on March 21, 2005
Circulation. 2005
Published online before print March 21, 2005, doi: 10.1161/01.CIR.0000159340.93220.E4
Published online before print March 21, 2005, doi: 10.1161/01.CIR.0000159340.93220.E4
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Submitted on August 13, 2004
From the Clinical Scholars Program, Division of Cardiology, North Shore University Hospital, Manhasset, NY (J.D.S.-B., H.A.S.), and Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (K.D.A.). * To whom correspondence should be addressed. E-mail: jonathansb{at}yahoo.com.
Background--Renal function is an important prognostic factor for patients with acutely decompensated heart failure (ADHF). We investigated the renal effects of nesiritide as treatment for ADHF. Methods and Results--Randomized clinical trials comparing nesiritide with either placebo or active control for ADHF were identified by electronic and manual searches and thorough review of US Food and Drug Administration files available via the website. Worsening renal function was defined as an increase in serum creatinine >0.5 mg/dL. Relative risk across all studies was determined by meta-analysis with Mantel-Haenszel fixed-effects models (RRMH). Risk of dialysis and medical intervention for worsening renal function were compared between therapies. Frequency of worsening renal function was determined from 5 randomized studies that included 1269 patients. Use of Food and Drug Administration-approved doses of nesiritide ( Conclusions--Nesiritide significantly increases the risk of worsening renal function in patients with ADHF. Whether worsening renal function reflects hemodynamic effect or renal injury is unknown, but the prognostic importance of worsening renal function suggests the need for further investigation in appropriately powered clinical trials.
Revised on November 26, 2004
Accepted on January 11, 2005
Risk of Worsening Renal Function With Nesiritide in Patients With Acutely Decompensated Heart Failure
Jonathan D. Sackner-Bernstein MD*,
0.03 µg · kg-1 · min-1) significantly increased the risk of worsening renal function compared with non-inotrope-based control (RRMH, 1.52; 95% CI, 1.16 to 2.00; P=0.003) or any control therapy, including non-inotrope- and inotrope-based therapies (RRMH, 1.54; 95% CI, 1.19 to 1.98; P=0.001). Even low-dose nesiritide (0.015 µg · kg-1 · min-1) significantly increased risk (P=0.012 and P=0.006 compared with non-inotrope- and inotrope-based controls, respectively), as did nesiritide administered at any dose up to 0.06 µg · kg-1 · min-1 (P=0.002 and P=0.001, respectively). There was no difference in the need for dialysis between therapies.
Key words: heart failure • kidney • meta-analysis • natriuretic peptides • pharmacology
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J. M. Hoffman, N. D. Shah, L. C. Vermeulen, G. T. Schumock, P. Grim, R. J. Hunkler, and K. M. Hontz Projecting future drug expenditures--2006 Am. J. Health Syst. Pharm., January 15, 2006; 63(2): 123 - 138. [Abstract] [Full Text] [PDF]
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M. Gheorghiade, F. Zannad, G. Sopko, L. Klein, I. L. Pina, M. A. Konstam, B. M. Massie, E. Roland, S. Targum, S. P. Collins, et al. Acute Heart Failure Syndromes: Current State and Framework for Future Research Circulation, December 20, 2005; 112(25): 3958 - 3968. [Full Text] [PDF]
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J. B. Bauer and M. A. Randazzo Nesiritide for outpatient treatment of heart failure Am. J. Health Syst. Pharm., December 15, 2005; 62(24): 2639 - 2642. [Full Text] [PDF]
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W.H. W. Tang and G. S. Francis The Year in Heart Failure J. Am. Coll. Cardiol., December 6, 2005; 46(11): 2125 - 2133. [Full Text] [PDF]
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H. M. Krumholz The Year in Epidemiology, Health Services, and Outcomes Research J. Am. Coll. Cardiol., October 4, 2005; 46(7): 1362 - 1370. [Full Text] [PDF]
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J. D. Sackner-Bernstein and K. Aaronson Risk of Death With Nesiritide--Reply JAMA, August 24, 2005; 294(8): 898 - 898. [Full Text] [PDF]
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Controversies in cardiology Circulation, August 23, 2005; 112(8): iv - iv. [Full Text] [PDF]
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E. J. Topol Nesiritide -- Not Verified N. Engl. J. Med., July 14, 2005; 353(2): 113 - 116. [Full Text] [PDF]
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J. D. Sackner-Bernstein, M. Kowalski, M. Fox, and K. Aaronson Short-term Risk of Death After Treatment With Nesiritide for Decompensated Heart Failure: A Pooled Analysis of Randomized Controlled Trials JAMA, April 20, 2005; 293(15): 1900 - 1905. [Abstract] [Full Text] [PDF]
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U. Elkayam, D. J. Wang, T. C. Dowling, D. Meadows, T. Ayala, J. Marshall, S. Minshall, N. Greenberg, E. Thattassery, M. L. Fisher, et al. Letter Regarding Article by Wang et al, "Nesiritide Does Not Improve Renal Function in Patients With Chronic Heart Failure and Worsening Serum Creatinine" * Response Circulation, April 12, 2005; 111(14): e182 - e183. [Full Text] [PDF]
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J. R. Teerlink and B. M. Massie Nesiritide and Worsening of Renal Function: The Emperor's New Clothes? Circulation, March 29, 2005; 111(12): 1459 - 1461. [Full Text] [PDF]
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