Key result
In Japanese patients with non-valvular atrial fibrillation receiving rivaroxaban, being underweight was independently associated with increased all-cause mortality (HR 3.56) but not with thromboembolic events (HR 1.64).
Why the study?
To evaluate relationships between body mass index and safety and effectiveness outcomes in Japanese patients with non-valvular atrial fibrillation receiving rivaroxaban.
Does body mass index impact the safety and effectiveness of rivaroxaban in Japanese patients with non-valvular atrial fibrillation?
Observational (n=7,618)
Open-label
Yes
Does body mass index impact the safety and effectiveness of rivaroxaban in Japanese patients with non-valvular atrial fibrillation?
In Japanese patients with NVAF taking rivaroxaban, being underweight is an independent predictor of all-cause mortality, highlighting the need for careful evaluation of comorbidities in this vulnerable population.
Answers are grounded in this paper and cite their sources.
Underweight Japanese NVAF patients on rivaroxaban may warrant closer monitoring; leaves open whether BMI modifies rivaroxaban effectiveness.
This sub-analysis of the XAPASS, a prospective, single-arm, observational study, aimed to evaluate relationships between body mass index (BMI) and safety (major bleeding and all-cause mortality) and effectiveness [stroke/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI)] outcomes in Japanese patients with non-valvular atrial fibrillation (NVAF) receiving rivaroxaban. Patients were categorized according to BMI (kg/m 2 ) as underweight (< 18.5), normal weight (18.5 to < 25), overweight (25 to < 30), or obese (≥ 30). In total, 9578 patients with NVAF completed the 1-year follow-up and were evaluated; of these, 7618 patients had baseline BMI data. Overall, 542 (5.7%), 4410 (46.0%), 2167 (22.6%), and 499 (5.2%) patients were underweight, normal weight, overweight, and obese, respectively. Multivariable Cox regression analysis demonstrated that none of the BMI categories were independent predictors of major bleeding whereas being underweight was independently associated with increased all-cause mortality [hazard ratio (HR) 3.56, 95% confidence interval (CI) 2.40–5.26, p < 0.001]. The incidence of stroke/non-CNS SE/MI was higher in patients who were underweight than in those of normal weight (HR 2.11, 95% CI 1.20–3.70, p = 0.009). However, in multivariable analyses, being underweight was not identified as an independent predictor of stroke/non-CNS SE/MI (HR 1.64, 95% CI 0.90–2.99, p = 0.104). In conclusion, the high incidence of thromboembolic events and all-cause mortality in patients who were underweight highlights that thorough evaluation of disease status and comorbidities may be required in this population.
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Murakawa et al. (2020) conducted an observational in Non-valvular atrial fibrillation (n=7,618). Underweight (BMI < 18.5 kg/m2) vs. Normal weight (BMI 18.5 to < 25 kg/m2) was evaluated on Composite of stroke, non-CNS systemic embolism, and myocardial infarction (HR 1.64, 95% CI 0.90-2.99, p=0.104). In Japanese patients with non-valvular atrial fibrillation receiving rivaroxaban, being underweight was independently associated with increased all-cause mortality (HR 3.56) but not with thromboembolic events (HR 1.64).
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