Summary

• There are no specific studies that evaluated the concomitant use of XARELTO and alcohol.
• An analysis of the XANTUS study identified heavy alcohol use as a modifiable risk factor associated with major bleeding.¹
• Additional citations identified during a literature search are included in the REFERENCES section for your review.²

POSTMARKETING STUDIES

XANTUS

The XANTUS study was a prospective, international, observational study designed to assess the safety and efficacy of XARELTO for stroke prevention in nonvalvular atrial fibrillation (NVAF) in routine clinical practice.¹

Kirchhof et al (2020)¹ analyzed the XANTUS data set and evaluated the impact of modifiable and nonmodifiable bleeding risk factors in patients with NVAF receiving XARELTO and estimated the impact of risk factor modification on bleeding events. Treatment-emergent major bleeding events occurred in 128 of the 6784 (1.9%) patients over a mean treatment duration of 329 days (2.1 events per 100 patient-years). An event was considered treatment emergent if it started on or after the day of the first dose of XARELTO and up to 2 days after the last dose.

Parameters showing univariate association with bleeding were used to construct a multivariable model identifying independent risk factors. Modeling was used to estimate attributed weights to risk factors. Heavy alcohol use was identified as one of the modifiable, independent bleeding risk factors.

Heavy alcohol use was categorized as greater than 80 g of alcohol per day at baseline.  When compared to abstinent/mild alcohol consumption at baseline, heavy consumption had a hazard ratio (HR) of 2.37 (95% CI: 1.24-4.53; p-value=0.009).  Incidence of major bleeding in the heavy alcohol use patients is presented in Table: Major Bleeding Events in Heavy Alcohol Use Patients in the XANTUS Study. A total of 606 patients reported moderate alcohol consumption that was characterized as 40 – 80 g/day. Moderate alcohol use was not considered a modifiable risk factor associated with major bleeding events (HR: 0.96; 95% CI: 0.62–1.46; p-value=0.819).  

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®,BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 21 May 2024.