| Trial | control | p<0.05 | harm | NS |
|---|
| NSGET (efficacy trial), 2000 | vs placebo | | | all cause death 1.48 [0.31; 7.03] |
| VMAC (24h), 2002 | vs placebo | | | all cause death 1.56 [0.80; 3.04] |
| PROACTION, 2003 | vs placebo | | | all cause death 4.88 [0.58; 41.10] |
| BNP-CARDS, 2007 | vs placebo | | | |
| FUSION 2, 2008 | vs placebo | | | |
| ASCEND-HF, 2011 | vs placebo | | amelioration of Dyspnea at 24 h 1.11 [1.03; 1.19] | all cause death 0.90 [0.71; 1.14] 30-d HF rehospitalization
0.98 [0.82; 1.19] 30-d death or HF hospitalization 0.93 [0.81; 1.08] 30 day death 0.90 [0.71; 1.14] |
| VMAC (intravenous neseritide), 2002 | vs placebo | | | |
| NSGET (comparative trial), 2000 | vs placebo | | | |
| FUSION 1, 2004 | vs placebo | | | |
| PRECEDENT, 2002 | vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| NSGET (efficacy trial), 2000 | nesiritide(0.015 and 0.030 microg/kg/min (n=85) vs. placebo (n=42) | acutely decompensated heart failure requiring invasive monitoring | Sample size: 85/42 Primary endpoint: FU duration: |
| VMAC (24h), 2002 | nesiritideinfusion for 24 hours (n=280) vs. nitroglycerin (n=218) | acutely decompensated heart failure requiring hospitalization | Sample size: 280/218 Primary endpoint: FU duration: |
| PROACTION, 2003 | nesiritidefor at least 12h (n=127) vs. placebo (n=123) | patients presenting to the ED with acutely decompensated
HF and dyspnea at rest or with minimal activity | double-blind Parallel groups Sample size: 127/123 Primary endpoint: FU duration: 30 days |
| BNP-CARDS, 2007 | nesiritide as a 0.01-µg/kg/min infusion for 48 hours (n=39) vs. placebo (n=36) | acute decompensated heart failure with moderate to severe renal insufficiency | Double blind Parallel groups Sample size: 39/36 Primary endpoint: >20% increase in SCr anytime during 1st hospital week FU duration: 7 days |
| FUSION 2, 2008 | nesiritide (2 µg/kg bolus plus 0.01 µg/kg-per-minute infusion for four to six hours) (n=911) vs. placebo (n=0) | patients with ACC/AHA stage C/D heart failure with two recent heart-failure hospitalizations, an ejection fraction of less than 40%, and NYHA class 4 symptoms or NYHA class 3 symptoms with creatinine clearance less than 60 mL/min | double-blind Parallel groups Sample size: 911/0 Primary endpoint: mortality and CV or renal hospitalization FU duration: 12 weeks |
| ASCEND-HF, 2011 | intravenous nesiritide for 24 hours to 7 days on top of standard therapy (n=3496) vs. matching placebo (n=3511) | Patients hospitalized for heart
failure (within 24 hours of hospitalization and institution of acute IV therapy for ADHF) | double-blind Parallel groups Sample size: 3496/3511 Primary endpoint: coprimary: dyspnea, death or HF hospitalization FU duration: 30 days |
| VMAC (intravenous neseritide), 2002 | intravenous nesiritidefor 3 hours (n=204) vs. placebo (n=142) 3rd arms with IV nitroglycerin for 3 hours(n=143) | acutely decompensated heart failure requiring hospitalization
| double-blind Sample size: 204/142 Primary endpoint: FU duration:
|
| NSGET (comparative trial), 2000 | nesiritide(0.015 and 0.030 microg/kg/min (n=203) vs. usual care (n=102)
| acutely decompensated heart failure requiring invasive monitoring
| open Parallel groups Sample size: 203/102 Primary endpoint: FU duration: <5 days
|
| FUSION 1, 2004 | nesiritide 0.005 microg/kg/min or 0.010 microg/kg/min once weekly (n=-9) vs. standard care (n=-9) | outpatient with co-morbid advanced heart failure and renal insufficiency | open Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks |
| PRECEDENT, 2002 | nesiritide(0.015 or 0.03 microg/kg/min) (n=-9) vs. Dobutamine (> or =5 microg/kg/min) (n=-9) | Symptomatic, Decompensated CHF | open Parallel groups Sample size: -9/-9 Primary endpoint: ECG Holter FU duration: |
