NEWS HIGHLIGHTS
Published Studies Related to Inspra (Eplerenone)
Effect of eplerenone in percutaneous coronary intervention-treated
post-myocardial infarction patients with left ventricular systolic dysfunction: a
subanalysis of the EPHESUS trial. [2014]
CONCLUSIONS: The beneficial effects of eplerenone in the EPHESUS trial exist for
A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism. [2011.05]
BACKGROUND: Eplerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. We compared the efficacy, safety and tolerability of eplerenone versus spironolactone in patients with hypertension associated with primary aldosteronism... CONCLUSION: The antihypertensive effect of spironolactone was significantly greater than that of eplerenone in hypertension associated with primary aldosteronism. (c) 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Eplerenone in patients with systolic heart failure and mild symptoms. [2011.01.06]
BACKGROUND: Mineralocorticoid antagonists improve survival among patients with chronic, severe systolic heart failure and heart failure after myocardial infarction. We evaluated the effects of eplerenone in patients with chronic systolic heart failure and mild symptoms... CONCLUSIONS: Eplerenone, as compared with placebo, reduced both the risk of death and the risk of hospitalization among patients with systolic heart failure and mild symptoms. (Funded by Pfizer; ClinicalTrials.gov number, NCT00232180.).
Truncated areas under the curve in the assessment of pioglitazone bioequivalence. Data from a single-center, single-dose, randomized, open-label, 2-way cross-over bioequivalence study of two formulations of pioglitazone 45 mg tablets under fasting conditions. [2011]
BACKGROUND: Pioglitazone (CAS 112529-15-4 for the HCl form) is an oral antidiabetic agent that is a member of the group of drugs known as thiazolidinediones. It is indicated for the treatment of type 2 diabetes mellitus. OBJECTIVE: The aim of this study was to assess the bioequivalence of a new pioglitazone 45 mg formulation (test formulation) vs. the reference product, as required by European regulatory authorities for the marketing of a generic product. Additionally, the applicability of the truncated area under the plasma concentration curve (AUC) approach to this drug and under these test conditions was determined... CONCLUSION: Bioequivalence between test and reference formulations, both in terms of rate and extension of absorption, under fasting conditions was concluded according to European guidelines. Both formulations were well tolerated. The conclusion of bioequivalence was also supported using the truncated AUCs approach.
Effect of eplerenone versus spironolactone on cortisol and hemoglobin A(c) levels in patients with chronic heart failure. [2010.11]
BACKGROUND: It has been reported that mineralocorticoid receptor antagonist improves the prognosis of chronic heart failure (CHF). Recently, hemoglobin A(c) (HbA(c)) levels have been reported to be an independent risk factor for mortality in CHF, suggesting the important role of insulin resistance in CHF. We compared the metabolic effect of a selective mineralocorticoid receptor blocker eplerenone with spironolactone in CHF patients... CONCLUSION: These findings indicated that the metabolic effect of eplerenone differed from that of spironolactone and that eplerenone had a superior metabolic effect especially on HbA(c) in CHF patients. Copyright (c) 2010 Mosby, Inc. All rights reserved.
Clinical Trials Related to Inspra (Eplerenone)
Eplerenone for the Treatment of Central Serous Chorioretinopathy [Active, not recruiting]
To test the effect oral eplerenone versus placebo in patients with central serious
chorioretinopathy .
Eplerenone for Central Serous Chorioretinopathy [Recruiting]
- The goal of the study is to examine the short-term effects and safety of a systemic
anti-aldosterone medication, eplerenone, in a small group of patients with central
serous chorioretinopathy (CSCR).
- There is currently no standard treatment or therapy for either acute or chronic CSCR, a
potentially debilitating eye disease.
- There is evidence in both animals and humans that high blood serum corticosteroid
levels can cause or worsen CSCR or findings similar to CSCR in the choroid and retina
- Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and
anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that
decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR
- The investigators' aim is to evaluate a standardized dose of eplerenone in a controlled
prospective fashion for both acute and chronic CSCR.
- The study consists of taking a standard dose of eplerenone, 50mg once daily, for 1
month
- Over the course of the month, patients will be monitored for side effects, as well as
visual and anatomical response to the medication
The Effect of EPLerenone on Ischemia Reperfusion Injury in Human myoCARDium [Recruiting]
In the laboratory, the researchers will investigate whether the drug eplerenone improves
contractile function after ischemia and reperfusion in heart tissue.
Eplerenone and Extracellular Adenosine Formation [Completed]
Various studies have reported cardioprotective effects of mineralocorticoid receptor (MR)
antagonists in the setting of an acute myocardial infarction. In a recent animal study, the
protective effect of MR antagonists on infarct size was completely abolished in CD73
knock-out and adenosine A2b receptor knock-out mice, and by co-administration of adenosine
receptor antagonists in rats. These findings suggest that extracellular formation of
adenosine is crucial for this protective effect and that MR antagonists stimulate
extracellular adenosine formation by the enzyme CD73.
To investigate whether eplerenone promotes adenosine receptor stimulation by activating
CD73, the investigators will measure forearm blood flow in response to various dosages of
dipyridamole with the use of plethysmography. Dipyridamole increases the extracellular
endogenous adenosine concentration by inhibition of the ENT transporter and induces local
vasodilation. Therefore, the vasodilator effect of dipyridamole accurately reflects
extracellular adenosine formation by the CD73 enzyme.
A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives [Completed]
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.
Reports of Suspected Inspra (Eplerenone) Side Effects
Renal Failure Acute (9),
Dyspnoea (8),
Renal Failure (7),
Drug Interaction (5),
Nausea (5),
Hyponatraemia (5),
Hypertensive Crisis (5),
Dizziness (4),
Blood Creatinine Increased (4),
Blood Pressure Increased (4), more >>
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