NEWBURY, England, January 23, 2015 /PRNewswire/ --
NICE FAD recommends 2.5mg Xarelto twice daily in combination with aspirin alone or aspirin plus clopidogrel or ticlopidine, as an option for secondary prevention following ACS in patients with elevated cardiac biomarkers, without prior stroke or TIA
The National Institute for Health and Care Excellence (NICE) today issued its Final Appraisal Determination (FAD) recommending Xarelto 2.5mg twice daily as an effective treatment option for preventing secondary events - such as death, heart attack or stroke - following acute coronary syndrome (ACS) in patients with elevated cardiac biomarkers, without prior stroke or transient ischaemic attack (TIA). The FAD is the final phase in a multi-step review process by NICE and recognises the improved patient outcomes using Xarelto as a treatment option on top of dual antiplatelet therapy*; publication of guidance is expected to follow in Q1 2015.
ACS is a term used for a group of conditions that includes heart attack and unstable angina, a severe type of chest pain. ACS generally occurs when there has been some narrowing of the blood vessels supplying the heart - narrowing of the vessels is referred to as coronary heart disease (CHD). CHD affects 2.3 million people in the UK and is the leading cause of death - around 73,000 people die from CHD in the UK every year. ACS itself results in over 114,000 UK hospital admissions each year; when this direct healthcare expenditure is added to economic losses, the burden of ACS is approximately £3.6 billion per year.
"Despite treatment advances in recent years, including newer antiplatelet agents, patients with ACS remain at risk, evidenced by the high incidence of cardiovascular death, myocardial infarction and stroke in patients following an ACS event," commented Professor Carlo di Mario, Professor of Cardiology, Imperial College London. "The addition of the anticoagulant Xarelto to standard antiplatelet therapy has been shown to reduce risk in this patient group, marking a significant advance in the management of ACS."
The FAD is based on a thorough review of the clinical effectiveness of 2.5mg Xarelto twice daily in the randomised controlled landmark ATLAS ACS 2 TIMI 51 trial in which Xarelto has shown significant advantages in the secondary prevention of ACS in patients with elevated cardiac biomarkers without prior stroke or TIA. The FAD also recommends Xarelto as a cost-effective treatment option.
Among patients with elevated cardiac biomarkers and no prior stroke or TIA, Xarelto 2.5mg twice daily on top of dual antiplatelet therapy* demonstrated statistically significant reductions in the primary outcome of death from cardiovascular causes, myocardial infarction or stroke in patients with a recent ACS compared with a placebo ((20%) ARR 2.1; HR 0.80(0.68-0.94), P = 0.007; NNT 48) as well as cardiovascular death by 45% RRR (ARR 2.0; HR 0.55 (0.41-0.74), P < 0.001; NNT=50) and all-cause death by 42% RRR (ARR 2.1; HR 0.58 (0.44-0.77), P < 0.001; NNT=49). Whilst there was an increase in bleeding rates with Xarelto, there was no difference in fatal bleeds or fatal intracranial haemorrhage.
The dual pathway treatment strategy tested in ATLAS ACS 2 TIMI 51 recognises the importance of thrombin generation (as well as the role of antiplatelets) following ACS events, and confirmed the clinical benefits that the anticoagulant Xarelto 2.5mg twice daily can deliver on top of dual antiplatelet therapy*.
*(in combination with aspirin alone or aspirin plus clopidogrel or ticlopidine)
The NICE announcement is in alignment with the current European Guidelines for the treatment of STEMI, set by the European Society of Cardiology and the approval by the European Medicines Agency.
"We're delighted with this FAD as it expands the clinical utility of Xarelto across different settings and patient populations, providing even more patients with access and improved outcomes," said Dr Luis Felipe Graterol, Medical Director, Bayer HealthCare UK. "Xarelto is approved to prevent and treat more thromboembolic conditions than any other novel oral anticoagulant, and is the leader in the market place both in the UK and worldwide. We remain committed to our growing clinical trial and lifecycle management programme to extend use into further areas of unmet need."
About Bayer HealthCare
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- National Institute for Health and Care Excellence. Final appraisal determination: Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome
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- The Future of Acute Coronary Syndromes Patient Outcomes Report, February 2011. Available from http://heartuk.org.uk/files/uploads/Big_Question_HUK_ACS2020Report.pdf [Last accessed January 2015]
- The ATLAS study investigators. Rivaroxaban in Patients with a recent Acute Coronary Syndrome. N. Engl. J. Med. 2012; 366: 9-19
- European Society of Cardiology Guidelines 2012. http://www.escardio.org/guidelines-surveys/esc-guidelines/GuidelinesDocuments/Guidelines_AMI_STEMI.pdf [Last accessed January 2015]
Date of preparation: January 2015
SOURCE Bayer HealthCare