Open AccessImpact of Acute Serum Creatinine Elevation in Patients Treated with Nesiritide
Author(s) -
Elkayam Uri,
Janmohamed Munir,
Hatamizadeh Parta,
Heywood J. Thomas,
Wei LeeJen,
Mills Roger M.
Publication year - 2009
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.20344
Subject(s) - nesiritide , medicine , creatinine , hazard ratio , confidence interval , renal function , odds ratio , acute decompensated heart failure , heart failure , cardiology , natriuretic peptide
Background We assessed the effect of increases in serum creatinine on mortality in nesiritide‐treated versus control subjects with acute decompensated heart failure (ADHF). Hypothesis Mortality effect of nesiritide‐related increases in serum creatinine differs from that of standard therapies. Methods Scios Inc., granted unrestricted access to data from all 5 randomized, controlled nesiritide infusion trials completed to date in patients hospitalized with ADHF. We used 2 different definitions of acute serum creatinine increase: >0.3 mg/dL and > 0.5mg/dL within 30 days of study enrollment and determined 30‐day mortality risk for nesiritide‐treated versus control subjects utilizing each definition. Results A total of 1,270 subjects participated in the 5 trials. A >0.3 mg/dL increase in serum creatinine was associated with a significant increase in mortality risk in control subjects, (hazard ratio [HR]: 3.47, 95% confidence interval [CI]: 1.49–8.09) but not in nesiritide‐treated subjects (HR: 1.65, 95% CI: 0.90–3.05). Results were similar for a >0.5 mg/dL increase (control HR: 5.12, 95% CI: 2.09–12.57 and nesiritide HR: 1.77, 95% CI: 0.90–3.51). In subjects with >0.3 mg/dL and >0.5 mg/dL increases in serum creatinine, respectively, the 30‐day mortality odds ratios for nesiritide relative to control were 0.73 (95% CI: 0.29–1.93) and 0.52 (95% CI: 0.17–1.63) using a stratified Mantel‐Haenszel analysis. Conclusions The impact of increased serum creatinine on mortality was attenuated in nesiritide‐treated patients compared to control, suggesting that the mechanism and clinical significance of increases in serum creatinine associated with nesiritide treatment may differ from those associated with standard therapies. Further investigation is warranted. Copyright © 2009 Wiley Periodicals, Inc.