Acutely Decompensated Heart Failure in a County Emergency Department: A Double-Blind Randomized Controlled Comparison of Nesiritide Versus Placebo Treatment. Answers to May 2008 Journal Club Questions

Annals of Emergency Medicine

Volumn 52, Issue 4, 2008, Pages 458-472

  Barrett, Tyler W ^a   Schriger, David L ^b  

^a VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMRINONE; DOBUTAMINE; DOPAMINE; GLYCERYL TRINITRATE; MILRINONE; NESIRITIDE; NITROPRUSSIDE SODIUM; PLACEBO;

ACUTE HEART FAILURE; ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRUG INFORMATION; DRUG RESEARCH; EMERGENCY WARD; HUMAN; PRIORITY JOURNAL; TREATMENT OUTCOME;

EID: 52049109434     PISSN: 01960644     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.annemergmed.2008.05.001     Document Type: Article

References (37)

1. Publication Committee for VMAC Investigators. Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial. JAMA. 287 (2002) 1531-1540
2. Sackner-Bernstein J.D., Kowalski M., Fox M., et al. Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials. JAMA. 293 (2005) 1900-1905
3. Miller A.H., Nazeer S., Pepe P., et al. Acutely decompensated heart failure in a county emergency department: a double-blind randomized controlled comparison of nesiritide versus placebo treatment. Ann Emerg Med 51 (2008) 571-578
4. Hauptman P.J., Schnitzler M.A., Swindle J., et al. Use of nesiritide before and after publications suggesting drug-related risks in patients with acute decompensated heart failure. JAMA. 296 (2006) 1877-1884
5. Greenland S., Pearl J., and Robins J.M. Causal diagrams for epidemiologic research. Epidemiology 10 (1999) 37-48
6. Glymour M.M., and Greenland S. Causal diagrams. In: Rothman K.J., Greenland S., and Lash T.L. (Eds). Modern Epidemiology. 3rd ed. (2008), LippincottM, Philadelphia, PA 183-212
7. Heart Failure Society of America. HFSA 2006 comprehensive heart failure practice guideline. J Card Fail 12 (2006) e1-e2
8. Dao Q., Krishnaswamy P., Kazanegra R., et al. Utility of B-type natriuretic peptide in the diagnosis of congestive heart failure in an urgent-care setting. J Am Coll Cardiol 37 (2001) 379-385
9. Maisel A.S., Krishnaswamy P., Nowak R.M., et al. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med 347 (2002) 161-167
10. Mills R.M., LeJemtel T.H., Horton D.P., et al., Natrecor Study Group. Sustained hemodynamic effects of an infusion of nesiritide (human b-type natriuretic peptide) in heart failure: a randomized, double-blind, placebo-controlled clinical trial. J Am Coll Cardiol. 34 (1999) 155-162
11. Colucci W.S., Elkayam U., Horton D.P., et al. Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure. Nesiritide Study Group. N Engl J Med. 343 (2000) 246-253
12. Topol E.J. Nesiritide-not verified. N Engl J Med. 353 (2005) 113-116
13. Collins S.P., Hinckley W.R., and Storrow A.B. Critical review and recommendations for nesiritide use in the emergency department. J Emerg Med. 29 (2005) 317-329
14. Marx J., Hockberger R., and Walls R. Rosen's Emergency Medicine. Concepts and Clinical Practice. 5th ed. (2002), Mosby, St. Louis, MO 1122
15. Burger A.J., Horton D.P., LeJemtel T., et al. 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. Am Heart J. 144 (2002) 1102-1108
16. Yancy C.W., Saltzberg M.T., Berkowitz R.L., et al. Safety and feasibility of using serial infusions of nesiritide for heart failure in an outpatient setting (from the FUSION I trial). Am J Cardiol. 94 (2004) 595-601
17. Sackner-Bernstein J.D., Skopicki H.A., and Aaronson K.D. Risk of worsening renal function with nesiritide in patients with acutely decompensated heart failure. Circulation 111 (2005) 1487-1491
18. Peacock W., Holland R., Gyarmathy R., et al. Observation unit treatment of heart failure with nesiritide: results from the Proaction Trial. J Emerg Med. 29 (2005) 243-252
19. Peacock W.F. Initial results from the PROACTION Study. J Emerg Med. 31 (2006) 435-436
20. Saul S. Heart drug maker will lay off 150. New York Times. February 24, 2006. http://www.nytimes.com/2006/02/24/business/24scios.html Access May 20, 2008
21. Mehrotra L., Weldon B., and Caruso D. JNJ-Q4 2007 Johnson & Johnson earnings conference call: final transcript. Thompson Financial (2008), Thomson StreetEvents 1-25
22. Hennessy S. Use of health care databases in pharmacoepidemiology. Basic Clin Pharmacol Toxicol. 98 (2006) 311-313
23. Pearl J. Causality (2000), Cambridge University Press, New York, NY
24. Greenland S., Rothman K.J., and Lash T.L. Measure of effect and measures of association. In: Rothman K.J., Greenland S., and Lash T.L. (Eds). Modern Epidemiology. 3rd ed. (2008), Lippincott, Philadelphia, PA 56-60
25. Altman D.G., and Dore C.J. Randomisation and baseline comparisons in clinical trials. Lancet 335 (1990) 149-152
26. Senn S. Testing for baseline balance in clinical trials. Stat Med 13 (1994) 1715-1726
27. Diercks D.B. Can we improve treatment of heart failure in the emergency department?. Ann Emerg Med 51 (2008) 583-584
28. Packer M., Lee W., Kessler P., et al. Prevention and reversal of nitrate tolerance in patients with congestive heart failure. N Engl J Med. 317 (1987) 799-804
29. Hulley S., Cummings S., Browner W., et al. Designing Clinical Research. 3rd ed. (2007), Lippincott Williams & Wilkins, Philadelphia, PA 168-169
30. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry. Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research; 1998:1-23.
31. US Department of Health and Human Services, Food and Drug Administration, eds. International Conference on Harmonisation: guidance on general considerations for clinical trials. Fed Reg (1997) 66113-66119
32. Kirsch I., Deacon B.J., Huedo-Medina T.B., et al. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med 5 (2008) e45 doi:10.1371/journal.pmed.0050045
33. McNamee D. Review of clinical protocols at The Lancet. Lancet. 357 (2001) 1819-1820
34. http://www.consort-statement.org/index.aspx?o=1210 Accessed April 20, 2008
35. Moher D., Schulz K.F., and Altman D.G. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 134 (2001) 657-662
36. Barrett T.W., and Schriger D.L. Practical considerations in HIV testing in the emergency department, characteristics of diagnostic tests, and the role of sensitivity analysis in observational studies: answers to March 2008 Journal Club questions. Ann Emerg Med. 52 (2008) 170-181
37. Goodman S.N., and Berlin J.A. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med 121 (1994) 200-206