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Stroke Prevention In Patients With Non-Valvular Atrial Fibrillation Using Oral Anticoagulants Including Once Daily Xarelto®

Once-daily oral rivaroxaban recommended by European Society of Cardiology (ESC) as a first line therapy option with a comparable efficacy and safety profile to warfarin for and systemic embolism in eligible patients with non-valvular atrial fibrillation (AF)1

Bayer HealthCare welcomes the inclusion of its once daily oral anticoagulant tablet Xarelto® (rivaroxaban) in from the European Society of Cardiology (ESC). The updated , announced at the ESC’s annual conference in Munich, recommend recently developed oral anticoagulants (OACs) including rivaroxaban as a first line stroke prevention therapy for the management of non-valvular atrial fibrillation (AF)1.

The update follows further positive news for rivaroxaban earlier this year – an appraisal by the National Institute for Health and Clinical Excellence (NICE) in May 2012 – which recommended rivaroxaban as an efficacious and cost-effective therapy option for eligible patients with non-valvular AF. Following this endorsement, a 90-day period began during which rivaroxaban was required to be listed on all NHS hospital formularies for appropriate patients.

The ESC guidelines also state that recently developed OACs are “broadly preferable” to the current standard of care, warfarin1. Warfarin is subject to a number of limitations, including a need for routine blood coagulation monitoring, as well as interactions with a wide array of food, drink and other medicines. The inclusion of recently developed OACs within the ESC guidelines reinforces the need for more convenient options and the clinical benefit they can provide patients within primary and secondary care.

NICE recommends rivaroxaban as a therapeutic option in non-valvular AF patients with one or more , such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, and prior stroke or transient ischaemic attack (TIA).

AF affects 750,000 people in the UK and increases the risk of stroke fivefold.2 An estimated 14% of all strokes are caused by AF3 and over 12,500 strokes in the UK are directly linked to the condition.3

Rivaroxaban was the first in a class of drugs known as Factor Xa inhibitors, which act at a critical point in the blood-clotting process to prevent the formation of clots. It is the first oral warfarin alternative to be licensed for use in three indications – the prevention of stroke and non-CNS systemic embolism in eligible with non-valvular atrial fibrillation, the treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and (PE) following an acute DVT in adults, and the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

About Xarelto® (Rivaroxaban)

Rivaroxaban is an oral anticoagulant that was discovered in Bayer HealthCare’s Pharmaceuticals’ Wuppertal laboratories in Germany, and is being jointly developed by and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. It has a predictable dose response and high bioavailability when taken with food, no requirement for routine coagulation monitoring, as well as a lower potential for food and drug interactions than warfarin. Like other anticoagulants, rivaroxaban may cause bleeding which may potentially be life threatening.

Rivaroxaban is marketed under the brand name Xarelto® for the prevention of stroke in eligible adult patients with non-valvular atrial fibrillation, the treatment of deep vein thrombosis (DVT), prevention of recurrent DVT and pulmonary embolism (PE), and for VTE prevention in adult patients following elective hip or knee replacement surgery. Rivaroxaban is approved in more than 120 countries worldwide and to date has been successfully launched in more than 85 countries by Bayer HealthCare Pharmaceuticals in the VTE prevention indication.

About Atrial Fibrillation

AF is the most common sustained cardiac rhythm disorder and affects 750,000 people in the UK. It increases the risk of stroke by up to five times, the effects of which can be devastating and include severe disability and death.

About the ROCKET AF Study

The global ROCKET AF study compared once daily rivaroxaban with dose adjusted warfarin in 14,264 patients with non-valvular AF who were at risk for stroke or non-CNS systemic embolism. The ROCKET study demonstrated that rivaroxaban was non-inferior to warfarin in prevention of stroke in non-valvular AF in patients with one or more risk factors. Rivaroxaban demonstrated a well-tolerated safety profile in the study.

Source

1. ”2012 focused update of the ESC Guidelines for the management of atrial fibrillation: An update of the 2010 ESC Guidelines for the management of atrial fibrillation”

2. The Stroke Association, Atrial Fibrillation, 2010

3. ”NHS Improvement. Heart and Stroke Improvement. Commissioning for Stroke Prevention in Primary Care – The Role of Atrial Fibrillation”

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Source: Bayer HealthCare