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The Studies of Oral Enoximone Therapy in Advanced Heart Failure

ESSENTIAL. The Studies of Oral Enoximone Therapy in Advanced Heart Failure. Presented at The European Society of Cardiology Congress 2005 Presented by Dr. Marco Metra. ESSENTIAL.

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The Studies of Oral Enoximone Therapy in Advanced Heart Failure

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  1. ESSENTIAL The Studies of Oral Enoximone Therapy in Advanced Heart Failure Presented at The European Society of Cardiology Congress 2005 Presented by Dr. Marco Metra

  2. ESSENTIAL 1854 patients who met the following criteria:Age ≥18 years, ischemic or non-ischemic cardiomyopathy, NYHA Class III or IV, one hospitalization or two outpatient visits for treatment of worsening heart failure in prior 12 months requiring the administration of intravenous heart failure therapy, impaired cardiac function (LVEF ≤30%), concomitant treatment with optimal conventional heart failure therapy (beta-blockers and ACE inhibitors or angiotensin receptor blockers). Placebo N=928 Oral Enoximone 25 mg three times daily, up-titrated to 50 mg three times daily; n=926 • Primary Endpoints: 1) Reduction in time to all-cause mortality or cardiovascular (CV) hospitalization in the pooled components; 2) increase in the six minute walk test distance in each component individually; 3) symptomatic improvement on the Patient Global Assessment (PGA) questionnaire in each component individually Presented at ACC 2005

  3. ESSENTIAL: Primary Endpoint Cardiovascular Hospitalization/All-cause Mortality P=0.71 • The primary endpoint of cardiovascular hospitalization or all-cause mortality did not differ significantly between groups Presented at ACC 2005

  4. ESSENTIAL: Primary Endpoint Median Change in six-minute walk distance (m)from baseline to six months East/West Europe P=0.82 • Median change in six minute walk distance was significantly different for the enoximone group compared to the placebo group within the North/South America cohort, but did not differ significantly between groups in the European cohort North/South America P=0.025

  5. ESSENTIAL: Primary Endpoint Marked improvement Reported on the Patient Global Assessment (PGA) Questionnaire North/South America p=0.79 East/West Europe P=0.11 • There was no significant difference in reported symptomatic improvement in patients treated with enoximone compared with placebo in either the American or European cohorts

  6. ESSENTIAL Trial Summary • Among patients with advanced chronic heart failure who were already receiving optimal conventional therapy, treatment with enoximone was not associated with improvements in all-cause mortality or CV hospitalization • For distance walked in a six-minute walk test, the median change from baseline to 6 months was 10 meters (p=0.025) with enoximone vs. placebo in the North/South America cohort. In the European cohort, the difference was only 1.5 meters with enoximone vs. placebo (p=0.82) • There was no difference in symptomatic improvement between groups as reported on the Patient Global Assessment Questionnaire.

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