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

Patrick H. Pun; Safa Abdalla; Geoffrey A. Block; Glenn M. Chertow; Ricardo Correa-Rotter; Bastian Dehmel; Tilman B. Drüeke; Jürgen Floege; William G. Goodman; Charles A. Herzog; Gerard M. London; Kenneth W. Mahaffey; Sharon M. Moe; Patrick S. Parfrey; David C. Wheeler; John P. Middleton

doi:10.1111/hdi.12382

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

Patrick H. Pun, Safa Abdalla, Geoffrey A. Block, Glenn M. Chertow, Ricardo Correa-Rotter, Bastian Dehmel, Tilman B. Drüeke, Jürgen Floege, William G. Goodman, Charles A. Herzog, Gerard M. London, Kenneth W. Mahaffey, Sharon M. Moe, Patrick S. Parfrey, David C. Wheeler, John P. Middleton

Medicine - Cardiology Division

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	421-431
Number of pages	11
Journal	Hemodialysis International
Volume	20
Issue number	3
DOIs	https://doi.org/10.1111/hdi.12382
State	Published - Jul 1 2016

Bibliographical note

Publisher Copyright:
© 2015 International Society for Hemodialysis

Keywords

Cardiovascular
dialysate fluid compatibility and quality
international dialysis issues
outcomes research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Publisher link

10.1111/hdi.12382

http://europepmc.org/articles/pmc4866914

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Pun, P. H., Abdalla, S., Block, G. A., Chertow, G. M., Correa-Rotter, R., Dehmel, B., Drüeke, T. B., Floege, J., Goodman, W. G., Herzog, C. A., London, G. M., Mahaffey, K. W., Moe, S. M., Parfrey, P. S., Wheeler, D. C., & Middleton, J. P. (2016). Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial. Hemodialysis International, 20(3), 421-431. https://doi.org/10.1111/hdi.12382

Pun, PH, Abdalla, S, Block, GA, Chertow, GM, Correa-Rotter, R, Dehmel, B, Drüeke, TB, Floege, J, Goodman, WG, Herzog, CA, London, GM, Mahaffey, KW, Moe, SM, Parfrey, PS, Wheeler, DC & Middleton, JP 2016, 'Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial', Hemodialysis International, vol. 20, no. 3, pp. 421-431. https://doi.org/10.1111/hdi.12382

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abstract = "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.",

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AU - Correa-Rotter, Ricardo

AU - Dehmel, Bastian

AU - Drüeke, Tilman B.

AU - Floege, Jürgen

AU - Goodman, William G.

AU - Herzog, Charles A.

AU - London, Gerard M.

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

Abstract

Bibliographical note

Keywords

UN SDGs

Publisher link

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