What are the Advantages of Xarelto® for Protecting Your Patients with Comorbidities?

Stroke Prevention in Non-Valvular Atrial Fibrillation

Xarelto is indicated for stroke prevention in adults with non-valvular atrial fibrillation with one or more risk factors1

Confidently Prevent Critical Events, Even in High-Risk Patients2

Avoid the most critical events as you reach your treatment goals2

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Xarelto gives your patients the highly effective protection they need2
ROCKET AF study: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation, primary efficacy endpoint (stroke or systemic embolism) in the the intention-to-treat population

ap value for superiority.

 
Xarelto can help you avoid the most critical events as you reach your treatment goalsb,2
ROCKET AF study: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation, safety and efficacy

ap value for superiority. bThe RRR RRR
Relative risk reduction (= RRR). Proportion of the control group experiencing a given outcome minus the proportion of the treatment group experiencing the outcome, divided by the proportion of the control group experiencing the outcome.
was calculated as 1–HR HR
Hazard ratio (= HR). This is a measure of how often a particular event happens in one group compared to how often it happens in another group, over time.
by Bayer. Stroke or systemic embolism: HR 0.79 (0.65–0.95), critical organ bleeding: HR 0.69 (0.53–0.91), intracranial haemorrhage: HR 0.67 (0.47–0.93), fatal bleeding: HR 0.50 (0.31–0.79).

 
Protection established in patients with a high bleeding risk3
PIONEER AF-PCI study: Prevention of bleeding in patients with atrial fibrillation undergoing PCI

cTrial was not powered to definitively establish either superiority or non-inferiority.

Study powered for non-inferiority for primary endpoint of stroke or systemic embolism vs warfarin. No significant difference in primary safety endpoint of major or clinically relevant non-major bleeding vs warfarin.2

Robust Evidence in Patients with the Highest Risk of Bleeding1

The pivotal clinical trial for Xarelto has the most patients with the highest HAS-BLED scores1

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62% of patients in ROCKET AF AF
Atrial fibrillation (= AF). A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
had a very high risk of bleeding1
The majority of patients in ROCKET AF had a very high risk of bleeding according to their HAS-BLED score

Real World Safety that Reflects the Patients You see Every Day4

Data from the real world that complements clinical evidence4

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In XANTUS POOLED:4
XANTUS pooled - a prospective international phase IV real world study

Prospective international phase IV real world study with independent event adjudication
Mean CHADS2-score: 2.0

Xarelto 15 mg OD Provides an Evidence-Based Choice for Your Patients with Renal Impairment5

Reassuring evidence for a reduced dose that was specifically tested for this high-risk group of patients5

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Robust evidence for Xarelto 15 mg OD in patients with renal impairment2,5
ROCKET AF study: Specifically tested reduced dose of Xarelto 15 mg OD in patients with renal impairment

The circle represents 100% of the total Xarelto study population in the trial.
dRenal impairment defined as CrCl 30–49 ml/min.

 
Xarelto 15 mg OD provides an evidence-based choice for your patients with renal impairment5
ROCKET AF study: Xarelto 15 mg OD provides an evidence-based choice for patients with renal impairment

Xarelto 15 mg once daily: For patients with NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
and CrCl 30–49 ml/min. With caution in patients with CrCl 15–29 ml/min. Use is not recommended in patients with CrCl <15 ml/min.6
ePrimary efficacy endpoint: composite of all stroke (both ischaemic and haemorrhagic) and systemic embolism.

 
Significant stroke reduction with a consistent safety profile in NVAF patients with worsening renal function7
ROCKET AF study: Significant stroke reduction with a consistent safety profile in NVAF patients with worsening renal function

Worsening renal function was defined as a decrease of >20% from screening creatinine clearance measurement at any time point during the study7

Convenient and Simple Dosing for NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
Patients6,2,3,5

Xarelto can be used in patients with different levels of renal impairment6,2,5

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Xarelto can be used in patients with different levels of renal impairmentf,6,2,5
Convenient and Simple Dosing for NVAF Patients with Xarelto

fXarelto 10 mg can be taken with or without food. Xarelto 15/20 mg is to be taken with food.6 gPlus P2Y12 inhibitor. hCrCl 15–29 ml/min – To be used with caution. CrCl <15 ml/min – Use not recommended.

OD, once daily; NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
, non-valvular atrial fibrillation; AF AF
Atrial fibrillation (= AF). A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
, atrial fibrillation; RRR RRR
Relative risk reduction (= RRR). Proportion of the control group experiencing a given outcome minus the proportion of the treatment group experiencing the outcome, divided by the proportion of the control group experiencing the outcome.
, relative risk reduction; ARR, absolute risk reduction; YR YR
year.
, year; PCI, percutaneous coronary intervention; NNT, numbers needed to treat; GI GI
Gastrointestinal.
, gastrointestinal; CrCl, creatinine clearance; NMCR, non-major clinically relevant; HR HR
Hazard ratio (= HR). This is a measure of how often a particular event happens in one group compared to how often it happens in another group, over time.
, hazard ratio.
HAS-BLED score HAS-BLED score
A score used to estimate bleeding risk in patients on anticoagulation for atrial fibrillation.
is used to estimate major bleeding risk in patients with NVAF. CHADS2-score is used to estimate stroke risk in patients with NVAF.