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Industry-Funded Study: Nesiritide 'Cannot Be Recommended for Routine Use' in Acute Heart Failure
Nesiritide "cannot be recommended for routine use in the broad population of patients with acute heart failure," according to a manufacturer-funded study published in the New England Journal of Medicine. (These results were first presented at the American Heart Association meeting in November 2010.)
Some 7100 patients, newly hospitalized with acute heart failure, were randomized to receive nesiritide (a recombinant B-type natriuretic peptide that promotes vasodilation) or placebo. All received other standard therapies, such as diuretics.
Patients' self-reported dyspnea scores in both groups improved at 6 and 24 hours, but there were no significant differences between groups. Similarly, the rate of rehospitalization or all-cause mortality by 30 days did not differ between the groups. Nesiritide recipients were more likely to experience hypotension.
An editorialist criticizes the FDA's actions in approving nesiritide, bemoaning that "well more than $1 billion was wasted on purchasing the drug." Writing in Journal Watch Cardiology, Dr. Harlan Krumholz observes: "This study clearly demonstrates the importance of testing the effects of new drugs on patient outcomes before approving them for clinical use."
LINK(S):
NEJM article (Free abstract)
NEJM editorial (Subscription required)
Journal Watch Cardiology summary (Your Journal Watch subscription required)
CardioExchange Expert Is In column on nesiritide following AHA 2010 (One-time registration required)
Published in Physician's First Watch July 7, 2011
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