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 =40%) and clinical evidence of congestive heart failure after an acute myocardial infarction. (See 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.)
Published Studies Related to Inspra (Eplerenone)
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. 
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.
The efficacy and safety of the novel aldosterone antagonist eplerenone in children with hypertension: a randomized, double-blind, dose-response study. [2010.08]
OBJECTIVES: To determine the efficacy and safety of eplerenone therapy in children with hypertension... CONCLUSIONS: Short-term treatment with eplerenone reduced blood pressure in children with hypertension and had acceptable tolerability. Copyright (c) 2010 Mosby, Inc. All rights reserved.
Clinical Trials Related to Inspra (Eplerenone)
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.
Study of the Effect of Eplerenone on Heart Function in Women Receiving Anthracycline Chemotherapy for Breast Cancer [Not yet recruiting]
Doxorubicin and other anthracyclines are commonly used to treat breast cancer and other
types of cancer. Unfortunately, they can cause heart muscle damage, resulting in scarring,
abnormal contraction and relaxation, and heart failure symptoms. This side effect occurs
more frequently at higher doses, and limits the total dose that can be given to cancer
patients. Eplerenone is an oral medication that prevents or reverses heart damage in other
disease states, and is commonly used to treat heart failure. This study will investigate
the use of eplerenone to protect the heart from these harmful side effects of doxorubicin.
Few therapies have been shown to prevent heart damage in patients receiving anthracyclines.
Small studies have suggested that other heart failure medications (ACE inhibitors,
beta-blockers) may reduce the incidence of cardiac toxicity, but eplerenone and other drugs
in its class (aldosterone antagonists) have not previously been studied. Eplerenone inhibits
enzyme pathways that cause scarring of the heart, and animal studies suggest that
anthracyclines cause damage through these same pathways.
This study aims to investigate whether eplerenone protects the heart from the harmful
effects of doxorubicin chemotherapy. Specifically, it will measure the effect that
eplerenone has on heart muscle relaxation. It will randomly assign women undergoing
chemotherapy with doxorubicin to one of two groups: one group will receive eplerenone, and
the other group will receive placebo (sugar) pills. The subjects will not know which type
of pills they are taking. Heart muscle relaxation will be measured at baseline, after
completion of chemotherapy (8-12 weeks), and after 6 months. There will also be various
blood tests measured in the study subjects, to determine whether there might be certain
blood tests that identify patients at particularly high risk of heart toxicity after
Eplerenone, ACE Inhibition and Albuminuria [Recruiting]
The purpose of this study is to determine whether eplerenone is more effective than doubling
the dose of ACE inhibitor in reducing urinary protein (albumin) loss in diabetes mellitus
Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction [Recruiting]
Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction,
in patients without heart failure, reduces cardiovascular mortality / morbidity.
Eplerenone in HIV Associated Abdominal Fat Accumulation [Recruiting]
The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle
modification to affect sugar metabolism, body fat distribution, and cardiovascular health in
HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that
aldosterone, a hormone that regulates salt and water balance, is increased in association
with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals,
aldosterone appears to be higher in individuals with increased belly fat, and increased
aldosterone appears to be strongly associated with impaired sugar metabolism. In this
study, the investigators will test the effects of eplerenone, which is a medication that
blocks the actions of aldosterone, along with lifestyle modification. The investigators
hypothesize that eplerenone may improve sugar metabolism, improve markers of cardiovascular
health, and reduce fat accumulation in liver and muscle.
Reports of Suspected Inspra (Eplerenone) Side Effects
Renal Failure Acute (9),
Renal Failure (7),
Drug Interaction (5),
Hypertensive Crisis (5),
Blood Creatinine Increased (4),
Blood Pressure Increased (4), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Inspra has an overall score of 2. The effectiveness score is 8 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
Inspra review by 51 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || Conn's Syndrome|
|Dosage & duration:|| || 50mgs twice per day taken twice per day for the period of 4 months|
|Other conditions:|| || None|
|Other drugs taken:|| || Parriet|
|Benefits:|| || Prior to the Inspra I was on Spiractin, which I am back on now. I took the inspra to reduce possibiity of gynecomastia, which was presenting in the form of breast pain.
My blood pressure normalised on both Spriractin and Inspra.|
|Side effects:|| || Severe anxiety attacks commenced approximately two months after starting, and in hind site was a slow build up, but got to the point that it interfered with normal day to day |
|Comments:|| || Spiractin originally prescribed for treatment of Conn's Syndrome, however some brease pain was experienced shortly after commencing the medication. Further consultation with treating doctor and Inspra was prescribed as alternative.
Inspra commenced and side effects described above experienced so reverted to Spiractin after short time. Side effects ceased almost immediately, 48 to 72 hours after cessation of Inspra completed.|
Page last updated: 2011-12-09