Dronedarone
This factsheet is intended to help those aff ected
Dronedarone has been shown to be eff ective in
by atrial fi brillation understand the medication
reducing the likelihood of recurrence of AF by
dronedarone, with a brief introduction to how it
around 25% in patients with paroxysmal AF
(episodes which come and go on their own) and persistent AF (AF which will not revert to sinus
The need for new drugs
Atrial fi brillation (AF) is the most common
cardioversion). It has been shown to slow the
sustained electrical abnormality of the heart
heart rate in AF both at rest and during exercise.
(arrhythmia). Treatment goals focus on stroke prevention and then one of two strategies may be
It has been demonstrated to off er clear clinical
pursued. A rhythm control strategy seeks to try to
benefi ts to patients with a history of atrial
Dronedarone - Patient Information
restore the normal electrical activity of the heart
fi brillation or atrial fl utter. This was shown in a
known as sinus rhythm whilst with a rate control
dronedarone reduced the combined risk of being admitted to hospital for a heart related problem
combination of anti-arrhythmic drugs (AADs) that try to stabilize the heart electrically, cardioversion
As might be anticipated, another study showed
and in some cases ablation. One would think that
that whilst dronedarone was less eff ective than
rhythm control should be superior to rate control
amiodarone in preventing AF recurrences, it had
but this not been shown to be the case in several
significantly fewer side eff ects. In particular it
does not increase the risk of related health problems in the thyroid or lungs that can occur
One concern has been the potential adverse
side eff ects from currently available AADs, such as sotalol and amiodarone, which may be more
Which AF patients can be
unpleasant or harmful than any benefit gained in
prescribed dronedarone?
using them. So, essentially we need AADs with
Dronedarone is indicated for the maintenance
better ‘risk profi les’. That is, they, improve a
of sinus rhythm after successful cardioversion in
patient’s symptoms whilst having fewer
adult clinically stable patients with paroxysmal or
What is dronedarone? Which AF patients should not
Dronedarone is a new drug, similar in structure
be prescribed dronedarone?
to amiodarone, where chemical changes have
Dronedarone should not be given to patients with
been made to shorten the time it remains in the
AF who have a weakness of the main pumping
body and to reduce the risk of thyroid damage.
chamber of the heart (left ventricle). This may
Its main mechanism of action, like that of
be known because of a history of heart failure or
amiodarone and sotalol, is to make the heart cells
if an echocardiogram that shows left ventricular
less excitable and thereby making AF less likely. What are the relative benefits and limitations of dronedarone?
permanent AF or any patient who remains consistently in AF for more than six months.
Founder & Chief Executive: Trudie Lobban MBE Trustees: Professor A John Camm,
Professor Richard Schilling, Mrs Jayne Mudd
Atrial Fibrillation Association Registered Charity No. 1122442
www.aa-international.org Affiliate
Published January 2009, Reviewed March 2012, Planned Review Date August 2014
If you would like further details on the sources of our information or would like to provide feedback please contact AFA.
Please remember that this publication provides general guidelines only. Individuals should always discuss their condition with their healthcare provider.
Currently there is not enough safety evidence
Liver function tests are required regularly and
an ECG should be performed at least every six
months to confi rm sinus rhythm. Patients should consult their physicians if they develop symptoms
What are the side effects and how can they be managed?
Dronedarone does not aff ect kidney function but
Dronedarone is generally well tolerated with no
can cause a modest rise in one of its measures
increase in serious adverse eff ects when
(creatinine) so this should be checked before and
after starting dronedarone to give a new baseline.
The most common side eff ects noted are:
Dronedarone - Patient Information Conclusions
diarrhoea, abdominal discomfort, nausea and vomiting. There is an increased incidence of skin
Dronedarone is the newest oral AAD and is a
rash, slow heart rates and rarely changes in the
welcome and very useful addition to the choice of
ECG (prolonged QT intervals). Most side eff ects
drugs available for the treatment of patients with
disappear within the first two weeks of starting
the drug, but in some patients, dronedarone will need to be discontinued because of intolerance.
As with all AADs it needs to be used in the right patient as well as monitoring for safety and
What other information needs to be passed on to GPs and patients?
dronedarone is more harmful for patients with heart failure and should not be used here.
Dronedarone should be taken with meals and is given at a dose of 400mg twice daily.
As the options for AF management continue to increase the need for expert specialist advice
Dronedarone may raise the blood concentration
to help patients to make properly informed
of drugs such as verapamil, simvastatin and
decisions will become more pressing.
digoxin so this may need to be closely monitored, though this did not cause problems in the major clinical trials. Dronedarone should not be taken together with grapefruit juice or certain herbal products such as St. John’s Wort.
Monitoring
All AADs require regular monitoring to ensure they are working and to pick up any possible harmful eff ects. Dronedarone should be started
Acknowledgements: Atrial Fibrillation Association would like to thank all those who helped in the development and review of
and monitored under “specialist” supervision
this publication. Particular thanks are given to Dr Khalid Khan,
(appropriate hospital consultant or specialist
Consultant Cardiologist, and Dr Matt Fay, GP. Founder & Chief Executive: Trudie Lobban MBE Trustees: Professor A John Camm,
Professor Richard Schilling, Mrs Jayne Mudd
Atrial Fibrillation Association Registered Charity No. 1122442
www.aa-international.org Affiliate
Published January 2009, Reviewed March 2012, Planned Review Date August 2014
If you would like further details on the sources of our information or would like to provide feedback please contact AFA.
Please remember that this publication provides general guidelines only. Individuals should always discuss their condition with their healthcare provider.
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Dronedarone
Currently there is not enough safety evidence
Liver function tests are required regularly and
an ECG should be performed at least every six
months to confi rm sinus rhythm. Patients should consult their physicians if they develop symptoms
What are the side effects and how can they