Population impact of regulatory activity restricting prescribing of COX-2 inhibitors: Ecological study

British Journal of Clinical Pharmacology

Volumn 68, Issue 5, 2009, Pages 752-764

  Wheeler, Benedict W ^a   Metcalfe, Chris ^a   Gunnell, David ^a   Stephens, Peter ^a   Martin, Richard M ^a  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

Author keywords

Cyclooxygenase 2 inhibitors; Drug regulations; Gastrointestinal haemorrhage; Myocardial infarction; Rofecoxib

Indexed keywords

ACECLOFENAC; ACEMETACIN; ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; ANTIULCER AGENT; AZAPROPAZONE; BENORILATE; CELECOXIB; CYCLOOXYGENASE 2 INHIBITOR; DEXIBUPROFEN; DICLOFENAC; ETODOLAC; ETORICOXIB; FENBUFEN; FENOPROFEN; FLURBIPROFEN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IBUPROFEN; INDOMETACIN; KETOPROFEN; LORNOXICAM; LUMIRACOXIB; MEFENAMIC ACID; MELOXICAM; PARECOXIB; ROFECOXIB; SEROTONIN UPTAKE INHIBITOR; UNINDEXED DRUG; VALDECOXIB;

ACUTE HEART INFARCTION; ADULT; AGE DISTRIBUTION; AGED; ARTICLE; CARDIOVASCULAR RISK; DRUG APPROVAL; DRUG INDICATION; DRUG LEGISLATION; DRUG SAFETY; FEMALE; GASTROINTESTINAL HEMORRHAGE; HOSPITAL ADMISSION; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; PRESCRIPTION; PRIORITY JOURNAL; RISK ASSESSMENT; SEX DIFFERENCE; TREND STUDY; UNITED KINGDOM;

AGED; AGED, 80 AND OVER; CYCLOOXYGENASE 2 INHIBITORS; DRUG UTILIZATION; FEMALE; GASTROINTESTINAL HEMORRHAGE; GREAT BRITAIN; HOSPITALIZATION; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; RISK ASSESSMENT; RISK FACTORS;

EID: 70449417778     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2009.03500.x     Document Type: Article

References (39)

1. Hawkey CJ, Langman MJ. Non-steroidal anti-inflammatory drugs: overall risks and management. Complementary roles for COX-2 inhibitors and proton pump inhibitors. Gut 2003 52 : 600 608.
2. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med 1999 340 : 1888 1899.
3. Tramer MR, Moore RA, Reynolds DJ, McQuay HJ. Quantitative estimation of rare adverse events which follow a biological progression: a new model applied to chronic NSAID use. Pain 2000 85 : 169 182.
4. Juni P, Rutjes AW, Dieppe PA. Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs? BMJ 2002 324 : 1287 1288. (Pubitemid 34606764)
5. Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal NM, Stenson WF, Burr AM, Zhao WW, Kent JD, Lefkowith JB, Verburg KM, Geis GS. 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 2000 284 : 1247 1255.
6. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000 343 : 1520 1528.
7. Dieppe PA, Ebrahim S, Martin RM, Juni P. Lessons from the withdrawal of rofecoxib. BMJ 2004 329 : 867 868.
8. Topol EJ. Failing the public health - rofecoxib, Merck, and the FDA. N Engl J Med 2004 351 : 1707 1709.
9. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001 286 : 954 959. (Pubitemid 33010342)
10. Cleland LG, James MJ, Stamp LK, Penglis PS. COX-2 inhibition and thrombotic tendency: a need for surveillance. Med J Aust 2001 175 : 214 217.
11. Food and Drug Administration. FDA Advisory Committee Briefing Document NDA 21-042 s007: VIOXX Gastrointestinal Safety. FDA, 2001. Available at: http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b2-03-med.pdf (last accessed 10 June 2009).
12. Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005 352 : 1092 1102.
13. Solomon SD, McMurray JJ, Pfeffer MA, Wittes J, Fowler R, Finn P, Anderson WF, Zauber A, Hawk E, Bertagnolli M. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005 352 : 1071 1080.
14. Nussmeier NA, Whelton AA, Brown MT, Langford RM, Hoeft A, Parlow JL, Boyce SW, Verburg KM. Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med 2005 352 : 1081 1091.
15. Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ 2006 332 : 1302 1308.
16. Gottlieb S. Warnings issued over COX-2 inhibitors in US and UK. BMJ 2005 330 : 9.
17. Juni P, Reichenbach S, Egger M. COX 2 inhibitors, traditional NSAIDs, and the heart. BMJ 2005 330 : 1342 1343.
18. Hippisley-Cox J, Coupland C, Logan R. Risk of adverse gastrointestinal outcomes in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis. BMJ 2005 331 : 1310 1316.
19. Shaughnessy AF, Gordon AE. Life without COX 2 inhibitors. BMJ 2006 332 : 1287 1288.
20. van Staa TP, Smeeth L, Persson I, Parkinson J, Leufkens HG. What is the harm-benefit ratio of Cox-2 inhibitors? Int J Epidemiol 2008 37 : 405 413.
21. Mamdani M, Juurlink DN, Kopp A, Naglie G, Austin PC, Laupacis A. Gastrointestinal bleeding after the introduction of COX 2 inhibitors: ecological study. BMJ 2004 328 : 1415 1416.
22. Wheeler BW, Gunnell D, Metcalfe C, Stephens P, Martin RM. The population impact on incidence of suicide and non-fatal self harm of regulatory action against the use of selective serotonin reuptake inhibitors in under 18s in the United Kingdom: ecological study. BMJ 2008 336 : 542 545.
23. Livermore DM, Stephens P, Weinberg J, Johnson AP, Gifford T, Northcott D, James D, George RC, Speller DC. Regional variation in ampicillin and trimethoprim resistance in Escherichia coli in England from 1990 to 1997, in relation to antibacterial prescribing. J Antimicrob Chemother 2000 46 : 411 422.
24. de Abajo FJ, Garcia-Rodriguez LA. Risk of upper gastrointestinal tract bleeding associated with selective serotonin reuptake inhibitors and venlafaxine therapy: interaction with nonsteroidal anti-inflammatory drugs and effect of acid-suppressing agents. Arch Gen Psychiatry 2008 65 : 795 803.
25. Department of Health. Prescription Cost Analysis. Leeds : The NHS Information Centre. 2007.
26. Department of Health. Hospital Episode Statistics Database. London : Department of Health, 2007.
27. Office for National Statistics. Population estimates for UK, England and Wales, Scotland and Northern Ireland. 2007. Available at http://www.statistics. gov.uk/StatBase/Product.asp?vlnk=601 (last accessed 10 June 2009).
28. Kim HJ, Fay MP, Feuer EJ, Midthune DN. Permutation tests for joinpoint regression with applications to cancer rates. Stat Med 2000 19 : 335 351.
29. Langman MJ. Ulcer complications associated with anti-inflammatory drug use. What is the extent of the disease burden? Pharmacoepidemiol Drug Saf 2001 10 : 13 9.
30. Martin RM, Hemingway H, Gunnell D, Karsch KR, Baumbach A, Frankel S. Population need for coronary revascularisation: are national targets for England credible? Heart 2002 88 : 627 633.
31. Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004 364 : 2021 2029.
32. Furberg CD. The COX-2 inhibitors - an update. Am Heart J 2006 152 : 197 199.
33. Spencer FA, Goldberg RJ, Becker RC, Gore JM. Seasonal distribution of acute myocardial infarction in the second National Registry of Myocardial Infarction. J Am Coll Cardiol 1998 31 : 1226 1233.
34. Hammad TA, Graham DJ, Staffa JA, Kornegay CJ, Dal Pan GJ. Onset of acute myocardial infarction after use of non-steroidal anti-inflammatory drugs. Pharmacoepidemiol Drug Saf 2008 17 : 315 321.
35. Levesque LE, Brophy JM, Zhang B. Time variations in the risk of myocardial infarction among elderly users of COX-2 inhibitors. CMAJ 2006 174 : 1563 1569.
36. Capewell S, Livingston BM, MacIntyre K, Chalmers JW, Boyd J, Finlayson A, Redpath A, Pell JP, Evans CJ, McMurray JJ. Trends in case-fatality in 117 718 patients admitted with acute myocardial infarction in Scotland. Eur Heart J 2000 21 : 1833 1840.
37. Liew R, Sulfi S, Ranjadayalan K, Cooper J, Timmis AD. Declining case fatality rates for acute myocardial infarction in South Asian and white patients in the past 15 years. Heart 2006 92 : 1030 1034.
38. Fries JF, Murtagh KN, Bennett M, Zatarain E, Lingala B, Bruce B. The rise and decline of nonsteroidal antiinflammatory drug-associated gastropathy in rheumatoid arthritis. Arthritis Rheum 2004 50 : 2433 2440.
39. Yi D, Pugh E, Farrar S. The effect of payment by results on the HRG creep in English hospitals: an empirical investigation. 2007. iHEA 2007 6th World Congress: Explorations in Health Economics Paper. Available at: http://ssrn.com/abstract=993390 (last accessed 10 June 2009).