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This will be a retrospective cohort study using national register linkage data (including prescription, inpatient, mortality, and socioeconomic data). The study period will be from May 29, 2013 to June 30, 2015. Patients will be followed from the start of treatment (index date) until their death, exiting the database, or until the end of the study period (June 30, 2015).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients for filled prescriptions for apixaban | |||
| Patients for filled prescriptions for warfarin |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare adherence among Atrial Fibrillation (AF) patients initiating treatment with apixaban (without previous warfarin or novel anticoagulant (NOAC) use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use) | Adherence: Adherence will be defined including missing doses and treatment discontinuation using the following approaches: "Drug at disposal" approach: Based on information on prescribed dosing (mg/day) and information on filled prescriptions (mg expensed from the pharmacy); it is possible to calculate for how long a period the drug will last for that specific patient. Adherence is then defined using the Medication Possession Ratio (MPR) calculated as the ratio of number of days of treatment supply divided by the total length of follow-up time, and converted to a percentage (in the graph below illustrated as the sum of the grey horizontal bars divided by the length of follow-up, ie, time between index date and end of follow-up). The MPR will be computed as a continuous and binary variable (MPR>80%, ie, high vs low adherence) | approximately 6 to 12 months |
| Compare persistence among AF patients initiating treatment with apixaban (without previous warfarin or NOAC use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use) | Persistence: Persistence will be defined as treatment discontinuation and will be measured by estimating the following:
| approximately 6 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Describe and compare patient characteristics (demographics) among AF patients through questionnaire | Describe and compare patient characteristics (eg, demographics and clinical) among AF patients who:
Demographic parameters : Age-groups, Sex, Socioeconomic variables (e.g. education, disposable income) |
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Inclusion Criteria:
For the AF cohort
Apixaban subcohort 1
Warfarin subcohort 1
Apixaban subcohort 2
Exclusion Criteria:
For the AF cohort:
Warfarin subcohort 1:
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The study will include all patients with filled prescriptions for apixaban or warfarin between May 29, 2013 and Dec 31, 2014 that are identified with a hospital diagnosis of non-valvular atrial fibrillation (NVAF)
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| approximately 6 to 12 months |
| Describe and compare patient characteristics (clinical) among AF patients through questionnaire | Describe and compare patient characteristics (eg, demographics and clinical) among AF patients who:
Clinical Characteristics: History of stroke/TIA/systemic, embolism, Diabetes, Hypertension, Heart failure, Vascular disease, Intracranial bleeding, Any bleeding, Kidney disease, Liver disease, Dementia, Valvular AF, Ischemic stroke, Unspecified stroke, TIA, Systemic embolism, Coronary disease, End Stage Renal Disease | approximately 6 to 12 months |