Safety and efficacy of six-month outpatient intermittent nesiritide infusions

Abstract

Background: In patients with acutely decompensated heart failure (HF), intravenous infusion of nesiritide improves hemodynamics and symptoms with few adverse effects. We investigated the tolerability as well as efficacy of outpatient intermittent infusions of nesiritide. Methods: Patients with severe chronic HF who were unresponsive to treatment with standard therapies were included. They received intermittent intravenous nesiritide (2 mcg/kg bolus dose followed by 0.01 mcg/kg/min over 4-6 hours) and were followed for 6 months for changes in NYHA class function, hospitalization for worsening of HF symptoms, frequency of visits to the HF clinic, cardiac index (CI), cardiac output (CO), and any possible side effects. Results: Forty patients (27 were males, with a mean age of 68 ± 14 years) were included. At the beginning of the study, 34 patients were in NYHA class III, 5 patients in class II, and 1 patient in class IV. At the end of study 16 had improvement in their class function (p= 0.0037), 22 remained in the same class, and 2 patients regressed. The total number of hospitalizations in the 6 month period prior to therapy was 42, which declined to 31 during the 6 months following initiation of therapy (p=0.1735). The number of visits to the HF clinic declined from an average of 3.75 ± 0.95 visits/month to an average of 2.53 ± 1.18 visits/month (p< 0.0001). Baseline CI was 2.77 ± 0.76L/min/m2 2 Conclusion: These results suggest that the use of nesiritide in end-stage HF patients refractory to standard medical treatment in an outpatient setting improves NYHA class function, and frequency of visits to the HF clinic, but not hospitalization for worsening HF or cardiac function. (mean ± SD) increased to 2.98 ± 0.91L/min/m2 (p=0.4717). On the other hand, CO increased from 5.60 ± 1.92L/min (mean ± SD) to 6.0 ± 2.06L/min (p=0.4999). Therapy was well tolerated by most patients. Symptomatic hypotension was observed in two patients