Intravenous Nesiritide, a Natriuretic Peptide, in the Treatment of Decompensated Congestive Heart Failure

Colucci, Wilson S.; Elkayam, Uri; Horton, Darlene P.; Abraham, William T.; Bourge, Robert C.; Johnson, Allen D.; Wagoner, Lynne E.; Givertz, Michael M.; Liang, Chang‐seng; Neibaur, M; Haught, W. Herbert; LeJemtel, Thierry H.

doi:10.1056/nejm200007273430403

Cited by 854 publications

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“…2 Nesiritide was approved in 2001 by the United States Food and Drug Administration and is indicated for intravenous treatment of patients with ADHF who have dyspnea at rest or with minimal activity. [13][14][15][16] The effects of nesiritide on discharge status, length of stay (LOS), total inpatient health care costs, and readmission rates are not fully determined. A recent meta-analysis suggests that nesiritide may have an adverse effect on mortality.…”

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confidence: 99%

Outcomes Associated with Vasoactive Therapy in Patients with Acute Decompensated Heart Failure

et al. 2006

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Study Objectives. To describe the clinical management of acute decompensated heart failure (ADHF) in patients receiving intravenous treatment with dobutamine, milrinone, or nesiritide, and to evaluate differences, based on treatment received, in the in-hospital mortality rate, length of stay (LOS), total health care costs, and 30-day hospital readmission rate. according to the vasoactive therapy received. To evaluate baseline characteristics, 2 analysis was used; logistic regression was employed to assess the relationships between drug therapy and in-hospital mortality rates, and multivariate linear regression was used to assess whether drug therapy was related to LOS and total health care costs. All regression analyses controlled for age, sex, race, region of the United States where the hospital was located, primary payer for the hospital stay, UHC patient severity class, and chronic renal failure. In-hospital mortality rates were 10.2%, 7.9%, and 2.9% in the dobutamine, milrinone, and nesiritide groups, respectively. This resulted in an adjusted odds ratio for death of 3.5 (95% confidence interval [CI] 1.8-6.8) for dobutamine and 3.9 (95% CI 1.8-8.3) for milrinone (p<0.0001). Compared with inotropic therapy (dobutamine and milrinone), mean LOS in the hospital and the intensive care unit were lower with nesiritide (p<0.001). Total health care costs were lowest with nesiritide, but this reached statistical significance only when compared with milrinone (p<0.001). Thirty-day hospital readmission rates with dobutamine, milrinone, and nesiritide were 5.0%, 9.5%, and 3.9%, respectively (p=NS). Conclusion. Nesiritide therapy was associated with a lower in-hospital mortality rate and shorter LOS compared with dobutamine and milrinone. In addition, total health care costs with nesiritide were decreased compared with milrinone. These observations need to be validated by a randomized controlled trial.

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Outcomes Associated with Vasoactive Therapy in Patients with Acute Decompensated Heart Failure

et al. 2006

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“…Among these 59 surrogate endpoint trials that had a subsequent clinical endpoint trial, in 24 cases the clinical endpoint trial results validated the positive surrogate trials, while in 20 the subsequent clinical endpoint trial was negative (Table 3). 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 A negative surrogate endpoint trial was less likely to be followed by a positive outcome trial and we identified only 3 such examples ( P =0.02, Figure 2). …”

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confidence: 99%

Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011

Bikdeli

Punnanithinont

Akram

et al. 2017

JAHA

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BackgroundSurrogate endpoint trials test strategies more efficiently but are accompanied by uncertainty about the relationship between changes in surrogate markers and clinical outcomes.Methods and ResultsWe identified cardiovascular trials with primary surrogate endpoints published in the New England Journal of Medicine, Lancet, and JAMA: Journal of the American Medical Association from 1990 to 2011 and determined the trends in publication of surrogate endpoint trials and the success of the trials in meeting their primary endpoints. We tracked for publication of clinical outcome trials on the interventions tested in surrogate trials. We screened 3016 articles and identified 220 surrogate endpoint trials. From the total of 220 surrogate trials, 157 (71.4%) were positive for their primary endpoint. Only 59 (26.8%) surrogate trials had a subsequent clinical outcomes trial. Among these 59 trials, 24 outcomes trial results validated the positive surrogates, whereas 20 subsequent outcome trials were negative following positive results on a surrogate. We identified only 3 examples in which the surrogate trial was negative but a subsequent outcomes trial was conducted and showed benefit. Findings were consistent in a sample cohort of 383 screened articles inclusive of 37 surrogate endpoint trials from 6 other high‐impact journals.ConclusionsAlthough cardiovascular surrogate outcomes trials frequently show superiority of the tested intervention, they are infrequently followed by a prominent outcomes trial. When there was a high‐profile clinical outcomes study, nearly half of the positive surrogate trials were not validated. Cardiovascular surrogate outcome trials may be more appropriate for excluding benefit from the patient perspective than for identifying it.

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“…B-type natriuretic peptide and nesiritide (human recombinant BNP) have potent angiotensin and aldosterone blocking properties. 12,14,15 Previous studies have demonstrated early elevation in serum creatinine with the use of other angiotensin or aldosterone blocking agents. 16 Neurohormonal blockade not only reduces mean arterial pressure, it also dilates efferent arterioles, reducing glomerular filtration rate (GFR) and thus leading to an increase in serum creatinine.…”

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confidence: 99%

Impact of Acute Serum Creatinine Elevation in Patients Treated with Nesiritide

Elkayam

Janmohamed

Hatamizadeh

et al. 2009

Clinical Cardiology

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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 >0.5 mg/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.

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Intravenous Nesiritide, a Natriuretic Peptide, in the Treatment of Decompensated Congestive Heart Failure

Abstract: In patients hospitalized with decompensated congestive heart failure, nesiritide improves hemodynamic function and clinical status. Nesiritide is useful for the treatment of decompensated congestive heart failure.

Cited by 854 publications

References 9 publications

Outcomes Associated with Vasoactive Therapy in Patients with Acute Decompensated Heart Failure

Outcomes Associated with Vasoactive Therapy in Patients with Acute Decompensated Heart Failure

Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011

Impact of Acute Serum Creatinine Elevation in Patients Treated with Nesiritide

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