Healthy Skepticism Library item: 6373

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Publication type: Journal Article

Hauptman PJ, Schnitzler MA, Swindle J, Burroughs TE.
Use of nesiritide before and after publications suggesting drug-related risks in patients with acute decompensated heart failure.
JAMA. 2006 Oct 18; 296:(15):1877-84

Abstract:

CONTEXT: The rate of adoption of new therapies for cardiovascular diseases
following the publication of favorable clinical trial results has been
studied; however, less is known about the rates of de-adoption of a drug
when negative studies are published. OBJECTIVE: To evaluate the use of
nesiritide before and after March and April 2005 publications in 2
high-impact journals that suggested an increased risk of renal failure and
mortality with intravenous nesiritide for acute decompensated heart failure.
DESIGN, SETTING, AND PATIENTS: Analysis of a large prospective hospital
database, developed for quality and utilization benchmarking, of 491 acute
care US hospitals at which 385,627 inpatient admissions occurred with a
primary International Classification of Diseases, Ninth Revision (ICD-9)
code for heart failure between January and August 2001 (prior to nesiritide
release) and January 2004 to December 2005 (before and after publication
periods). In addition, any patient admitted who received nesiritide in the
absence of a primary or secondary heart failure code was evaluated for
potential off-label use of the drug. MAIN OUTCOME MEASURE: Use of nesiritide
and other intravenous vasoactive therapy among patients admitted with heart
failure. RESULTS: Nesiritide use decreased from a peak of 16.6% (2351 of
14,167 admissions) in March 2005 to 5.6% (611 of 10,822 admissions) in
December 2005 (P<.001). Among those patients treated with nesiritide, the
mean duration of treatment changed minimally, from 2.3 to 2.1 days. Although
the use of inotropes also decreased during the period under study, the
changes were more modest; furthermore, of those patients who were prescribed
intravenous vasoactive therapy, a higher percentage were prescribed
inotropes after publication (3272 [21.5%] of 15 193 patients from
January-April 2005 vs 5750 [29.6%] of 19 445 patients from May-December
2005, P<.001). The use of nesiritide, in the absence of an ICD-9 heart
failure code, was small. CONCLUSIONS: Rapid de-adoption of nesiritide
occurred following 2 publications suggesting risk with the drug. Further
analyses are required to evaluate the consequences of these changes on
patient outcomes and to anticipate how publications of adverse findings can
influence practice.