In 2001, Nesiritide ( Natrecor ) has been approved by the FDA for the intravenous treatment of patients with acutely decompensated congestive heart failure ( ADHF ), who have dyspnea at rest or with minimal activity.

Nesiritide is a recombinant form of human B-type natriuretic peptide ( hBNP ), that has a balanced arterial and venous dilator effect, with natriuretic, diuretic, anti-aldosterone and antisympathetic action.

The main side effects associated with Nesiritide therapy are: hypotension, ventricular tachycardia, angina pectoris, bradycardia, headache, abdominal pain, back pain, insomnia , dizziness, anxiety, nausea, vomiting.

Investigators at North Shore University Hospital in Manhasset, N.Y., and University of Michigan analyzed data from randomized controlled trials, comparing Nesiritide with either placebo or active control, to evaluate the renal effects of Nesiritide as treatment for ADHF.

Worsening renal function was defined as an increase in serum creatinine greater than 0.5 mg/dL.

Use of Food and Drug Administration-approved doses of Nesiritide ( less than or equal 0.03 microg · kg-1 · min-1 ) significantly increased the risk of worsening renal function compared with control ( relative risk, 1.52-1.54 ).

Even low-dose Nesiritide ( less than or equal 0.015 microg · kg-1 · min-1 ) significantly increased risk, as did Nesiritide administered at any dose up to 0.06 microg · kg-1 · min-1.

This study has shown that Nesiritide significantly increases the risk of worsening renal function in patients with ADHF.

European Medicines Agency ( EMEA ) has not approved Natrecor.

Source: Circulation, 2005


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