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Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial
Author(s) -
Pun Patrick H.,
Abdalla Safa,
Block Geoffrey A.,
Chertow Glenn M.,
CorreaRotter Ricardo,
Dehmel Bastian,
Drüeke Tilman B.,
Floege Jürgen,
Goodman William G.,
Herzog Charles A.,
London Gerard M.,
Mahaffey Kenneth W.,
Moe Sharon M.,
Parfrey Patrick S.,
Wheeler David C.,
Middleton John P.
Publication year - 2016
Publication title -
hemodialysis international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.658
H-Index - 47
eISSN - 1542-4758
pISSN - 1492-7535
DOI - 10.1111/hdi.12382
Subject(s) - cinacalcet , medicine , calcium , hemodialysis , clinical endpoint , dialysis , cardiology , myocardial infarction , endocrinology , urology , randomized controlled trial , secondary hyperparathyroidism , parathyroid hormone
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 E valuation of C inacalcet H ydrochloride T herapy to L ower C ardiovascular E vents ( 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 E urope and L atin A merica compared with N orth A merica. 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.