Science or Fiction: Use of Nesiritide as a First-Line Agent?

John A. Noviasky, Pharm.D., Michael Kelberman, M.D., Karen M. Whalen, B.S., Roy Guharoy, Pharm.D., William Darko, Pharm.D.

Disclosures

Pharmacotherapy. 2003;23(8) 

In This Article

Introduction

Nesiritide (Natrecor; Scios Inc., Sunnyvale, CA), a recombinant form of human B-type natriuretic peptide, was recently approved by the Food and Drug Administration (FDA) for the treatment of acute decompensated chronic heart failure (CHF). This novel agent is a valuable addition, as there have been no new therapies developed for this indication in more than a decade. Though originally rejected by the FDA,[1] completion of the Vasodilation in the Management of Acute CHF (VMAC) trial[2] has resulted in its approval and general use. Indeed, numerous reviews of this agent indicate that it is appropriate as first-line therapy for symptomatic patients with decompensated CHF.[1,3,4,5,6] We, however, dispute this place in therapy, using data from the VMAC trial[2] and additional unpublished data provided to the FDA about the VMAC trial. Although other studies of nesiritide exist, the VMAC trial is the only one in which both randomized and blinded patients receiving nesiritide were compared with patients receiving active control (nitroglycerin).

The VMAC trial showed that patients receiving nesiritide had fewer symptomatic adverse effects than those receiving nitroglycerin. The main difference was more frequent headache associated with nitroglycerin (20%) compared with nesiritide (8%; p<0.001). In addition, there was a small difference favoring nesiritide for less abdominal pain. Although headache is an adverse effect that should be of concern, it is not clear to what degree it affected patient care, as the number of patients who discontinued therapy due to headache was not included in the study results. On the other hand, a 50% relative-risk increase in patient dropout due to adverse effects was reported for patients receiving nesiritide (4.8%) compared with nitroglycerin (3.2%).[2]

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