Technology Appraisal Guidance No. 249
Source: National Institute for Health and Care Excellence
1.1 Dabigatran etexilate is recommended as an option for the prevention of stroke and systemic embolism within its licensed indication, that is, in people with nonvalvular atrial fibrillation with one or more of the following risk factors:
- previous stroke, transient ischaemic attack or systemic embolism
- left ventricular ejection fraction below 40%
- symptomatic heart failure of New York Heart Association (NYHA) class 2 or above
- age 75 years or older
- age 65 years or older with one of the following: diabetes mellitus, coronary artery disease or hypertension.
1.2 The decision about whether to start treatment with dabigatran etexilate should be made after an informed discussion between the clinician and the person about the risks and benefits of dabigatran etexilate compared with warfarin. For people who are taking warfarin, the potential risks and benefits of switching to dabigatran etexilate should be considered in light of their level of international normalised ratio (INR) control.
The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA249
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
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Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation
Issue Date: March 2012