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Dear Editor, it is disappointing that the BMJ has published such a poorly researched and unreferenced letter. The guidance advocating selective COX-2 inhibitors (coxibs) for patients at high risk of gastrointestinal complications is completely correct and evidence based (1,2,3) and to follow another path and use a non-selective NSAID in this situation is putting patients unnecessarily at risk and cannot be supported.
I accept that the early years after the launch of the coxibs were characterised by considerable pharmaceutical hype and some somewhat opaque reporting of clinical trial results (4). However in the light of subsequent studies and with the benefit of time, it is clear that the coxibs are much safer than non-selective NSAIDs for the gastrointestinal tract, including when combined with aspirin in those at highest risk of GI and cardiovascular adverse effects (4,5). Additionally, there is no convincing evidence that the cardiovascular risk with coxibs is any greater and in fact the risks of stroke may actually be lower (4). In retrospect, rofecoxib appears to be a particular outlier and the cardiovascular effects of rofecoxib (now withdrawn) should not be extrapolated to the rest of the class (4), although relative cardiovascular safety is only really best established for celecoxib in moderate doses up to 100 mg twice daily (4, 6). Otherwise the cardiovascular risk associated with non-aspirin cyclo-oxygenase inhibitors appears to be a class effect (4).
The concept of excessive cardiovascular risk associated with the currently available selective COX-inhibitors is outdated and not-supported by recent data. To ignore this and continue to use other non-selective NSAIDs in those with a high risk of GI complications will expose patients to avoidable risk and although the BMJ has an important role is stimulating debate, it is important that such debates are always fully informed.
1. Beales ILP. Recent advances in the management of peptic ulcer bleeding. F1000Res. 2017 Sep 27;6:1763. doi: 10.12688/f1000research.11286.1.
2. Hensley A, Beales IL. Use of Cyclo-Oxygenase Inhibitors Is Not Associated with Clinical Relapse in Inflammatory Bowel Disease: A Case-Control Study. Pharmaceuticals (Basel). 2015 Sep 7;8(3):512-24. doi: 10.3390/ph803051
3. Brooks J, Warburton R, Beales IL. Prevention of upper gastrointestinal haemorrhage: current controversies and clinical guidance. Ther Adv Chronic Dis. 2013 Sep;4(5):206-22. doi: 10.1177/2040622313492188
4. Beales ILP. Time to reappraise the therapeutic place of celecoxib. Ther Adv Chronic Dis. 2018 May;9(5):107-110. doi: 10.1177/2040622317749394
5. Beales ILP. Advances in the therapy of bleeding peptic ulcer. Clinical Medicine Insights; Therapeutics (2018) 10: 1-15. doi; 10.1177/1179559X18790258
6. Nissen SE, Yeomans ND, Solomon DH, Lüscher TF, Libby P, Husni ME, Graham DY, Borer JS, Wisniewski LM, Wolski KE, Wang Q, Menon V, Ruschitzka F, Gaffney M, Beckerman B, Berger MF, Bao W, Lincoff AM; PRECISION Trial Investigators. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016 Dec 29;375(26):2519-29. doi: 10.1056/NEJMoa1611593. Epub 2016 Nov 13
selective COX-2 inhibitors are both safe and effective
Dear Editor, it is disappointing that the BMJ has published such a poorly researched and unreferenced letter. The guidance advocating selective COX-2 inhibitors (coxibs) for patients at high risk of gastrointestinal complications is completely correct and evidence based (1,2,3) and to follow another path and use a non-selective NSAID in this situation is putting patients unnecessarily at risk and cannot be supported.
I accept that the early years after the launch of the coxibs were characterised by considerable pharmaceutical hype and some somewhat opaque reporting of clinical trial results (4). However in the light of subsequent studies and with the benefit of time, it is clear that the coxibs are much safer than non-selective NSAIDs for the gastrointestinal tract, including when combined with aspirin in those at highest risk of GI and cardiovascular adverse effects (4,5). Additionally, there is no convincing evidence that the cardiovascular risk with coxibs is any greater and in fact the risks of stroke may actually be lower (4). In retrospect, rofecoxib appears to be a particular outlier and the cardiovascular effects of rofecoxib (now withdrawn) should not be extrapolated to the rest of the class (4), although relative cardiovascular safety is only really best established for celecoxib in moderate doses up to 100 mg twice daily (4, 6). Otherwise the cardiovascular risk associated with non-aspirin cyclo-oxygenase inhibitors appears to be a class effect (4).
The concept of excessive cardiovascular risk associated with the currently available selective COX-inhibitors is outdated and not-supported by recent data. To ignore this and continue to use other non-selective NSAIDs in those with a high risk of GI complications will expose patients to avoidable risk and although the BMJ has an important role is stimulating debate, it is important that such debates are always fully informed.
1. Beales ILP. Recent advances in the management of peptic ulcer bleeding. F1000Res. 2017 Sep 27;6:1763. doi: 10.12688/f1000research.11286.1.
2. Hensley A, Beales IL. Use of Cyclo-Oxygenase Inhibitors Is Not Associated with Clinical Relapse in Inflammatory Bowel Disease: A Case-Control Study. Pharmaceuticals (Basel). 2015 Sep 7;8(3):512-24. doi: 10.3390/ph803051
3. Brooks J, Warburton R, Beales IL. Prevention of upper gastrointestinal haemorrhage: current controversies and clinical guidance. Ther Adv Chronic Dis. 2013 Sep;4(5):206-22. doi: 10.1177/2040622313492188
4. Beales ILP. Time to reappraise the therapeutic place of celecoxib. Ther Adv Chronic Dis. 2018 May;9(5):107-110. doi: 10.1177/2040622317749394
5. Beales ILP. Advances in the therapy of bleeding peptic ulcer. Clinical Medicine Insights; Therapeutics (2018) 10: 1-15. doi; 10.1177/1179559X18790258
6. Nissen SE, Yeomans ND, Solomon DH, Lüscher TF, Libby P, Husni ME, Graham DY, Borer JS, Wisniewski LM, Wolski KE, Wang Q, Menon V, Ruschitzka F, Gaffney M, Beckerman B, Berger MF, Bao W, Lincoff AM; PRECISION Trial Investigators. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016 Dec 29;375(26):2519-29. doi: 10.1056/NEJMoa1611593. Epub 2016 Nov 13
Competing interests: No competing interests