Novartis heart failure drug provides host of benefits: study

[November 18, 2014] By Bill Berkrot

CHICAGO (Reuters) - An experimental heart failure medicine from Novartis that previously showed it reduced death and hospitalizations also curtailed worsening of symptoms, need for additional therapy and emergency room visits, adding to evidence that it will become the drug of choice once approved.

A lengthy list of additional benefits including significantly fewer intensive care unit stays from treatment with the drug, LCZ696, in the Paradigm-HF study of 8,442 patients were presented at the American Heart Association meeting in Chicago on Monday.

Chronic heart failure, in which the heart is unable to pump enough blood, tends to get progressively worse, leaving patients weak and with diminished quality of life.

The Novartis drug, expected to become a multibillion-dollar seller, wowed doctors at a European heart meeting in August with data showing it cut the risk of cardiovascular death and first-time hospitalizations due to heart failure by a fifth over the widely used generic medicine enalapril, already known to improve survival.

Further details showed it has the potential to change the course of the disease in many ways.

"If you wanted to keep a patient with heart failure well, you'd want to stop their symptoms getting worse, you want to stop them needing more treatment, you want to stop their having to go to the emergency room, you want to stop them being admitted to hospital, you want to stop them needing devices or surgery and you want to stop them dying, and we did all of those things," said Dr. John McMurray, co-lead investigator of the study from the University of Glasgow, who presented the data.

"It's almost too good to be true, at least in my long experience of doing trials in heart failure," he said.

Novartis said it plans to file applications seeking U.S. approval this year and in Europe in early 2015.

"This therapy offers hope to millions of people living with (heart failure) that they can also reduce or slow the decline in their heart function, potentially altering the progression of their disease," David Epstein, head of Novartis' pharmaceuticals division, said in a statement.

The drug could significantly reduce the expense of treating these patients at a time of increasing pressure to slash healthcare costs. "Reduction in cost of patient care will depend on how much Novartis charges for their drug," McMurray noted.

(This story has been refiled to delete extraneous word in second paragraph)

(Reporting by Bill Berkrot; Editing by Cynthia Osterman)

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