USA. Nesiritide is indicated for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnoea at rest or with minimal activity. Recently, Scios Inc. has issued a 'Dear Health-care Provider' letter to advise of recommendations on nesiritide (Natrecor) made by an expert panel of cardiology and heart failure clinicians. Following a review of available data with respect to questions of worsened renal function and mortality with nesiritide, the panel agreed that:
• the dose-dependent increase in serum creatinine associated with nesiritide indicated renal dysfunction at the doses detailed in the nesiritide (Natrecor) package insert;
• there was no evidence that nesiritide improved renal function;
• there was a trend towards an increased 30-day mortality rate with nesiritide, but that the confidence intervals were too wide and the number of deaths too small to be certain of an increased mortality risk.
The panel recommended that additional trials be undertaken to investigate these adverse effects further, encouraged the continued enrolment of patients into ongoing and planned nesiritide (Natrecor) trials, and recommended additional data analyses from completed trials. In addition, the panel provided recommendations on the appropriate use of nesiritide (Natrecor), including:
• strictly limiting the use to patients who are hospitalized with acutely decompensated congestive heart failure and dyspnoea at rest, and
• not using nesiritide (Natrecor) to replace diuretics, enhance diuresis or improve renal function, or for scheduled repetitive use, or intermittent outpatient infusion.
The panel also encouraged Scios Inc. to initiate an educational programme to inform physicians about when nesiritide (Natrecor) should and should not be used.
'Dear Health-care Provider' letter from Scios Inc., 13 July 2005 (http://www.fda.gov).