Outcomes Associated With Nesiritide Administration for Acute Decompensated Heart Failure in the Emergency Department Observation Unit: A Single Center Experience
Abstract:The authors' purpose was to determine 30- and 180-day readmission and mortality rates for acutely decompensated heart failure patients receiving nesiritide in the emergency department observation unit. The authors conducted a retrospective evaluation of all patients admitted to the emergency department observation unit, stratified by nesiritide administration, from January 2002 to January 2004. Eligible patients had a primary diagnosis of acutely decompensated heart failure. Observation unit treatment was by p… Show more
“…Three trials contributed to the analysis on total mortality with a comparison between nesiritide and placebo ( figure 3 ). 16 21 23 30–35 Compared with placebo, nesiritide indicated no increasing risk of total mortality, with an RR of 1.04 (95% CI 0.79 to 1.38; p=0.76; figure 3 ). As shown in figure 4 , there was no significant difference between the nesiritide and dobutamine group, regarding total mortality (RR 0.69; 95% CI 0.46 to 1.05; I 2 =0%; p=0.09).…”
Section: Resultsmentioning
confidence: 99%
“…Fourteen trials were double blind, 11 16 19 22 23 25 27–29 35 36 seven were open-label trials 8 12 20 26 31 32 34 and the remaining had concealed allocation. 21 24 30 33 The dose of nesiritide varied between 0 and 2 µg/kg (as an intravenous bolus) or between 0.005 and 0.03 µg/kg/min (as a continuous infusion). Follow-up durations were ≤30 days in 14 trials, 8 12 16 19–21 23 24 26 27 31 36 37 3 months in 3 trials 32 34 35 and 6 months in 6 trials.…”
Section: Resultsmentioning
confidence: 99%
“…Follow-up durations were ≤30 days in 14 trials, 8 12 16 19–21 23 24 26 27 31 36 37 3 months in 3 trials 32 34 35 and 6 months in 6 trials. 11 22 25 28 30 33 A PRISMA flow diagram is shown in figure 1 .…”
ObjectivesCurrent evidence suggests that nesiritide may have effects on renal function and decrease the incidence of mortality. However, a clear superiority using nesiritide in terms of renal toxicity and mortality in patients with heart failure was not consistently proven by previous studies. We performed a meta-analysis of all randomised trials to obtain the best estimates of efficacy and safety of nesiritide for the initial treatment of decompensated heart failure.MethodWe performed a meta-analysis of randomised trials of nesiritide in patients with decompensated heart failure (n=38 064 patients, in 22 trials). Two reviewers independently extracted data. Data on efficacy and safety outcomes were collected. We calculated pooled relatives risk (RRs), weighted mean difference and associated 95% CIs.ResultsCompared with placebo, dobutamine and nitroglycerin, nesiritide indicated no increasing risk of total mortality. Compared with the combined control therapy, nesiritide was associated with non-significant differences in short-term mortality (RR 1.24; 95% CI 0.85 to 1.80; p=0.27), mid-term mortality (RR 0.86; 95% CI 0.60 to 1.24; p=0.42) and long-term mortality (RR 0.94; 95% CI 0.75 to 1.18; p=0.61). Nesiritide therapy increased the risk of hypotension (p<0.00 001) and bradycardia (p=0.02) when compared with control therapy. Compared with dobutamine or placebo therapy, no differences in serum creatinine, blood urea nitrogen and creatinine clearance, and no risk of the need for dialysis was observed in nesiritide therapy.ConclusionsOur findings indicated that, in patients with heart failure, nesiritide was not associated with the risk of mortality. However, it increased the risk of cardiovascular adverse events. The change of serum creatinine and creatinine clearance had no significant difference, and no risk of the need for dialysis was observed after low-dose nesiritide treatment.
“…Three trials contributed to the analysis on total mortality with a comparison between nesiritide and placebo ( figure 3 ). 16 21 23 30–35 Compared with placebo, nesiritide indicated no increasing risk of total mortality, with an RR of 1.04 (95% CI 0.79 to 1.38; p=0.76; figure 3 ). As shown in figure 4 , there was no significant difference between the nesiritide and dobutamine group, regarding total mortality (RR 0.69; 95% CI 0.46 to 1.05; I 2 =0%; p=0.09).…”
Section: Resultsmentioning
confidence: 99%
“…Fourteen trials were double blind, 11 16 19 22 23 25 27–29 35 36 seven were open-label trials 8 12 20 26 31 32 34 and the remaining had concealed allocation. 21 24 30 33 The dose of nesiritide varied between 0 and 2 µg/kg (as an intravenous bolus) or between 0.005 and 0.03 µg/kg/min (as a continuous infusion). Follow-up durations were ≤30 days in 14 trials, 8 12 16 19–21 23 24 26 27 31 36 37 3 months in 3 trials 32 34 35 and 6 months in 6 trials.…”
Section: Resultsmentioning
confidence: 99%
“…Follow-up durations were ≤30 days in 14 trials, 8 12 16 19–21 23 24 26 27 31 36 37 3 months in 3 trials 32 34 35 and 6 months in 6 trials. 11 22 25 28 30 33 A PRISMA flow diagram is shown in figure 1 .…”
ObjectivesCurrent evidence suggests that nesiritide may have effects on renal function and decrease the incidence of mortality. However, a clear superiority using nesiritide in terms of renal toxicity and mortality in patients with heart failure was not consistently proven by previous studies. We performed a meta-analysis of all randomised trials to obtain the best estimates of efficacy and safety of nesiritide for the initial treatment of decompensated heart failure.MethodWe performed a meta-analysis of randomised trials of nesiritide in patients with decompensated heart failure (n=38 064 patients, in 22 trials). Two reviewers independently extracted data. Data on efficacy and safety outcomes were collected. We calculated pooled relatives risk (RRs), weighted mean difference and associated 95% CIs.ResultsCompared with placebo, dobutamine and nitroglycerin, nesiritide indicated no increasing risk of total mortality. Compared with the combined control therapy, nesiritide was associated with non-significant differences in short-term mortality (RR 1.24; 95% CI 0.85 to 1.80; p=0.27), mid-term mortality (RR 0.86; 95% CI 0.60 to 1.24; p=0.42) and long-term mortality (RR 0.94; 95% CI 0.75 to 1.18; p=0.61). Nesiritide therapy increased the risk of hypotension (p<0.00 001) and bradycardia (p=0.02) when compared with control therapy. Compared with dobutamine or placebo therapy, no differences in serum creatinine, blood urea nitrogen and creatinine clearance, and no risk of the need for dialysis was observed in nesiritide therapy.ConclusionsOur findings indicated that, in patients with heart failure, nesiritide was not associated with the risk of mortality. However, it increased the risk of cardiovascular adverse events. The change of serum creatinine and creatinine clearance had no significant difference, and no risk of the need for dialysis was observed after low-dose nesiritide treatment.
“…The use of nesiritide in patients with AHF is also associated with reductions in endogenously produced BNP, a laboratory value used clinically as a surrogate for cardiovascular congestion [24, 25]. Several small studies have shown a benefit of adding nesiritide to standard therapy on patient-reported relief of dyspnea [20, 26], but additional studies provided little support for nesiritide in reducing the frequency of rehospitalization [27-34] or mortality [26-28] in patients with AHF (Table 1). The previously mentioned VMAC study included 204 patients who received IV nesiritide [16] and demonstrated a statistically significant improvement in dyspnea at three hours post infusion in patients treated with nesiritide over those treated with NTG or placebo – leading to FDA approval of nesiritide for use in the United States.…”
Section: Resultsmentioning
confidence: 99%
“…However, studies which enrolled patients within 24 hours of ED presentation provide evidence of blood pressure and dyspnea improvement, but lack conclusive evidence regarding their impact on long term outcomes such as hospital readmission and mortality rates. Studies which enrolled patients in the ED, or in an ED associated observation unit,[27, 30, 31] showed neutrality or only modest benefits of adding IV vasodilators in comparison to standard care alone. None of the large, multicenter investigations of IV vasodilators, such as ASCEND-HF or RELAX-AHF, specifically mandated ED enrollment, though some were conducted across numerous sites internationally and did enroll ED patients.…”
There are nearly 700,000 annual US emergency department (ED) visits for acute heart failure (AHF). While blood pressure is elevated on most of these visits, acute therapy remains focused on preload and not afterload reduction. Data from recent prospective studies suggest AHF patients with concomitant acute hypertension benefit from intravenous (IV) vasodilators. To better understand the use of vasodilators for such patients, we conducted a systematic review of 1) currently available intravenous vasodilators for ED patients with AHF, or 2) intravenous vasodilators which are not yet available, but have completed Phase III clinical trials in AHF, and may be available for ED use in the future. We employed multi-term search queries to retrieve research involving nitroglycerin, nitroprusside, enalaprilat, hydralazine, relaxin and nesiritide. A total of 2001 unique citations were identified from three databases: PubMed, EMBASE, and CINAHL. Of these, 1966 were excluded based on established review criteria, leaving 35 published papers for inclusion. Our primary finding was that IV nitrovasodilators, when used in the treatment of AHF in ED and ED-like settings, do improve short-term symptoms and appear safe to administer. There is no data suggesting they impact mortality. Other commonly used vasodilators such as hydralazine and enalaprilat have very little published data about their safety and efficacy. Of note, few studies enrolled patients early in their course of treatment. Thus, to assess the specific impact of vasodilator therapy on both short- and long-term outcomes, future research efforts should focus on patient recruitment in the ED setting.
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