Natrecor, a drug used to treat heart failure, can worsen kidney function and make patients more likely to die, U.S. researchers reported Monday.
The drug, known generically as nesiritide, worsened the risk by as much as 50 percent, the researchers report in the latest issue of the journal Circulation.
Scios Inc., the unit of Johnson and Johnson that makes Natrecor, said reduced kidney function was a well-known side effect already noted on the drug’s label.
The researchers at North Shore University Hospital in New York and the University of Michigan analyzed data from controlled trials of the drug conducted by Scios in 1,200 patients.
'Significant risk of kidney dysfunction'
“Nesiritide was associated with a 40 to 50 percent higher risk of worsening kidney function when used for the treatment of acutely decompensated heart failure,” Dr. Jonathan Sackner-Bernstein of North Shore Hospital, who led the study, said in a statement.
“Whether using low or high doses, nesiritide was associated with significant risk of kidney dysfunction.”
Decompensated heart failure is the most common reason for hospitalization among people over the age of 65 in the United States, leading to more than a million hospitalizations every year.
Dr. Darlene Horton, senior vice president for clinical research and medical affairs at Scios, said the new study was misleading because researchers had lumped together results from various doses, including ones higher than recommended.
The risk of deteriorating kidney function increases by about 30 percent when the suggested starting dose is given, she said. “This is a well-known phenomenon. It’s dose related, and it is not associated with worse outcomes,” she said.
Heart failure is a chronic condition in which the heart loses its ability to pump blood effectively. The heart often enlarges as it struggles to work, and fluid can build up, causing breathlessness and a loss of energy.
Diuretics are the main treatments for the condition, which affects an estimated 5 million Americans.
Natrecor is given in nearly 10 percent of heart failure-related hospitalizations. It quickly improves symptoms by stimulating the heart to pump blood more forcefully.
