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April 6, 2020Heart and VesselsOpen Access

Impact of body mass index on real-world outcomes of rivaroxaban treatment in Japanese patients with non-valvular atrial fibrillation

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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?

Population

7618 Japanese patients with NVAF receiving rivaroxaban and with baseline BMI data

Comparison

Underweight vs normal weight vs overweight vs obese BMI categories

Design

Prospective single-arm observational study sub-analysis

Follow-up

1-year

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).

Authors

YMYuji MurakawaTITakanori IkedaSOSatoshi Ogawa

Discussion

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Overview

Underweight Japanese NVAF patients on rivaroxaban may warrant closer monitoring; leaves open whether BMI modifies rivaroxaban effectiveness.

Study Design

Type

Observational (n=7,618)

Blinding

Open-label

Multicenter

Yes

Structured PICO

Does body mass index impact the safety and effectiveness of rivaroxaban in Japanese patients with non-valvular atrial fibrillation?

P
Population
7,618 Japanese patients with non-valvular atrial fibrillation receiving rivaroxaban, categorized by body mass index, followed for 1 year.
E
Exposure
Oral rivaroxaban 15 mg once daily or 10 mg once daily (for patients with creatinine clearance <50 ml/min) for 1 year.
C
Comparator
Normal weight patients (BMI 18.5 to <25) receiving the same rivaroxaban treatment.
O
Outcome
Primary safety outcome: any bleeding (major bleeding and intracranial hemorrhage). Primary effectiveness outcome: composite of stroke (hemorrhagic or ischemic), non-central nervous system systemic embolism (SE), and myocardial infarction (MI).composite

Main Result

Hazard Ratio: 1.64 (95% CI 0.9–2.99)

Absolute Event Rate: 3.67% vs 1.69%

p-value: p=0.104

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.

Limitations

  • BMI information was missing for 20.5% of patients
  • Rivaroxaban doses used in Japan differ from those used globally
  • Single-arm, open-label observational study design precludes direct comparison with other treatments
  • Short follow-up duration of only 1 year limits assessment of late clinical events
  • Potential selection bias by physicians and loss of patients to follow-up
  • Observational design
  • Potential residual confounding from pre-existing disease leading to weight loss (lead time bias)
  • Differences in demographic characteristics between BMI groups

Cite This Study

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).

synapsesocial.com/papers/6a859e8ad06b31cc19d0ceeahttps://doi.org/10.1007/s00380-020-01587-z
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Clinical Outcomes in Patients With Atrial Fibrillation Treated With Non–Vitamin K Oral Anticoagulants Across Varying Body Mass Index2023 · 2 citations
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  3. 3Impact of weight/BMI on clinical and bleeding events in 26 805 atrial fibrillation patients on edoxaban from the Global ETNA-AF Registry2025
  4. 4Association of body mass index with outcomes in patients with newly diagnosed atrial fibrillation: GARFIELD-AF2022 · 5 citations
  5. 5Body Mass Index and Clinical Outcomes in Asian Patients With Atrial Fibrillation Receiving Oral Anticoagulation2021 · 26 citations