Sanofi’s Multaq reduces hospitalization: study

By Bill Berkrot and Ransdell Pierson

NEW ORLEANS (Reuters) - Sanofi-Aventis’s experimental drug Multaq significantly reduced the incidence of hospitalization and length of hospital stays in patients with atrial fibrillation, according to a new analysis of a previously reported study, researchers said on Tuesday.

Multaq, known chemically as dronedarone, cut the total number of hospital days by 28 percent compared to a placebo — 9,995 vs. 13,986 — and decreased total length of time spent in the hospital for heart-related reasons by 35 percent — 5,875 nights vs. 9,073 nights — according to the analysis presented at the American Heart Association scientific meeting in New Orleans.

The results were deemed to be statistically significant, researchers said.

The drug is under review for marketing approval by health regulators in the United States and Europe. U.S. approval is expected in the first quarter of 2009.

If approved, researchers said it could become a safer alternative to amiodarone, a generic drug widely used to control irregular heartbeats although it is not approved for that condition and can cause damage to the lungs and thyroid gland.

Multaq also reduced by 14 percent the incidence of initial non-atrial fibrillation-related hospitalization for other heart problems, such as heart attack and unstable angina, or chest pains.

Atrial fibrillation is an abnormal heart rhythm in which the upper chambers of the heart beat in an uncoordinated manner, which can cause palpitations, shortness of breath and fatigue.

“These new data showed that, for the first time, an anti-arrhythmic drug significantly and consistently reduced hospitalization incidence and duration, which led to a substantial reduction in total hospitalization burden in this patient population,” said Dr Christian Torp-Pedersen of Gentofte University Hospital in Copenhagen and a member of the study’s steering committee.

A second analysis of the study found that Multaq significantly reduced time to first recurrence of atrial fibrillation by 25 percent, compared to a placebo, in patients with normal heart rhythm at the time of the trial’s initiation.

“Why would I consider prescribing amiodarone if I can give a drug like this that is effective, but does not have amiodarone’s toxicities,” said Dr. Richard Page, a cardiologist at the University of Washington School of Medicine that helped lead the Multaq study.

Page noted, however, that no head-to-head trial comparing the relative effectiveness of Multaq and amiodarone had been conducted.

He said the Sanofi drug was very well tolerated in contrast to harsh side effects often seen with amiodarone.

(Editing by Tim Dobbyn)


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