J&J Natrecor Has Small Benefit, Pfizer Inspra Works

Johnson & Johnson’s Natrecor is safe for heart failure patients, though it offers few benefits, according to a study.

Natrecor, given intravenously, was one of the first drugs for congestive heart failure when it was approved in 2001, and in 2004 it generated $230 million in revenue. Sales plummeted to less than $100 million in 2006 after reviews of its use in less than 1,000 patients tied the medicine to worsening kidney function and higher death rates.

The newest study, in 7,141 patients, was reported today at the American Heart Association meeting in Chicago. It found the drug is safe, and that it slightly improved shortness of breath, a symptom of worsening heart failure. The benefit, though, didn’t last and the findings are unlikely to make Natrecor a significant contributor to J&J’s sales, said Michael Weinstein, a New York-based analyst at JPMorgan Securities.

“Natrecor died years ago, so it would be hard to revitalize,” Weinstein said in an e-mail.

Nearly 6 million people in the U.S. have heart failure, when a weakened heart is unable to pump enough blood to fuel the body. The U.S. will spend $39.2 billion treating it this year, according to the Centers for Disease Control and Prevention.

The $100 million study from New Brunswick, New Jersey-based Johnson & Johnson, dubbed Ascend-HF, was carried out in 30 countries worldwide. It started treatment within 24 hours and continued to use the drug for as long as a week.

Died or Re-Hospitalized

A month after treatment, 9.4 percent of Natrecor patients and 10.1 percent given placebo had died or were re-hospitalized because of their heart failure, the study found. All patients were also receiving standard treatment, generally diuretics, morphine and other medicines intended to offer comfort.

In February 2009, the U.S. Justice Department joined two whistleblower lawsuits accusing J&J’s Scios unit of marketing Natrecor for uses other than those approved by the U.S. The suit alleges that after the drug went on the market, Scios began an “aggressive” campaign to market the drug to doctors for patients outside the hospital with less severe heart failure.

“The criminal investigation is continuing and discussions are under way in an effort to settle this matter,” J&J said in a regulatory filing on Oct. 3.

The study answers many scientific questions and should help doctors better understand the drug’s effects, said Peter DiBattiste, J&J’s vice president of cardiovascular development.

Findings to Regulators

The findings will be sent to U.S. regulators, he said in a statement.

“This is the largest trial ever conducted in patients with acute decompensated heart failure, and affirms our commitment to patients and physicians who have limited treatment options to fight this life threatening disorder,” DeBattiste said.

In another study reported at the heart meeting, Pfizer Inc.’s Inspra slashed deaths from cardiovascular causes and hospitalizations for worsening heart failure disease by one-third in patients with mild levels of the disease. That trial, in 2,737 people, was funded by New York-based Pfizer and halted in May, when the benefit was first announced.

Inspra is already approved for use in patients with moderate to severe disease. The newest findings should increase use of Inspra and similar medicines, said Mariell Jessup, medical director of the University of Pennsylvania’s heart and vascular center and chair of the meeting’s scientific program.

“When we are applying these therapies to less sick patients, we can prevent them from becoming severely debilitated,” Jessup said. ‘When patients get so sick, we have very limited therapies.”

Inspra Results

In the study, 18.3 percent of patients treated with Inspra died or were hospitalized for heart failure, compared with 25.9 percent given placebo. The results were simultaneously published by the New England Journal of Medicine.

The drug, also sold in generic form under the chemical name eplerenone, is an aldosterone antagonist. The drugs help prevent salt retention, which can cause the body to retain fluids. Reducing fluid build-up eases shortness of breath, reduces fatigue and lessens swelling.

Drugs including diuretics, nitroglycerine and blood-pressure medications known as ACE inhibitors have been effective at reducing symptoms and deaths in heart-failure patients, said Andrew Smith, director of Emory University’s Center for Heart Failure Therapy and Heart Transplantation in Atlanta, in a Nov. 10 interview. There is a need for new treatments, he said.

“There really has not been a trial that has shown a clear-cut benefit as far as reducing future hospitalizations,” said Smith, who was not involved in the study.

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