Scios, a division of Johnson & Johnson (J&J), has announced plans to launch a large-scale international study, involving upwards of 7,000 patients, to further assess the benefits and safety profile of its cardiovascular drug Natrecor in people with acutely decompensated heart failure (DHF). The program, when completed, will be the largest and most comprehensive study of its kind, the company reported.
The upcoming trial will be conducted at centers in the U.S., Canada and Europe, and will evaluate improvement in dyspnea, rehospitalization, mortality, renal effects, quality of life and pharmacoeconomics. Patient enrollment is expected to begin in the first quarter of 2007, the company said.
Natrecor (nesiritide), approved by the FDA in 2001, is currently indicated for intravenous treatment of patients with DHF who have dyspnea -- shortness of breath -- either at rest or with minimal activity.
The drug has been under scrutiny during the past year. An article published in the Journal of the American Medical Association in April 2005 (DID, April 21, 2005) indicated the drug was associated with an 80 percent increase in the risk of mortality one month after treatment compared with conventional therapies. In July 2005, prompted by these study results, the U.S. Attorney's Office in Boston issued Scios a subpoena requesting documents related to the sales and marketing of the drug.
Subsequently, the FDA requested more information about the drug's risks, and asked that further trials be conducted. The company complied with these directives, and launched a physician education program for the drug.