Representativeness of the dabigatran, apixaban and rivaroxaban clinical trial populations to real-world atrial fibrillation patients in the United Kingdom: A cross-sectional analysis using the General Practice Research Database

BMJ Open

Volumn 2, Issue 6, 2012, Pages

  Lee, Sally ^a   Monz, Brigitta U ^b   Clemens, Andreas ^b   Brueckmann, Martina ^b   Lip, Gregory Y H ^c  

^a BOEHRINGER INGELHEIM LTD   (United Kingdom)

^b BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^c UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

APIXABAN; DABIGATRAN; RIVAROXABAN;

ADULT; AGED; ANTICOAGULANT THERAPY; ARTICLE; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL (TOPIC); CROSS-SECTIONAL STUDY; FEMALE; HEART ATRIUM FIBRILLATION; HUMAN; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; RISK; UNITED KINGDOM;

EID: 84873806439     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2012-001768     Document Type: Article

References (34)

1. Camm AJ, Kirchhof P, Lip GYH, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology. Eur Heart J 2010;31:2369-429.
2. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
3. National Collaborating Centre for Chronic Conditions. Atrial fibrillation: national clinical guidelines for management in primary and secondary care. London: Royal College of Physicians, 2006.
4. Ruigomez A, Johansson S, Wallander MA, et al. Risk of mortality in a cohort of patients newly diagnosed with chronic atrial fibrillation. BMC Cardiovasc Disord 2002;2:5.
5. Wolowacz SE, Samuel M, Brennan VK, et al. The cost of illness of atrial fibrillation: a systematic review of the recent literature. Europace 2011;13:1375-85.
6. Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). Circulation 2006;114:e257-354.
7. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation (with supplementary appendix). N Engl J Med 2009;361:1139-51.
8. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (with supplementary appendix). New Engl J Med 2011;365:883-91.
9. Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation (including upplementary appendix and study protocol). New Engl J Med 2011;365:981-92.
10. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Newly identified events in the RE-LY trial. New Engl J Med 2010;363:1875-6.
11. Boehringer Ingelheim. Pradaxa 150 mg: summary of product characteristics. emc 2011 August 18 (cited 8 Nov 2011). http://www.medicines.org.uk/EMC/ medicine/24839/SPC/Pradaxa+150+mg+hard+capsules
12. Bayer plc. Xarelto 20 mg film-coated tablets. emc 2011 (cited 13 Feb 2012). http://www.medicines.org.uk/EMC/medicine/25586/SPC/Xarelto+20mg+film- coated+tablets/
13. Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran). A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Heart Rhythm 2011;8:e1-8.
14. You JJ, Singer DE, Howard PA, et al. Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141:e531S-75S.
15. Skanes AC, Healey JS, Cairns JA, et al. Focused 2012 update of the Canadian Cardiovascular Society atrial fibrillation guidelines: recommendations for stroke prevention and rate/rhythm control. Can J Cardiol 2012;28:125-36.
16. Lip GYH, Nieuwlaat R, Pisters R, et al. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the Euro heart survey on atrial fibrillation. Chest 2010;137:263-72.
17. Rietbrock S, Heeley E, Plumb J, et al. Chronic atrial fibrillation: incidence, prevalence, and prediction of stroke using the congestive heart failure, hypertension, age >75, diabetes mellitus, and prior stroke or transient ischemic attack (CHADS2) risk stratification scheme. Am Heart J 2008;156:57-64.
18. General Practice Research Database. The database. Medicines and Healthcare products Regulatory Agency 2011 (cited 2 Nov 2011). http://www.gprd.com/products/database.asp
19. Garcia Rodriguez LA, Perez Gutthann S. Use of the UK General Practice Research Database for pharmacoepidemiology. Br J Clin Pharmacol 1998;45:419-25.
20. Herrett E, Thomas SL, Schoonen WM, et al. Validation and validity of diagnoses in the General Practice Research Database: a systematic review. Br J Clin Pharmacol 2010;69:4-14.
21. General Practice Research Database. Ethical review for GPRD protocols. Medicines and Healthcare products Regulatory Agency 2012 (cited 26 Jan 2012). http://www.gprd.com/isac/#ethicalReview
22. Patel M. Rivaroxaban once-daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation: rationale and design of the ROCKET AF study. Am Heart J 2010;159:340-7.
23. Lopes RD, Alexander JH, Al-Khatib SM, et al. Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am Heart J 2010;159:331-9.
24. Ezekowitz MD, Connolly S, Parekh A, et al. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J 2009;157:805-10.
25. National Health Service. READ codes. NHS Connecting for Health 2011 (cited 14 Dec 2011). http://www.connectingforhealth.nhs.uk/systemsandservices/ data/uktc/readcodes
26. Weiss NS, Koepsell TD, Psaty BM. Generalizability of the results of randomized trials. Arch Intern Med 2008;168:133-5.
27. Chio A, Canosa A, Gallo S, et al. ALS clinical trials: do enrolled patients accurately represent the ALS population? Neurology 2011;77:1432-7.
28. Olesen JB, Torp-Pedersen C, Hansen ML, et al. The value of the CHA2DS2-VASc score for refining stroke risk stratification in patients with atrial fibrillation with a CHADS2 score 0-1: a nationwide cohort study. Thromb Haemost 2012;107:1172-9.
29. Camm AJ, Lip GYH, De Caterina R, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. An update of the 2010 ESC Guidelines for the management of atrial fibrillation. Eur Heart J 2012;33:2719-47.
30. Khan N, Harrison S, Rose P. Validity of diagnostic coding within the General Practice Research Database: a systematic review. Br J Gen Pract 2011;60:e128-36.
31. Fleming TR, Emerson SS. Evaluating rivaroxaban for nonvalvular atrial fibrillation-regulatory considerations. N Engl J Med 2011;365:1557-9.
32. Burns T. NICE guidance in schizophrenia: how generalisable are drug trials? Psychiatrist 2006;30:210-12.
33. National Institute for Health and Clinical Excellence. Erlotinib monotherapy for maintenance treatment of non-small-cell lung cancer. 2011. Report No.: TA227.
34. National Institute for Health and Clinical Excellence. Dronedarone for the treatment of non-permanent atrial fibrillation. 2010. Report No.: TA197.