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Study: New heart failure drug cuts death by 37 percent

By Catholic Online (NEWS CONSORTIUM)
November 7th, 2012
Catholic Online (www.catholic.org)

An experimental drug, called serelaxin from the Novartis AG drug group to treat hospitalized acute heart failure patients has reported remarkable success. The death rate was decreased by as much as 37 percent compared with a placebo and appeared to be safe.

LOS ANGELES, CA (Catholic Online) - According to data from a late stage clinical trial presented this week, serelaxin, a form of a human hormone that relaxes blood vessels and eases stress on the heart and other organs, is now considered one of the most important medicines in the Swiss drug maker's developmental pipeline.

"With a meaningful mortality benefit, we believe Serelaxin could represent a $2.5 billion (annual) sales opportunity," Deutsche Bank analysts said.

Novartis says that it now seeks approval for serelaxin. Researchers say that in a study of 1,161 patients, the drug cut deaths from any cause at six months by 37 percent and led to a marked reduction in worsening of heart failure during hospitalization.

In fact, patients that received 48 hours of continuously infused serelaxin experienced more than 45 percent fewer episodes of worsening heart failure symptoms than those treated with a placebo.

Novartis had previously disclosed that serelaxin met one of the study's two primary goals measuring relief of dyspnea, or extreme shortness of breath, which is a common symptom of acute heart failure. By one measure, serelaxin led to a 19 percent improvement in dyspnea, researchers said.

The drug failed to hit a secondary goal of the study that combined cardiovascular death with need for re-hospitalizations. Researchers feel that the life saving benefit is far more important.

"We did have a startling death benefit. One of the reasons there may have been an inability to show a decrease in hospitalizations is more patients was alive to be re-hospitalized," Dr. John Teerlink, one of the trial's co-lead researchers says. A cardiologist and heart failure specialist at the San Francisco VA Medical Center says that the data showed that only 29 acute heart failure patients would have to be treated with serelaxin to prevent one cardiovascular death.

There is a pressing need for a treatment for acute heart failure, with few available options for the condition in which the heart is unable to pump enough blood.

"If it was approved we would not only use it, there would be a mandate to use it because we don't have anything for acute decompensated heart failure," Dr. Milton Packer, a prominent cardiologist from the University of Texas says.

While he was not part of the study, Packer is excited about the possibilities presented by the new drug. "If that mortality finding is real, boy, are we going to get excited!"

There are more than one million hospitalizations in the United States each year for acute heart failure and another million in Europe.

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