reilly M, Jaskowiak J, Kishel L, Chittams J et al (2005) Patients exposed to rofecoxib and celecoxib have different odds of nonfatal myocardial infarction. Ann Intern Med 142:157–164PubMed
5.
Zurück zum Zitat Solomon DH, Schneeweiss S, Glynn RJ, Kiyota Y, Levin R, Mogun H et al (2004) Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 109:2068–2073PubMedCrossRef Solomon DH, Schneeweiss S, Glynn RJ, Kiyota Y, Levin R, Mogun H et al (2004) Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 109:2068–2073PubMedCrossRef
6.
Zurück zum Zitat Ray WA, Stein CM, Daugherty JR, Hall K, Arbogast PG, Griffin MR (2002) COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 360:1071–1073PubMedCrossRef Ray WA, Stein CM, Daugherty JR, Hall K, Arbogast PG, Griffin MR (2002) COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 360:1071–1073PubMedCrossRef
7.
Zurück zum Zitat Mamdani M, Juurlink DN, Lee DS, Rochon PA, Kopp A, Naglie G et al (2004) Cyclo-oxygenase-2 inhibitors versus non-selective non-steroidal anti-inflammatory drugs and congestive heart failure outcomes in elderly patients: a population-based cohort study. Lancet 363:1751–1756PubMedCrossRef Mamdani M, Juurlink DN, Lee DS, Rochon PA, Kopp A, Naglie G et al (2004) Cyclo-oxygenase-2 inhibitors versus non-selective non-steroidal anti-inflammatory drugs and congestive heart failure outcomes in elderly patients: a population-based cohort study. Lancet 363:1751–1756PubMedCrossRef
8.
Zurück zum Zitat Mamdani M, Rochon P, Juurlink DN, Anderson GM, Kopp A, Naglie G, et al (2003) Effect of selective cyclooxygenase 2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly. Arch Intern Med 163:481–486PubMedCrossRef Mamdani M, Rochon P, Juurlink DN, Anderson GM, Kopp A, Naglie G, et al (2003) Effect of selective cyclooxygenase 2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly. Arch Intern Med 163:481–486PubMedCrossRef
9.
Zurück zum Zitat Graham DJ, Campen D, Hui R, Spence M, Cheetham C, Levy G et al (2005) Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 365:475–481PubMed Graham DJ, Campen D, Hui R, Spence M, Cheetham C, Levy G et al (2005) Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 365:475–481PubMed
10.
Zurück zum Zitat Levesque LE, Brophy JM, Zhang B (2005) The risk for myocardial infarction with cyclooxygenase-2 inhibitors: a population study of elderly adults. Ann Intern Med 142:481–489PubMed Levesque LE, Brophy JM, Zhang B (2005) The risk for myocardial infarction with cyclooxygenase-2 inhibitors: a population study of elderly adults. Ann Intern Med 142:481–489PubMed
11.
Zurück zum Zitat White WB, Faich G, Borer JS, Makuch RW (2003) Cardiovascular thrombotic events in arthritis trials of the cyclooxygenase-2 inhibitor celecoxib. Am J Cardiol 92:411–418PubMedCrossRef White WB, Faich G, Borer JS, Makuch RW (2003) Cardiovascular thrombotic events in arthritis trials of the cyclooxygenase-2 inhibitor celecoxib. Am J Cardiol 92:411–418PubMedCrossRef
12.
Zurück zum Zitat Mukherjee D, Nissen SE, Topol EJ (2001) Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 286:954–959PubMedCrossRef Mukherjee D, Nissen SE, Topol EJ (2001) Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 286:954–959PubMedCrossRef
13.
Zurück zum Zitat Bucher HC, Guyatt GH, Griffith LE, Walter SD (1997) The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 50:683–691PubMedCrossRef Bucher HC, Guyatt GH, Griffith LE, Walter SD (1997) The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 50:683–691PubMedCrossRef
14.
Zurück zum Zitat Song F, Glenny AM, Altman DG (2000) Indirect comparison in evaluating relative efficacy illustrated by antimicrobial prophylaxis in colorectal surgery. Control Clin Trials 21:488–497PubMedCrossRef Song F, Glenny AM, Altman DG (2000) Indirect comparison in evaluating relative efficacy illustrated by antimicrobial prophylaxis in colorectal surgery. Control Clin Trials 21:488–497PubMedCrossRef
15.
Zurück zum Zitat Song F, Altman DG, Glenny AM, Deeks JJ (2003) Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ 326:472PubMedCrossRef Song F, Altman DG, Glenny AM, Deeks JJ (2003) Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ 326:472PubMedCrossRef
16.
Zurück zum Zitat Fisher LD, Gent M, Buller HR (2001) Active-control trials: how would a new agent compare with placebo? A method illustrated with clopidogrel, aspirin, and placebo. Am Heart J 141:26–32PubMedCrossRef Fisher LD, Gent M, Buller HR (2001) Active-control trials: how would a new agent compare with placebo? A method illustrated with clopidogrel, aspirin, and placebo. Am Heart J 141:26–32PubMedCrossRef
17.
Zurück zum Zitat Solomon SD, McMurray JJ, Pfeffer MA, Wittes J, Fowler R, Finn P et al (2005) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352:1071–1080PubMedCrossRef Solomon SD, McMurray JJ, Pfeffer MA, Wittes J, Fowler R, Finn P et al (2005) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352:1071–1080PubMedCrossRef
18.
Zurück zum Zitat Warner TD, Giuliano F, Vojnovic I, Bukasa A, Mitchell JA, Vane JR (1999) Nonsteroid drug selectivities for cyclo-oxygenase-1 rather than cyclo-oxygenase-2 are associated with human gastrointestinal toxicity: a full in vitro analysis. Proc Natl Acad Sci USA 96:7563–7568PubMedCrossRef Warner TD, Giuliano F, Vojnovic I, Bukasa A, Mitchell JA, Vane JR (1999) Nonsteroid drug selectivities for cyclo-oxygenase-1 rather than cyclo-oxygenase-2 are associated with human gastrointestinal toxicity: a full in vitro analysis. Proc Natl Acad Sci USA 96:7563–7568PubMedCrossRef
19.
Zurück zum Zitat Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M (2004) Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 364:2021–2029PubMedCrossRef Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M (2004) Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 364:2021–2029PubMedCrossRef
20.
Zurück zum Zitat Ott E, Nussmeier NA, Duke PC, Feneck RO, Alston RP, Snabes MC, et al (2003) Efficacy and safety of the cyclooxygenase 2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg 125:1481–1492PubMedCrossRef Ott E, Nussmeier NA, Duke PC, Feneck RO, Alston RP, Snabes MC, et al (2003) Efficacy and safety of the cyclooxygenase 2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg 125:1481–1492PubMedCrossRef
21.
Zurück zum Zitat Sanmuganathan PS, Ghahramani P, Jackson PR, Wallis EJ, Ramsay LE (2001) Aspirin for primary prevention of coronary heart disease: safety and absolute benefit related to coronary risk derived from meta-analysis of randomised trials. Heart 85:265–271PubMedCrossRef Sanmuganathan PS, Ghahramani P, Jackson PR, Wallis EJ, Ramsay LE (2001) Aspirin for primary prevention of coronary heart disease: safety and absolute benefit related to coronary risk derived from meta-analysis of randomised trials. Heart 85:265–271PubMedCrossRef
22.
Zurück zum Zitat Topol EJ (2004) Failing the public health—rofecoxib, Merck, and the FDA. N Engl J Med 351:1707–1709PubMedCrossRef Topol EJ (2004) Failing the public health—rofecoxib, Merck, and the FDA. N Engl J Med 351:1707–1709PubMedCrossRef
23.
Zurück zum Zitat McAdam BF, Catella-Lawson F, Mardini IA, Kapoor S, Lawson JA, FitzGerald GA (1999) Systemic biosynthesis of prostacyclin by cyclooxygenase (COX)-2: the human pharmacology of a selective inhibitor of COX-2. Proc Natl Acad Sci USA 96:272–277PubMedCrossRef McAdam BF, Catella-Lawson F, Mardini IA, Kapoor S, Lawson JA, FitzGerald GA (1999) Systemic biosynthesis of prostacyclin by cyclooxygenase (COX)-2: the human pharmacology of a selective inhibitor of COX-2. Proc Natl Acad Sci USA 96:272–277PubMedCrossRef
24.
Zurück zum Zitat Catella-Lawson F, McAdam B, Morrison BW, Kapoor S, Kujubu D, Antes L et al (1999) Effects of specific inhibition of cyclooxygenase-2 on sodium balance, hemodynamics, and vasoactive eicosanoids. J Pharmacol Exp Ther 289:735–741PubMed Catella-Lawson F, McAdam B, Morrison BW, Kapoor S, Kujubu D, Antes L et al (1999) Effects of specific inhibition of cyclooxygenase-2 on sodium balance, hemodynamics, and vasoactive eicosanoids. J Pharmacol Exp Ther 289:735–741PubMed
25.
Zurück zum Zitat Aw TJ, Haas SJ, Liew D, Krum H (2005) Meta-analysis of cyclooxygenase-2 inhibitors and their effects on blood pressure. Arch Intern Med 165:490–496PubMedCrossRef Aw TJ, Haas SJ, Liew D, Krum H (2005) Meta-analysis of cyclooxygenase-2 inhibitors and their effects on blood pressure. Arch Intern Med 165:490–496PubMedCrossRef
26.
Zurück zum Zitat Collins R, Peto R, MacMahon S, Hebert P, Fiebach NH, Eberlein KA et al (1990) Blood pressure, stroke, and coronary heart disease. Part 2, Short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context. Lancet 335:827–838PubMedCrossRef Collins R, Peto R, MacMahon S, Hebert P, Fiebach NH, Eberlein KA et al (1990) Blood pressure, stroke, and coronary heart disease. Part 2, Short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context. Lancet 335:827–838PubMedCrossRef
27.
Zurück zum Zitat Shinmura K, Tang XL, Wang Y, Xuan YT, Liu SQ, Takano H et al (2000) Cyclooxygenase-2 mediates the cardioprotective effects of the late phase of ischemic preconditioning in conscious rabbits. Proc Natl Acad Sci USA 97:10197–10202PubMedCrossRef Shinmura K, Tang XL, Wang Y, Xuan YT, Liu SQ, Takano H et al (2000) Cyclooxygenase-2 mediates the cardioprotective effects of the late phase of ischemic preconditioning in conscious rabbits. Proc Natl Acad Sci USA 97:10197–10202PubMedCrossRef
28.
Zurück zum Zitat Egan KM, Wang M, Lucitt MB, Zukas AM, Pure E, Lawson JA et al (2005) Cyclooxygenases, thromboxane, and atherosclerosis: plaque destabilization by cyclooxygenase-2 inhibition combined with thromboxane receptor antagonism. Circulation 111:334–342PubMedCrossRef Egan KM, Wang M, Lucitt MB, Zukas AM, Pure E, Lawson JA et al (2005) Cyclooxygenases, thromboxane, and atherosclerosis: plaque destabilization by cyclooxygenase-2 inhibition combined with thromboxane receptor antagonism. Circulation 111:334–342PubMedCrossRef
Metadaten
Titel
Adjusted indirect comparison of celecoxib versus rofecoxib on cardiovascular risk
verfasst von
Young Ho Lee
Jong Dae Ji
Gwan Gyu Song
Publikationsdatum
01.03.2007
Verlag
Springer-Verlag
Erschienen in
Rheumatology International / Ausgabe 5/2007
Print ISSN: 0172-8172
Elektronische ISSN: 1437-160X
DOI
https://doi.org/10.1007/s00296-006-0244-y

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