Health Canada approves Multaq (Dronedarone) for atrial fibrillation

Aug 12 2009

Sanofi-aventis Canada announced today that Multaq (dronedarone, 400 mg tablets) has received Health Canada approval for the treatment of patients with a history of, or current atrial fibrillation to reduce their risk of cardiovascular hospitalization due to this condition.

This approval marks the only new treatment for the management of atrial fibrillation to come to market in two decades, and the only antiarrhythmic drug ever with proven clinical results to reduce cardiovascular hospitalization in patients with this serious heart-related illness.

"What's unique about the outcome data we have with Multaq is that it will likely make us think differently about the way we manage atrial fibrillation in the future," said Dr. Stuart Connolly, Director, Division of Cardiology, McMaster University in Hamilton, who was the co-principal investigator in ATHENA, the key pivotal study evaluating Multaq. "We now have a new treatment option that goes beyond what has been available up until now thanks to Multaq's ability to decrease hospitalizations.

For patients, this is significant because their quality of life will be enhanced if we can keep them out of the hospital setting." In the ATHENA study, the largest clinical trial ever conducted in patients with atrial fibrillation, Multaq 400 mg BID reduced the combined endpoint of risk of cardiovascular hospitalization or death from any cause by 24 per cent. The trial, published in the New England Journal of Medicine in February 2009, enrolled 4,628 patients followed for up to 30 months (median: 22 months), 2,300 of whom received Multaq on top of standard therapy.

A total of 27 Canadian sites and 148 patients were involved. "Multaq represents a major therapeutic advancement in atrial fibrillation," said Hugh O'Neill, President and CEO of sanofi-aventis Canada. "Patients will now be able to benefit from the years of research that have gone into the development of this product. We are very pleased that we can offer innovative solutions that will not only benefit patients and enhance their quality of life but also help reduce the stress on our already overburdened healthcare system." Multaq fills an unmet medical need in the management of atrial fibrillation, as the antiarrhythmic drugs currently used to treat this chronic condition have many limitations due to their side effects. Because of Multaq's favourable safety profile, it can be initiated in an outpatient setting, making it easy for patients and physicians to use.

The medical and financial burden of atrial fibrillation in Canada Atrial fibrillation is a potentially life-threatening condition that places a significant burden on patients, healthcare providers, hospitals and our healthcare system. For patients with atrial fibrillation, the risk of mortality is increased two-fold, the risk of heart failure by two- to three-fold, and the risk of stroke by up to five-fold. For every 100,000 people in the population, 194 are hospitalized each year due to atrial fibrillation.

This represents more than 43,000 hospitalizations each year in Canada. The average cost of hospitalization for arrhythmia in Ontario, for example, is $5,161 per event, bringing the annual hospitalization cost in that province alone to $84.2 million. This would translate into annual hospitalization costs of $222.5 million if extrapolated to the entire country. "We know that 15 per cent of all strokes are due to atrial fibrillation," said Dr. Connolly. "These strokes are typically more severe and often leave patients with serious after-effects. This has a huge impact not only on the patients themselves, but on their caregivers and the healthcare system as a whole."

Atrial fibrillation is the most common form of arrhythmia and is more frequent in men than women across all age groups. Because atrial fibrillation affects primarily people over the age of 45 - the baby boomer generation - the numbers have only one way to go, and that's up, according to the Heart & Stroke Foundation of Canada. The incidence is growing worldwide in tandem with the aging population, and the condition is being recognized as an emerging public health concern. Atrial fibrillation affects 2.5 million people in the United States and 4.5 million people in the European Union. In Canada, approximately 250,000 are affected. Currently, three per cent of the population over the age of 45 and six per cent over the age of 65 have atrial fibrillation. The risk of developing this condition increases with age; after 55, its incidence doubles with each decade of life.

Multaq (dronedarone) Multaq was discovered and developed by sanofi-aventis. Its efficacy and safety were evaluated in more than 6,000 patients. The most frequently observed adverse reactions in a clinical setting were diarrhea, nausea, abdominal pain, vomiting, asthenia (weakness) and cutaneous rash. Multaq is contraindicated in patients with severe congestive heart failure (classified as Stage IV by the NYHA or New York Heart Association) and other unstable hemodynamic (cardiovascular) conditions, and should be used with caution in patients with moderate congestive heart failure (NYHA Stage III).