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Espeland MA, O'leary DH, Terry JG, et al. Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors. Curr Control Trials Cardiovasc Med. 2005;6(1):3doi: 10.1186/1468-6708-6-3.
Espeland, M. A., O'leary, D. H., Terry, J. G., Morgan, T., Evans, G., & Mudra, H. (2005). Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors. Current controlled trials in cardiovascular medicine, 6(1), 3. https://doi.org/10.1186/1468-6708-6-3
Espeland, Mark A, et al. "Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors." Current controlled trials in cardiovascular medicine vol. 6,1 (2005): 3. doi: https://doi.org/10.1186/1468-6708-6-3
Espeland MA, O'leary DH, Terry JG, Morgan T, Evans G, Mudra H. Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors. Curr Control Trials Cardiovasc Med. 2005 Mar 10;6(1):3. doi: 10.1186/1468-6708-6-3. PMID: 15760471; PMCID: PMC555546.
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Curr Control Trials Cardiovasc Med. 2005 Mar 10;6(1):3. doi: 10.1186/1468-6708-6-3.

Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors.

Current controlled trials in cardiovascular medicine

Mark A Espeland, Daniel H O'leary, James G Terry, Timothy Morgan, Greg Evans, Harald Mudra

Affiliations

  1. Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA. [email protected].

PMID: 15760471 PMCID: PMC555546 DOI: 10.1186/1468-6708-6-3

Abstract

BACKGROUND: Surrogate measures for cardiovascular disease events have the potential to increase greatly the efficiency of clinical trials. A leading candidate for such a surrogate is the progression of intima-media thickness (IMT) of the carotid artery; much experience has been gained with this endpoint in trials of HMG-CoA reductase inhibitors (statins). METHODS AND RESULTS: We examine two separate systems of criteria that have been proposed to define surrogate endpoints, based on clinical and statistical arguments. We use published results and a formal meta-analysis to evaluate whether progression of carotid IMT meets these criteria for HMG-CoA reductase inhibitors (statins).IMT meets clinical-based criteria to serve as a surrogate endpoint for cardiovascular events in statin trials, based on relative efficiency, linkage to endpoints, and congruency of effects. Results from a meta-analysis and post-trial follow-up from a single published study suggest that IMT meets established statistical criteria by accounting for intervention effects in regression models. CONCLUSION: Carotid IMT progression meets accepted definitions of a surrogate for cardiovascular disease endpoints in statin trials. This does not, however, establish that it may serve universally as a surrogate marker in trials of other agents.

References

  1. Stat Med. 1989 Apr;8(4):415-25 - PubMed
  2. Atherosclerosis. 1988 Apr;70(3):253-61 - PubMed
  3. Atherosclerosis. 2003 Nov;171(1):137-43 - PubMed
  4. J Am Coll Cardiol. 2002 Feb 20;39(4):610-6 - PubMed
  5. Circulation. 2001 Apr 3;103(13):1721-6 - PubMed
  6. Am J Epidemiol. 2000 Mar 1;151(5):478-87 - PubMed
  7. N Engl J Med. 1999 Jan 7;340(1):14-22 - PubMed
  8. Stroke. 2001 Jul;32(7):1532-8 - PubMed
  9. Am J Epidemiol. 1997 Sep 15;146(6):483-94 - PubMed
  10. J Am Coll Cardiol. 1998 Jun;31(7):1561-7 - PubMed
  11. Stat Med. 1989 Apr;8(4):431-40 - PubMed
  12. Circulation. 1986 Dec;74(6):1399-406 - PubMed
  13. Am J Med. 1996 Dec;101(6):627-34 - PubMed
  14. Cardiovasc Drugs Ther. 2002 Jul;16(4):341-51 - PubMed
  15. Circulation. 1994 Oct;90(4):1679-87 - PubMed
  16. Circulation. 1993 Jul;88(1):20-8 - PubMed
  17. Stat Med. 2002 Feb 28;21(4):589-624 - PubMed
  18. Circulation. 1995 Oct 1;92 (7):1758-64 - PubMed
  19. Circulation. 1997 Sep 2;96(5):1432-7 - PubMed
  20. Stat Med. 1992 Jan 30;11(2):167-78 - PubMed
  21. Atheroscler Suppl. 2003 Mar;4(1):31-6 - PubMed
  22. Arterioscler Thromb. 1994 Feb;14 (2):177-92 - PubMed
  23. Stat Med. 2004 May 30;23(10):1571-8 - PubMed
  24. Am J Cardiol. 1995 Mar 1;75(7):455-9 - PubMed
  25. Circulation. 1993 Mar;87(3 Suppl):II3-16 - PubMed
  26. Eur J Clin Pharmacol. 1992;43(3):235-44 - PubMed
  27. Arterioscler Thromb Vasc Biol. 1999 Jun;19(6):1484-90 - PubMed
  28. Ann Intern Med. 1998 Feb 15;128(4):262-9 - PubMed
  29. Arterioscler Thromb Vasc Biol. 1999 Jun;19(6):1491-8 - PubMed

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