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Subgroup analyses to determine cardiovascular risk associated with nonsteroidal antiinflammatory drugs and coxibs in specific patient groups

  1. Daniel H. Solomon1,†,*,
  2. Robert J. Glynn1,
  3. Kenneth J. Rothman2,
  4. Sebastian Schneeweiss1,‡,
  5. Soko Setoguchi1,
  6. Helen Mogun1,
  7. Jerry Avorn1,§,
  8. Til Stürmer1,§

Article first published online: 30 JUL 2008

DOI: 10.1002/art.23911

Issue

Arthritis Care & Research

Arthritis Care & Research

Volume 59, Issue 8, pages 1097–1104, 15 August 2008

Additional Information

How to Cite

Solomon, D. H., Glynn, R. J., Rothman, K. J., Schneeweiss, S., Setoguchi, S., Mogun, H., Avorn, J. and Stürmer, T. (2008), Subgroup analyses to determine cardiovascular risk associated with nonsteroidal antiinflammatory drugs and coxibs in specific patient groups. Arthritis & Rheumatism, 59: 1097–1104. doi: 10.1002/art.23911

Author Information

  1. 1

    Brigham and Women's Hospital, Boston, Massachusetts

  2. 2

    Brigham and Women's Hospital, Boston, Massachusetts, and RTI Health Solutions, Research Triangle Park, North Carolina

  1. †

    Dr. Solomon has received a research grant (more than $10,000) from Pfizer.

  2. ‡

    Dr. Schneeweiss has received consultant fees (more than $10,000) from i3 Drug Safety and a research grant from Pfizer.

  3. §

    Dr. Avorn has served as an unpaid pro bono expert witness for plaintiffs in Vioxx litigation.

*Division of Pharmacoepidemiology, Brigham and Women's Hospital, 1620 Tremont Street, Suite 3030, Boston, MA 02120

Publication History

  1. Issue published online: 30 JUL 2008
  2. Article first published online: 30 JUL 2008
  3. Manuscript Accepted: 4 APR 2008
  4. Manuscript Received: 9 JUN 2007

Funded by

  • Pfizer
  • NIH. Grant Numbers: AR-48616, DA-15507, AR-48264
  • Arthritis Foundation, Atlanta, Georgia
  • Engalitcheff Arthritis Outcomes Initiative, Baltimore, Maryland
  • Merck

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REFERENCES

  • 1
    Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, et al, for the Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial [published erratum appears in N Engl J Med 2006;355:221]. N Engl J Med 2005; 352: 1092–102.
  • 2
    Solomon SD, McMurray JJ, Pfeffer MA, Wittes J, Fowler R, Finn P, et al, for the Adenoma Prevention with Celecoxib (APC) Study Investigators. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005; 352: 1071–80.
  • 3
    Nussmeier NA, Whelton AA, Brown MT, Langford RM, Hoeft A, Parlow JL, et al. Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med 2005; 352: 1081–91.
  • 4
    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: 1302–8.
  • 5
    Proposed NSAID package insert labeling template 1 (revised XXX/05) [package insert]. 2005. URL: http://www.fda.gov/cder/drug/infopage/COX2/NSAIDRxtemplate.pdf.
  • 6
    Solomon DH. Selective cyclooxygenase 2 inhibitors and cardiovascular events [review]. Arthritis Rheum 2005; 52: 1968–78.
    Direct Link:
  • 7
    Solomon DH, Avorn J, Sturmer T, Glynn RJ, Mogun H, Schneeweiss S. Cardiovascular outcomes in new users of coxibs and nonsteroidal antiinflammatory drugs: high-risk subgroups and time course of risk. Arthritis Rheum 2006; 54: 1378–89.
    Direct Link:
  • 8
    Kiyota Y, Schneeweiss S, Glynn RJ, Cannuscio CC, Avorn J, Solomon DH. Accuracy of Medicare claims-based diagnosis of acute myocardial infarction: estimating positive predictive value on the basis of review of hospital records. Am Heart J 2004; 148: 99–104.
  • 9
    Birman-Deych E, Waterman AD, Yan Y, Nilasena DS, Radford MJ, Gage BF. Accuracy of ICD-9-CM codes for identifying cardiovascular and stroke risk factors. Med Care 2005; 43: 480–5.
  • 10
    Lee DS, Donovan L, Austin PC, Gong Y, Liu PP, Rouleau JL, et al. Comparison of coding of heart failure and comorbidities in administrative and clinical data for use in outcomes research. Med Care 2005; 43: 182–8.
  • 11
    Hermann M, Krum H, Ruschitzka F. To the heart of the matter: coxibs, smoking, and cardiovascular risk. Circulation 2005; 112: 941–5.
  • 12
    Grosser T, Fries S, Fitzgerald GA. Biological basis for the cardiovascular consequences of COX-2 inhibition: therapeutic challenges and opportunities. J Clin Invest 2006; 116: 4–15.
  • 13
    Romano PS, Roos LL, Jollis JG. Adapting a clinical comorbidity index for use with ICD-9-CM administrative data: differing perspectives. J Clin Epidemiol 1993; 46: 1075–9.
  • 14
    Rothman KJ. No adjustments are needed for multiple comparisons. Epidemiology 1990; 1: 43–6.
  • 15
    Savitz DA, Olshan AF. Describing data requires no adjustment for multiple comparisons: a reply from Savitz and Olshan [letter]. Am J Epidemiol 1998; 147: 813–4.
  • 16
    Greenland S, Robins JM. Empirical-Bayes adjustments for multiple comparisons are sometimes useful. Epidemiology 1991; 2: 244–51.
  • 17
    Rothman KJ. Epidemiology: an introduction. New York: Oxford University; 2002.
  • 18
    Assmann SF, Hosmer DW, Lemeshow S, Mundt KA. Confidence intervals for measures of interaction. Epidemiology 1996; 7: 286–90.
  • 19
    Andersson T, Alfredsson L, Kallberg H, Zdravkovic S, Ahlbom A. Calculating measures of biological interaction. Eur J Epidemiol 2005; 20: 575–9.
  • 20
    Ahlbom A, Alfredsson L. Interaction: word with two meanings creates confusion [editorial]. Eur J Epidemiol 2005; 20: 563–4.
  • 21
    Catella-Lawson F, Reilly MP, Kapoor SC, Cucchiara AJ, DeMarco S, Tournier B, et al. Cyclooxygenase inhibitors and the antiplatelet effects of aspirin. N Engl J Med 2001; 345: 1809–17.
  • 22
    Schneeweiss S, Glynn RJ, Tsai EH, Avorn J, Solomon DH. Adjusting for unmeasured confounders in pharmacoepidemiologic claims data using external information: the example of COX2 inhibitors and myocardial infarction. Epidemiology 2005; 16: 17–24.
  • 23
    Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, et al, for the VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520–8.
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