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The study tested them in 1,800 Canadian patients with mild to moderate heart failure. More than three years later, 40 percent of those with simple defibrillators had died or been hospitalized for heart failure versus 33 percent of those with combo devices, said Dr. Anthony Tang of the University of Ottawa in Ontario, Canada.
Medtronic and the Canadian Institutes of Health Research paid for the study, and results were published online by the New England Journal of Medicine.
The bad news came from a test of Natrecor, a drug that had meteoric sales after its approval in 2001 because it was the only medicine that seemed to help shortness of breath. One out of every six people hospitalized with heart failure were given Natrecor until it came under a cloud in 2005 when studies suggested it raised the risk of death and kidney problems.
An independent panel recommended that its maker -- Scios Inc., a division of New Brunswick, N.J.-based Johnson & Johnson -- do a large study to resolve the issue.
In tests involving more than 7,000 patients in 30 countries, Natrecor made no difference in rates of hospitalization or death in the following month and only modestly relieved shortness of breath within 6 hours of its infusion, said Drs. Robert Califf and Adrian Hernandez, Duke University cardiologists who led the study.
Natrecor costs $500 to $700 plus infusion costs, Jessup said. If the drug "makes people feel better faster but doesn't impact outcomes, I'm not sure what the role is," she said.
Natrecor still had $66 million in annual sales in the United States last year, according to IMS Health, a health care information company.
Heart failure information:
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