| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| heart failure | amrinone | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| AMTG, 1985 | Amrinone vs placebo | | | Total mortality 1.11 [0.16; 7.55] Worsening heart failure (requiring intervention) 0.74 [0.22; 2.45] |
| Trial | Treatments | Patients | Method |
|---|
| AMTG, 1985 | Amrinone <600mg/day (n=-9) vs. placebo (n=-9) | patients with heart failure NYHA III/IV | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 3 months |
|
| heart failure | Enoximone | not classified | versus placebo or control No demonstrated result for efficacy Enoximone inferior to placebo in terms of Total mortality in EMTG, 1990 Enoximone inferior to placebo in terms of Cardiac death in EMTG, 1990 | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| WESG, 1991 | Enoximone vs placebo | | | Total mortality 1.38 [0.38; 5.01] Sudden death 1.04 [0.20; 5.49] | | EMTG, 1990 | Enoximone vs placebo | | Total mortality 3.47 [1.01; 11.87] Cardiac death 3.47 [1.01; 11.87] | Myocardial infarction (fatal & non fatal) ∞ [NaN; ∞] Sudden death ∞ [NaN; ∞] Worsening heart failure (requiring intervention) 0.91 [0.36; 2.32] Vertigo 0.52 [0.10; 2.71] | | ESG, 2000 | Enoximone vs placebo | | | Total mortality 0.25 [0.05; 1.30] Arrhythmia ∞ [NaN; ∞] | | Lardoux, 1987 | Enoximone vs placebo | | | Total mortality 0.80 [0.17; 3.81] | | ESSENTIAL (I and II), 2009 | enoximone vs placebo | | | Total mortality 0.98 [0.86; 1.12] all-cause death or HF hospitalization 0.97 [0.84; 1.12] | | Cowley, 1994 | Enoximone vs placebo | | | Total mortality 1.52 [0.92; 2.52] Cardiac death 1.46 [0.84; 2.53] | | EMOTE, 2007 | enoximone vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| WESG, 1991 | Enoximone 150, 300 mg/d (n=108) vs. placebo (n=56) | NYHA II, III | double blind Parallel groups Sample size: 108/56 Primary endpoint: Exercise tolerance FU duration: 3 months | | EMTG, 1990 | Enoximone <450 mg/d (n=50) vs. placebo (n=52) | NYHA II, III | double blind Parallel groups Sample size: 50/52 Primary endpoint: FU duration: 4 months | | ESG, 2000 | Enoximone 75-150 mg/d (n=70) vs. placebo (n=35) | NYHA II, III | double blind Parallel groups Sample size: 70/35 Primary endpoint: FU duration: 3 months | | Lardoux, 1987 | Enoximone 150, 300mg/d (n=30) vs. placebo (n=13) | NYHA NA | double blind Parallel groups Sample size: 30/13 Primary endpoint: none FU duration: 3 months | | ESSENTIAL (I and II), 2009 | enoximone titrated to 50 mg three times daily (n=926) vs. placebo (n=928) | Patients with New York Heart Association class III–IV HF symptoms, left ventricular
ejection fraction 30%, and one hospitalization or two ambulatory visits for worsening HF in the previous
year | double blind Parallel groups Sample size: 926/928 Primary endpoint: detah or CV hospitalisation FU duration: 16.6 mo (median) three co-primary endpoints: the composite of time
to all-cause mortality or cardiovascular hospitalization, analysed in the two ESSENTIAL trials combined; the
6 month change from baseline in the 6 min walk test distance (6MWTD); and the Patient Global Assessment
(PGA) at 6 months | | Cowley, 1994 | Enoximone 300mg/d (n=75) vs. placebo (n=76) | NYHA III,IV | double blind Parallel groups Sample size: 75/76 Primary endpoint: total mortality FU duration: 12 months | | EMOTE, 2007 | enoximone (n=101) vs. placebo (n=100) | patients with ultra-advanced heart failure requiring IV inotropic therapy | double blind Parallel groups Sample size: 101/100 Primary endpoint: FU duration: 26 weeks |
|
| heart failure | Flosequinan | not classified | versus placebo or control No demonstrated result for efficacy Flosequinan inferior to placebo in terms of Vertigo in REFLECT, 1993 | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Cowley, 1993 | Flosequinan vs placebo | | | Total mortality 1.11 [0.07; 17.37] Sudden death 1.11 [0.07; 17.37] Worsening heart failure (requiring intervention) 4.44 [0.51; 38.68] | | FACET, 1993 | Flosequinan vs placebo | | | Total mortality 1.12 [0.44; 2.88] Sudden death 0.00 [0.00; NaN] Worsening heart failure (requiring intervention) 1.19 [0.59; 2.42] Arrhythmia 2.77 [0.82; 9.29] Vertigo 1.62 [0.76; 3.47] | | REFLECT, 1993 | Flosequinan vs placebo | | Vertigo 2.80 [1.04; 7.54] | Total mortality 3.76 [0.80; 17.66] Myocardial infarction (fatal & non fatal) 1.61 [0.28; 9.44] Sudden death 2.69 [0.53; 13.52] Worsening heart failure (requiring intervention) 0.51 [0.24; 1.07] Arrhythmia ∞ [NaN; ∞] | | REFLECT II, 1991 | Flosequinan vs placebo | | | Total mortality 1.11 [0.39; 3.10] |
| Trial | Treatments | Patients | Method |
|---|
| Cowley, 1993 | Flosequinan 125mg/d (n=64) vs. placebo (n=71) | NYHA II, III | double blind Parallel groups Sample size: 64/71 Primary endpoint: FU duration: 4 months | | FACET, 1993 | Flosequinan 100 and 150 mg/d (n=212) vs. placebo (n=110) | NYHA II, III | double blind Parallel groups Sample size: 212/110 Primary endpoint: FU duration: 4 months | | REFLECT, 1993 | Flosequinan 100mg/d (n=93) vs. placebo (n=100) | NYHA II,III | double blind Parallel groups Sample size: 93/100 Primary endpoint: Exercise tolerance FU duration: 3 months | | REFLECT II, 1991 | Flosequinan 100, 150 mg/d (n=207) vs. (n=104) | NYHA II-IV | double blind Parallel groups Sample size: 207/104 Primary endpoint: Exercise tolerance FU duration: 3 months |
|
| heart failure | ibopamine | not classified | versus placebo or control No demonstrated result for efficacy ibopamine inferior to placebo in terms of Total mortality in PRIME II, 1997 ibopamine inferior to placebo in terms of Sudden death in PRIME II, 1997 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PRIME II, 1997 | ibopamine vs placebo | | Total mortality 1.20 [1.02; 1.42] Sudden death 1.50 [1.04; 2.15] | Cardiac death 0.71 [0.37; 1.38] Transplantation 0.95 [0.53; 1.72] |
| Trial | Treatments | Patients | Method |
|---|
| PRIME II, 1997 | oral ibopamine 100 mg three times daily (n=953) vs. placebo (n=953) | patients with heart failure NYHA III-IV | double blind Parallel groups Sample size: 953/953 Primary endpoint: Total mortality FU duration: mean 11.4 months |
|
| heart failure | Milrinone | not classified | versus placebo or control No demonstrated result for efficacy Milrinone inferior to placebo in terms of Total mortality in PROMISE, 1991 Milrinone inferior to placebo in terms of Sudden death in PROMISE, 1991 Milrinone inferior to placebo in terms of Cardiac death in PROMISE, 1991 Milrinone inferior to placebo in terms of Vertigo in PROMISE, 1991 | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PROMISE, 1991 | Milrinone vs placebo | | Total mortality 1.24 [1.02; 1.51] Sudden death 1.57 [1.14; 2.17] Cardiac death 1.30 [1.06; 1.60] Vertigo 1.90 [1.40; 2.57] | Myocardial infarction (fatal & non fatal) 5.64 [0.68; 46.66] Worsening heart failure (requiring intervention) 1.88 [0.65; 5.46] Transplantation 0.63 [0.11; 3.73] Arrhythmia 1.22 [0.95; 1.56] | | MMTG, 1989 | Milrinone vs placebo | | | Total mortality 2.33 [0.94; 5.80] Myocardial infarction (fatal & non fatal) ∞ [NaN; ∞] Cardiac death 1.87 [0.72; 4.80] Worsening heart failure (requiring intervention) 0.87 [0.57; 1.34] Arrhythmia 1.87 [0.91; 3.81] Vertigo 2.05 [0.74; 5.72] |
| Trial | Treatments | Patients | Method |
|---|
| PROMISE, 1991 | Milrinone 40mg/d (n=561) vs. placebo (n=527) | NYHA III,IV | double blind Parallel groups Sample size: 561/527 Primary endpoint: Total mortality FU duration: 20 months | | MMTG, 1989 | Milrinone <40mg/d (n=119) vs. placebo (n=111) | NYHA II-IV | double blind Parallel groups Sample size: 119/111 Primary endpoint: none FU duration: 3 months |
|
| heart failure | vesnarinone | not classified | versus placebo or control No demonstrated result for efficacy Vesnarinone inferior to placebo in terms of Total mortality in VEST, 1998 Vesnarinone inferior to placebo in terms of Sudden death in VEST, 1998 | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| OPC-8212 MRG, 1990 | Vesnarinone vs placebo | | | Total mortality 0.00 [0.00; NaN] Worsening heart failure (requiring intervention) 0.14 [0.02; 1.12] Arrhythmia ∞ [NaN; ∞] Vertigo ∞ [NaN; ∞] | | VEST, 1998 | Vesnarinone vs placebo | | Total mortality 1.16 [1.02; 1.33] Sudden death 1.26 [1.03; 1.54] | Myocardial infarction (fatal & non fatal) 1.41 [0.51; 3.90] Cardiac death 1.13 [0.98; 1.30] Worsening heart failure (requiring intervention) 0.95 [0.85; 1.05] | | VSG, 1993 | Vesnarinone vs placebo | Total mortality 0.39 [0.21; 0.73] Sudden death 0.20 [0.06; 0.68] Cardiac death 0.36 [0.19; 0.68] Worsening heart failure (requiring intervention) 0.54 [0.31; 0.94] | | Myocardial infarction (fatal & non fatal) 1.00 [0.33; 3.04] Transplantation 0.46 [0.18; 1.19] Arrhythmia 2.99 [0.31; 28.52] |
| Trial | Treatments | Patients | Method |
|---|
| OPC-8212 MRG, 1990 | Vesnarinone 60mg/d (n=45) vs. placebo (n=48) | NYHA II-IV | double blind Parallel groups Sample size: 45/48 Primary endpoint: none FU duration: 3 months | | VEST, 1998 | Vesnarinone 30, 60mg/d (n=2550) vs. placebo (n=1283) | NYHA III,IV | double blind Parallel groups Sample size: 2550/1283 Primary endpoint: Total mortality FU duration: 9 months | | VSG, 1993 | Vesnarinone 60mg/d (n=-9) vs. placebo (n=-9) | NYHA II-IV | double blind Parallel groups Sample size: -9/-9 Primary endpoint: total mortality or major cardiovascular morbidity FU duration: 6 months |
|
