INSPRA SUMMARY
INSPRA™ contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor.
INSPRA is indicated to improve survival of stable patients with left ventricular systolic dysfunction (ejection fraction CLINICAL STUDIES,
Congestive Heart Failure Post-Myocardial Infarction.)
INSPRA is indicated for the treatment of hypertension. INSPRA may be used alone or in combination with other antihypertensive agents. (See CLINICAL STUDIES, Hypertension.)
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NEWS HIGHLIGHTS
Published Studies Related to Inspra (Eplerenone)
The effects of eplerenone on length of stay and total days of heart failure hospitalization after myocardial infarction in patients with left ventricular systolic dysfunction. [2009.09]
BACKGROUND: Heart failure (HF) with reduced left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI) is associated with increased readmission rates. This study evaluated the effects of eplerenone, a selective aldosterone blocking agent, on the duration of subsequent hospitalizations for HF in the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS)... CONCLUSIONS: In patients post-AMI with reduced LVEF and HF or diabetes, eplerenone added to standard therapy reduced the mean length and total days of HF hospitalizations compared to placebo in all regions. Given the high cost of hospital care for HF, these findings may translate into an economic benefit to health care worldwide.
Left ventricular remodeling after acute myocardial infarction: does eplerenone have an effect? [2009.06]
AIMS: Aldosterone antagonism reduces cardiovascular morbidity and mortality in patients with left ventricular (LV) systolic dysfunction and heart failure or diabetes after acute myocardial infarction (AMI). The mechanism of this effect is unclear. We performed a contrast-enhanced cardiac magnetic resonance study to assess the effects of eplerenone on LV remodeling after AMI... CONCLUSIONS: In a population of patients with AMI with high uptake of contemporary antiremodeling therapy, eplerenone provides modest incremental protection against LV remodeling, only after covariate adjustment.
Extracellular cardiac matrix biomarkers in patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure: insights from the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) study. [2009.05.12]
CONCLUSIONS: Changes in biomarkers of collagen synthesis and degradation suggest that extracellular matrix remodeling is an active process in patients with congestive heart failure and left ventricular systolic dysfunction after acute myocardial infarction. High type I collagen telopeptide and high brain natriuretic peptide serum levels are associated with the highest event rate. Eplerenone suppresses post-acute myocardial infarction collagen turnover changes.
Patient health status and costs in heart failure: insights from the eplerenone post-acute myocardial infarction heart failure efficacy and survival study (EPHESUS). [2009.01.27]
CONCLUSIONS: Health status assessment predicts resource use and costs over the next year in stable heart failure outpatients with left ventricular dysfunction after myocardial infarction.
Cost-effectiveness analysis of aldosterone blockade with eplerenone in patients with heart failure after acute myocardial infarction in the French context: the EPHESUS study. [2008.09]
BACKGROUND: The Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) randomized clinical trial demonstrated the efficacy of eplerenone, a new aldosterone antagonist diuretic, with standard treatment versus standard treatment alone in the reduction of cardiovascular mortality and cardiovascular-related hospital readmissions for patients with heart failure after an acute myocardial infarction. AIM: We assessed the incremental cost per life-year saved of eplerenone in the French context versus standard treatment... CONCLUSION: The cost of eplerenone leads to an acceptable level of incremental cost per life-year saved when compared with existing treatments in the cardiovascular domain for the prevention of cardiovascular death and morbidity in patients with heart failure after an acute myocardial infarction.
Clinical Trials Related to Inspra (Eplerenone)
The Long-Term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years [Completed]
To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16
years with high blood pressure. The study will last at least 1 year and about 140 patients
will participate.
A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children. [Completed]
To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children
aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and
about 320 patients will participate.
A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives [Recruiting]
Obesity and hypertension are independent risks for congestive heart failure (CHF) and
chronic kidney disease. In obesity induced hypertension, the most common cause of human
essential hypertension, the potential importance of mineralocorticoid receptor blockade has
not been widely investigated. We propose to test the hypothesis that eplerenone reduces
metabolic demand, improves cardiac function and attenuates glomerular hyperfiltration and
microalbuminuria in obese patients. Our specific aims are to assess changes in basal
metabolic rate, cardiac and renal function in obese hypertensive subjects treated with
eplerenone compared to amlodipine.
Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity [Recruiting]
Effects of Eplerenone on Left Ventricular Remodelling Following Heart Attack [Completed]
The purpose of this study is to ascertain whether treatment with the drug eplerenone, taken
early after a heart attack, prevents or reduces some of the adverse changes that may
otherwise naturally occur within the heart muscle, that lead ultimately to weakening of the
heart muscle and premature death.
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