Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial.

Autor: Pun PH; Department of Medicine, Duke University, Durham, North Carolina, USA., Abdalla S; Department of Medicine, Stanford University School of Medicine, Palo Alto, California, USA., Block GA; Denver Nephrology, Denver, Colorado, USA., Chertow GM; Department of Medicine, Stanford University School of Medicine, Palo Alto, California, USA., Correa-Rotter R; Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, District Federal, Mexico., Dehmel B; Amgen, Inc, Thousand Oaks, California, USA., Drüeke TB; Inserm Unit 1088, UFR Médecine/Pharmacie, Université de Picardie, Amiens, France., Floege J; Department of Nephrology, Universitätsklinikum der RWTH Aachen, Aachen, Germany., Goodman WG; Amgen, Inc, Thousand Oaks, California, USA., Herzog CA; University of Minnesota, Minneapolis, Minnesota, USA., London GM; Hôpital Manhès, Paris, France.; Indiana University School of Medicine and Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA., Mahaffey KW; Department of Medicine, Stanford University School of Medicine, Palo Alto, California, USA., Moe SM; Hôpital Manhès, Paris, France.; Indiana University School of Medicine and Roudebush Veterans Administration Medical Center, Indianapolis, Indiana, USA., Parfrey PS; Health Sciences Center, St. John's, Newfoundland, Canada., Wheeler DC; University College London, London, United Kingdom., Middleton JP; Department of Medicine, Duke University, Durham, North Carolina, USA.
Jazyk: angličtina
Zdroj: Hemodialysis international. International Symposium on Home Hemodialysis [Hemodial Int] 2016 Jul; Vol. 20 (3), pp. 421-31. Date of Electronic Publication: 2015 Nov 13.
DOI: 10.1111/hdi.12382
Abstrakt: Among patients receiving hemodialysis, abnormalities in calcium regulation have been linked to an increased risk of cardiovascular events. Cinacalcet lowers serum calcium concentrations through its effect on parathyroid hormone secretion and has been hypothesized to reduce the risk of cardiovascular events. In observational cohort studies, prescriptions of low dialysate calcium concentration and larger observed serum-dialysate calcium gradients have been associated with higher risks of in-dialysis facility or peri-dialytic sudden cardiac arrest. We performed this study to examine the risks associated with dialysate calcium and serum-dialysate gradients among participants in the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial. In EVOLVE, 3883 hemodialysis patients were randomized 1:1 to cinacalcet or placebo. Dialysate calcium was administered at the discretion of treating physicians. We examined whether baseline dialysate calcium concentration or the serum-dialysate calcium gradient modified the effect of cinacalcet on the following adjudicated endpoints: (1) primary composite endpoint (death or first non-fatal myocardial infarction, hospitalization for unstable angina, heart failure, or peripheral vascular event); (2) cardiovascular death; and (3) sudden death. In EVOLVE, use of higher dialysate calcium concentrations was more prevalent in Europe and Latin America compared with North America. There was a significant fall in serum calcium concentration in the cinacalcet group; dialysate calcium concentrations were changed infrequently in both groups. There was no association between baseline dialysate calcium concentration or serum-dialysate calcium gradient and the endpoints examined. Neither the baseline dialysate calcium nor the serum-dialysate calcium gradient significantly modified the effects of cinacalcet on the outcomes examined. The effects of cinacalcet on cardiovascular death and major cardiovascular events are not altered by the dialysate calcium prescription and serum-dialysate calcium gradient.
(© 2015 International Society for Hemodialysis.)
Databáze: MEDLINE
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