What is Multaq?
Fine is a medicine that contains dronedarone as an active ingredient. It is available as white oblong tablets (400 mg).
What is Multaq used for?
Multaq is used in adults who have suffered from atrial fibrillation in the past or who currently suffer from non-permanent fibrillation. Atrial fibrillation occurs when the ventricles (the upper cavities of the heart) contract rapidly and irregularly. Multaq is used to prevent recurrence of fibrillation or to lower the heart rate.
The medicine can only be obtained with a prescription.
How is Multaq used?
The recommended dose of Multaq is one tablet twice a day, one during breakfast and one during dinner. You should not take the tablets with grapefruit juice.
How does Multaq work?
The active substance in Multaq, dronedarone, is an antiarrhythmic drug. It works mainly by blocking the channels through which the potassium-laden particles enter and leave the muscle cells. The flow of charged particles entering and leaving the muscle cells produces excessive electrical activity that causes atrial fibrillation and an acceleration of the heartbeat. By reducing the flow of potassium through the channels, Multaq prevents the onset of fibrillation and slows the heart rate.
How has Multaq been studied?
The effects of Multaq were tested in experimental models before being studied in humans.
Five main studies were conducted on the use of Multaq in adult patients who had suffered from atrial fibrillation. Three of these studies involved 1141 patients and compared Multaq with placebo. The main measures of effectiveness consisted in the time elapsed before patients had a new episode of atrial fibrillation or in the change of heart rate of patients after two weeks.
The fourth study compared the effectiveness of Multaq with amiodarone (another medicine used to prevent atrial fibrillation) in 504 patients and examined the number of patients whose atrial fibrillation recurred or who had to stop treatment because was causing them unwanted effects or because it was not working.
The fifth study compared Multaq with placebo in almost 5000 patients and examined the effectiveness of Multaq in reducing and delaying death or hospitalization due to cardiovascular problems (problems with the heart and blood vessels).
What benefit has Multaq shown during the studies?
Multaq was more effective than placebo in preventing the return of atrial fibrillation.
In the first three placebo studies, atrial fibrillation recurred after 116 days in patients treated with Multaq and after 53 days in patients treated with placebo. Furthermore, the heart rate decreased on average by 11.0 beats per minute (bpm) in patients treated with Multaq, while in the patients treated with placebo there was an increase of 0.7 bpm.
In the fourth study, Multaq was less effective than amiodarone in maintaining a normal heart rhythm: after one year, atrial fibrillation had recurred or the treatment was suspended in 75% of patients treated with Multaq and in 59% of patients treated with amiodarone. Atrial fibrillation was repeated more frequently in patients treated with Multaq, but more patients treated with amiodarone had to stop treatment due to side effects.
The fifth study further supported the use of Multaq in maintaining normal heart rhythm and reducing heart rate. The study showed some reduction in the number of hospitalizations for cardiovascular reasons, in particular related to atrial fibrillation.
What are the risks associated with Multaq?
The most common side effects of Multaq (seen in more than one in ten patients) are increased blood creatinine levels (a breakdown product of muscle) and a "QTc calculated by Bazett formula" (a alteration of the electrical activity of the heart). For the full list of all side effects reported with Multaq, see the Package Leaflet.
Multaq should not be used in patients who are potentially hypersensitive (allergic) to the active substance or any of the other components. It must not be taken together with medicines capable of inducing "torsades de pointes" (a type of rapid heartbeat). Multaq should not be used in patients with certain heart problems, such as certain types of alterations in the heart's electrical activity, a very slow heart rate or when the heart is unable to pump enough blood throughout the body. It must also not be used in patients with severe liver or kidney problems. For the complete list of contraindications, see the package leaflet.
Why has Multaq been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that although Multaq was less effective than the comparator in maintaining normal heart rhythm, it is associated with fewer side effects. Multaq is also more effective than placebo in preventing the return of atrial fibrillation and controlling heart rate. The number of patients in the main studies who took Multaq and the duration of treatment with this medicine also allowed the committee to adequately assess the benefits and risks.
Based on the available evidence, the CHMP decided that Multaq's benefits are greater than its risks and recommended that Multaq be given marketing authorization.
What measures have been taken to ensure the safe use of Multaq?
The company that makes Multaq intends to make sure that healthcare professionals who prescribe the drug in all Member States and pharmacists receive a list of drugs that interact with Multaq and information on how to use Multaq safely.
More information on Multaq
On 26 November 2009, the European Commission granted Sanofi-Aventis a marketing authorization valid throughout the European Union for Multaq. The marketing authorization remains valid for a period of five years, after which it can be renewed.
For the full EPAR for Multaq, click here.
Last update of this summary: 12-2009.
