Effect of Nesiritide in Patients with Acute Decompensated Heart Failure

Natriuretic Peptides in the Regulation of Cardiovascular Physiology and Metabolic Events

“…Recombinant BNP (nesiritide) has been approved by the U.S. Food and Drug Administration (FDA) for the same indication in 2001. However, data from the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Trial (ASCEND‐HF) showed a lack of efficacy on rehospitalization for HF or death from any cause—the major clinical endpoints 107. In a pilot study conducted with 40 patients with New York Heart Association functional class II to III HF, indicating slight to marked limitation in activity owing to cardiovascular symptoms, chronic protein therapy with subcutaneous BNP was sufficient to improve Minnesota Living with Heart Failure score, LV remodeling, and LV filling pressure 108…”

Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011

“…Among these 59 surrogate endpoint trials that had a subsequent clinical endpoint trial, in 24 cases the clinical endpoint trial results validated the positive surrogate trials, while in 20 the subsequent clinical endpoint trial was negative (Table 3). 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 A negative surrogate endpoint trial was less likely to be followed by a positive outcome trial and we identified only 3 such examples ( P =0.02, Figure 2). …”

Clinical and Research Considerations for Patients With Hypertensive Acute Heart Failure: A Consensus Statement from the Society of Academic Emergency Medicine and the Heart Failure Society of America Acute Heart Failure Working Group

“…Smaller studies have shown a benefit of nesiritide (exogenous b-type natriuretic peptide) on dyspnea relief, but the pivotal mortality trial [67] found no significant difference in rehospitalization or mortality. Although initial studies did not demonstrate any increased risk of hypotension, hypotensive events were over 2 hours duration in the VMAC trial [68], and the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failrue (ASCEND-HF) study reported an increased risk of both symptomatic and asymptomatic hypotension in patients randomized to nesiritide.…”

“…Although initial studies did not demonstrate any increased risk of hypotension, hypotensive events were over 2 hours duration in the VMAC trial [68], and the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failrue (ASCEND-HF) study reported an increased risk of both symptomatic and asymptomatic hypotension in patients randomized to nesiritide. [67] This may have occurred because the ASCEND-HF study did not specifically target H-AHF, with a mean baseline systolic blood pressure of enrolled patients of 124 mm Hg. Nesiritide does not result in substantial clinical improvement when added to standard care and is a second line agent, utilized when nitroglycerin is ineffective or contraindicated.…”