Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Bristol-Myers Squibb1,144 enrolled

Overview

To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations, consultations, medications, and tests) of adequately controlling a patient (i.e. INR between 2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.

Study Type

OBSERVATIONAL

Enrollment

1,144

Conditions

Anticoagulation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Patients aged 18 or older over the study period * Patients with a diagnosis for NVAF or VTE anytime in their medical records * Patients having at least one year of enrolment in the database prior to the index date * Patients newly initiated with VKA during the study period (index date) Exclusion Criteria: * Patients with a diagnosis for both NVAF and VTE anytime in their medical records

Outcomes

Primary Outcomes

Annualized total and per patient cost of patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records

Per patient cost: direct medical costs from hospitalizations, consultations, medications, and tests; Coagulation control status: adequately controlled patients defined by INR between 2-3 and TTR≥ 60%

Time frame: Approximately 60 months

Secondary Outcomes

Demographic and clinical characteristics for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records

Variables measured: age, gender, employment status, smoking status, BMI, major co-morbidities (including CHARLSON index), CHA2DS2-VASc score, presence and frequency of INR measurement, and INR therapeutic range.

Time frame: Approximately 60 months

Healthcare resource rates for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records

Healthcare resources used (i.e. hospitalizations, consultations, medication, and tests) by patients will be measured according to coagulation control status. For each healthcare resource the number and percentage of patients using it and the mean, SD, median min, max and valid n will be reported; as well as the number of times that each patient uses the resource.

Time frame: Approximately 60 months

Data from ClinicalTrials.gov

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