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Originally published August 30, 2014 at 6:15 PM | Page modified August 30, 2014 at 6:31 PM

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Study: Novel heart-failure drug shows big promise

Heart failure is the leading cause of hospitalization in the United States and Europe.


The New York Times

A look at heart failure

Heart failure affects 5 to 6 million people in the U.S. and about 26 million worldwide. The progressive disorder begins when heart cells are injured by a heart attack, infection, chemotherapy or other causes, and the heart can no longer pump effectively. Healthy cells try to compensate by overworking and enlarging, while the body retains water and increases blood pressure in a futile effort to improve blood flow. Fluid can back up into the lungs and leave people gasping for breath.

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The article states that some insurance plans may balk a paying the price for this new "breakthrough" drug, $2,500 per... MORE

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An experimental drug has shown a striking efficacy in prolonging the lives of people with heart failure and could replace what has been the bedrock treatment for more than 20 years, researchers said Saturday.

In a large clinical trial, the twice-a-day pill developed by the Swiss company Novartis reduced deaths, hospitalizations and disabling symptoms of heart failure. It also had fewer serious side effects than the standard therapy, a blood-pressure-lowering medication called enalapril.

“I think that when physicians see these data, they will find it compelling, and what we will see is a paradigm shift,” said Dr. Milton Packer, a professor of clinical sciences at the University of Texas Southwestern Medical Center in Dallas and one of the two principal investigators in the study.

The results are being presented at the European Society of Cardiology congress in Barcelona, Spain, this weekend and were published online Saturday in The New England Journal of Medicine.

Some 5 million to 6 million Americans and an estimated 26 million people globally have heart failure, and it is the leading cause of hospitalization in the United States and Europe, according to a recent paper in the Journal of the American College of Cardiology.

Some doctors not involved in the study agreed that the results were compelling.

“They are not just positive, they are remarkably positive and positive in every dimension,” said Dr. Clyde Yancy, chief of the cardiology division at the Northwestern University Feinberg School of Medicine. “Patients with heart failure are eager, if not desperate, to have better options.”

Novartis executives say the company will file for approval of the drug, known by the code name LCZ696, in the United States by the end of the year and in Europe in the first quarter of 2015. That means the drug could get to patients as early as next year.

Independent monitors stopped the study in April, seven months earlier than planned, when it was clear the drug was better than an older one that is standard now. Until Saturday, it was not known how much better.

The study — paid for, designed and partly run by Novartis — involved more than 8,400 patients in 47 countries who were randomized to receive either LCZ696 or enalapril, one of a class of drugs called ACE inhibitors that have been the standard treatment for heart failure. Most patients also used beta blockers and other drugs, as their doctors saw fit.

The patients were followed for a median of 27 months. By that point, 21.8 percent of those who received LCZ696 had died from a cardiovascular cause or had been hospitalized for worsening heart failure. That figure was 26.5 percent for those receiving enalapril. That represents a 20 percent relative reduction in risk using a statistical measure called the hazard ratio.

The reductions in risk for both cardiovascular death alone and hospitalization alone were also about 20 percent.

About 32 people would need to be treated with the new drug to prevent one death from heart-related causes. “That’s a favorable number,” said Dr. Joseph Rogers, a Duke University cardiologist with no role in the study. He said the benefits were big enough that “I would switch people over” as soon as the drug is available.

Yancy of Northwestern said one caution was that only about 5 percent of patients in the study were of African descent, even though in the United States blacks experience disproportionately from heart failure.

He said that about a decade ago, a somewhat similar drug never made it to the market because it caused a serious side effect called angioedema, mainly in African Americans. He said, however, that LCZ696 did not seem to pose that risk, though more observation was needed.

LCZ696 is a combination of two drugs. One is valsartan, the heart drug that Novartis sells as Diovan. The other component inhibits the enzyme neprilysin, a new mechanism for a heart-failure drug.

Until the 1980s, the standard treatments for heart failure — digoxin, which strengthens heart contractions, and diuretics, which increase urine output — did nothing to reduce mortality and little to relieve the symptoms of breathlessness, fatigue and swelling.

Then came enalapril, approved in 1985. It and other ACE inhibitors improved symptoms and survival. Further progress was made by combining ACE inhibitors with drugs that block adrenaline, as well as more sophisticated diuretics.

Even with this, heart-failure patients typically take four to eight drugs — about 50 percent die within five years.

Some Wall Street analysts predict the drug, a tablet taken twice a day, will achieve billions of dollars in annual sales. Seamus Fernandez, an analyst at Leerink Partners, said Saturday that the results were “near best case” and “could result in faster uptake, higher penetration and more robust branded pricing.”

As a proprietary drug, LCZ696 is likely to be expensive. Tim Anderson, an analyst at Sanford C. Bernstein & Co., estimates that it might cost $7 a day in the United States, or about $2,500 a year. Existing drugs are generic, costing as little as $4 a month, so insurers might balk at paying for the new drug.

Material from The Associated Press and The Philadelphia Inquirer is included in this report.



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