(Adds study details, reaction from doctors, byline)
By Kim Dixon
NEW ORLEANS, March 25 (Reuters) - A large study of a controversial Johnson & Johnson (JNJ.N) heart-failure drug failed to prove it helps patients with severe disease treated outside a hospital, the latest setback for a drug once thought to have blockbuster potential.
The company-sponsored, 920-patient trial fell short of its primary goal of showing the drug, Natrecor, could reduce the risk of death or heart and kidney-related hospitalizations. Results were presented on Sunday at an American College of Cardiology meeting in New Orleans.
The trial failed to find a difference between a group of patients getting standard treatment and those getting standard treatment plus Natrecor, known generically as nesiritide and given by infusion.
The use of Natrecor, sold by J&J unit Scios, plummeted in recent years after several studies suggested it may actually boost the risk of death and worsen kidney function. There was also concern about its use in patients for which it was not approved, including those outside the hospital.
“The take-home message is, giving (Natrecor) intermittently did not reduce patients’ risk of death or hospitalization. The strategy didn’t work,” said Steven Nissen, chief of cardiology at the Cleveland Clinic and president of the American College of Cardiology.
Natrecor treats heart failure, a weakened heart muscle resulting in inadequate blood supply to the body and build-up of fluid in the lungs.
It is currently approved to treat patients with heart failure serious enough to land them in a hospital.
The study also found no difference in severe side effects between both patient groups. The drug’s supporters hope that result will allay safety concerns among doctors about its use.
“If one says the compound simply does not work that misses the point,” said Clyde Yancy, a Baylor University Medical Center researcher who led the study for J&J.
He and Scios vice president for medical affairs Roger Mills said the study should reassure doctors who cut back on the drug’s use when the negative studies came to light several years ago.
“There is no hint of a problem with renal function or mortality. I think for the most part physicians should find these data very reassuring,” Mills said.
But doctors on a panel discussing the study disputed the claim that the drug can be declared safe as a result of the study, noting there were more drug-related side effects in the Natrecor group. And there was a trend toward more days alive outside the hospital in the placebo group.
“I‘m a little perplexed about your conclusions that this drug is safe,” one panel member said.
Natrecor was once believed to have blockbuster potential, with sales topping $1 billion. J&J does not disclose sales for drugs with sales of less than $500 million a year and would not give sales figures.
In the study, patients were followed for six months. The primary goal, or endpoint, of the trial was time to death or first occurrence of heart and renal-related hospitalization. Its secondary goal was days alive out of hospital, heart-related mortality, and quality of life.
It failed to prove any better than the standard cocktail of drug treatments in either of these categories.
Mills said it has not been decided whether the company will continue to test the drug in this setting.