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Erschienen in: Drug Safety 3/2005

01.03.2005 | Current Opinion

Do Selective Cyclo-Oxygenase-2 Inhibitors Have a Future?

verfasst von: Professor Bernard Bannwarth

Erschienen in: Drug Safety | Ausgabe 3/2005

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Abstract

The dramatic withdrawal of rofecoxib on 30 September 2004, along with safety concerns about other cyclo-oxygenase (COX)-2 inhibitors (especially valdecoxib), raises important issues for clinicians, pharmaceutical companies and regulatory authorities. Some of these are examined in this article, including: (i) was the cardiotoxicity of rofecoxib evident long before its withdrawal?; (ii) is the thrombotic hazard a class effect that is applicable to all COX-2 inhibitors?; (iii) may conventional NSAIDs also confer a risk of cardiovascular thrombosis?; and (iv) is there any future for selective COX-2 inhibitors?
Fußnoten
1
The use of trade names is for product identification purposes only and does not imply endorsement.
 
Literatur
1.
Zurück zum Zitat Vioxx: an unequal partnership between safety and efficacy. Lancet 2004; 364: 1287–8 Vioxx: an unequal partnership between safety and efficacy. Lancet 2004; 364: 1287–8
2.
Zurück zum Zitat Langton PE, Hankey GJ, Eikelboom JW. Cardiovascular safety of rofecoxib (Vioxx): lessons learned and unanswered questions. Med J Aust 2004; 181: 524–5PubMed Langton PE, Hankey GJ, Eikelboom JW. Cardiovascular safety of rofecoxib (Vioxx): lessons learned and unanswered questions. Med J Aust 2004; 181: 524–5PubMed
3.
Zurück zum Zitat Dieppe PA, Ebrahim S, Martin RM, et al. Lessons from the withdrawal of rofecoxib. BMJ 2004; 329: 867–8PubMedCrossRef Dieppe PA, Ebrahim S, Martin RM, et al. Lessons from the withdrawal of rofecoxib. BMJ 2004; 329: 867–8PubMedCrossRef
4.
Zurück zum Zitat Topol EJ. Failing the public health: Rofecoxib, Merck, and the FDA. N Engl J Med 2004; 351: 1707–9PubMedCrossRef Topol EJ. Failing the public health: Rofecoxib, Merck, and the FDA. N Engl J Med 2004; 351: 1707–9PubMedCrossRef
6.
Zurück zum Zitat Horton R. Vioxx, the implosion of Merck, and aftershocks at the FDA. Lancet 2004; 364: 1995–6PubMedCrossRef Horton R. Vioxx, the implosion of Merck, and aftershocks at the FDA. Lancet 2004; 364: 1995–6PubMedCrossRef
7.
Zurück zum Zitat Clark DWJ, Layton D, Shakir SAW. Do some inhibitors of COX-2 increase the risk of thromboembolic events? Linking pharmacology with pharmacoepidemiology. Drug Saf 2004; 27: 427–56PubMedCrossRef Clark DWJ, Layton D, Shakir SAW. Do some inhibitors of COX-2 increase the risk of thromboembolic events? Linking pharmacology with pharmacoepidemiology. Drug Saf 2004; 27: 427–56PubMedCrossRef
8.
Zurück zum Zitat Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001; 286: 954–9PubMedCrossRef Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001; 286: 954–9PubMedCrossRef
9.
Zurück zum Zitat FitzGerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med 2001; 345: 433–42PubMedCrossRef FitzGerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med 2001; 345: 433–42PubMedCrossRef
10.
Zurück zum Zitat Baron JA, Cole BF, Sandler RS, et al. A randomized trial of aspirin to prevent colorectal adenomas. N Engl J Med 2003; 348: 891–9PubMedCrossRef Baron JA, Cole BF, Sandler RS, et al. A randomized trial of aspirin to prevent colorectal adenomas. N Engl J Med 2003; 348: 891–9PubMedCrossRef
11.
Zurück zum Zitat Mukherjee D. Selective cyclooxygenase-2 (COX-2) inhibitors and potential risk of cardiovascular events. Biochem Pharmacol 2002; 63: 817–21PubMedCrossRef Mukherjee D. Selective cyclooxygenase-2 (COX-2) inhibitors and potential risk of cardiovascular events. Biochem Pharmacol 2002; 63: 817–21PubMedCrossRef
12.
Zurück zum Zitat Solomon DH, Schneeweiss S, Glynn RJ, et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 2004; 109: 2068–73PubMedCrossRef Solomon DH, Schneeweiss S, Glynn RJ, et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 2004; 109: 2068–73PubMedCrossRef
13.
Zurück zum Zitat Campen DH, Graham D, Cheetham C, et al. Risk of acute cardiac events among patients treated with cyclooxygenase-2 selective and non-selective-nonsteroidal antiinflammatory drugs [abstract 1756]. Arthritis Rheum 2004; 50(9 Suppl.): S657 Campen DH, Graham D, Cheetham C, et al. Risk of acute cardiac events among patients treated with cyclooxygenase-2 selective and non-selective-nonsteroidal antiinflammatory drugs [abstract 1756]. Arthritis Rheum 2004; 50(9 Suppl.): S657
14.
Zurück zum Zitat Meagher EA. Balancing gastroprotection and cardioprotection with selective cyclo-oxygenase-2 inhibitors: clinical implications. Drug Saf 2003; 26: 913–24PubMedCrossRef Meagher EA. Balancing gastroprotection and cardioprotection with selective cyclo-oxygenase-2 inhibitors: clinical implications. Drug Saf 2003; 26: 913–24PubMedCrossRef
15.
Zurück zum Zitat Jüni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004; 364: 2021–9PubMedCrossRef Jüni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004; 364: 2021–9PubMedCrossRef
16.
Zurück zum Zitat Lipsky PE, Brooks P, Crofford LJ, et al. Unresolved issues in the role of cyclooxygenase-2 in normal physiologic processes and disease. Arch Intern Med 2000; 160: 913–20PubMedCrossRef Lipsky PE, Brooks P, Crofford LJ, et al. Unresolved issues in the role of cyclooxygenase-2 in normal physiologic processes and disease. Arch Intern Med 2000; 160: 913–20PubMedCrossRef
17.
Zurück zum Zitat Ott E, Nussmeier NA, Duke PC, et al. Efficacy and safety of the cyclooxygenase-2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg 2003; 125: 1481–92PubMedCrossRef Ott E, Nussmeier NA, Duke PC, et al. Efficacy and safety of the cyclooxygenase-2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg 2003; 125: 1481–92PubMedCrossRef
18.
19.
Zurück zum Zitat Jüni P, Rutjes AWS, Dieppe PA. Are selective COX-2 inhibitors superior to traditional non steroidal anti-inflammatory drugs? BMJ 2002; 324: 1287–8PubMedCrossRef Jüni P, Rutjes AWS, Dieppe PA. Are selective COX-2 inhibitors superior to traditional non steroidal anti-inflammatory drugs? BMJ 2002; 324: 1287–8PubMedCrossRef
20.
21.
Zurück zum Zitat Cyclo-Oxygenase - 2 Inhibitors. WHO pharmaceuticals newsletter, 2004; 5: 7-8 [online]. Available from URL: http://www.who.int/medicines/library/pnewslet/5news2004.pdf [Accessed 2005 Feb 16] Cyclo-Oxygenase - 2 Inhibitors. WHO pharmaceuticals newsletter, 2004; 5: 7-8 [online]. Available from URL: http://​www.​who.​int/​medicines/​library/​pnewslet/​5news2004.​pdf [Accessed 2005 Feb 16]
22.
Zurück zum Zitat Topol EJ. Arthritis medicines and cardiovascular events: ‘house of coxibs’. JAMA 2005; 293: 366–8PubMedCrossRef Topol EJ. Arthritis medicines and cardiovascular events: ‘house of coxibs’. JAMA 2005; 293: 366–8PubMedCrossRef
23.
Zurück zum Zitat Day R. Hypertension in the patients with arthritis: have we been underestimating its significance. J Rheumatol 2003; 30: 642–5PubMed Day R. Hypertension in the patients with arthritis: have we been underestimating its significance. J Rheumatol 2003; 30: 642–5PubMed
24.
Zurück zum Zitat Singh G, Miller JD, Huse DM, et al. Consequences of increased systolic blood pressure in patients with osteoarthritis and rheumatoid arthritis. J Rheumatol 2003; 30: 714–9PubMed Singh G, Miller JD, Huse DM, et al. Consequences of increased systolic blood pressure in patients with osteoarthritis and rheumatoid arthritis. J Rheumatol 2003; 30: 714–9PubMed
25.
Zurück zum Zitat Ray WA, Griffin MR, Stein CM. Cardiovascular toxicity of valdecoxib. N Engl J Med 2004; 351: 2767PubMedCrossRef Ray WA, Griffin MR, Stein CM. Cardiovascular toxicity of valdecoxib. N Engl J Med 2004; 351: 2767PubMedCrossRef
26.
Zurück zum Zitat Bannwarth B, Berenbaum F. Clinical pharmacology of lumiracoxib, a second generation COX-2 selective inhibitor. Exp Opin Invest Drugs. In press Bannwarth B, Berenbaum F. Clinical pharmacology of lumiracoxib, a second generation COX-2 selective inhibitor. Exp Opin Invest Drugs. In press
27.
Zurück zum Zitat Fiorucci S, Antonnelli E, Burgaud JL, et al. Nitric oxide-releasing NSAIDs. A review of their current status. Drug Saf 2001; 24: 801–11PubMedCrossRef Fiorucci S, Antonnelli E, Burgaud JL, et al. Nitric oxide-releasing NSAIDs. A review of their current status. Drug Saf 2001; 24: 801–11PubMedCrossRef
28.
Zurück zum Zitat Wallace JL, Del Soldato P. The therapeutic potential of NONSAIDs. Fundam Clin Pharmacol 2003; 17: 11–20PubMedCrossRef Wallace JL, Del Soldato P. The therapeutic potential of NONSAIDs. Fundam Clin Pharmacol 2003; 17: 11–20PubMedCrossRef
29.
Zurück zum Zitat Bannwarth B. Is licofelone, a dual inhibitor of cyclo-oxygenase and 5-lipoxygenase, a promising alternative in anti-inflammatory therapy? Fundam Clin Pharmacol 2004; 18: 125–30PubMedCrossRef Bannwarth B. Is licofelone, a dual inhibitor of cyclo-oxygenase and 5-lipoxygenase, a promising alternative in anti-inflammatory therapy? Fundam Clin Pharmacol 2004; 18: 125–30PubMedCrossRef
30.
Zurück zum Zitat Day RO, Quinn DI, Conaghan PG, et al. Adverse drug reactions and their measurement in the rheumatic diseases. J Rheumatol 1995; 22: 983–8PubMed Day RO, Quinn DI, Conaghan PG, et al. Adverse drug reactions and their measurement in the rheumatic diseases. J Rheumatol 1995; 22: 983–8PubMed
31.
Zurück zum Zitat Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287: 2215–20PubMedCrossRef Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287: 2215–20PubMedCrossRef
Metadaten
Titel
Do Selective Cyclo-Oxygenase-2 Inhibitors Have a Future?
verfasst von
Professor Bernard Bannwarth
Publikationsdatum
01.03.2005
Verlag
Springer International Publishing
Erschienen in
Drug Safety / Ausgabe 3/2005
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI
https://doi.org/10.2165/00002018-200528030-00001

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