In a large clinical trial, the drug Nesiritide ( Natrecor ) proved to be safe but had little effect on dyspnea, and no significant effect on hospital readmission or death rates among patients with acutely decompensated heart failure ( ADHF ).

In the ASCEND-HF ( Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Trial ), researchers randomized 7,141 patients with acute, severe heart failure to receive either continuous intravenous Nesiritide or a placebo, both added to standard therapy, which includes diuretics, Morphine and other medications.

Six hours after treatment, Nesiritide slightly improved shortness of breath compared with placebo, with significant improvement occurring in 947 Nesiritide patients ( 13.4% ) and 874 placebo patients ( 15% ).
Similarly, 24 hours after treatment, more patients on Nesiritide displayed markedly improved breathing function compared to placebo [ 1,063 Nesiritide patients ( 30.4% ) compared to 966 placebo patients ( 27.5% ) ]. However, there was no significant difference in the pre-specified endpoint for dyspnea.
At 30 days post-treatment, the rates of death from any cause and hospital readmission for heart failure were slightly lower with Nesiritide compared to placebo. At 9.4% versus 10.1%, however, the difference in these rates was not statistically significant either.

Nesiritide is a manufactured drug derived from a naturally occurring protein known as human B-type natriuretic peptide. The drug helps to relax the blood vessels, which can improve circulation, and increase the body’s output of excess salt and water.

Nesiritide was marketed and widely used in the U.S. because of a perception that it had a major effect on dyspnea and then largely abandoned in clinical use because of concerns that it might increase rates of death and renal failure.
Now, the ASCEND-HF trial has shown that Nesiritide is safe but has only a modest effect on dyspnea.

ASCEND-HF, a randomized double-blind trial, included participants from 400 international centers in 30 countries. Average age of patients studies was 67 years, 34% were female and 15% were African American. More than half ( 60% ) had blockages or narrowing of the blood vessels supplying the heart. Treatment began within 24 hours of hospitalization for worsening symptoms and continued for between one to seven days. The study ran from May 2007 to September 2010; patients were followed for 30 days.

Previous studies showed that Nesiritide can relieve shortness of breath if given within three hours of the onset of worsening heart failure, but it was unclear whether this improvement persisted. Also unknown was whether Nesiritide caused renal impairment or increased the risk of death, which previous, much smaller studies have indicated. An important finding from this trial is that the drug did not increase these risks.

Source: American Heart Association’s Scientific Sessions, 2010

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