Nesiritide

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Uri Elkayam - One of the best experts on this subject based on the ideXlab platform.

  • Impact of acute serum creatinine elevation in patients treated with Nesiritide.
    Clinical cardiology, 2009
    Co-Authors: Uri Elkayam, J. Thomas Heywood, Munir Janmohamed, Parta Hatamizadeh, Lee-jen Wei, Roger M. Mills
    Abstract:

    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.

  • Assessment of Renal Hemodynamic Effects of Nesiritide in Patients With Heart Failure Using Intravascular Doppler and Quantitative Angiography
    JACC. Cardiovascular imaging, 2008
    Co-Authors: Uri Elkayam, Parta Hatamizadeh, Mohammed W. Akhter, Ming Liu, Mohamad N. Barakat
    Abstract:

    Objectives We evaluated the magnitude and site of action of the Nesiritide mediated renal vasodilatory effect in patients with heart failure (HF). Background Nesiritide, a recombinant human B-type natriuretic peptide is approved for the treatment of acute decompensated HF and has been shown to exert favorable hemodynamic, neurohormonal, and symptomatic effects. The renal effect of Nesiritide in HF patients has not been well defined. Methods In 15 patients with acute decompensated HF, intravascular Doppler and quantitative angiography of the renal artery were used to assess the effect of Nesiritide on renal artery diameter and velocity time integral as well as renal blood flow and vascular resistance. Nesiritide was administered intravenously at a standard dose of 2 μg/kg bolus followed by a continuous infusion at a rate of 0.01 μg/kg/min. Assessment of Nesiritide effect was made at 15 min. Results Nesiritide infusion was associated with a significant central hemodynamic effect including a fall in mean pulmonary artery pressure (36 ± 12 mm Hg to 31 ± 13 mm Hg, p Conclusions The Nesiritide effect on the renal circulation in patients with HF is complex, with a marked vasodilatory action on the large, conductance renal arteries but a concomitant fall in velocity time integral and no effect on renal vascular resistance or renal blood flow. Lack of increase in renal blood flow may be due to a fall in renal blood pressure or an intrarenal vasoconstrictive effect.

  • effect of Nesiritide versus dobutamine on short term outcomes in the treatment of patients with acutely decompensated heart failure
    Journal of the American College of Cardiology, 2002
    Co-Authors: Marc A Silver, Darlene P Horton, Jalal K Ghali, Uri Elkayam
    Abstract:

    Abstract Objectives This study was designed to determine whether Nesiritide, administered for acute decompensated congestive heart failure (CHF), affects healthcare costs by hospital length of stay (LOS), readmissions and short-term mortality, compared to dobutamine. Background Dobutamine is a commonly used inotropic treatment for CHF. Although dobutamine may have favorable hemodynamic and symptomatic effects, its use may be associated with side effects such as tachycardia, cardiac arrhythmias and myocardial ischemia. Nesiritide (B-type natriuretic peptide) is a new intravenous (IV) drug that produces hemodynamic and symptomatic improvement through balanced vasodilatory effects, neurohormonal suppression and enhanced natriuresis and diuresis. Methods From an open-label randomized study of Nesiritide versus standard care (SC) in patients with CHF requiring hospitalization, we compared short-term outcome data from patients given Nesiritide (0.015 or 0.03 μg/kg per min) with a subgroup of SC patients given dobutamine. A total of 261 patients are included in this analysis. Results Compared to dobutamine, both Nesiritide doses were administered for a shorter total duration (p Conclusions Treatment of decompensated CHF with Nesiritide may lead to lower healthcare costs and reduced mortality compared to treatment with dobutamine.

  • Nesiritide: A New Drug for the Treatment of Decompensated Heart Failure
    Journal of cardiovascular pharmacology and therapeutics, 2002
    Co-Authors: Uri Elkayam, Mohammed Waseem Akhter, Priya Tummala, Salman Khan, Harpreet Singh
    Abstract:

    Nesiritide, a recombinant human B-type natriuretic peptide, is the first in a new drug class for the treatment of decompensated heart failure. The drug binds to receptors in the vasculature, kidney, adrenal gland, and brain, and overcomes resistance to endogenous BNP present in patients with CHF. Nesiritide administration leads to a rapid and balanced vasodilatory effect, which results in a significant decrease in right and left ventricular filling pressures and systemic vascular resistance and at the same time in an increase in stroke volume and cardiac output without a change in heart rate. These early hemodynamic changes result in a rapid improvement in symptoms of heart failure. In addition, Nesiritide lowers aldosterone, catecholamines, and endothelin-1 levels and its effect on the kidney leads to an increased natriuresis and diuresis without effect on serum potassium or renal function. Prior to its approval for clinical use, Nesiritide was studied in 10 different clinical trials involving 941 patients with moderate and severe CHF, including elderly patients, patients with both systolic and diastolic dysfunction, and patients with arrhythmias, renal insufficiency, and acute ischemic syndrome. In comparative studies with available vasoactive therapies frequently used for treatment of patients with decompensated heart failure, Nesiritide was proven comparable in efficacy to inotropic drugs such as dobutamine, but superior in safety. In a recent study, Nesiritide was found to be more effective and better tolerated than the vasodilator, nitroglycerin. The most common side effects expected with the use of Nesiritide are headaches and decrease in blood pressure. At the recommended dose of Nesiritide, headache was reported during the first 24 hours of treatment in 8% of patients and symptomatic hypotension in 4% of patients, compared to 20% and 5% in nitroglycerin-treated patients.

  • comparison of the occurrence of ventricular arrhythmias in patients with acutely decompensated congestive heart failure receiving dobutamine versus Nesiritide therapy
    American Journal of Cardiology, 2001
    Co-Authors: Andrew J. Burger, Uri Elkayam, Darlene P Horton, Jalal K Ghali, Mathew T Neibaur, Herbert Haught, Doron Aronson
    Abstract:

    Ventricular arrhythmias are common in patients with congestive heart failure (CHF) and may be exacerbated by positive inotropic therapy. Because human B-type natriuretic peptide (Nesiritide), an arterial and venodilator, inhibits sympathetic activity, it may decrease the incidence of arrhythmias. Our investigation compares the arrhythmogenicity of dobutamine with Nesiritide. A total of 305 patients with decompensated CHF requiring intravenous vasoactive therapy were randomized to receive standard therapy (n = 102) or Nesiritide (0.015 μg/kg/min [n = 103] or 0.030 μg/kg/min [n = 100]) to gain additional data on the relative safety and efficacy of Nesiritide compared with standard parenteral care. Dobutamine was chosen as the standard care agent in 58 subjects. During study drug infusion, all patients had continuous clinical hemodynamic and electrocardiographic monitoring. The dobutamine and Nesiritide groups were similar with respect to baseline use of antiarrhythmic agents, including β blockers. Serious arrhythmias and the incidence of cardiac arrest were more common in patients who received dobutamine than in those taking Nesiritide: sustained ventricular tachycardia, 4 (7%) versus 2 (1%), respectively (p = 0.014); nonsustained ventricular tachycardia, 10 (17%) versus 23 (11%), respectively (p = 0.029); cardiac arrest, 3 (5%) versus 0, respectively (p = 0.011). We conclude that among patients with decompensated CHF for whom dobutamine is selected as standard therapy, the incidence of serious ventricular arrhythmias and cardiac arrest is significantly greater than the incidence of these events in patients randomized to Nesiritide.

Clyde W. Yancy - One of the best experts on this subject based on the ideXlab platform.

  • safety and efficacy of outpatient Nesiritide in patients with advanced heart failure results of the second follow up serial infusions of Nesiritide fusion ii trial
    Circulation-heart Failure, 2008
    Co-Authors: Clyde W. Yancy, Marc A Silver, Henry Krum, Barry M. Massie, Lynne W. Stevenson, Mei Cheng, Sun Sook Kim, Rosemary Evans
    Abstract:

    BACKGROUND Patients with American College of Cardiology/American Heart Association stage C/D heart failure experience substantial morbidity and mortality, but available interventions beyond standard medical and device therapies are limited. Nesiritide relieves dyspnea and reduces pulmonary congestion, but its risk profile is uncertain. Pilot data suggested a potential benefit of Nesiritide given as serial outpatient infusions. METHODS AND RESULTS The Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial was a randomized, double-blind, placebo-controlled trial of outpatient serial Nesiritide infusions for patients with American College of Cardiology/American Heart Association stage C/D heart failure. Patients with 2 recent heart failure hospitalizations, ejection fraction <40%, and New York Heart Association class IV symptoms, or New York Heart Association class III symptoms with creatinine clearance <60 mL/min, were randomized to Nesiritide (2-microg/kg bolus plus 0.01-microg/kg-per-minute infusion for 4 to 6 hours) or matching placebo, once or twice weekly for 12 weeks. All patients were treated to optimal goals with evidence-based medical/device therapy facilitated by careful disease management during the study. The primary end point was time to all-cause death or cardiovascular or renal hospitalization at 12 weeks. A total of 911 patients were randomized and treated. The primary end point occurred in 36.8% and 36.7% of the placebo and Nesiritide groups, respectively (hazard ratio, 1.03; 95% confidence interval, 0.82 to 1.3; log-rank test P=0.79). There were no statistically significant differences between groups in any of the secondary end points, including the number of cardiovascular or renal hospitalizations, the number of days alive and out of the hospital, change in Kansas City Cardiomyopathy Questionnaire score, or cardiovascular death. Adverse events were similar between groups; Nesiritide was associated with more hypotension but less predefined worsening renal function. CONCLUSIONS Serial outpatient Nesiritide infusions do not provide a demonstrable clinical benefit over intensive outpatient management of patients with advanced American College of Cardiology/American Heart Association stage C/D heart failure.

  • safety and efficacy of outpatient Nesiritide in patients with advanced heart failureclinical perspective
    Circulation-heart Failure, 2008
    Co-Authors: Clyde W. Yancy, Marc A Silver, Henry Krum, Barry M. Massie, Lynne W. Stevenson, Mei Cheng, Sun Sook Kim, Rosemary Evans
    Abstract:

    Background— Patients with American College of Cardiology/American Heart Association stage C/D heart failure experience substantial morbidity and mortality, but available interventions beyond standard medical and device therapies are limited. Nesiritide relieves dyspnea and reduces pulmonary congestion, but its risk profile is uncertain. Pilot data suggested a potential benefit of Nesiritide given as serial outpatient infusions. Methods and Results— The Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial was a randomized, double-blind, placebo-controlled trial of outpatient serial Nesiritide infusions for patients with American College of Cardiology/American Heart Association stage C/D heart failure. Patients with 2 recent heart failure hospitalizations, ejection fraction <40%, and New York Heart Association class IV symptoms, or New York Heart Association class III symptoms with creatinine clearance <60 mL/min, were randomized to Nesiritide (2-μg/kg bolus plus 0.01-μg/kg-per-minute infusion for 4 to 6 hours) or matching placebo, once or twice weekly for 12 weeks. All patients were treated to optimal goals with evidence-based medical/device therapy facilitated by careful disease management during the study. The primary end point was time to all-cause death or cardiovascular or renal hospitalization at 12 weeks. A total of 911 patients were randomized and treated. The primary end point occurred in 36.8% and 36.7% of the placebo and Nesiritide groups, respectively (hazard ratio, 1.03; 95% confidence interval, 0.82 to 1.3; log-rank test P =0.79). There were no statistically significant differences between groups in any of the secondary end points, including the number of cardiovascular or renal hospitalizations, the number of days alive and out of the hospital, change in Kansas City Cardiomyopathy Questionnaire score, or cardiovascular death. Adverse events were similar between groups; Nesiritide was associated with more hypotension but less predefined worsening renal function. Conclusions— Serial outpatient Nesiritide infusions do not provide a demonstrable clinical benefit over intensive outpatient management of patients with advanced American College of Cardiology/American Heart Association stage C/D heart failure. Received January 17, 2008; accepted February 5, 2008.

  • acutely decompensated heart failure in a county emergency department a double blind randomized controlled comparison of Nesiritide versus placebo treatment
    Annals of Emergency Medicine, 2008
    Co-Authors: Adam H Miller, Shameem R Nazeer, Paul E Pepe, Barbi Estes, April R Gorman, Clyde W. Yancy
    Abstract:

    Study objective Acutely decompensated congestive heart failure is a major cause of emergency department (ED) visits in county hospitals. This often underserved population has a high rate of return visits to the ED for heart failure. Nesiritide has been demonstrated to relieve symptoms of acutely decompensated congestive heart failure. We examined the effect of an 8-hour infusion of Nesiritide on the composite of return to the ED or hospitalization at 30 days. Methods A prospective, randomized, double-blinded, placebo-controlled trial of Nesiritide plus protocol-specified standard therapy versus standard therapy done in the ED for acutely decompensated congestive heart failure. Results One hundred one patients were randomized during a 16-month enrollment period. Sixty-six percent of the patients were men and 34% were women. Fifty-six percent were black; all patients had New York Heart Association class II to IV heart failure and most had dyspnea at rest or with minimal exertion. Complete follow-up data were available in 97 of 101 patients. After the 8-hour treatment period, acute symptom relief was experienced in 95.7% of the Nesiritide group (95% confidence interval [CI] 88.9% to 100%) versus 86.8% of the placebo group (95% CI 72% to 98.9%), with an absolute difference between the 2 groups of 8.9% (95% CI –3.3% to 24.2%). Diuresis was similar between the 2 groups, but hypotension occurred more frequently in the Nesiritide-treated group. The primary outcome measure of return visit to the ED or hospitalization at 30 days was higher for Nesiritide (41.5%) than placebo (39.6%; absolute difference 1.9%; 95% CI –17.2% to 21.1%). There was only 1 death. No measurable change in renal function was observed. Conclusion Administration of Nesiritide for acutely decompensated congestive heart failure in a county ED was no better than standard therapy alone for return to the ED or hospitalization at 30 days.

  • Safety and Efficacy of Outpatient Nesiritide in Patients With Advanced Heart Failure Results of the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) Trial
    Circulation. Heart failure, 2008
    Co-Authors: Clyde W. Yancy, Marc A Silver, Henry Krum, Barry M. Massie, Lynne W. Stevenson, Mei Cheng, Sun Sook Kim, Rosemary Evans
    Abstract:

    BACKGROUND Patients with American College of Cardiology/American Heart Association stage C/D heart failure experience substantial morbidity and mortality, but available interventions beyond standard medical and device therapies are limited. Nesiritide relieves dyspnea and reduces pulmonary congestion, but its risk profile is uncertain. Pilot data suggested a potential benefit of Nesiritide given as serial outpatient infusions. METHODS AND RESULTS The Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial was a randomized, double-blind, placebo-controlled trial of outpatient serial Nesiritide infusions for patients with American College of Cardiology/American Heart Association stage C/D heart failure. Patients with 2 recent heart failure hospitalizations, ejection fraction

  • Benefit-risk assessment of Nesiritide in the treatment of acute decompensated heart failure.
    Drug safety, 2007
    Co-Authors: Clyde W. Yancy
    Abstract:

    Nesiritide is a recombinant form of human B-type natriuretic peptide, a naturally occurring endogenous hormone released by cardiac ventricles in response to an increase in ventricular wall stress. Its use in the treatment of acute decompensated heart failure (ADHF) has been evaluated in a series of randomised controlled clinical trials. It is currently approved in the US for the treatment of ADHF. Nesiritide induces a balanced vasodilation and an indirect increase in cardiac output, but has no actual inotropic effects and exerts a neutral effect on heart rate. In addition, it inhibits adverse neurohormonal activation and, in some individuals, promotes natriuresis and diuresis. In adults with ADHF, Nesiritide reduces pulmonary capillary wedge pressure, right atrial pressure and systemic vascular resistance; decreases symptoms of heart failure; and enhances global clinical status. Important questions regarding the risks of Nesiritide therapy have recently been raised, and resolution of the safety of Nesiritide is a process that remains in evolution. The most frequently reported adverse effect is dose-related hypotension. In addition, Nesiritide may cause an acute increase in serum creatinine concentration. This increase seems to be a haemodynamic response to a combination of volume depletion, vasodilation and neurohormonal inhibition. Nesiritide-induced changes in renal function have not been definitively shown to negatively affect mortality. The effect of Nesiritide on all-cause mortality is currently unresolved. Recent meta-analyses of existing databases have raised concerns regarding adverse effects of the drug on 30-day mortality. However, reviews of large, observational, registry databases do not suggest an adverse inpatient mortality effect compared with other vasodilator therapies. Further resolution of the mortality question awaits completion of pending randomised controlled clinical trials.

Marc A Silver - One of the best experts on this subject based on the ideXlab platform.

  • safety and efficacy of outpatient Nesiritide in patients with advanced heart failure results of the second follow up serial infusions of Nesiritide fusion ii trial
    Circulation-heart Failure, 2008
    Co-Authors: Clyde W. Yancy, Marc A Silver, Henry Krum, Barry M. Massie, Lynne W. Stevenson, Mei Cheng, Sun Sook Kim, Rosemary Evans
    Abstract:

    BACKGROUND Patients with American College of Cardiology/American Heart Association stage C/D heart failure experience substantial morbidity and mortality, but available interventions beyond standard medical and device therapies are limited. Nesiritide relieves dyspnea and reduces pulmonary congestion, but its risk profile is uncertain. Pilot data suggested a potential benefit of Nesiritide given as serial outpatient infusions. METHODS AND RESULTS The Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial was a randomized, double-blind, placebo-controlled trial of outpatient serial Nesiritide infusions for patients with American College of Cardiology/American Heart Association stage C/D heart failure. Patients with 2 recent heart failure hospitalizations, ejection fraction <40%, and New York Heart Association class IV symptoms, or New York Heart Association class III symptoms with creatinine clearance <60 mL/min, were randomized to Nesiritide (2-microg/kg bolus plus 0.01-microg/kg-per-minute infusion for 4 to 6 hours) or matching placebo, once or twice weekly for 12 weeks. All patients were treated to optimal goals with evidence-based medical/device therapy facilitated by careful disease management during the study. The primary end point was time to all-cause death or cardiovascular or renal hospitalization at 12 weeks. A total of 911 patients were randomized and treated. The primary end point occurred in 36.8% and 36.7% of the placebo and Nesiritide groups, respectively (hazard ratio, 1.03; 95% confidence interval, 0.82 to 1.3; log-rank test P=0.79). There were no statistically significant differences between groups in any of the secondary end points, including the number of cardiovascular or renal hospitalizations, the number of days alive and out of the hospital, change in Kansas City Cardiomyopathy Questionnaire score, or cardiovascular death. Adverse events were similar between groups; Nesiritide was associated with more hypotension but less predefined worsening renal function. CONCLUSIONS Serial outpatient Nesiritide infusions do not provide a demonstrable clinical benefit over intensive outpatient management of patients with advanced American College of Cardiology/American Heart Association stage C/D heart failure.

  • safety and efficacy of outpatient Nesiritide in patients with advanced heart failureclinical perspective
    Circulation-heart Failure, 2008
    Co-Authors: Clyde W. Yancy, Marc A Silver, Henry Krum, Barry M. Massie, Lynne W. Stevenson, Mei Cheng, Sun Sook Kim, Rosemary Evans
    Abstract:

    Background— Patients with American College of Cardiology/American Heart Association stage C/D heart failure experience substantial morbidity and mortality, but available interventions beyond standard medical and device therapies are limited. Nesiritide relieves dyspnea and reduces pulmonary congestion, but its risk profile is uncertain. Pilot data suggested a potential benefit of Nesiritide given as serial outpatient infusions. Methods and Results— The Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial was a randomized, double-blind, placebo-controlled trial of outpatient serial Nesiritide infusions for patients with American College of Cardiology/American Heart Association stage C/D heart failure. Patients with 2 recent heart failure hospitalizations, ejection fraction <40%, and New York Heart Association class IV symptoms, or New York Heart Association class III symptoms with creatinine clearance <60 mL/min, were randomized to Nesiritide (2-μg/kg bolus plus 0.01-μg/kg-per-minute infusion for 4 to 6 hours) or matching placebo, once or twice weekly for 12 weeks. All patients were treated to optimal goals with evidence-based medical/device therapy facilitated by careful disease management during the study. The primary end point was time to all-cause death or cardiovascular or renal hospitalization at 12 weeks. A total of 911 patients were randomized and treated. The primary end point occurred in 36.8% and 36.7% of the placebo and Nesiritide groups, respectively (hazard ratio, 1.03; 95% confidence interval, 0.82 to 1.3; log-rank test P =0.79). There were no statistically significant differences between groups in any of the secondary end points, including the number of cardiovascular or renal hospitalizations, the number of days alive and out of the hospital, change in Kansas City Cardiomyopathy Questionnaire score, or cardiovascular death. Adverse events were similar between groups; Nesiritide was associated with more hypotension but less predefined worsening renal function. Conclusions— Serial outpatient Nesiritide infusions do not provide a demonstrable clinical benefit over intensive outpatient management of patients with advanced American College of Cardiology/American Heart Association stage C/D heart failure. Received January 17, 2008; accepted February 5, 2008.

  • Safety and Efficacy of Outpatient Nesiritide in Patients With Advanced Heart Failure Results of the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) Trial
    Circulation. Heart failure, 2008
    Co-Authors: Clyde W. Yancy, Marc A Silver, Henry Krum, Barry M. Massie, Lynne W. Stevenson, Mei Cheng, Sun Sook Kim, Rosemary Evans
    Abstract:

    BACKGROUND Patients with American College of Cardiology/American Heart Association stage C/D heart failure experience substantial morbidity and mortality, but available interventions beyond standard medical and device therapies are limited. Nesiritide relieves dyspnea and reduces pulmonary congestion, but its risk profile is uncertain. Pilot data suggested a potential benefit of Nesiritide given as serial outpatient infusions. METHODS AND RESULTS The Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial was a randomized, double-blind, placebo-controlled trial of outpatient serial Nesiritide infusions for patients with American College of Cardiology/American Heart Association stage C/D heart failure. Patients with 2 recent heart failure hospitalizations, ejection fraction

  • Nesiritide added to standard care favorably reduces systolic blood pressure compared with standard care alone in patients with acute decompensated heart failure
    American Journal of Emergency Medicine, 2005
    Co-Authors: Franklin W Peacock, Charles L. Emerman, Marc A Silver
    Abstract:

    Abstract The Prospective Randomized Outcomes study of Acutely decompensated Congestive heart failure Treated Initially as Outpatients with Nesiritide (PROACTION) trial evaluated the safety of Nesiritide administration in the emergency department in patients with decompensated heart failure. Patients (N = 237) were treated for at least 12 hours with standard care plus either intravenous Nesiritide or placebo. Compared to placebo, Nesiritide favorably decreased systolic blood pressure (SBP) in patients with elevated baseline SBP, without negatively impacting patients with lower baseline SBP (SBP, >140 mm Hg: Nesiritide, −28.7 mm Hg, vs placebo, −8.4 mm Hg [ P P P

  • safety and feasibility of using serial infusions of Nesiritide for heart failure in an outpatient setting from the fusion i trial
    American Journal of Cardiology, 2004
    Co-Authors: Clyde W. Yancy, Ron M. Oren, Darlene P Horton, Mitchell T Saltzberg, Robert Berkowitz, Barry D Bertolet, Krishnaswami Vijayaraghavan, Kenneth Burnham, Kirk W Walker, Marc A Silver
    Abstract:

    The Follow-Up Serial Infusions of Nesiritide pilot study was designed to assess the safety and tolerability of outpatient serial infusions of Nesiritide in 210 patients with decompensated heart failure who were randomly assigned to usual care only or usual care plus weekly infusions of Nesiritide at dosages of 0.005 or 0.01 μg/kg/min for 12 weeks. The mean age ± SD of the entire population was 67 ± 13 years; 70% were men, and 80% were white. Mean baseline serum creatinine levels were 1.8 ± 0.7 mg/dl, and mean left ventricular ejection fraction was 0.28 ± 0.15%. Diabetes mellitus was present in 106 patients (50%), and atrial arrhythmias were present in 100 patients (48%). A totalof 1,645 Nesiritide infusions was administered; 11 (

Roger M. Mills - One of the best experts on this subject based on the ideXlab platform.

  • Natriuretic and neurohormonal responses to Nesiritide, furosemide, and combined Nesiritide and furosemide in patients with stable systolic dysfunction.
    Clinical cardiology, 2010
    Co-Authors: Domenic A. Sica, Ron M. Oren, Mildred D. Gottwald, Roger M. Mills
    Abstract:

    Background In patients with heart failure, few data describe the neurohormonal response to Nesiritide and furosemide either alone or in combination. This study systematically compared the effects of Nesiritide, furosemide, and their combination on natriuresis/diuresis and plasma aldosterone in patients with chronic stable heart failure who were relatively diuretic resistant. Hypothesis Natriuretic, diuretic, and neurohormonal responses to furosemide and Nesiritide will differ when these agents are administered alone vs. in combination. Methods Twenty-eight subjects completed a multicenter, open-label, three-arm crossover study. Each subject received the following treatments in random order on alternate days: (1) furosemide, 40 mg intravenous bolus; (2) Nesiritide, 2 µg/kg intravenous bolus followed by a 0.01 µg/kg/min infusion for 6 hours; (3) both furosemide and Nesiritide, with furosemide given at least 15 minutes after initiation of Nesiritide. Results Plasma aldosterone increased by 2.2 ± 1.6 ng/dL after furosemide alone, decreased by 3.9 ± 1.6 ng/dL after Nesiritide alone (P = 0.005 vs furosemide alone and P = 0.56 vs furosemide plus Nesiritide), and decreased by 2.8 ± 1.6 ng/dL after furosemide plus Nesiritide (P = 0.02 vs furosemide alone). Conclusions Furosemide alone produced natriuresis/diuresis and a prompt rise in plasma aldosterone values. Nesiritide alone produced no significant natriuresis/diuresis, but decreased plasma aldosterone values. When furosemide was administered on a background of Nesiritide infusion, the observed natriuresis/diuresis was similar to that seen with furosemide alone, without the anticipated increase in plasma aldosterone observed with furosemide alone. Copyright © 2010 Wiley Periodicals, Inc.

  • Impact of acute serum creatinine elevation in patients treated with Nesiritide.
    Clinical cardiology, 2009
    Co-Authors: Uri Elkayam, J. Thomas Heywood, Munir Janmohamed, Parta Hatamizadeh, Lee-jen Wei, Roger M. Mills
    Abstract:

    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.

  • BNP" for heart failure: role of Nesiritide in cardiovascular therapeutics.
    Congestive heart failure (Greenwich Conn.), 2002
    Co-Authors: Roger M. Mills, Robert E. Hobbs, James B. Young
    Abstract:

    B-type natriuretic peptide, or Nesiritide, recently gained US Food and Drug Administration approval as the first new parenteral agent approved for heart failure therapy in more than a decade. Nesiritide refers to a peptide identical to endogenous B-type natriuretic peptide, currently manufactured by recombinant DNA technology. Nesiritide has been evaluated in clinical trials involving more than 700 subjects. The drug produces a prompt fall in systemic vascular resistance and pulmonary capillary wedge pressure, associated with rapid clinical improvement in decompensated heart failure. Nesiritide represents an attractive choice for “first-line therapy” of acutely decompensated heart failure patients. In this review, the authors summarize the currently available data regarding the use of Nesiritide, and offer recommendations for its use based on our experience with the compound in clinical trials.

  • Therapeutic potential of Nesiritide (recombinant b-type natriuretic peptide) in the treatment of heart failure.
    Expert opinion on investigational drugs, 1999
    Co-Authors: Robert E. Hobbs, Roger M. Mills
    Abstract:

    This review outlines the chemical properties, pharmacology and clinical trials data which support the development of Nesiritide (synthetic human B-type natriuretic peptide, or hBNP) as a therapeutic agent for patients with decompensated congestive heart failure. Nesiritide is a 32-amino acid peptide, structurally identical to endogenous hBNP. Clinical trials with single bolus, repeated boluses and sustained infusions of Nesiritide have demonstrated prompt, significant and sustained reductions in pulmonary capillary wedge pressure and increases in cardiac output, consistent with a direct vasodilator effect. Nesiritide has a short half-life, approximately 18 min, which is not dependent upon renal function. It not associated with tachyphylaxis through 24 h of therapy. Nesiritide is not an inotrope, and its action is not dependent upon beta adrenergic receptors. The safety profile has been excellent; the major adverse effect is hypotension. The frequency of ventricular arrhythmia is not increased in patients ...

Charles L. Emerman - One of the best experts on this subject based on the ideXlab platform.

  • Outcomes associated with Nesiritide administration for acute decompensated heart failure in the emergency department observation unit: a single center experience.
    Congestive Heart Failure, 2009
    Co-Authors: Joseph F. Styron, Charles L. Emerman, Randall C Starling, Preeti Jois-bilowich, T. Tallman, W. Frank Peacock
    Abstract:

    The authors’ purpose was to determine 30- and 180-day readmission and mortality rates for acutely decompensated heart failure patients receiving Nesiritide in the emergency department observation unit. The authors conducted a retrospective evaluation of all patients admitted to the emergency department observation unit, stratified by Nesiritide administration, from January 2002 to January 2004. Eligible patients had a primary diagnosis of acutely decompensated heart failure. Observation unit treatment was by previously published protocols, except for Nesiritide administration, which was per attending physician choice. Of 595 patients, 196 (33%) received Nesiritide. The crude and adjusted odds ratios comparing readmission rates and mortality rates of the Nesiritide group with the control group failed to demonstrate significant differences at either the 30- or the 180-day endpoints. The use of Nesiritide for acute decompensated heart failure in the emergency department observation unit is not associated with mortality or readmission differences compared with standard therapy alone.

  • Nesiritide added to standard care favorably reduces systolic blood pressure compared with standard care alone in patients with acute decompensated heart failure
    American Journal of Emergency Medicine, 2005
    Co-Authors: Franklin W Peacock, Charles L. Emerman, Marc A Silver
    Abstract:

    Abstract The Prospective Randomized Outcomes study of Acutely decompensated Congestive heart failure Treated Initially as Outpatients with Nesiritide (PROACTION) trial evaluated the safety of Nesiritide administration in the emergency department in patients with decompensated heart failure. Patients (N = 237) were treated for at least 12 hours with standard care plus either intravenous Nesiritide or placebo. Compared to placebo, Nesiritide favorably decreased systolic blood pressure (SBP) in patients with elevated baseline SBP, without negatively impacting patients with lower baseline SBP (SBP, >140 mm Hg: Nesiritide, −28.7 mm Hg, vs placebo, −8.4 mm Hg [ P P P

  • Observation unit treatment of heart failure with Nesiritide: Results from the proaction trial
    The Journal of emergency medicine, 2005
    Co-Authors: William F. Peacock, R. Holland, R. Gyarmathy, L. Dunbar, Marc Klapholz, D. P. Horton, G. De Lissovoy, Charles L. Emerman
    Abstract:

    This was a multicenter, randomized, double-blind, placebo-controlled pilot study, evaluating the safety and efficacy of a standard care treatment regimen with the addition of either Nesiritide or placebo (SCP) in 237 Emergency Department (ED)/Observation Unit (OU) patients with decompensated heart failure (HF). Efficacy measures included initial admission, length of hospital stay (LOS), and inpatient rehospitalization through 30 days. Compared to the standard care group, patients who also received Nesiritide had 11% fewer inpatient hospital admissions at the index ED visit (55% SCP, 49% Nesiritide, p = 0.436), and 57% fewer inpatient hospitalizations within 30 days after discharge from the index hospitalization (23% SCP, 10% Nesiritide, p = 0.058). The duration of rehospitalization was shorter for Nesiritide patients (median LOS 2.5 vs. 6.5 days, p = 0.032). The incidence of symptomatic hypotension was low and did not differ between the groups. This study showed that Nesiritide is safe when used in the emergency department, observation units, or similar settings.

  • the efficacy and safety of b type natriuretic peptide Nesiritide in patients with renal insufficiency and acutely decompensated congestive heart failure
    Nephrology Dialysis Transplantation, 2004
    Co-Authors: Javed Butler, Charles L. Emerman, Frank W Peacock, Vandana Mathur, James B. Young
    Abstract:

    Background. Nesiritide (B-type natriuretic peptide) reduces preload and afterload, and causes natriuresis, diuresis and suppression of norepinephrine, endothelin-1 and aldosterone. In this study, we sought to explore the safety and efficacy of Nesiritide in patients with acute congestive heart failure (CHF) and renal insufficiency (RI). Methods. We studied the effects of Nesiritide in patients with RI in the VMAC trial database, a multi-centre, randomized controlled trial (n ¼ 489) of patients with acute decompensated CHF. Results. The mean serum creatinine (SCr) in Nesiritidetreated patients with RI (SCr � 2.0 mg/dl, n ¼ 60, range 2.0–11.1 mg/dl) and without RI (SCr < 2.0 mg/dl, n ¼ 209) was 3.0±1.51 and 1.2±0.34 mg/dl, respectively. Pulmonary capillary wedge pressure (PCWP) was reduced significantly and similarly in both RI and no RI groups starting at 15 min into Nesiritide infusion from a baseline of 29.9±8.1 and 26.6±6.0 mmHg, respectively. Addition of placebo to standard therapies yielded no further improvement in PCWP in patients with RI; in contrast, Nesiritide significantly reduced PCWP at every time point during 24 h. The effects of nitroglycerin were less robust than those of Nesiritide, and PCWP was not significantly reduced by nitroglycerin at the 3 h primary end-point. At 24 h, 83% of the RI patients and 91% of patients without RI treated with Nesiritide reported improvements in dyspnoea. Nesiritide was well tolerated in patients with RI and no RI, and renal function was preserved in both groups. Conclusions. In patients with RI, Nesiritide was safe and improved haemodynamics and dyspnoea.

  • Nesiritide in congestive heart failure associated with acute coronary syndromes: a pilot study of safety and efficacy
    Journal of cardiac failure, 2004
    Co-Authors: W. Frank Peacock, Charles L. Emerman, James B. Young
    Abstract:

    Abstract Background To compare the safety and efficacy of Nesiritide versus intravenous nitroglycerin (NTG) in patients with acute coronary syndromes enrolled in the Vasodilation in the Management of Acute Congestive heart failure trial. Methods and results Retrospective review of Vasodilation in the Management of Acute Congestive heart failure trial data for heart failure associated with prospectively diagnosed acute coronary syndromes. Sixty-one patients were included; 34 received Nesiritide and 27 received NTG. Pulmonary capillary wedge pressure was measured in right heart–catheterized patients (11 Nesiritide, 9 NTG). Death at 6 months occurred in 2 Nesiritide and 5 NTG patients ( P  > .2). Hypotension occurred in 4 Nesiritide and 3 NTG patients ( P  > .6). At 24 hours, pulmonary capillary wedge pressure improvements persisted ( P  = .001) in the Nesiritide group, whereas the NTG group had returned to baseline ( P  > .1). In non–right heart–catheterized patients, 24-hour dyspnea scores were at least moderately improved in all Nesiritide and 71% of NTG ( P  = .031). At least minimal dyspnea improvement was seen in 100% of Nesiritide versus 71% of NTG patients ( P  > .3), and 6-hour global clinical scores were at least moderately better in 75% of Nesiritide versus 32% of NTG ( P  = .031). In non–right heart–catheterized patients, there were no 30-day readmissions with Nesiritide versus 17% with NTG ( P  > .2). Conclusions Nesiritide is as safe as NTG in heart failure patients with acute coronary syndromes.