Sanofi Heart Drug Worsens Heart Failure
3 CommentsBy Ed Silverman // June 19th, 2008 // 9:11 am
File this under tough sell. The drug 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, Dow Jones reports.
Sanofi still plans to resubmit the drug, dronedarone, for regulatory approval this fall, because a more recent study suggested the drug reduced the risk of death in patients with atrial fibrillation. Two years ago, the FDA rejected the drug, called Multaq. “I would say a majority of patients would be eligible for this treatment,” Paul Chew of Sanofi’s R&D unit tells Dow Jones.
Meanwhile, the newly published data suggests Multaq shouldn’t be used by people with severe heart failure because it appears to worsen heart failure, the wire notes. Hmm… That might dampen use of a drug that Sanofi hopes will generate annual sales of more than $1 billion.
The study in The New England Journal of Medicine shows that 25 of about 310 people who took Multaq died after two months, versus 12 deaths among 317 people given a placebo. The death rates in the Multaq group were 8.1 percent compared with 3.8 percent in the placebo group.
Among those who died during the study, 10 Multaq users had worsening heart failure, compared with two in the placebo group, which suggests Multaq contributes to worsening heart failure, according to the researchers.
Nathan
It may or may not be a tough sell. The 2007 study of this drug (N Engl J Med 357: 987–999) showed it to slow the recurrence of atrial fibrillation from 52 days (placebo) to 116 days (drug). In this trial (~1400 people), 22.8% of patients in the dronedarone group had been hospitalized or had died at 12 months, as compared with 30.9% of those in the placebo group. The rate of actual death was comparable — about 1% in each group. The currently available drug for this condition has significant tox issues.
The title of the article “Sanofi Heart Drug Causes Heart Failure” isn’t accurate. It appears to cause heart failure in patients who already had a severe heart failure. Based on the NEJM article above, the same does NOT appear to be true for less serious events.
Ed Silverman
Hi Nathan,
Good point. I’ve altered the headline. As to tough sell, we’ll have to see, depending upon the patient population deemed to most need whatever benefit is offered.
Regards
ed
Lili
To Nathan,
What gives you the right to give your opinuion? Doctors should treat patients as idviduals,we are all different. Many people have adverse side effects that are nor reported. Medications are not always the answer.
More studies should be conducted on preventive medicine.