Advertisement

Journal of Thrombosis and Thrombolysis

, Volume 39, Issue 2, pp 222–227 | Cite as

Review of race/ethnicity in non vitamin K antagonist oral anticoagulants clinical trials

  • Larry R. JacksonIIEmail author
  • Eric D. Peterson
  • Eze Okeagu
  • Kevin Thomas
Article

Abstract

Non vitamin K antagonist oral anticoagulants (NOACs) have advantages relative to traditional vitamin K antagonist oral anticoagulants and represents an important advance in the management of patients with atrial fibrillation and venous thromboembolism. Yet it is unclear whether the clinical trials evaluating these agents were inclusive of diverse populations. To assess the inclusion and reporting of race and ethnicity in clinical trials of NOACs across disease states including, atrial fibrillation, venous thromboembolism, and acute coronary syndromes, we queried PubMed and ClinicalTrials.gov for trials of NOACs between 2007 and 2013. We determined the reporting rate and inclusion of the following ethnic groups: whites, blacks, Asians, and Hispanics. We reviewed data from 30 randomized clinical trials of NOACs that enrolled 184,414 patients. Among these trials, 21 (70 %) reported race/ethnicity data in the primary manuscript or on ClinicalTrials.gov. Principal investigators provided race/ethnicity data for two additional trials. Enrollment by race included: 109,729 (75.2 %) white, 20,901 (14.3 %) Asian, 5,718 (3.9 %) Hispanic, and 2,941 (2.0 %) black. Hispanic ethnicity was only reported in 10 trials. The major clinical trials of NOACs inconsistently reported race/ethnicity and overall black and Hispanic patient enrollment was poor. As such, the relative safety and efficacy of NOACs in minority populations remains uncertain.

Keywords

Race Ethnicity Novel oral anticoagulants Cardiovascular diseases 

References

  1. 1.
    Levi M, Hobbs FD, Jacobson AK et al (2009) Improving antithrombotic management in patients with atrial fibrillation: current status and perspectives. Semin Thromb Hemost 35:527–542PubMedCrossRefGoogle Scholar
  2. 2.
    Ezekowitz MD, Falk RH (2004) The increasing need for anticoagulant therapy to prevent stroke in patients with atrial fibrillation. Mayo Clin Proc 79:904–913PubMedCrossRefGoogle Scholar
  3. 3.
    Arts DL, Abu-Hanna A, Buller HR, Peters RJ, Eslami S, van Weert HC (2013) Improving stroke prevention in patients with atrial fibrillation. Trials 14:193PubMedCentralPubMedCrossRefGoogle Scholar
  4. 4.
    Baglin TP, White K, Charles A (1997) Fatal pulmonary embolism in hospitalised medical patients. J Clin Pathol 50:609–610PubMedCentralPubMedCrossRefGoogle Scholar
  5. 5.
    Monreal M, Kakkar AK, Caprini JA et al (2004) The outcome after treatment of venous thromboembolism is different in surgical and acutely ill medical patients. findings from the RIETE registry. J Thromb Haemost 2:1892–1898PubMedCrossRefGoogle Scholar
  6. 6.
    Piccini JP, Hernandez AF, Zhao X et al (2009) Quality of care for atrial fibrillation among patients hospitalized for heart failure. J Am Coll Cardiol 54:1280–1289PubMedCrossRefGoogle Scholar
  7. 7.
    Thomas KL, Piccini JP, Liang L et al (2013) Racial differences in the prevalence and outcomes of atrial fibrillation among patients hospitalized with heart failure. J Am Heart Assoc 2:e000200PubMedCentralPubMedCrossRefGoogle Scholar
  8. 8.
    Lefebvre P, Coleman CI, Bookhart BK et al (2014) Cost-effectiveness of rivaroxaban compared with enoxaparin plus a vitamin K antagonist for the treatment of venous thromboembolism. J Med Econ 17:52–64PubMedCrossRefGoogle Scholar
  9. 9.
    Connolly SJ, Ezekowitz MD, Yusuf S et al (2009) Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361:1139–1151PubMedCrossRefGoogle Scholar
  10. 10.
    Granger CB, Alexander JH, McMurray JJ et al (2011) Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365:981–992PubMedCrossRefGoogle Scholar
  11. 11.
    Investigators E, Bauersachs R, Berkowitz SD et al (2010) Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 363:2499–2510CrossRefGoogle Scholar
  12. 12.
    Patel MR, Mahaffey KW, Garg J et al (2011) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365:883–891PubMedCrossRefGoogle Scholar
  13. 13.
    Kim MH. The Relationship between patient diversity and warfarin use in atrial fibrillation: A ten-year perspective (2000-2010) on cardiovascular outcomes. Quality of care and outcomes research (QCOR) 2013 scientific sessionsGoogle Scholar
  14. 14.
    Ibrahim SA, Stone RA, Obrosky DS, Sartorius J, Fine MJ, Aujesky D (2006) Racial differences in 30-day mortality for pulmonary embolism. Am J Public Health 96:2161–2164PubMedCentralPubMedCrossRefGoogle Scholar
  15. 15.
    Burroughs VJ, Maxey RW, Levy RA (2002) Racial and ethnic differences in response to medicines: towards individualized pharmaceutical treatment. J Natl Med Assoc 94:1–26PubMedCentralPubMedGoogle Scholar
  16. 16.
    Hori M, Connolly SJ, Zhu J et al (2013) Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in asians and non-asians with atrial fibrillation. Stroke 44:1891–1896PubMedCrossRefGoogle Scholar
  17. 17.
    Schulman S, Kakkar AK, Goldhaber SZ et al (2014) Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 129:764–772PubMedCrossRefGoogle Scholar
  18. 18.
    Oddone EZ, Olsen MK, Lindquist JH et al (2004) Enrollment in clinical trials according to patients race: experience from the VA cooperative studies program (1975-2000). Control Clin Trials 25:378–387PubMedCrossRefGoogle Scholar
  19. 19.
    Kaplan JB, Bennett T (2003) Use of race and ethnicity in biomedical publication. JAMA, J Am Med Assoc 289:2709–2716CrossRefGoogle Scholar
  20. 20.
    Protocol registration system and U.S. public law 110-85 http://prsinfo.clinicaltrials.gov/fdaaa.html Accessed Dec 3 2013
  21. 21.
    Tse T, Williams RJ, Zarin DA (2009) Reporting “basic results” in clinicaltrials.gov. Chest 136:295–303PubMedCentralPubMedCrossRefGoogle Scholar
  22. 22.
  23. 23.
    Shen AY, Yao JF, Brar SS, Jorgensen MB, Chen W (2007) Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. J Am Coll Cardiol 50:309–315PubMedCrossRefGoogle Scholar
  24. 24.
    Bhandari VK, Wang F, Bindman AB, Schillinger D (2008) Quality of anticoagulation control: do race and language matter? J Health Care Poor Underserved 19:41–55PubMedCrossRefGoogle Scholar
  25. 25.
    Lloyd-Jones D, Adams R, Carnethon M et al (2009) Heart disease and stroke statistics–2009 update: a report from the american heart association statistics committee and stroke statistics subcommittee. Circulation 119:e21–e181PubMedCrossRefGoogle Scholar
  26. 26.
    Aithal GP, Day CP, Kesteven PJ, Daly AK (1999) Association of polymorphisms in the cytochrome P450 CYP2C9 with warfarin dose requirement and risk of bleeding complications. Lancet 353:717–719PubMedCrossRefGoogle Scholar
  27. 27.
    Takahashi H, Wilkinson GR, Caraco Y et al (2003) Population differences in S-warfarin metabolism between CYP2C9 genotype-matched caucasian and japanese patients. Clin Pharmacol Ther 73:253–263PubMedCrossRefGoogle Scholar
  28. 28.
    Dang MT, Hambleton J, Kayser SR (2005) The influence of ethnicity on warfarin dosage requirement. Ann Pharmacother 39:1008–1012PubMedCrossRefGoogle Scholar
  29. 29.
    Hankey GJ, Stevens SR, Piccini JP et al (2014) Intracranial hemorrhage among patients with atrial fibrillation anticoagulated with warfarin or rivaroxaban: the rivaroxaban once daily, oral, direct factor xa inhibition compared with vitamin k antagonism for prevention of stroke and embolism trial in atrial fibrillation. Stroke 45:1304–1312PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Larry R. JacksonII
    • 1
    Email author
  • Eric D. Peterson
    • 1
  • Eze Okeagu
    • 2
  • Kevin Thomas
    • 1
  1. 1.Duke Clinical Research Institute, Duke University School of MedicineDurhamUSA
  2. 2.University of North Carolina School of MedicineChapel HillUSA

Personalised recommendations