Pfizer heart-failure drug helps milder patients: study

People with mild heart failure lived longer and fared better by adding Pfizer’s drug Inspra to standard medications, a finding that could widely expand use of such drugs in healthier patients, researchers said on Sunday.

In an ironic twist, another study presented at the American Heart Association meeting showed Johnson & Johnson’s Natrecor heart failure drug—which is not widely used because of long-standing safety concerns—is in fact safe, but provides little benefit.

Nearly 5 million Americans have heart failure, a chronic condition that costs the United States an estimated $30 billion a year to manage. Unlike a heart attack, in which a heart artery becomes blocked, heart failure is gradual. It occurs when the heart loses its ability to efficiently pump blood.

Patients taking Inspra along with standard treatment were 37 percent less likely to die or be hospitalized for heart failure compared with those who were taking standard treatment alone, Dr. Faiez Zannad, a researcher from France’s Henri Poincare University of Nancy, told the meeting.

He said the results were in line with strong results seen in previous trials of Inspra in sicker heart failure patients and now should expand the drug’s use to those with milder disease.

The latest trial was stopped in May when it became clear that it would succeed.

Inspra, which is sold under the generic name eplerenone, is a member of the family of medicines called aldosterone antagonists that also includes an older generic drug called spironolactone. They block a hormone that the body uses to hold onto salt.

The new study should greatly expand the use of this family of drugs, Zannad said.

“Now we are filling the gap and we have all the continuum of heart failure—after a heart attack, among the most severe patients, and now mild patients are eligible,” Zannad said.

Inspra is currently approved for patients that have had a heart attack and have heart failure. Spironolactone is approved for patients with severe heart failure.

For mild heart failure, patients typically now take drugs known as beta blockers and ACE inhibitors, two standard medicines. Zannad predicted aldosterone antagonists will now be added to their drug regimens.

A second study presented at the meeting answered some lingering questions about J&J’s heart drug Natrecor, whose use plunged in 2005 after several studies suggested it could damage the kidneys.

J&J, which in 2003 acquired Natrecor through its $2.4 billion purchase of biotech company Scios Inc, fought hard to counter the negative findings, but most doctors stopped prescribing it.

J&J continues to sell the product, but doctors say the company does not actively market the niche drug.

Researchers on Sunday said a trial sponsored by J&J surprisingly showed the medicine does not harm the kidneys, as earlier studies suggested, but is minimally effective at helping people with heart failure.

A big former use of the medicine was frequent infusions among patients treated outside of the hospital, even though the drug was not approved for that population.

“There is no patient who should receive intermittent infusion,” Dr. Clyde Yancy of Baylor University Medical Center in Dallas, told the meeting.

“The trial provided very little evidence that its addition would improve the outcome of patients with acute decompensated heart failure who are receiving excellent standard of care,” said Dr. Eugene Braunwald of Harvard University.

He said the study “... joins a large number of other trials conducted with a variety of agents since the 1970s in acute heart failure that have not shown a clinical benefit. How to improve outcomes in this very common condition remains a significant challenge.”

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By Ransdell Pierson and Julie Steenhuysen

CHICAGO