heart failure | All results are NS for efficacy inferior to placebo in terms of Total mortality in EMTG, 1990 inferior to placebo in terms of Cardiac death in EMTG, 1990 | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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WESG, 1991 | vs placebo | | | Total mortality 1.38 [0.38; 5.01] Sudden death 1.04 [0.20; 5.49] | EMTG, 1990 | 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 | vs placebo | | | Total mortality 0.25 [0.05; 1.30] Arrhythmia ∞ [NaN; ∞] | Lardoux, 1987 | vs placebo | | | Total mortality 0.80 [0.17; 3.81] | ESSENTIAL (I and II), 2009 | vs placebo | | | Total mortality 0.98 [0.86; 1.12] all-cause death or HF hospitalization 0.97 [0.84; 1.12] | Cowley, 1994 | vs placebo | | | Total mortality 1.52 [0.92; 2.52] Cardiac death 1.46 [0.84; 2.53] | EMOTE, 2007 | vs placebo | | | |
Trial | Treatments | Patients | Method |
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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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