Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare

Pfizer

Status: Completed

Conditions: Atrial Fibrillation; Anticoagulants; Obesity

Treatments: Drug: Apixaban

Study type: Observational

Funder types: Industry

Identifiers

NCT04681482

B0661162

Details and patient eligibility

About

The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who initiate therapy with OACs (oral anti-coagulants). The aim of this study is to compare all DOACs (direct oral anti-coagulants) to warfarin.

However, the primary analysis will be conducted among apixaban vs warfarin patients only. If sample size permits, we will also conduct other DOAC vs warfarin and DOAC vs DOAC analysis.

Enrollment: 107,383 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obese or severely obese.
• Initiated an OAC from July 1, 2013 - December 31, 2017; the first DOAC pharmacy claim date during the identification period will be designated as the index date. The first warfarin prescription date will be designated as the index date for patients without any DOAC claim.
• Individuals ≥18 years old as of the index date.
• Had 6 months continuous health plan enrollment with medical benefits (Parts A & B) for at least 6 months pre-index date (baseline period).
• At least 1 diagnosis of AF prior to or on index date, identified by any medical claim associated with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code of 427.31 or International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code of I480-I482, and I4891.
• Had body weight or BMI value reported within ±6 months of the index date.

Exclusion criteria

• Had medical claims indicating a diagnosis or procedure of rheumatic mitral valvular heart disease, heart valve replacement/transplant, venous thromboembolism, or transient AF 6 months prior to or on the index date.
• Had hip/knee replacement surgery within 6 weeks prior to or on the index date.
• Were pregnant during the study period.
• Had an OAC prescription during the 6 months pre-index date.
• Had follow-up time equal to 0 days.
• Had more than one OAC on the index date.

Trial design

107,383 participants in 2 patient groups

Apixaban Group

Description:

The cohort prescribed apixaban and diagnosed with Atrial Fibrillation

Treatment:

Drug: Apixaban

Warfarin Group

Description:

patients prescribed warfarin only diagnosed with Atrial Fibrillation.