A landmark study has, for the first time, demonstrated a 30% cut in the risk of cardiovascular death among patients with atrial fibrillation given Sanofi-Aventis’ offering Multaq (dronedarone).

The trial, the largest of its kind, enrolled more than 4,600 patients across 37 countries.
In addition, the risk of arrhythmic death dropped 45%, there were numerically fewer deaths from any cause in the Multaq group compared to placebo and first cardiovascular hospitalisation was also reduced 25% among patients taking Sanofi-Aventis’ medicine on top of standard treatment, including antithrombotic drugs. These results, says Sanofi-Aventis, “have the potential to change the face of atrial fibrillation management. Dronedarone is the first safe treatment for atrial fibrillation that has been demonstrated to reduce cardiovascular hospitalisation or mortality in patients with AF.”

AF is a major cause of hospitalisation and death, affecting some 2.5 million people in the USA and 4.5 million across the European Union – figures that are expected to double over the next 20 years - and is associated with a doubling in the risk of death and increased risk of stroke and cardiovascular complications, including congestive heart failure. Prior treatment options have focused only on symptom relief, says the firm, which hopes Multaq will become a first-line therapy in combating AF.

AF is a condition in which the upper chambers of the heart beat in an uncoordinated way. When blood is not completely pumped out of the heart’s chambers, it can pool and clot; this can then exit the heart and block an artery in the brain resulting in a stroke. About 15% of all strokes result from AF.

This is the first in a programme of five Phase III clinical trials being conducted by Sanofi-Aventis on Multaq, a multi-channel blocker that affects calcium, potassium and sodium blockers and has anti-adrenergic properties. The Franco-German firm says it plans to make regulatory submissions during the third quarter to both European and US regulatory bodies.

It’s great news for the company, which saw its initial application for Multaq rejected by the US Food and Drug Administration in 2006 and subsequently withdrew from European review after an advisory panel called for additional clinical data.