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Safety Profile - NVAF | XARELTO® (rivaroxaban) HCP

XARELTO®: Safety profile in stroke risk reduction in patients with nonvalvular atrial fibrillation (NVAF)

Proven safety profile versus warfarin in ROCKET AF1,2

Bleeding events (on treatment plus 2 days) versus warfarin in ROCKET AF*

  • Similar major bleeding
  • ICH and fatal bleeding rates
  • GI bleeding with no difference in fatal GI bleeding
Graphic highlighting lower ICH and fatal bleeding rates in Rocket AF versus warfarin

Similar rates of bleeding regardless of BMI in ROCKET AF subgroup analysis3   

Chart showing XARELTO® ROCKET AF obesity subgroup safety

Similar rates of major bleeding** in a real-world study in patients with NVAF and morbid obesity4

Chart showing consistent major bleeding events in subgroup analysis regardless of weight


Trial design: A randomized, phase 3, multicenter, active-controlled, double-blind, double-dummy, event-driven study. Patients received XARELTO® 20 mg once daily (15 mg once daily in patients with moderate renal impairment defined as CrCl 30 mL/min to 49 mL/min) (n=7131) or dose-adjusted warfarin (n=7133) titrated to an INR range of 2.0 to 3.0.

Study endpoints: The primary efficacy endpoint was stroke (ischemic or hemorrhagic) and SE. The principal safety endpoint was a combination of major bleeding and clinically relevant nonmajor bleeding events.

ROCKET AF Post Hoc Obesity Analysis3

Study design: Post hoc analysis of the ROCKET AF trial where patients were grouped according to BMI: 18.50 kg/m2 to 24.99 kg/m2 (n=3289); 25.00 kg/m2 to 29.99 kg/m2 (n=5535); 30 kg/m2 (n=5206).

Study endpoints: The primary efficacy endpoint was the composite of stroke and SE. Secondary efficacy endpoints were stroke and ischemic stroke. The principal safety endpoint was the composite of major and nonmajor clinically relevant bleeding events.

NVAF and Morbid Obesity Real-World Study4

Study design: Retrospective cohort study using data from the Truven MarketScan Commercial Claims and Encounters and Medicare Supplemental databases from December 1, 2010, through December 31, 2016. Patients were identified who were initiated on XARELTO® or warfarin (first pharmacy claim date was the index date), who had 1 medical claim with an AF diagnosis during the past 12 months prior to or on the index date, and 1 medical claim for morbid obesity. Patients were required to have continuous enrollment 12 months before index date and at least 3 months after treatment initiation. Patients receiving XARELTO® or warfarin were 1:1 propensity score matched.

Study endpoints: The primary outcome was the composite risk of ischemic stroke and SE. Secondary outcomes included major bleeding risk.

*Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. These events occurred during treatment or within 2 days of stopping treatment (on-treatment period).

Major bleeding was defined as clinically overt bleeding associated with hemoglobin decrease 2 g/dL, transfusion of 2 units of packed red blood cells or whole blood, bleeding at a critical site, or with fatal outcomes (ISTH criteria).

Defined as clinically overt bleeding associated with a decrease in hemoglobin of 2 g/dL, a transfusion of 2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome.

§Intracranial bleeding events included intraparenchymal, intraventricular, subdural, subarachnoid, and/or epidural hematoma.

llHemorrhagic stroke in this table specifically refers to nontraumatic intraparenchymal and/or intraventricular hematoma in patients on treatment plus 2 days.

Gl bleeding events included upper GI, lower GI, and rectal bleeding.

#Fatal bleeding is adjudicated death with the primary cause of death from bleeding.

**Major bleeding defined using the validated Cunningham algorithm.

AF = atrial fibrillation; BMI = body mass index; CrCl = creatinine clearance; GI = gastrointestinal; ICH = intracranial hemorrhage; INR = international normalized ratio; ISTH = International Society on Thrombosis and Haemostasis; N/A = not applicable; NVAF = nonvalvular atrial fibrillation; OR = odds ratio; SE = systemic embolism; VTE = venous thromboembolism.