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Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized

|March 28, 2002

Insights

Nesiritide improved hemodynamic function and reduced dyspnea in patients with decompensated congestive heart failure (CHF) more effectively than nitroglycerin or placebo. This study compared nesiritide, nitroglycerin, and placebo in hospitalized CHF patients.

Area of Science:

Cardiology
Pharmacology

Background:

Decompensated congestive heart failure (CHF) is a leading cause of hospitalization for patients over 65.
Effective treatments for acute decompensated CHF are crucial for improving patient outcomes.

Purpose of the Study:

To compare the efficacy and safety of intravenous nesiritide versus intravenous nitroglycerin and placebo.
To evaluate the impact of these treatments on hemodynamic function and patient-reported symptoms.

Main Methods:

A randomized, double-blind trial involving 489 inpatients with acute decompensated CHF.
Patients received intravenous nesiritide, nitroglycerin, or placebo for 3 hours, with nesiritide or nitroglycerin continued for 24 hours.
Primary outcomes included changes in pulmonary capillary wedge pressure (PCWP) and patient-reported dyspnea.

Main Results:

Nesiritide significantly reduced PCWP compared to placebo and nitroglycerin at 3 hours.
At 3 hours, nesiritide improved dyspnea compared to placebo, but not significantly compared to nitroglycerin.
At 24 hours, nesiritide showed a greater reduction in PCWP than nitroglycerin, with similar patient-reported dyspnea.

Conclusions:

Intravenous nesiritide, when added to standard care, offers superior hemodynamic improvement in acutely decompensated CHF compared to nitroglycerin or placebo.
Nesiritide also demonstrated benefits in self-reported symptoms, suggesting its utility in managing acute decompensated heart failure.

Read full analysis

Abstract

Context:

Decompensated congestive heart failure (CHF) is the leading hospital discharge diagnosis in patients older than 65 years.

Objective:

To compare the efficacy and safety of intravenous nesiritide, intravenous nitroglycerin, and placebo.

Design, Setting, And Patients:

Randomized, double-blind trial of 489 inpatients with dyspnea at rest from decompensated CHF, including 246 who received pulmonary artery catheterization, that was conducted at 55 community and academic hospitals between October 1999 and July 2000.

Interventions:

Intravenous nesiritide (n = 204), intravenous nitroglycerin (n = 143), or placebo (n = 142) added to standard medications for 3 hours, followed by nesiritide (n = 278) or nitroglycerin (n = 216) added to standard medication for 24 hours.

Main Outcome Measures:

Change in pulmonary capillary wedge pressure (PCWP) among catheterized patients and patient self-evaluation of dyspnea at 3 hours after initiation of study drug among all patients. Secondary outcomes included comparisons of hemodynamic and clinical effects between nesiritide and nitroglycerin at 24 hours.

Results:

At 3 hours, the mean (SD) decrease in PCWP from baseline was -5.8 (6.5) mm Hg for nesiritide (vs placebo, P<.001; vs nitroglycerin, P =.03), -3.8 (5.3) mm Hg for nitroglycerin (vs placebo, P =.09), and -2 (4.2) mm Hg for placebo. At 3 hours, nesiritide resulted in improvement in dyspnea compared with placebo (P =.03), but there was no significant difference in dyspnea or global clinical status with nesiritide compared with nitroglycerin. At 24 hours, the reduction in PCWP was greater in the nesiritide group (-8.2 mm Hg) than the nitroglycerin group (-6.3 mm Hg), but patients reported no significant differences in dyspnea and only modest improvement in global clinical status.

Conclusion:

When added to standard care in patients hospitalized with acutely decompensated CHF, nesiritide improves hemodynamic function and some self-reported symptoms more effectively than intravenous nitroglycerin or placebo.

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