Another awareness alert.

Read this…and then go to the second report published on Heartwire.
Dr. Natale is quoted.

Sounds to me like it might prove to be a good thing, yet I envision Sanofi - with one failed drug trial - now salivating over revenue from another market - 6.7 million afibbers globally…hoping to push this through quickly.

Until more long-term studies are out we should heighten our awareness about this drug, Multaq.

Jackie


SANOFI TO RESUBMIT HEART DRUG TO FDA AS NEW DATA EMERGE

By Peter Loftus published 6/19/08 – Wall Street Journal

An experimental heart drug from Sanofi-Aventis more than doubled the risk of death in people with heart failure in a study that was terminated early in 2003 due to safety concerns.

Sanofi still plans to resubmit the drug, dronedarone, for regulatory approval in the U.S. and Europe by the end of September because a more recent study suggested the drug reduced the risk of death in patients with a heart condition known as atrial fibrillation, or irregular heartbeat. In 2006, the U.S. Food and Drug Administration rejected the drug, which Sanofi proposes to market under the brand Multaq. "I would say a majority of patients would be eligible for this treatment,” said Paul Chew of Sanofi’s research and development unit.

But even if Sanofi gets the regulatory green light to market Multaq. the newly published data suggest it shouldn’t be used by people with severe heart failure because it appears to worsen heart failure. That could limit its market potential. Sanofi has predicted the drug could generate annual sales of more than $1 billion.

Paris-based Sanofi said in January 2003 that it terminated he “Andromeda” study of Multaq in people with congestive heart failure and ventricular dysfunction. Heart failure involves a weakened heart that causes fatigue and shortness of breath. An independent safety committee monitoring the study said at the time there was a potential excess risk of death inpatients taking Multaq.

Five years later, the full results of the Andromeda study are being published online by the New England Journal of Medicine. They show that 25 of about 310 people who took Multaq died after two months, versus 12 deaths among 317 people taking a placebo. The rates of death were 8.1% in the Multaq group versus 3.8% in the placebo group.

Sanofi developed Multaq as a so-called antiarrhythmic drug to treat atrial fibrillation, which affects about 2.2 million Americans and 4.5 million people in the European union, according to figures from the American Heart Association and Sanofi.

A common treatment for atrial fibrillation includes an older, generic drug called amiodarone but it is associated with side effects such as damage to the lung and liver and muscle weakness. Sanofi’s Multaq was designed to have equal or better effectiveness than amiodarone but with less sever side effects.

Sanofi tested Multaq in people with heart failure partly because people with that condition have an increased risk of atrial fibrillation and it can contribute to the death heart-failure patients.

The company had planned to study 1000 people who were hospitalized with symptomatic heart failure and left ventricular systolic dysfunction. Some 627 patients in Europe were enrolled at the time of the study’s termination in 2003.

Among those who died during the study 10 Multaq users had worsening heart failure, versus only two with worsening heart failure in the placebo group. Researchers say this suggest the possibility that Multaq contributes to worsening heart failure.”
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Further press release:

Dronedarone safety, efficacy standings bolstered in huge atrial-fibrillation trial

MAY 19, 2008 | by (just clips – incomplete article - read entire article online)

San Francisco, CA- An investigational drug envisioned as a safer alternative to amiodarone for maintaining sinus rhythm in patients with atrial fibrillation (AF) has shown that it may also lower the risk of some clinical outcomes, at least in a population with the arrhythmia described at increased cardiovascular risk, in a large randomized trial [1].

Compared with those who received placebo, patients who received dronedarone (Multaq, Sanofi-Aventis) showed a 24% drop in risk of CV hospitalizations or death over almost two years in the ATHENA trial, reported here at the Heart Rhythm Society (HRS) 2008 Scientific Sessions.

A range of secondary clinical end points also improved with dronedarone, according to Dr Stefan H Hohnloser (JW Goethe University, Frankfurt, Germany). A significant drop in risk of cardiovascular death with the drug was driven by fewer arrhythmic deaths, and a significant decline in CV hospitalizations owed primarily to reductions in admissions for AF and acute coronary syndromes, he said when formally presenting ATHENA at the meeting. Hohnloser chairs the trial's steering committee.

Cautiously anticipating a dronedarone approval, as all experts heartwire contacted appear to be doing, Dr Andrea Natale (Texas Cardiac Arrhythmia Institute at St David's Medical Center, Austin, TX) said clinicians are hoping that the drug's efficacy against AF will at least approach that of amiodarone while being free of significant adverse effects. "We don't have that information right now, because the drug was compared with placebo," he noted, observing, however, that ATHENA's design was typical of drug trials intended to win regulatory approval.

Natale, who isn't connected with ATHENA, said dronedarone had "a good result" in the trial, "considering that even amiodarone, which is one of the most effective drugs we have [for AF], has a long-term efficacy only in the 50% range." He observed that no antiarrhythmic drug is going to be effective against AF in every patient; treatment is highly individualized.

"So this is just another drug we can use, which is promising because it's proven to be more effective than placebo and in a range that is comparable to what we have available," he said. "It would be another option for our patients."

Complete the article here:
[www.theheart.org]