Literature DB >> 17047218

Use of nesiritide before and after publications suggesting drug-related risks in patients with acute decompensated heart failure.

Paul J Hauptman1, Mark A Schnitzler, Jason Swindle, Thomas E Burroughs.   

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.

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Year:  2006        PMID: 17047218      PMCID: PMC2840641          DOI: 10.1001/jama.296.15.1877

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


  41 in total

1.  Between Scylla and Charybdis: The choice of inotropic agent for decompensated heart failure.

Authors:  G M Felker; C M O'connor
Journal:  Am Heart J       Date:  2001-12       Impact factor: 4.749

2.  The rise and fall of Natrecor for congestive heart failure: implications for drug policy.

Authors:  Aaron S Kesselheim; Michael A Fischer; Jerry Avorn
Journal:  Health Aff (Millwood)       Date:  2006 Jul-Aug       Impact factor: 6.301

3.  Effect of nesiritide (B-type natriuretic peptide) and dobutamine on ventricular arrhythmias in the treatment of patients with acutely decompensated congestive heart failure: the PRECEDENT study.

Authors:  Andrew J Burger; Darlene P Horton; Thierry LeJemtel; Jalal K Ghali; Guillermo Torre; George Dennish; Michael Koren; Jay Dinerman; Marc Silver; Mei L Cheng; Uri Elkayam
Journal:  Am Heart J       Date:  2002-12       Impact factor: 4.749

4.  Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial.

Authors:  Michael S Cuffe; Robert M Califf; Kirkwood F Adams; Raymond Benza; Robert Bourge; Wilson S Colucci; Barry M Massie; Christopher M O'Connor; Ileana Pina; Rebecca Quigg; Marc A Silver; Mihai Gheorghiade
Journal:  JAMA       Date:  2002-03-27       Impact factor: 56.272

5.  Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial.

Authors: 
Journal:  JAMA       Date:  2002-03-27       Impact factor: 56.272

6.  Digoxin use and digoxin toxicity in the post-DIG trial era.

Authors:  Zainal Hussain; Jason Swindle; Paul J Hauptman
Journal:  J Card Fail       Date:  2006-06       Impact factor: 5.712

7.  Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure. Nesiritide Study Group.

Authors:  W S Colucci; U Elkayam; D P Horton; W T Abraham; R C Bourge; A D Johnson; L E Wagoner; M M Givertz; C S Liang; M Neibaur; W H Haught; T H LeJemtel
Journal:  N Engl J Med       Date:  2000-07-27       Impact factor: 91.245

8.  The striking effect of the Heart Outcomes Prevention Evaluation (HOPE) on ramipril prescribing in Ontario.

Authors:  Karen Tu; Muhammad M Mamdani; Robert M Jacka; Natalie J Forde; Deanna M Rothwell; Jack V Tu
Journal:  CMAJ       Date:  2003-03-04       Impact factor: 8.262

9.  Complications of inappropriate use of spironolactone in heart failure: when an old medicine spirals out of new guidelines.

Authors:  Biykem Bozkurt; Ildiko Agoston; A A Knowlton
Journal:  J Am Coll Cardiol       Date:  2003-01-15       Impact factor: 24.094

10.  Attitudes and behaviour of general practitioners and their prescribing costs: a national cross sectional survey.

Authors:  C Watkins; I Harvey; P Carthy; L Moore; E Robinson; R Brawn
Journal:  Qual Saf Health Care       Date:  2003-02
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  17 in total

Review 1.  Nesiritide for acute decompensated heart failure: does the benefit justify the risk?

Authors:  Jonathan Sackner-Bernstein; Keith D Aaronson
Journal:  Curr Cardiol Rep       Date:  2007-05       Impact factor: 2.931

Review 2.  Concerns about health care warnings and their impact on prescribing behaviour.

Authors:  Laurence Y Katz
Journal:  CMAJ       Date:  2008-08-26       Impact factor: 8.262

Review 3.  Nesiritide in acute decompensated heart failure: current status and future perspectives.

Authors:  Selma F Mohammed; Josef Korinek; Horng H Chen; John C Burnett; Margaret M Redfield
Journal:  Rev Cardiovasc Med       Date:  2008       Impact factor: 2.930

4.  The tumultuous journey of nesiritide: past, present, and future.

Authors:  John C Burnett; Josef Korinek
Journal:  Circ Heart Fail       Date:  2008-05       Impact factor: 8.790

5.  Current Understanding of the Compensatory Actions of Cardiac Natriuretic Peptides in Cardiac Failure: A Clinical Perspective.

Authors:  Noel S Lee; Lori B Daniels
Journal:  Card Fail Rev       Date:  2016-05

6.  Understanding mis-implementation in public health practice.

Authors:  Ross C Brownson; Peg Allen; Rebekah R Jacob; Jenine K Harris; Kathleen Duggan; Pamela R Hipp; Paul C Erwin
Journal:  Am J Prev Med       Date:  2015-05       Impact factor: 5.043

Review 7.  Safety and efficacy of nesiritide for acute decompensated heart failure: recent literature and upcoming trials.

Authors:  Brian Hiestand; William T Abraham
Journal:  Curr Cardiol Rep       Date:  2007-05       Impact factor: 2.931

Review 8.  Insights into natriuretic peptides in heart failure: an update.

Authors:  Josef Korinek; Guido Boerrigter; Selma F Mohammed; John C Burnett
Journal:  Curr Heart Fail Rep       Date:  2008-06

9.  Oncologists' response to new data regarding the use of epidermal growth factor receptor inhibitors in colorectal cancer.

Authors:  Efrat Dotan; Tianyu Li; Michael J Hall; Neal J Meropol; J Robert Beck; Yu-Ning Wong
Journal:  J Oncol Pract       Date:  2014-07-22       Impact factor: 3.840

Review 10.  The role of natriuretic peptides in heart failure.

Authors:  Daniel D Correa de Sa; Horng H Chen
Journal:  Curr Cardiol Rep       Date:  2008-05       Impact factor: 2.931

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