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Francesco Pichi, Paola Carrai, Antonio Ciardella, Francine Behar-Cohen, Paolo Nucci
PURPOSE: To evaluate the effect of oral spironolactone and eplerenone, two specific antagonists of the mineralocorticoid receptor, in central serous chorioretinopathy (CSCR). METHODS: In this prospective, placebo-controlled trial, sixty patients with persistent CSCR were assigned to three treatment group. Twenty patients in Group 1 were treated with 25 mg of spironolactone (Aldactone; Pfizer) for 1 week, then increased to 50 mg for the following 3 weeks, then shifted to eplerenone 50 mg for 1 month...
October 18, 2016: International Ophthalmology
Jie V Zhao, Lin Xu, Shi Lin Lin, C Mary Schooling
Diabetes predicts cardiovascular disease (CVD); some drugs are effective for CVD prevention but increase the risk of diabetes. In a systematic review and meta-analysis of placebo-controlled trials, we assessed if spironolactone, a mineralocorticoid receptor antagonist, affected glycemic control. We searched PubMed using ("spironolactone" or "aldactone") and trial and ("glucose" or "diabetes" or "insulin" or "insulin resistance") until January 4, 2016. In total, 18 eligible trials were identified; 10 on fasting glucose, 8 on hemoglobin A1c (HbA1c), 7 on homeostatic model assessment (HOMA)-insulin resistance (IR), and 8 on insulin...
August 2016: Journal of the American Society of Hypertension: JASH
Herbert I Weisberg, Victor P Pontes
BACKGROUND: There is currently much interest in generating more individualized estimates of treatment effects. However, traditional statistical methods are not well suited to this task. Post hoc subgroup analyses of clinical trials are fraught with methodological problems. We suggest that the alternative research paradigm of predictive analytics, widely used in many business contexts, can be adapted to help. METHODS: We compare the statistical and analytics perspectives and suggest that predictive modeling should often replace subgroup analysis...
August 2015: Clinical Trials: Journal of the Society for Clinical Trials
Anna Gabrielian, Mathew W MacCumber
PURPOSE: To report a case of central serous chorioretinopathy caused by the use of spironolactone, a competitive antagonist of aldosterone. METHODS: Case report and review of the literature. RESULTS: A 26-year-old white woman on Aldactone (spironolactone) for the treatment of acne and Adderall (dextroamphetamine/amphetamine) for the treatment of attention deficit hyperactivity disorder, developed central serous chorioretinopathy, which resolved upon discontinuation of spironolactone and remitted after restarting it...
2012: Retinal Cases & Brief Reports
Fernando J Verdugo, Felipe A Montellano, Juan E Carreño, Elisa T Marusic
In recent years, much attention has focused on the role of aldosterone and mineralocorticoid receptors (MRs) in the pathophysiology of hypertension and cardiovascular disease. Patients with primary aldosteronism, in whom angiotensin II levels are low, have a higher incidence of cardiovascular complications than patients with essential hypertension. The Randomized Aldactone Evaluation Study (RALES) demonstrated that adding a non-specific MR antagonist, spironolactone, to a standard therapy that included angiotensin-converting enzyme (ACE) inhibitors, loop diuretics, and digoxin, significantly reduced morbidity and mortality in patients with moderate to severe heart failure...
January 2014: Revista Médica de Chile
Orly Vardeny, Brian Claggett, Inder Anand, Patrick Rossignol, Akshay S Desai, Faiez Zannad, Bertram Pitt, Scott D Solomon
BACKGROUND: Mineralocorticoid receptor antagonists reduce morbidity and mortality in patients with heart failure but can cause hyperkalemia, which contributes to reduced use of these drugs. Hypokalemia also leads to worse outcomes in patients with heart failure and may be attenuated by mineralocorticoid receptor antagonists. METHODS AND RESULTS: We assessed incidence and predictors of hyperkalemia (potassium ≥5.5 mmol/L) and hypokalemia (potassium <3.5 mmol/L) and the relationship to outcomes in 1663 patients with class III or IV heart failure and left ventricular ejection fraction <35% randomized to treatment with spironolactone 25 mg or placebo in the Randomized Aldactone Evaluation Study (RALES) trial...
July 2014: Circulation. Heart Failure
Orly Vardeny, Larisa H Cavallari, Brian Claggett, Akshay S Desai, Inder Anand, Patrick Rossignol, Faiez Zannad, Bertram Pitt, Scott D Solomon
BACKGROUND: The incidence of hyperkalemia caused by mineralocorticoid receptor antagonists may vary by race, but whether race influences efficacy of mineralocorticoid receptor antagonists in heart failure (HF) is unknown. METHODS AND RESULTS: We assessed hyperkalemia and outcomes in African Americans (AAs; n=120) and non-AAs (n=1543; white 93%) with New York Heart Association (NYHA) class III or IV HF and left ventricular dysfunction who were randomized to spironolactone, titrated to 25 or 50 mg daily or placebo, in the Randomized Aldactone Evaluation Study (RALES)...
September 1, 2013: Circulation. Heart Failure
Basile Gravez, Antoine Tarjus, Frederic Jaisser
Mineralocorticoid receptor (MR) activation has been shown to play a deleterious role in the development of heart disease in studies using specific MR antagonists (spironolactone, eplerenone) in both experimental models and patients. Pharmacological MR blockade attenuates the transition to heart failure (HF) in models of systolic left ventricular dysfunction and myocardial infarction, as well as diastolic dysfunction, in rats and mice. In humans, MR antagonism is highly beneficial in patients with mild or advanced HF and postinfarct HF...
December 2013: Clinical and Experimental Pharmacology & Physiology
D Luke Glancy, Jameel Ahmed, Siby G Ayalloore, Paul A LeLorier, Pranav M Diwan, Frederick R Helmcke
The patient underwent closure of an atrial septal defect at age 3, had a leaking "mitral" valve repaired at age 9, and at age 13 had a "mitral" valve replacement. He began taking warfarin sodium at that time and remained symptom-free until 10 days before his initial visit here when he presented to another hospital with dyspnea and palpitations. Treatment there consisted of lisinopril 10 mg qd, carvedilol 6.25 mg bid, aldactone 25 mg qd, furosemide 40 mg qd, digoxin 0.25 mg qd, and a continuation of warfarin sodium 7...
January 2013: Journal of the Louisiana State Medical Society: Official Organ of the Louisiana State Medical Society
Cardiac pump failure leads to a reduction of the effective arterial volume. This is sensed by the kidney via afferent sympathetic fibres. The renal response to the perceived lack of volume is the retention of sodium and water. Although initially homeostatic, this renal counterregulation is maladaptive later on and may contribute to further cardiac compromise by increasing preload (volume retention) and afterload (hyperreninism). The renal sodium retention in congestive heart failure is a consequence of the activation of the sympathetic nervous system and of the renin-angiotensin-aldosterone system...
June 1, 2000: Therapeutische Umschau. Revue Thérapeutique
Orly Vardeny, Dong Hong Wu, Akshay Desai, Patrick Rossignol, Faiez Zannad, Bertram Pitt, Scott D Solomon
OBJECTIVES: This study investigated the influence of baseline and worsening renal function (WRF) on the efficacy of spironolactone in patients with severe heart failure (HF). BACKGROUND: Renal dysfunction or decline in renal function is a known predictor of adverse outcome in patients with HF, and treatment decisions are often on the basis of measures of renal function. METHODS: We used data from the RALES (Randomized Aldactone Evaluation Study) in 1,658 patients with New York Heart Association functional class III or IV HF and an ejection fraction <35%...
November 13, 2012: Journal of the American College of Cardiology
Vijaiganesh Nagarajan, Mohammed Chamsi-Pasha, W H Wilson Tang
The aldosterone receptor antagonists (ARAs) spironolactone (Aldactone) and eplerenone (Inspra) have become part of standard medical therapy for heart failure, having shown clinical efficacy in randomized trials in patients with advanced symptomatic systolic heart failure, postinfarction heart failure with cardiac dysfunction, and systolic heart failure with mild symptoms. The benefits include a lower rate of death. Yet to be answered is whether the two drugs are clinically equivalent; another question is whether they may benefit everyone with symptomatic heart failure, including diastolic heart failure...
September 2012: Cleveland Clinic Journal of Medicine
Janet Wittes
BACKGROUND: This article addresses a problem arising when a trial shows such strong evidence of benefit of the tested intervention that it stops early with an observed effect size for the experimental treatment that is statistically significantly better than the control. Within the classical frequentist framework of group sequential trials, the observed estimated effect size, the associated naïve confidence interval, and the p-value are all biased estimates of the true values. The bias is in the direction of the overestimation of the treatment effect, creation of narrower confidence intervals than appropriate, and a p-value that is too small...
December 2012: Clinical Trials: Journal of the Society for Clinical Trials
Saurav Chatterjee, Chaim Moeller, Nidhi Shah, Oluwaseyi Bolorunduro, Edgar Lichstein, Norbert Moskovits, Debabrata Mukherjee
INTRODUCTION: Eplerenone is publicized to be extremely effective in reducing mortality from heart failure, with a reasonable side-effect profile. However, it is much more expensive compared with older aldosterone antagonists. We reviewed available evidence to assess whether increased expense was justified with outcomes data. METHODS AND RESULTS: The authors searched the PubMed, CENTRAL, CINAHL, and EMBASE databases for randomized controlled trials from 1966 through July 2011...
August 2012: American Journal of Medicine
Jean M Nappi, Adam Sieg
Aldosterone is a mineralocorticoid hormone synthesized by the adrenal glands that has several regulatory functions to help the body maintain normal volume status and electrolyte balance. Studies have shown significantly higher levels of aldosterone secretion in patients with congestive heart failure compared with normal patients. Elevated levels of aldosterone have been shown to elevate blood pressure, cause left ventricular hypertrophy, and promote cardiac fibrosis. An appreciation of the true role of aldosterone in patients with chronic heart failure did not become apparent until the publication of the Randomized Aldactone Evaluation Study...
2011: Vascular Health and Risk Management
Nathalie Bénéton-Benhard
Bullous pemphigoid is the most frequent autoimmune bullous skin disease and affects subjects who are about 80 years old. The risk factors are neurological degenerative diseases, poor Karnovski's status and some drugs (aldactone and neuroleptics). Typically, the disease consists of itching eczematous or urticarial sheets, surmounted by blisters. The blisters heal without scars. Mouth and head are rarely involved. The diagnostic is made by histological examination . It shows a subepidermal blister with some degree of dermal infiltrate with lymphocytes and eosinophils...
October 2010: La Presse Médicale
Rana Al-Shaikh Hamid, Faisal Al-Akayleh, Mohammad Shubair, Iyad Rashid, Mayyas Al Remawi, Adnan Badwan
The performance of the novel chitin metal silicate (CMS) co-precipitates as a single multifunctional excipient in tablet formulation using direct compression and wet granulation methods is evaluated. The neutral, acidic, and basic drugs Spironolactone (SPL), ibuprofen (IBU) and metronidazole (MET), respectively, were used as model drugs. Commercial Aldactone, Fleximex and Dumazole tablets containing SPL, IBU and MET, respectively, and tablets made using Avicel 200, were used in the study for comparison purposes...
2010: Marine Drugs
C McKenna, J Burch, S Suekarran, S Walker, A Bakhai, K Witte, M Harden, K Wright, N Woolacott, P Lorgelly, L Fenwick, S Palmer
BACKGROUND: Two aldosterone inhibitors are currently licensed for heart failure (HF) in the UK: spironolactone and eplerenone. Recent clinical guidelines recommend eplerenone after an acute myocardial infarction (MI) for patients with symptoms and/or signs of HF and left ventricular dysfunction. OBJECTIVES: The primary objective was to evaluate relative clinical effectiveness and cost-effectiveness of spironolactone and eplerenone in patients with postMI HF and explore the possibility of conducting an indirect comparison of spironolactone and eplerenone...
May 2010: Health Technology Assessment: HTA
Li Wei, Allan D Struthers, Tom Fahey, Alexander D Watson, Thomas M Macdonald
OBJECTIVE: To determine the safety of spironolactone prescribing in the setting of the UK National Health Service. DESIGN: Population based longitudinal analysis using a record linkage database. SETTING: Tayside, Scotland. Population All patients who received one or more dispensed prescriptions for spironolactone between 1994 and 2007. MAIN OUTCOME MEASURES: Rates of prescribing for spironolactone, hospital admissions for hyperkalaemia, and hyperkalaemia and renal function without admission, before and after the publication of results from the Randomised Aldactone Evaluation Study (RALES)...
2010: BMJ: British Medical Journal
William I Cohen, Yi Hui Liu, Martin T Stein
Steve is a 7-year-old child with Down syndrome who was referred to the Developmental and Behavioral Pediatrics Clinic for increasing hyperactivity and disruptive behaviors. He is followed closely for complex congenital heart disease, oxygen dependent pulmonary hypertension and chronic lung disease. He is accompanied by his mother who, while greeting the staff with a smile, apologizes as Steve attempts to get out of his stroller. His mother reports that the pulmonologist requested an evaluation of Steve's disruptive behaviors during recent clinic visits...
April 2010: Journal of Developmental and Behavioral Pediatrics: JDBP
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