(Adds study details, reaction from doctors, byline)
By Kim Dixon
NEW ORLEANS, March 25 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
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
"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.