Heart failure remains a highly prevalent disease with high mortality despite current treatment. The presently available steroidal MRAs spironolactone and eplerenone have been shown to improve outcomes, but adverse effects and the need for frequent monitoring of serum potassium and renal function throughout treatment have limited their uptake in routine clinical practice. Several potential new indications for MRAs are yet to be systematically investigated. BAY 94-8862 is a novel non-steroidal MRA that could potentially combine high potency (similar to spironolactone) with high selectivity (greater than eplerenone), improved end-organ protective activity, and improved safety compared with previous MRAs, based on differences in physicochemical properties. ARTS—a multicentre, randomized, double-blind, placebo-controlled study—is the first clinical trial of BAY 94-8862 in patients and is expected to provide a wealth of information on BAY 94-8862 in individuals with HFREF and CKD. Should the hypothesis prove correct and BAY 94-8862 is demonstrated to have improved safety at a given efficacy than presently available steroidal MRAs in these high-risk patients with HFREF and moderate CKD, this would open the way for larger clinical outcome studies in this patient group and possibly other indications, potentially leading to reductions in cardiovascular mortality, hospitalizations for HF, and healthcare resource use.
Bayer HealthCare AG. Dr Claire Mulligan and Dr Charlotte Cookson of Oxford PharmaGenesis™ Ltd provided medical writing support funded by Bayer HealthCare AG.
Conflicts of interest: B.P. has received consulting fees from Bayer, Pfizer, Merck, Novartis, Takeda, AstraZeneca, Lilly, GE Healthcare, Relypsa, BG Medicine, Amorcyte, Cytopherx, and Aurasense, stock options from Relypsa, BG Medicine, and Aurasense, and grants from Novartis, Medtronic, and Forest Laboratories. G.F. has received consulting fees from Bayer. M.G. has been a consultant for Abbott Laboratories, Astellas, AstraZeneca, Bayer HealthCare AG, Corthera, Cytokinetics, Debiopharm S.A., Errekappa Terapeutici, GlaxoSmithKline, Ikaria, Johnson & Johnson, Medtronic, Merck, Novartis Pharma AG, Otsuka Pharmaceuticals, Palatin Technologies, PeriCor Therapeutics, Protein Design Laboratories, Sanofi-Aventis, Sigma-Tau, Solvay Pharmaceuticals, Takeda Pharmaceutical, and Trevena Therapeutics. L.K. has received consulting fees from Bayer HealthCare AG, Novartis Pharma AG, and Sanofi-Aventis. H.K. has received consulting fees from Bayer. P.P. has received consulting fees from Bayer and speaker honoraria from Pfizer. C.N. is an employee of Bayer Pharma AG. P.K. is an employee of Bayer HealthCare Pharmaceuticals. S.-Y.K. is an employee of Bayer Vital GmbH. F.Z. has received speaker/consultant honoraria from Alere, AstraZeneca, BG Medicine, Boston Scientific, Novartis, Pfizer, Resmed, Servier, and Takeda.
ARTS investigators: Austria: F. Fruhwald, H. Drexel, A. Podczeck-Schweighofer, J. Altenberger, P. Siostrzonek; Belgium: A-C. Pouleur, W. Droogné, W. Smolders, M. De Ceuninck; Czech Republic: J. Spinar, E. Nemecek, F. Malek, T. Belza; Germany: E. Vester, B. R. Winkelmann, F. Baer, W. Sehnert, J. Beermann, F. Richard, U. Schulze, S. Anker, A. Al-Zoebi, H. Hohensee; Denmark: L. Køber, C. Torp-Pedersen, H. Nielsen, S. Lind Rasmussen, K. Skagen, K. Egstrup, L. Videbæk, T. Nielsen; Finland: V.-P. Harjola, H. Ukkonen, K. Nyman; Israel: A. Marmor, A. Katz, T. B. Gal, S. Goland, A. Shotan, G. Keren, Y. Turgeman; Norway: S. Ørn, A. Westheim; Poland: P. Ponikowski; E. Mirek-Bryniarska, J. Niegowska, M. Ogorek, W. Krysiak; Sweden: Å. Ohlsson, C.-J. Lindholm, I. Torstensson, R. Zlatewa, M. Rosenqvist.