| heart failure | 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 |
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