| pathology | Demonstrated benefit and harm | k | | | |
|---|
| acute heart failure | versus placebo or control No demonstrated result for efficacy nesiritide inferior to placebo in terms of amelioration of Dyspnea at 24 h in ASCEND-HF, 2011 | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| NSGET (efficacy trial), 2000 | nesiritide vs placebo | | | all cause death 1.48 [0.31; 7.03] | | PROACTION, 2003 | nesiritide vs placebo | | | all cause death 4.88 [0.58; 41.10] | | BNP-CARDS, 2007 | nesiritide vs placebo | | | | | FUSION 2, 2008 | nesiritide vs placebo | | | | | ASCEND-HF, 2011 | nesiritide 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 | nesiritide vs placebo | | | | | NSGET (comparative trial), 2000 | nesiritide vs control | | | |
| 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: | | 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
|
|
| acute heart failure | versus active treatment No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| VMAC (24h), 2002 | nesiritide vs nitroglycerin | | | all cause death 1.56 [0.80; 3.04] | | FUSION 1, 2004 | nesiritide vs standard care | | | | | PRECEDENT, 2002 | nesiritide vs dobutamine | | | |
| Trial | Treatments | Patients | Method |
|---|
| 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: | | 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: |
|
| heart failure | versus placebo or control No demonstrated result for efficacy nesiritide inferior to placebo in terms of amelioration of Dyspnea at 24 h in ASCEND-HF, 2011 | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| NSGET (efficacy trial), 2000 | nesiritide vs placebo | | | all cause death 1.48 [0.31; 7.03] | | PROACTION, 2003 | nesiritide vs placebo | | | all cause death 4.88 [0.58; 41.10] | | BNP-CARDS, 2007 | nesiritide vs placebo | | | | | FUSION 2, 2008 | nesiritide vs placebo | | | | | ASCEND-HF, 2011 | nesiritide 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 | nesiritide vs placebo | | | | | NSGET (comparative trial), 2000 | nesiritide vs control | | | |
| 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: | | 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
|
|
| heart failure | versus active treatment No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| VMAC (24h), 2002 | nesiritide vs nitroglycerin | | | all cause death 1.56 [0.80; 3.04] | | FUSION 1, 2004 | nesiritide vs standard care | | | | | PRECEDENT, 2002 | nesiritide vs dobutamine | | | |
| Trial | Treatments | Patients | Method |
|---|
| 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: | | 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: |
|
| restenosis after PCI | versus placebo or control No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PREVENT, 2000 | P-32 vs placebo | TLR 0.26 [0.09; 0.78] binary restenosis 0.21 [0.08; 0.53] | | death ∞ [NaN; ∞] MACE 0.68 [0.29; 1.59] MI 2.50 [0.33; 19.03] TVR 0.66 [0.33; 1.35] | | INHIBIT, 2002 | P-32 vs placebo | MACE 0.70 [0.49; 0.99] TVR 0.63 [0.43; 0.94] | | death 1.00 [0.29; 3.39] MI 1.00 [0.20; 4.88] | | START, 2000 | P-32 vs placebo | MACE 0.67 [0.47; 0.94] TLR 0.56 [0.38; 0.83] TVR 0.63 [0.44; 0.91] | | death 2.73 [0.29; 26.01] MI 0.52 [0.15; 1.75] |
| Trial | Treatments | Patients | Method |
|---|
| PREVENT, 2000 | intracoronary radiotherapy with the beta-emitting (32)P, 16, 20, or 24 Gy to a depth of 1 mm in the artery wall (n=80) vs. sham procedure (n=25) | patients with de novo (70%) or restenotic (30%) lesions who were treated by stenting (61%) or balloon angioplasty (39%) | double blind Parallel groups Sample size: 80/25 Primary endpoint: MACE FU duration: 6 mo The primary objective of this study was to demonstrate the safety and performance of teh studied intracoronary
radiation therapy | | INHIBIT, 2002 | intracoronary beta radiation with a phosphorus-32 source (n=166) vs. placebo (n=166) | patients with in-stent restenosis and successful coronary intervention | double blind Parallel groups Sample size: 166/166 Primary endpoint: binary angiographic restenosis FU duration: 9 mo | | START, 2000 | intracoronary radiation with 90Sr/90Y source (n=244) vs. placebo (n=232) | patients with in-stent restenosis | double blind Parallel groups Sample size: 244/232 Primary endpoint: clinically driven TVR FU duration: 8 mo |
|
