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Journal of Primary Health Care Journal of Primary Health Care Society
Journal of The Royal New Zealand College of General Practitioners
RESEARCH ARTICLE (Open Access)

Deprivation and inequalities lead to worse outcomes with dabigatran etexilate

Bryan H. Simpson 1 , David Reith 2 , Natalie J. Medlicott 1 , Alesha Smith 1
+ Author Affiliations
- Author Affiliations

1 University of Otago, School of Pharmacy Dunedin, New Zealand

2 University of Otago, School of Medicine, Department of Women’s and Children’s Health, Dunedin, New Zealand

Correspondence to: Bryan H. Simpson, University of Otago, School of Pharmacy Dunedin, New Zealand. Email: bryan.simpson@postgrad.otago.ac.nz

Journal of Primary Health Care 10(4) 303-311 https://doi.org/10.1071/HC17081
Published: 7 December 2018

Journal Compilation © Royal New Zealand College of General Practitioners 2018.
This is an open access article licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Abstract

INTRODUCTION: Dabigatran etexilate is now prescribed for 51% of the patients receiving oral anticoagulation treatment in New Zealand. Its prescribing trends in relation to patient outcomes are, however, largely unknown for these patients.

AIM: To describe patient characteristics, effectiveness and safety of treatment with dabigatran etexilate in the New Zealand population.

METHODS: This retrospective cohort study used administrative health data for patients dispensed dabigatran etexilate between 1 July 2011 and 31 December 2015. Adverse events (haemorrhage) and treatment failure (thromboembolism or cerebrovascular accident) data were extracted and linked to patient-specific demographic data. Baseline patient characteristics were analysed with descriptive statistics to examine trends in dabigatran etexilate prescribing. Raw and adjusted hazard ratios (HRs), including covariates, were derived using Cox proportional hazard models.

RESULTS: In total, 52,413 patients were dispensed dabigatran etexilate. Multivariate analysis indicated the risk of haemorrhagic events were significantly increased for Māori (HR and 95% Confidence Interval (CI): 2.10 (1.54–2.86)) and Pacific Peoples (HR = 2.20 (1.49–3.24)); those aged >80 years (HR = 1.25 (1.08–1.43)); and more deprived populations in quintile 4 (HR = 1.24 (1.08–1.43)) and quintile 5 (HR = 1.30 (1.12–1.50)). There was an increased risk of thromboembolism and cerebrovascular accident among people aged >80 years (HR = 1.79 (1.49–2.15)).

DISCUSSION: Demographic factors are associated with adverse outcomes in patients treated with dabigatran etexilate. Targeted strategies are needed to prescribe dabigatran etexilate more appropriately in these populations.

KEYWORDS: Dabigatran etexilate; Deprivation; Haemorrhage


References

[1]  bpacNZ. Dabigatran monitoring—an update. Dunedin: bpacNZ; 2017. [cited 2017 September]. Available from: http://www.bpac.org.nz/ report/2017/September/2017Dabigatran_report_Sample.pdf

[2]  Schulman S. Advantages and limitations of the new anticoagulants. J Intern Med. 2014; 275 1–11.
Advantages and limitations of the new anticoagulants.Crossref | GoogleScholarGoogle Scholar |

[3]  Alexander GC, O’Connor AB, Stafford RS. Enhancing prescription drug innovation and adoption. Ann Intern Med. 2011; 154 833–7.
Enhancing prescription drug innovation and adoption.Crossref | GoogleScholarGoogle Scholar |

[4]  Boehringer Ingelheim (N.Z.) Limited. Pradaxa: New Zealand Datasheet (2017). Auckland: Boehringer Ingelheim; 2017. [cited 2017 November]. Available from: http://www.medsafe.govt.nz/profs/datasheet/p/Pradaxacap.pdf

[5]  Weitz JI, Semchuk W, Turpie AGG, et al. Trends in prescribing oral anticoagulants in Canada, 2008–2014. Clin Ther. 2015; 37 2506–2514.e4.
Trends in prescribing oral anticoagulants in Canada, 2008–2014.Crossref | GoogleScholarGoogle Scholar |

[6]  European Medicines Agency. European Medicines Agency updates on safety of Pradaxa. London: European Medicines Agency; 2011. [cited 2016 April]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/ 2011/11/WC500117818.pdf

[7]  Loo SY, Dell’Aniello S, Huiart L, Renoux C. Trends in the prescription of novel oral anticoagulants in UK primary care. Br J Clin Pharmacol. 2017; 83 2096–106.
Trends in the prescription of novel oral anticoagulants in UK primary care.Crossref | GoogleScholarGoogle Scholar |

[8]  Yao X, Abraham NS, Sangaralingham LR, et al. Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J Am Heart Assoc. 2016; 5 e003725
Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation.Crossref | GoogleScholarGoogle Scholar |

[9]  Metcalfe S, Moodie P. National prescribing data for dabigatran. N Z Med J. 2012; 125 97–105.

[10]  New Zealand Ministry of Health. Pharmaceutical Collection. Wellington: Ministry of Health; 2016.

[11]  U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry. E7 studies in support of special populations: geriatrics. Questions and answers. Silver Spring: U.S. Food and Drug Administration; 2012. [cited 2017 October]. Available from: https://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM189544.pdf

[12]  Committee for Human Medicinal Products (CHMP). Adequacy of guidance on the elderly regarding medicinal products for human use. European Medicines Agency. London: European Medicines Agency; 2011. [cited 2017 October]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2010/01/WC500049541.pdf

[13]  New Zealand Ministry of Health, National Minimum Dataset (Hospital Events) data dictionary. Wellington: Ministry of Health; 2015.

[14]  Australian Consortium for Classification Development. The International statistical classification of diseases and related health problems. Tenth revision, Australian modification (ICD-10-AM). 6th edn. Lidcombe, NSW: National Centre for Classification in Health; 2008.

[15]  Abas MA, Vanderpyl J, Robinson E, et al. Socio-economic deprivation and duration of hospital stay in severe mental disorder. Br J Psychiatry 2006; 188 581–82.
Socio-economic deprivation and duration of hospital stay in severe mental disorder.Crossref | GoogleScholarGoogle Scholar |

[16]  Atkinson J, Salmond C, Crampton P. NZDep2013 Index of Deprivation. Wellington, New Zealand: Ministry of Health; 2014.

[17]  Barnett R, Lauer G. Urban deprivation and public hospital admissions in Christchurch, New Zealand, 1990–1997. Health Soc Care Community. 2003; 11 299–313.
Urban deprivation and public hospital admissions in Christchurch, New Zealand, 1990–1997.Crossref | GoogleScholarGoogle Scholar |

[18]  Exeter DJ, Zhao J, Crengle S, et al. The New Zealand Indices of Multiple Deprivation (IMD): a new suite of indicators for social and health research in Aotearoa, New Zealand. PLoS One. 2017; 12 e0181260
The New Zealand Indices of Multiple Deprivation (IMD): a new suite of indicators for social and health research in Aotearoa, New Zealand.Crossref | GoogleScholarGoogle Scholar |

[19]  New Zealand Ministry of Health. Annual update of key results. 2015/16 New Zealand Health Survey. 2016. Wellington: Ministry of Health; 2016. [cited 2017 October]. Available from: http://www.health.govt.nz/publication/annual-update-key-results-2015-16-new-zealand-health-survey

[20]  Abraham NS, Noseworthy PA, Yao X, et al. Gastrointestinal safety of direct oral anticoagulants: a large population-based study. Gastroenterology. 2017; 152 1014–1022.e1.
Gastrointestinal safety of direct oral anticoagulants: a large population-based study.Crossref | GoogleScholarGoogle Scholar |

[21]  Böhm M, Ezekowitz MD, Connolly SJ, et al. Changes in renal function in patients with atrial fibrillation: an analysis from the RE-LY trial. J Am Coll Cardiol. 2015; 65 2481–93.
Changes in renal function in patients with atrial fibrillation: an analysis from the RE-LY trial.Crossref | GoogleScholarGoogle Scholar |

[22]  Thorne K, Dee S, Jayathissa S. Prescriber compliance with renal function monitoring in patients taking dabigatran (Pradaxa). N Z Med J. 2015; 128 83–7.

[23]  Wong SW, McGrath NM. Screening, prevalence and ethnic variation of diabetes mellitus in people with acute stroke and transient ischaemic attack: a cross-sectional study in Northland, New Zealand. N Z Med J. 2016; 129 62–6.