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Pharmacotherapy Oct 2006Nesiritide is the recombinant form of human B-type (brain) natriuretic peptide (BNP), and its amino acid sequence is identical to that of endogenous human BNP.... (Review)
Review
Nesiritide is the recombinant form of human B-type (brain) natriuretic peptide (BNP), and its amino acid sequence is identical to that of endogenous human BNP. Administration of nesiritide results in venous and arterial vasodilation, as well as enhanced diuresis. Given the many limitations of therapies previously available for the treatment of acute decompensated heart failure, the anticipation was that nesiritide would offer a safer and more effective therapeutic option. Recently, two meta-analyses raised the question of safety with nesiritide therapy, specifically an increased risk of renal dysfunction and mortality. Although several studies generated information regarding the potential role of nesiritide in various settings, the questions raised by the meta-analyses are concerning. Our hope is that future clinical trials will address the concerns raised and provide a better understanding of the role of nesiritide in the management of acute decompensated heart failure. Until these data are available, nesiritide use should be limited.
Topics: Acute Disease; Heart Failure; Humans; Kidney; Length of Stay; Natriuretic Agents; Natriuretic Peptide, Brain
PubMed: 16999657
DOI: 10.1592/phco.26.10.1465 -
Journal of Cardiovascular Pharmacology... Sep 2006Standard therapy for acute decompensated heart failure, a major health problem, consists of intravenous diuretics, vasodilators, and positive inotropic agents.... (Review)
Review
Standard therapy for acute decompensated heart failure, a major health problem, consists of intravenous diuretics, vasodilators, and positive inotropic agents. Nesiritide, a recombinant form of human B-type natriuretic peptide, is the only drug specifically approved for this indication. Recent meta-analyses have reported an increased risk of worsening renal function and 30-day mortality with nesiritide administration. These data understandably require physicians to carefully reevaluate their current use of nesiritide in patients with acute decompensated heart failure. In performing this reevaluation, it is important to consider our understanding of the underlying disease state, the limitations and results of these meta-analyses, and new data that provide additional insight into the possible risks and benefits associated with nesiritide therapy. Until additional therapeutic trials are conducted, therapeutic choices must be based on symptomatic and hemodynamic improvement and limited, imperfect available data, which may continue to support the use of nesiritide for its established indication.
Topics: Acute Disease; Creatinine; Decision Making; Heart Failure; Humans; Meta-Analysis as Topic; Natriuretic Agents; Natriuretic Peptide, Brain; Randomized Controlled Trials as Topic; Renal Insufficiency; Research Design; Risk Assessment; Risk Factors
PubMed: 17056828
DOI: 10.1177/1074248406291155 -
American Journal of Therapeutics 2017To evaluate the therapeutic effects of dobutamine and nesiritide in the treatment of heart failure (HF), a meta-analysis of published studies was conducted. Computerized... (Meta-Analysis)
Meta-Analysis Review
To evaluate the therapeutic effects of dobutamine and nesiritide in the treatment of heart failure (HF), a meta-analysis of published studies was conducted. Computerized bibliographic databases in Chinese and English languages were carefully searched to identify the relevant literature. A total of 6 cohort studies were enrolled in current meta-analysis for statistical analyses. The effect of dobutamine and nesiritide in patients with HF was estimated by odds ratios (ORs) and 95% confidence interval (CI). Our results revealed a significantly higher survival rate in nesiritide-treated patients, compared with those treated with dobutamine (OR = 1.97; 95% CI, 1.43-2.71; P < 0.001). In addition, a lower readmission rate was also associated with the nesiritide-treated group in comparison with the dobutamine-treated group (OR = 1.96; 95% CI, 1.39-2.78; P < 0.001). A stratified analysis revealed that the subgroup of patients with HF treated with nesiritide showed higher survival outcomes than those patients with HF treated with dobutamine when follow-up period was greater than 6 months (OR = 1.70; 95% CI, 1.21-2.38; P = 0.002) but not under 6 months (P > 0.05). This indicated that nesiritide treatment had longer term benefits as well. Interestingly, based on the reason for readmission, a subgroup analysis of the HF subgroup and the "all-cause" subgroup showed that higher readmission rates were associated with dobutamine treatment in both subgroups (HF: OR = 2.71; 95% CI, = 1.51-4.83; P = 0.001; all-cause: OR = 1.64; 95% CI, 1.06-2.53; P = 0.026; respectively). Our results suggest that nesiritide therapy is associated with a lower in-hospital mortality rates and decreased readmission rates compared with dobutamine treatment in patients with HF.
Topics: Cardiotonic Agents; Dobutamine; Heart Failure; Hospital Mortality; Humans; Natriuretic Agents; Natriuretic Peptide, Brain; Odds Ratio; Patient Readmission; Survival Rate
PubMed: 26164026
DOI: 10.1097/MJT.0000000000000278 -
Expert Opinion on Pharmacotherapy Apr 2004Nesiritide (Natrecor) is a recombinant form of the human B-type natriuretic peptide (BNP) that has been shown, through several studies, to have beneficial natriuretic,... (Review)
Review
Nesiritide (Natrecor) is a recombinant form of the human B-type natriuretic peptide (BNP) that has been shown, through several studies, to have beneficial natriuretic, diuretic and vasodilatory effects in the treatment of congestive heart failure (CHF). Nesiritide mimics the actions of endogenous BNP by binding to and stimulating receptors in the heart, kidney and vasculature. Nesiritide functions as both a potent venous and arterial vasodilator and has been shown to improve cardiac haemodynamics more rapidly and to a greater extent than intravenous nitroglycerin, as well as having fewer side effects. When compared in an open-label trial, nesiritide has also been shown to be less proarrhythmic than dobutamine. The major adverse effect of nesiritide, as with other vasodilators, is symptomatic hypotension, which occurred infrequently in clinical trials. Overall, nesiritide represents an effective and safe therapeutic option for the treatment of decompensated CHF.
Topics: Diuretics; Heart Failure; Humans; Natriuretic Agents; Natriuretic Peptide, Brain; Randomized Controlled Trials as Topic; Vasodilator Agents
PubMed: 15102572
DOI: 10.1517/14656566.5.4.901 -
The Canadian Journal of Cardiology Jul 2008Nesiritide is an effective therapy in decreasing symptoms and left ventricular filling pressure in patients with acute decompensated heart failure. Health Canada has... (Meta-Analysis)
Meta-Analysis Review
Nesiritide is an effective therapy in decreasing symptoms and left ventricular filling pressure in patients with acute decompensated heart failure. Health Canada has recently approved this agent for the management of this patient population. The clinical trials to date using nesiritide for the management of decompensated heart failure have been summarized. The clinical experience including indications for use, contraindications, dosage and monitoring has been reviewed. The following should serve as a general guide for the clinical use of nesiritide.
Topics: Acute Disease; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Heart Failure; Humans; Infusions, Intravenous; Male; Natriuretic Agents; Natriuretic Peptide, Brain; Nitroglycerin; Prognosis; Randomized Controlled Trials as Topic; Risk Assessment; Survival Analysis; Treatment Outcome
PubMed: 18629384
DOI: 10.1016/s0828-282x(08)71025-0 -
Circulation. Heart Failure Aug 2018
Topics: Biomarkers, Pharmacological; Clinical Trials as Topic; Endpoint Determination; Evidence-Based Medicine; Heart Failure; Humans; Natriuretic Agents; Natriuretic Peptide, Brain; Recovery of Function; Treatment Outcome
PubMed: 30354567
DOI: 10.1161/CIRCHEARTFAILURE.118.005440 -
Expert Opinion on Drug Metabolism &... Jul 2009Heart failure afflicts > 5 million patients in the US, with about 550,000 new diagnoses a year. Side effects and increased mortality limit heart failure treatment.... (Review)
Review
BACKGROUND
Heart failure afflicts > 5 million patients in the US, with about 550,000 new diagnoses a year. Side effects and increased mortality limit heart failure treatment. Nesiritide is the newest addition to therapeutic options for treatment of acute decompensated heart failure (ADHF). It has been used as single in-patient infusions, multiple out-patient infusions, and perioperatively to improve hemodynamics and promote diuresis. Initially well-received, meta-analyses suggesting increased mortality and renal dysfunction after nesiritide use were published 4 - 5 years after its introduction in the US. These reports prompted new recommendations on nesiritide use by an expert panel.
OBJECTIVE
Critical review of the studies leading to approval of nesiritide and the current recommendations for its use.
METHODS
Medline search and Pubmed search using nesiritide or natrecor for text word searches.
CONCLUSION
Nesiritide represents the first drug in a new class designed for treatment of ADHF. In patients with ADHF, nesiritide improves hemodynamic parameters and reduces dyspnea. Questions remain about possible increased mortality and side effects. A continuing study expected to enroll 7000 patients by 2010 has been designed to clarify whether nesiritide reduces mortality, hospital length-of-stay and renal parameters in patients with ADHF.
Topics: Animals; Heart Failure; Humans; Length of Stay; Natriuretic Peptide, Brain; Randomized Controlled Trials as Topic
PubMed: 19538002
DOI: 10.1517/17425250903042300 -
Cardiovascular Toxicology 2003Human BNP serves to compensate for deteriorating cardiac function causing preload and afterload reductions, natriuresis, diuresis, suppression of the... (Review)
Review
Human BNP serves to compensate for deteriorating cardiac function causing preload and afterload reductions, natriuresis, diuresis, suppression of the renin-angiotensin-aldosterone system (RAAS) and endothelin-1, and lowering of norepinephrine. Based on its unique pharmacologic profile, nesiritide results in clinically significant balanced vasodilation of arteries and veins, and may be well suited for patients presenting with various scenarios of decompensated CHF usually due to volume overload (NYHA classes II-IV). More than 1000 subjects have participated in clinical trials with nesiritide and more than 55,000 patients have been treated with nesiritide since it was approved for use in August 2001. Unlike nitroglycerin, tachyphylaxis did not appear to occur with Natrecor. The complete efficacy profile of nesiritide included preload reduction (PCWP and RAP), reductions in pulmonary artery pressures, afterload reduction (systemic vascular resistance), and increases in cardiac index and stroke volume index (which are dose-dependent and not the result of a direct inotropic effect), without increasing heart rate. Unlike inotropes, the beneficial hemodynamic effects produced by nesiritide do not cause an increase in myocardial oxygen consumption (MVO(2)), an important consideration for patients with acutely decompensated heart failure. Because Nesiritide is not an inotrope, it does not affect myocardial contractility, as does a beta-adrenergic receptor agonist, or a phosphodiesterase III inhibitor. As a result, nesiritide is not arrhythmogenic. Nesiritide should be considered for patients presenting with acutely typical or useful decompensated heart failure, especially those with dyspnea at rest or with minimal activity.
Topics: Clinical Trials as Topic; Heart Failure; Humans; Injections, Intravenous; Natriuretic Agents; Natriuretic Peptide, Brain
PubMed: 12668889
DOI: 10.1385/ct:3:1:37 -
Expert Opinion on Pharmacotherapy Feb 2007The treatment of acute decompensated heart failure (ADHF) remains a therapeutic challenge. Nesiritide was approved by the FDA in 2001 for the treatment of patients with... (Review)
Review
The treatment of acute decompensated heart failure (ADHF) remains a therapeutic challenge. Nesiritide was approved by the FDA in 2001 for the treatment of patients with ADHF who have dyspnea at rest or with minimal exertion. Although widely adopted for the treatment of ADHF due to its ability to decrease ventricular filling pressures and to provide mild symptomatic benefit, recent analyses have suggested that nesiritide worsens renal function and increases mortality. Although some discount these analyses that demonstrate the potential dangers of nesiritide, others have stated that its use at the present time must be weighed against the possibility of worse outcomes. A large outcomes trial in patients with ADHF would help clarify the role of nesiritide.
Topics: Animals; Heart Failure; Humans; Kidney Diseases; Natriuretic Peptide, Brain; Risk Factors
PubMed: 17266470
DOI: 10.1517/14656566.8.3.361 -
Reviews in Cardiovascular Medicine 2008Acute decompensated heart failure (ADHF) is a growing public health problem with high mortality and costs. ADHF often, if not usually, occurs in the setting of... (Review)
Review
Acute decompensated heart failure (ADHF) is a growing public health problem with high mortality and costs. ADHF often, if not usually, occurs in the setting of cardiovascular and noncardiovascular comorbidities as well as advanced age. New insights provide support for the concept of heart failure as a state of deficiency of and/or resistance to endogenous B-type natriuretic peptide. The primary goals of ADHF therapy are to relieve symptoms and optimize volume status with minimal side effects. Few therapies are proven to effectively do so. Nesiritide is a balanced vasodilator with favorable neurohumoral effects and is superior to placebo in providing rapid symptom relief and to nitroglycerin in reducing filling pressures. Recent trials confirm a lack of renal toxicity at recommended doses. An adequately powered multinational mortality trial is underway. Nesiritide represents a proven therapy for normotensive/hypertensive ADHF patients with severe symptoms at rest.
Topics: Acute Disease; Antihypertensive Agents; Clinical Trials as Topic; Cost-Benefit Analysis; Drug Costs; Heart Failure; Humans; Hypertension; Kidney; Natriuretic Peptide, Brain; Patient Selection; Risk Assessment; Treatment Outcome; Vasodilator Agents
PubMed: 18953274
DOI: No ID Found