| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| heart failure | epoprostenol | not classified | versus placebo or no treatment No demonstrated result for efficacy epoprostenol inferior to standard care in terms of All cause death in FIRST, 1997 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FIRST, 1997 | epoprostenol vs standard care | | All cause death 1.29 [1.05; 1.60] | |
| Trial | Treatments | Patients | Method |
|---|
| FIRST, 1997 | epoprostenol infusion (n=237) vs. standard care (n=234) | Patients with class IIIB/IV congestive
heart failure and decreased left ventricular ejection fraction | NA Parallel groups Sample size: 237/234 Primary endpoint: all cause death FU duration: 3 and 6 months |
|
| heart failure | hydralazine | not classified | versus placebo or no treatment No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| hydralazine vs control | | | | | hydralazine vs placebo | | | | | hydralazine vs placebo | | | | | hydralazine vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Chatterjee, 1980 | oral hydralazine (n=-9) vs. NA (n=-9) | patients with chronic CHF | Sample size: -9/-9 Primary endpoint: FU duration: | | Franciosa, 1982 | hydralazine 200 mg daily (n=16) vs. placebo (n=16) | patients with class III and IV symptoms while they were taking digitalis and diuretics | double blind Sample size: 16/16 Primary endpoint: FU duration: 20 weeks | | Conradson , 1984 | hydralazine (n=-9) vs. placebo (n=-9) | patients with chronic congestive heart failure (NYHA class III) | Sample size: -9/-9 Primary endpoint: FU duration: 1 year | | Magorien , 1984 | hydralazine 100 mg orally every eight hours (n=-9) vs. placebo (n=-9) | patients with idiopathic dilated cardiomyopathy | double blind Sample size: -9/-9 Primary endpoint: FU duration: |
|
| heart failure | hydralazine-ISDN | not classified | versus placebo or no treatment No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| VHeFT I (hydralazine ISDN), 1986 | hydralazine-ISDN vs placebo | | | All cause death 0.88 [0.70; 1.10] |
| Trial | Treatments | Patients | Method |
|---|
| VHeFT I (hydralazine ISDN), 1986 | hydralazine 300mg/d ISDN 160mg/d (n=186) vs. placebo (n=273) | patienst with chronic congestive heart failure and cardiac dilatation (CT ratio>0.55) or LVEF <45% in association with reduced exercise tolerance | double blind Parallel groups Sample size: 186/273 Primary endpoint: FU duration: 2.3 y (range 0.5-5.7 years) |
|
| heart failure | isosorbide dinitrate | not classified | versus placebo or no treatment No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| isosorbide dinitrate vs placebo | | | | | isosorbide dinitrate vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| NICE (Lewis), 1999 | isosorbide-5-mononitrate 50 mg once daily (n=-9) vs. placebo (n=-9) | patients (NYHA Class 2-3) treated for heart failure, all receiving captopril and most also furosemide | Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks | | Franciosa , 1978 | isosorbide dinitrate (n=16) vs. placebo (n=16) | | double blind Sample size: 16/16 Primary endpoint: FU duration: |
|
| heart failure | nesiritide | not classified | 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 | nesiritide | not classified | 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: |
|
| peripheral vascular diseases | buflomedil | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| LIMB, 2008 | buflomedil vs placebo | cardiovascular events 0.74 [0.57; 0.95] | | Mortalité 0.88 [0.64; 1.20] cardiovascular death 0.76 [0.49; 1.16] effets indésirables liés au traitement 0.93 [0.80; 1.10] AVC 1.17 [0.53; 2.61] IDM 0.90 [0.38; 2.11] | | Diamantopoulos, 2001 | buflomédil vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| LIMB, 2008 | buflomedil 150-300 mg twice daily adjusted to creatinine clearance (n=1043) vs. placebo (n=1035) | Patients >40 years with documented peripheral arterial obstructive disease, intermittent claudication, and an ankle-brachial index between 0.30 and 0.80 | double blind Parallel groups Sample size: 1043/1035 Primary endpoint: cardiovascular events FU duration: 33 months | | Diamantopoulos, 2001 | Buflomedil 600 mg/ d (n=21) vs. placebo (n=19) | Stade de la maladie: II de 3.4 ans en moyenne. | Double aveugle Parallel groups Sample size: 21/19 Primary endpoint: périmètre de marche (maximal, sans douleur) FU duration: 6 mois |
|
| peripheral vascular diseases | cilostazol | not classified | versus placebo or control No demonstrated result for efficacy | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Beebe, 1999 | cilostazol vs placebo | | | | | Dawson, 1998 | cilostazol vs placebo | | | | | Money, 1998 | cilostazol vs placebo | | | | | Strandness, 2002 | cilostazol vs placebo | | | | | Dawson (cilostazol), 2000 | cilostazol vs placebo | | | | | Elam, 1998 | cilostazol vs placebo | | | | | Otsuka 21-95-201 | cilostazol vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Beebe, 1999 | Cilostazol 100 ou 200 mg / j (2 groupes) (n=346) vs. placebo (n=170) | AOMI stade II | Double aveugle Parallel groups Sample size: 346/170 Primary endpoint: Périmètre de marche sans douleur, périmètre de marche maximum à 6 mois FU duration: 6 mois La randomisation a été efectuée par permutation par blocs. | | Dawson, 1998 | Cilostazol 200 mg/d (n=54) vs. placebo (n=27) | Stade de la maladie: II, avec durée des symptomes (années) de : 6.25+/-0.82 | Double aveugle Parallel groups Sample size: 54/27 Primary endpoint: Périmètre de marche FU duration: 3 mois | | Money, 1998 | Cilostazol 200 mg/d (n=119) vs. placebo (n=120) | Stade de la maladie: II | Double aveugle Parallel groups Sample size: 119/120 Primary endpoint: Périmètres de marche FU duration: 4 mois | | Strandness, 2002 | cilostazol 50 or 100 mg twice daily (n=265) vs. placebo (n=129) | AOMI stade II. | Double aveugle Parallel groups Sample size: 265/129 Primary endpoint: périmètre de marche FU duration: 6 mois | | Dawson (cilostazol), 2000 | Cilostazol 200 mg/d (n=227) vs. placebo (n=239) | Stade de la maladie: II en situation chronique. | Double aveugle Parallel groups Sample size: 227/239 Primary endpoint: FU duration: 6 mois | | Elam, 1998 | cilostazol 100 mg twice daily (n=-9) vs. placebo (n=-9) | | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: | | Otsuka 21-95-201 | cilostazol 100 or 150 mg twice daily (n=-9) vs. (n=-9) 3 arms trial: cilostazol 100, 150 mg twice daily and placebo | | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks |
|
| peripheral vascular diseases | ginko biloba | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Bauer, 1984 | ginko biloba vs placebo | | | | | Peters, 1998 | ginko biloba vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Bauer, 1984 | ginko biloba 40 mg three times daily (n=44) vs. placebo (n=35) | AOMI stade IIb | Double aveugle Parallel groups Sample size: 44/35 Primary endpoint: amélioration subjective symptomes FU duration: 6 mois | | Peters, 1998 | ginko biloba EGb 761 three times daily (n=53) vs. placebo (n=58) | AOMI stade IIb | Double aveugle Parallel groups Sample size: 53/58 Primary endpoint: périmètre de marche FU duration: 6 mois |
|
| peripheral vascular diseases | naftidrofuryl | not classified | versus placebo or control No demonstrated result for efficacy | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| NIQOL germany, 1999 | Naftidrofuryl vs placebo | | | | | Clyne, 1980 | naftidrofuryl vs placebo | | | | | NIQOL belgium, 2001 | naftidrofuryl vs placebo | | | | | NCIS, 2001 | naftidrofuryl vs placebo | | | | | naftidrofuryl IV vs control | | | | | naftidrofuryl IV vs placebo | | | | | naftidrofuryl IV vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| NIQOL germany, 1999 | Naftidrofuryl 600 mg/d (n=142) vs. placebo (n=127) | Stade de la maladie: II, durée (années): 2.41+/-2.67 en moyenne. | Double aveugle Parallel groups Sample size: 142/127 Primary endpoint: Qualité de vie FU duration: 6 mois | | Clyne, 1980 | Naftidrofuryl 100 mg/d (n=63) vs. placebo (n=65) | AOMI stade II | Double aveugle Parallel groups Sample size: 63/65 Primary endpoint: Périmètre de marche FU duration: 6 mois | | NIQOL belgium, 2001 | Naftidrofuryl 200mg three times daily (n=108) vs. placebo (n=112) | Stade de la maladie :II pendant 4.1 ans en moyenne | Double aveugle Parallel groups Sample size: 108/112 Primary endpoint: qualité de vie FU duration: 6 mois Avant le début de l'essai,tous les patients ont suivi une période de run-in de 1 mois sous placebo en simple aveugle a été observée | | NCIS, 2001 | naftidrofuryl 200 mg three times daily (n=89) vs. placebo (n=92) | Stade de la maladie: II pendant 5.25 ans en moyenne | Double aveugle Parallel groups Sample size: 89/92 Primary endpoint: périmètre de marche (maximal, sans douleur) FU duration: 12 mois 221 patients ont suivi une période de run-in de 4 semaines sous placebo. Parmi lesquels, 196 ont été randomisés, mais 181 étaient disponibles pour l'analyse en ITT. | | Meehan, 1982 | Naftidrofuryl (Nafronyl): par voie IV ( 200 mg*2/ jour pendant 2 heures dans 500 ml de sérum salé isotonique) et par voie orale ( 200mg*3/ jour)+ repos au lit + réchauffement pendant 7 jours (n=24) vs. Repos au lit + réchauffement (n=16) | AOMI stade III | Simple aveugle Parallel groups Sample size: 24/16 Primary endpoint: amélioration de la douleur au repos, l'état mental,évaluée par une echelle FU duration: 7 days | | Testart, 1994 | 2 daily infusions of 400 mg of naftidrofuryl for 8 days (n=20) vs. placebo (n=17) | AOMI stade III ou IV | Double aveugle Parallel groups Sample size: 20/17 Primary endpoint: Appréciation du niveau de douleur ressentie FU duration: 8 jours La randomisation est effectuée à l'aide d'une table de permutation au hasard de 4 éléments. | | D'Hooge D, 2001 | - effet de naftidrofuryl sur la qualité de vie de patients souffrant de claudication intermittente stable :
3x200mg pdt 6 mois (n=116) vs. - placebo pdt 6 mois (n=119) | - 235 patients
- âge moyen 66,5 ans
- 66,4% d'hommes | Double aveugle Parallel groups Sample size: 116/119 Primary endpoint: Amélioration de la qualité de vie FU duration: 6 mois analyse en ITT |
|
| peripheral vascular diseases | naftidrofuryl | not classified | versus prostaglandine No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| naftidrofuryl IV vs prostacyclin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Negus, 1987 | Naftidrofuryl 0.02 mg/kg/min, intra-arterial, 3 days (n=15) vs. intra-arterial prostacyclin 8 ng/kg/min, 3 days (n=14) | Stade de la maladie: III: 55.2%; IV: 44.8%Durée de la douleur (semaines): groupe contrôle: 30 +/-54.2 groupe ttt: 19.7 +/- 44.6 | Double aveugle Parallel groups Sample size: 15/14 Primary endpoint: Soulagement de la douleur au repos FU duration: 24 h Le choix de la substance administrée a été effectué avec une table de nombres aléatoires.
32 patients ont été initialement randomisés, mais 3 ont été exclus secondairement. |
|
| peripheral vascular diseases | pentoxifylline | not classified | versus placebo or control No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Dawson (pentoxifylline), 2000 | pentoxifylline vs placebo | | | | | APIC, 1989 | pentoxifylline vs placebo | | | | | Donaldson, 1984 | pentoxifylline vs placebo | | | | | Porter, 1982 | pentoxifylline vs placebo | | | | | Belcaro, 2002 | pentoxifylline vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Dawson (pentoxifylline), 2000 | Pentoxifylline 1200 mg/d (n=232) vs. placebo (n=239) Le cilostazol pouvant être aussi considéré comme vasodilatateur, les groupes pentoxifylline et cilostazol ont été regroupés. | Stade de la maladie: II en situation chronique. | Double aveugle Parallel groups Sample size: 232/239 Primary endpoint: Périmètre de marche maximal FU duration: 6 mois Randomisation centralisée | | APIC, 1989 | Pentoxifylline 800 mg/d (n=37) vs. placebo (n=37) | Stade de la maladie : II, avec durée des symptômes de 10 mois en moyenne. | Double aveugle Factorial plan Sample size: 37/37 Primary endpoint: Périmètre de marche FU duration: 12 mois | | Donaldson, 1984 | Oxpentifylline 600 mg/d (n=40) vs. placebo (n=40) | AOMI stade II | Double aveugle Parallel groups Sample size: 40/40 Primary endpoint: Pas de critère primaire clairement indiqué FU duration: 2 mois | | Porter, 1982 | Pentoxifylline between 600 mg/d and 1200 mg/d (n=67) vs. placebo (n=61) | Stade de l'artériopathie: II, avec durée des symptomes de 2.9 ans en moyenne. | Double aveugle Parallel groups Sample size: 67/61 Primary endpoint: Périmètre de marche FU duration: 6 mois 4 patients ont reçu le mauvais traitement pendant une courte période. | | Belcaro, 2002 | Pentoxifylline 1600 mg/d (n=30) vs. placebo (n=30) | Stade de la maladie: II avec durée de la claudication de: 3+/- 2 mois en moyenne. | Double aveugle Parallel groups Sample size: 30/30 Primary endpoint: amélioration du périmétre de marche maximal FU duration: 6 mois |
|
