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Inspra (Eplerenone) - Summary

 
 



INSPRA SUMMARY

INSPRAcontains 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.)


See all Inspra indications & dosage >>

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.

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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.

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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 >>


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

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
  
Treatment Info
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
  
Reported Results
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.

See all Inspra reviews / ratings >>

Page last updated: 2015-08-10

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