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L M Ruilope, C Nowack, G L Bakris
No abstract text is available yet for this article.
July 2016: Journal of the American Society of Hypertension: JASH
Pingping Yang, Tianlun Huang, Gaosi Xu
No abstract text is available yet for this article.
September 2016: Metabolism: Clinical and Experimental
Roland Heinig, Nina Kimmeskamp-Kirschbaum, Atef Halabi, Silvia Lentini
Finerenone (BAY 94-8862) is a nonsteroidal mineralocorticoid receptor antagonist in development for the treatment of diabetic kidney disease. This observational trial compared the pharmacokinetics of a single oral dose of finerenone 10 mg (immediate-release tablet) in adults with mild (creatinine clearance [CLCR ] 50-80 mL/min; n = 8), moderate (CLCR 30 to < 50 mL/min; n = 8), or severe (CLCR < 30 mL/min; n  =  9) renal impairment with those in adults with normal renal function (CLCR > 80 mL/min; n  = 8) over 96 hours postdose...
March 31, 2016: Clinical Pharmacology in Drug Development
Claire McCune, Peter McKavanagh, Ian B A Menown
INTRODUCTION: Multiple significant, potentially practice changing clinical trials in cardiology have been conducted and subsequently presented throughout the past year. METHODS: In this paper, the authors have reviewed and contextualized significant cardiovascular clinical trials presented at major international conferences of 2015 including American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, American Diabetes Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, Heart Rhythm Congress, and the American Heart Association Scientific Sessions...
June 8, 2016: Cardiology and Therapy
Karina Huynh
No abstract text is available yet for this article.
July 2016: Nature Reviews. Cardiology
Duygu Batu Demir, Mark E Cooper
PURPOSE OF REVIEW: The purpose of this review is to provide an overview of recent preclinical and clinical studies, which demonstrate new insights for the treatment of diabetic kidney disease (DKD) and to outline future directions with respect to novel therapies. RECENT FINDINGS: Positive findings with respect to new glucose-lowering agents such as sodium-dependent glucose transporter 2 inhibitors may lead to a change in the way we treat diabetic individuals with or at risk of DKD...
July 2016: Current Opinion in Nephrology and Hypertension
Matthias Naegele, Adrian F Hernandez, Frank Ruschitzka
No abstract text is available yet for this article.
July 14, 2016: European Heart Journal
Gerasimos Filippatos, Stefan D Anker, Michael Böhm, Mihai Gheorghiade, Lars Køber, Henry Krum, Aldo P Maggioni, Piotr Ponikowski, Adriaan A Voors, Faiez Zannad, So-Young Kim, Christina Nowack, Giovanni Palombo, Peter Kolkhof, Nina Kimmeskamp-Kirschbaum, Alexander Pieper, Bertram Pitt
AIMS: To evaluate oral doses of the non-steroidal mineralocorticoid receptor antagonist finerenone given for 90 days in patients with worsening heart failure and reduced ejection fraction and chronic kidney disease and/or diabetes mellitus. METHODS AND RESULTS: Miner Alocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF) was a randomized, double-blind, phase 2b multicentre study ( NCT01807221). Of 1286 screened patients, 1066 were randomized...
July 14, 2016: European Heart Journal
Hermann Haller, Anna Bertram, Klaus Stahl, Jan Menne
Aldosterone binds to the mineralocorticoid receptor and has an important regulatory role in body fluid and electrolyte balance. It also influences a variety of different cell functions such as oxidative stress, inflammation and organ fibrosis. The important role of the tissue-specific mineralocorticoid receptors in cardiovascular and renal injury has been shown in knockout animals and in clinical studies Mineralocorticoid receptor antagonists seem to exert their beneficial effects via anti-oxidative, anti-inflammatory and anti-fibrotic effects...
April 2016: Current Hypertension Reports
Hao A Tran, Felice Lin, Barry H Greenberg
INTRODUCTION: The prevalence of heart failure (HF) has increased globally in recent decades. Advances in our understanding of underlying pathophysiologic mechanisms have given rise to new therapies for treating the growing HF population. Nonetheless, morbidity and mortality associated with HF and its financial implications are daunting. Thus, novel therapies that can improve the natural history of HF patients are urgently needed. AREAS COVERED: This article reviews new investigational drugs being developed for the treatment of both acute decompensated heart failure (ADHF) and chronic heart failure with reduced ejection fraction (HFrEF)...
July 2016: Expert Opinion on Investigational Drugs
Naoki Sato, Masayoshi Ajioka, Takahisa Yamada, Masaharu Kato, Masafumi Myoishi, Takashi Yamada, So-Young Kim, Christina Nowack, Peter Kolkhof, Tsuyoshi Shiga
BACKGROUND: Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, was evaluated in Japanese patients with heart failure (HF) with reduced ejection fraction and chronic kidney disease and/or diabetes mellitus. METHODS AND RESULTS: ARTS-HF Japan was a randomized, double-blind, phase 2b study. Patients (n=72) received oral, once-daily (o.d.) finerenone (2.5, 5, 7.5, 10 or 15 mg, up-titrated to 5, 10, 15, 20, or 20 mg, respectively, on day 30) or eplerenone (25 mg every other day, increased to 25 mg o...
April 25, 2016: Circulation Journal: Official Journal of the Japanese Circulation Society
Alexandre Gueret, Najah Harouki, Julie Favre, Guillaume Galmiche, Lionel Nicol, Jean-Paul Henry, Marie Besnier, Christian Thuillez, Vincent Richard, Peter Kolkhof, Paul Mulder, Frédéric Jaisser, Antoine Ouvrard-Pascaud
Mineralocorticoid receptor (MR) antagonists slow down the progression of heart failure after myocardial infarction (MI), but the cell-specific role of MR in these benefits is unclear. In this study, the role of MR expressed in vascular smooth muscle cells (VSMCs) was investigated. Two months after coronary artery ligation causing MI, mice with VSMC-specific MR deletion (MI-MR(SMKO)) and mice treated with the MR antagonist finerenone (MI-fine) had improved left ventricular compliance and elastance when compared with infarcted control mice (MI-CTL), as well as reduced interstitial fibrosis...
April 2016: Hypertension
Jana Grune, Verena Benz, Sarah Brix, Janek Salatzki, Annelie Blumrich, Beata Höft, Robert Klopfleisch, Anna Foryst-Ludwig, Peter Kolkhof, Ulrich Kintscher
Pharmacological blockade of mineralocorticoid receptors (MR) is known as an efficacious therapy in chronic heart failure. Therapy with steroidal MR antagonists such as spironolactone or eplerenone (EPL) is often limited because of side effects. Recently, a new highly selective and potent, nonsteroidal MR antagonist, finerenone (FIN), has been developed. To investigate the effects of FIN on pressure-induced cardiac hypertrophy, the transverse aortic constriction (TAC) model was used in C57BL/6 mice treated with FIN (10 mg·kg·d), EPL (200 mg·kg·d) or vehicle (VEH)...
May 2016: Journal of Cardiovascular Pharmacology
Peter Bramlage, Stephanie L Swift, Martin Thoenes, Joan Minguet, Carmen Ferrero, Roland E Schmieder
Pharmaceutical antagonism of the mineralocorticoid receptor (MR) can protect against organ damage caused by elevated aldosterone levels in patients experiencing heart failure (HF), chronic kidney disease (CKD), primary aldosteronism, and hypertension. While traditional steroid-based MR antagonists effectively reduce mortality rates and extend patient survival, their broad application has been limited by significant side effects, most notably hyperkalaemia. Recently, finerenone (BAY 94-8862) has emerged as a next-generation non-steroidal dihydropyridine-based MR antagonist designed to minimize off-target effects while maintaining potent efficacy...
January 2016: European Journal of Heart Failure
Silvia Lentini, Roland Heinig, Nina Kimmeskamp-Kirschbaum, Georg Wensing
The safety, tolerability and pharmacokinetics of the selective nonsteroidal mineralocorticoid receptor antagonist finerenone were evaluated in healthy male volunteers in two randomized, single-centre studies. Study 1 was a first-in-man, single-blinded, placebo-controlled, parallel-group, dose-escalation study. Fasted participants (n = 45) received single oral doses of finerenone 1-40 mg polyethylene glycol (PEG) solution or placebo. Study 2 was a relative bioavailability study comparing a finerenone 10 mg immediate-release (IR) tablet with finerenone 10 mg PEG solution in the fasted state, investigating the effect of a high-fat/high-calorie meal on the pharmacokinetics of the IR tablet and assessing a further dose escalation to finerenone 80 mg (eight × finerenone 10 mg IR tablets), in an open-label, fourfold crossover design (n = 15)...
April 2016: Fundamental & Clinical Pharmacology
George L Bakris, Rajiv Agarwal, Juliana C Chan, Mark E Cooper, Ron T Gansevoort, Hermann Haller, Giuseppe Remuzzi, Peter Rossing, Roland E Schmieder, Christina Nowack, Peter Kolkhof, Amer Joseph, Alexander Pieper, Nina Kimmeskamp-Kirschbaum, Luis M Ruilope
IMPORTANCE: Steroidal mineralocorticoid receptor antagonists, when added to a renin-angiotensin system blocker, further reduce proteinuria in patients with chronic kidney disease but may be underused because of a high risk of adverse events. OBJECTIVE: To evaluate the safety and efficacy of different oral doses of the nonsteroidal mineralocorticoid receptor antagonist finerenone, given for 90 days to patients with diabetes and high or very high albuminuria who are receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker...
September 1, 2015: JAMA: the Journal of the American Medical Association
Larbi Amazit, Florian Le Billan, Peter Kolkhof, Khadija Lamribet, Say Viengchareun, Michel R Fay, Junaid A Khan, Alexander Hillisch, Marc Lombès, Marie-Edith Rafestin-Oblin, Jérôme Fagart
Aldosterone regulates sodium homeostasis by activating the mineralocorticoid receptor (MR), a member of the nuclear receptor superfamily. Hyperaldosteronism leads todeleterious effects on the kidney, blood vessels, and heart. Although steroidal antagonists such as spironolactone and eplerenone are clinically useful for the treatment of cardiovascular diseases, they are associated with several side effects. Finerenone, a novel nonsteroidal MR antagonist, is presently being evaluated in two clinical phase IIb trials...
September 4, 2015: Journal of Biological Chemistry
Licette C Y Liu, Elise Schutte, Ron T Gansevoort, Peter van der Meer, Adriaan A Voors
INTRODUCTION: The mineralocorticoid receptor antagonists (MRAs) spironolactone and eplerenone reduce the risk of hospitalizations and mortality in patients with heart failure (HF) with reduced ejection fraction (HFrEF), and attenuate progression of diabetic kidney disease. However, their use is limited by the fear of inducing hyperkalemia, especially in patients with renal dysfunction. Finerenone is a novel nonsteroidal MRA, with higher selectivity toward the mineralocorticoid receptor (MR) compared to spironolactone and stronger MR-binding affinity than eplerenone...
2015: Expert Opinion on Investigational Drugs
Peter Kolkhof, Christina Nowack, Frank Eitner
PURPOSE OF REVIEW: The broad clinical use of steroidal mineralocorticoid receptor antagonists (MRAs) is limited by the potential risk of inducing hyperkalemia when given on top of renin-angiotensin system blockade. Drug discovery campaigns have been launched aiming for the identification of nonsteroidal MRAs with an improved safety profile. This review analyses the evidence for the potential of improved safety profiles of nonsteroidal MRAs and the current landscape of clinical trials with nonsteroidal MRAs...
September 2015: Current Opinion in Nephrology and Hypertension
Bertram Pitt, Stefan D Anker, Michael Böhm, Mihai Gheorghiade, Lars Køber, Henry Krum, Aldo P Maggioni, Piotr Ponikowski, Adriaan A Voors, Faiez Zannad, Christina Nowack, So-Young Kim, Alexander Pieper, Nina Kimmeskamp-Kirschbaum, Gerasimos Filippatos
AIMS: To investigate the safety and potential efficacy of the novel non-steroidal mineralocorticoid receptor antagonist finerenone in patients with worsening chronic heart failure and reduced left ventricular ejection fraction (HFrEF) and at high risk of hyperkalaemia and worsening renal dysfunction. METHODS AND RESULTS: The MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF; NCT01807221) is a multicentre, randomized, double-blind, active-comparator-controlled, six-parallel-group, phase 2b dose-finding study...
February 2015: European Journal of Heart Failure
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