Effects of SNF472, a Novel Inhibitor of Hydroxyapatite Crystallization in Patients Receiving Hemodialysis - Subgroup Analyses of the CALIPSO Trial
Raggi, Paolo (Division of Cardiology and Department of Medicine, University of Alberta, Edmonton, Alberta, Canada)
Bellasi, Antonio (Research, Innovation and Brand Reputation Unit, ASST Papa Giovanni XXIII, Bergamo, Italy)
Sinha, Smeeta (Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom)
Bover, Jordi (Institut d'Investigació Biomèdica Sant Pau)
Rodriguez, Mariano (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Ketteler, Markus (Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany)
Bushinsky, David A. (Department of Medicine, University of Rochester School of Medicine, Rochester, New York, USA)
Garg, Rekha (PharmaDRS, LLC, San Diego, California, USA)
Perelló, Joan (University of the Balearic Islands, Palma, Spain)
Gold, Alex (Department of Medicine, Stanford University, Palo Alto, California, USA)
Chertow, Glenn M. (Department of Medicine, Stanford University, Palo Alto, California, USA)
Universitat Autònoma de Barcelona

Fecha:	2020
Resumen:	Coronary artery calcium (CAC) is highly prevalent and linked with poor outcomes in patients receiving maintenance hemodialysis, and its reduction may improve patient prognosis. SNF472, a selective inhibitor of hydroxyapatite crystallization, slows CAC progression in patients receiving maintenance hemodialysis. In this analysis, we assessed the efficacy of SNF472 in prespecified patient subgroups. In a randomized clinical trial SNF472 300 mg, SNF472 600 mg, or placebo were infused thrice weekly in 91, 92, and 91 patients receiving maintenance hemodialysis and with CAC at baseline, respectively. In prespecified subanalyses, the percent change in CAC volume score (CACvs) from baseline to week 52 in modified intention-to-treat (mITT) and per-protocol (PP) populations was calculated in the following subgroups: age, sex, diabetes mellitus, dialysis vintage, prior atherosclerotic cardiovascular disease, baseline use of non-calcium and calcium-based phosphate binders, calcimimetics, activated vitamin D, warfarin, and statins. In the main trial, SNF472 significantly reduced CACvs progression compared with placebo (11% versus 20% mITT analyses; P = 0. 016; 8% vs. 24% PP analyses; P < 0. 001). Treatment differences for CACvs progression were similar across all subgroups, and all interaction P values were non-significant in mITT and PP analyses. SNF472 treatment for 52 weeks reduced CACvs progression compared with placebo in a broad range of patients receiving maintenance hemodialysis. Future studies will determine the impact of SNF472 on cardiovascular events in this population.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Coronary calcification ; Vascular calcification ; Hemodialysis
Publicado en:	Kidney International Reports, Vol. 5 (november 2020) , p. 2178-2182, ISSN 2468-0249

DOI: 10.1016/j.ekir.2020.09.032
PMID: 33305110

5 p, 1.6 MB

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