60 research outputs found
Effect of nesiritide in patients with acute decompensated heart failure.
BACKGROUND: Nesiritide is approved in the United States for early relief of
dyspnea in patients with acute heart failure. Previous meta-analyses have raised
questions regarding renal toxicity and the mortality associated with this agent.
METHODS: We randomly assigned 7141 patients who were hospitalized with acute
heart failure to receive either nesiritide or placebo for 24 to 168 hours in
addition to standard care. Coprimary end points were the change in dyspnea at 6
and 24 hours, as measured on a 7-point Likert scale, and the composite end point
of rehospitalization for heart failure or death within 30 days.
RESULTS: Patients randomly assigned to nesiritide, as compared with those
assigned to placebo, more frequently reported markedly or moderately improved
dyspnea at 6 hours (44.5% vs. 42.1%, P=0.03) and 24 hours (68.2% vs. 66.1%,
P=0.007), but the prespecified level for significance (P≤0.005 for both
assessments or P≤0.0025 for either) was not met. The rate of rehospitalization
for heart failure or death from any cause within 30 days was 9.4% in the
nesiritide group versus 10.1% in the placebo group (absolute difference, -0.7
percentage points; 95% confidence interval [CI], -2.1 to 0.7; P=0.31). There were
no significant differences in rates of death from any cause at 30 days (3.6% with
nesiritide vs. 4.0% with placebo; absolute difference, -0.4 percentage points;
95% CI, -1.3 to 0.5) or rates of worsening renal function, defined by more than a
25% decrease in the estimated glomerular filtration rate (31.4% vs. 29.5%; odds
ratio, 1.09; 95% CI, 0.98 to 1.21; P=0.11).
CONCLUSIONS: Nesiritide was not associated with an increase or a decrease in the
rate of death and rehospitalization and had a small, nonsignificant effect on
dyspnea when used in combination with other therapies. It was not associated with
a worsening of renal function, but it was associated with an increase in rates of
hypotension. On the basis of these results, nesiritide cannot be recommended for
routine use in the broad population of patients with acute heart failure. (Funded
by Scios; ClinicalTrials.gov number, NCT00475852.
A complete dynamical ozone budget measured in the tropical marine boundary layer during PASE
Implementation of Continuous Flow in the Cabinet Process at the Schneider Electric Plant in Tlaxcala, Mexico
- …