Technology Appraisal Guidance No. 197
Source: National Institute for Health and Care Excellence
1.1 Dronedarone is recommended as an option for the treatment of non-permanent atrial fibrillation only in people:
- whose atrial fibrillation is not controlled by first-line therapy (usually including beta-blockers), that is, as a second-line treatment option, and
- who have at least one of the following cardiovascular risk factors:
- hypertension requiring drugs of at least two different classes
- diabetes mellitus
- previous transient ischaemic attack, stroke or systemic embolism
- left atrial diameter of 50 mm or greater
- left ventricular ejection fraction less than 40% (noting that the summary of product characteristics [SPC] does not recommend dronedarone for people with left ventricular ejection fraction less than 35% because of limited experience of using it in this group) or
- age 70 years or older, and
- who do not have unstable New York Heart Association (NYHA) class III or IV heart failure.
1.2 People who do not meet the criteria in section 1.1 who are currently receiving dronedarone should have the option to continue treatment until they and their clinicians consider it appropriate to stop.
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/TA197
An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing email@example.com and quoting reference number N2274. It is also available on the Internet at http://guidance.nice.org.uk/TA197/QuickRefGuide/pdf/English
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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Dronedarone for the treatment of non permanent atrial fibrillation
Issue Date: August 2010
Review Date: March 2013