Heart Failure Drug Natrecor Fails Efficacy Part Of "Off-label" Use Study

Safety Profile Of Natrecor Continues To Be Subject Of Controversy And Debate

(Posted by Tom Lamb at DrugInjuryWatch.com)

The results of a large study for Johnson & Johnson's heart failure drug Natrecor failed to prove that its out-patient use in people with severe disease in addition to the current standard treatment regimen was any more beneficial than the standard treatment alone.

According to a March 25, 2007 Reuters article about this Natrecor study:

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 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 is sold by the Johnson & Johnson subsidiary Scios.  Natrecor is approved to treat patients with heart failure serious enough to have them admitted to a hospital.  In recent years there has been growing concern about its "off-label, or unapproved, use in patients outside the hospital, i.e., out-patient setting.  In addition, several studies have suggested that Natrecor may actually increase the risk of death and worsen kidney function.

There was some debate about whether this recent study did anything to alleviate those concerns about the safety profile of Natrecor.  From the March 25 Reuters article:

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....

...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.

In response to inquiries about the results of this Natrecor study, Scios said it had not decided, yet, whether the company will continue to test the efficacy and safety of Natrecor use in any out-patient setting.