The announcement comes more than 15 months after an expert panel led by a Harvard University cardiologist recommended such a study in the wake of concerns that the medicine might increase the risk of death or kidney failure within 30 days of treatment among patients hospitalized with acute heart failure. The Cleveland Clinic also will help lead the study.
By naming two prestigious centers to run a large-scale study, expected to cost more than $100 million, the company is making an important investment in the future of the drug, known generically as nesiritide -- albeit a commitment that some critics would like to have seen earlier.
Robert M. Califf, director of the Duke institute at Duke University in Durham, N.C., will serve as chairman of the study and lead "a global consortium of academic leaders who will conduct the study with the type of independence" intended to instill confidence among cardiologists and patients in the findings.
Natrecor was approved in 2001 on the basis of studies demonstrating its ability to quickly improve symptoms of shortness of breath among patients suffering from what doctors call acute decompensated heart failure, and it was a strong performer for J&J, which is based in New Brunswick, N.J. But the lack of data to resolve safety concerns has undermined physician confidence in the drug in the past year, contributing to a significant drop in sales.
Dr. Califf said the study is also an opportunity to make an important advance for patients for whom there are few effective remedies. More than one million U.S. patients are admitted to hospitals with acute decompensated heart failure a year and as many as 8% die in the hospital.
When he began his career in a coronary care unit in 1980, Dr. Califf said, there were two kinds of patients: those with unstable chest pain called acute coronary syndrome that leads to heart attacks, and those with acute heart failure. Medicine has made major strides against heart attacks since, but almost no progress for acute heart failure.
"Patients come in feeling like they're drowning and there is a very high rate of death and readmissions," Dr. Califf said. Natrecor helps relieve shortness of breath, "but what is not settled is what are the longer-term effects," he said. "I'm glad there's now a commitment to get the trial done."
The study, whose precise design has yet to be finalized, is expected to first evaluate safety and efficacy at 30 days after treatment. Enrollment of patients -- about half from North America and the rest from elsewhere around the world -- is expected to begin in the first half of next year. Dr. Califf said the first results should be ready in two to three years.
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