Effects of cinacalcet on atherosclerotic and nonatherosclerotic cardiovascular events in patients receiving hemodialysis: The evaluation of cinacalcet hcl therapy to lower cardiovascular events (EVOLVE) trial

Evaluation Of Cinacalcet HCl Therapy to Lower Cardio Vascular Events (EVOLVE) Trial Investigators

Research output: Contribution to journalArticle

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Abstract

Background-Premature cardiovascular disease limits the duration and quality of life on long-term hemodialysis. The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms, risk factors for these events, and the effects of cinacalcet, using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial. Methods and Results-EVOLVE was a randomized, double-blind, placebo-controlled clinical trial that randomized 3883 hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to 64 months. For this post hoc analysis, the outcome measure was fatal and nonfatal cardiovascular events reflecting atherosclerotic and nonatherosclerotic cardiovascular diseases. During the trial, 1518 patients experienced an adjudicated cardiovascular event, including 958 attributable to nonatherosclerotic disease. Of 1421 deaths during the trial, 768 (54%) were due to cardiovascular disease. Sudden death was the most frequent fatal cardiovascular event, accounting for 24.5% of overall mortality. Combining fatal and nonfatal cardiovascular events, randomization to cinacalcet reduced the rates of sudden death and heart failure. Patients randomized to cinacalcet experienced fewer nonatherosclerotic cardiovascular events (adjusted relative hazard 0.84, 95% CI 0.74 to 0.96), while the effect of cinacalcet on atherosclerotic events did not reach statistical significance. Conclusions-Accepting the limitations of post hoc analysis, any benefits of cinacalcet on cardiovascular disease in the context of hemodialysis may result from attenuation of nonatherosclerotic processes.

Original languageEnglish
Article number001363
JournalJournal of the American Heart Association
Volume3
Issue number6
DOIs
StatePublished - 2014

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Renal Dialysis
Cardiovascular Diseases
Sudden Death
Therapeutics
Placebos
Secondary Hyperparathyroidism
Random Allocation
Cinacalcet Hydrochloride
Randomized Controlled Trials
Heart Failure
Quality of Life
Outcome Assessment (Health Care)
Mortality

Keywords

  • Atherosclerosis
  • Cardiovascular diseases
  • Heart failure
  • Kidney
  • Sudden death

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Effects of cinacalcet on atherosclerotic and nonatherosclerotic cardiovascular events in patients receiving hemodialysis : The evaluation of cinacalcet hcl therapy to lower cardiovascular events (EVOLVE) trial. / Evaluation Of Cinacalcet HCl Therapy to Lower Cardio Vascular Events (EVOLVE) Trial Investigators.

In: Journal of the American Heart Association, Vol. 3, No. 6, 001363, 2014.

Research output: Contribution to journalArticle

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title = "Effects of cinacalcet on atherosclerotic and nonatherosclerotic cardiovascular events in patients receiving hemodialysis: The evaluation of cinacalcet hcl therapy to lower cardiovascular events (EVOLVE) trial",
abstract = "Background-Premature cardiovascular disease limits the duration and quality of life on long-term hemodialysis. The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms, risk factors for these events, and the effects of cinacalcet, using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial. Methods and Results-EVOLVE was a randomized, double-blind, placebo-controlled clinical trial that randomized 3883 hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to 64 months. For this post hoc analysis, the outcome measure was fatal and nonfatal cardiovascular events reflecting atherosclerotic and nonatherosclerotic cardiovascular diseases. During the trial, 1518 patients experienced an adjudicated cardiovascular event, including 958 attributable to nonatherosclerotic disease. Of 1421 deaths during the trial, 768 (54{\%}) were due to cardiovascular disease. Sudden death was the most frequent fatal cardiovascular event, accounting for 24.5{\%} of overall mortality. Combining fatal and nonfatal cardiovascular events, randomization to cinacalcet reduced the rates of sudden death and heart failure. Patients randomized to cinacalcet experienced fewer nonatherosclerotic cardiovascular events (adjusted relative hazard 0.84, 95{\%} CI 0.74 to 0.96), while the effect of cinacalcet on atherosclerotic events did not reach statistical significance. Conclusions-Accepting the limitations of post hoc analysis, any benefits of cinacalcet on cardiovascular disease in the context of hemodialysis may result from attenuation of nonatherosclerotic processes.",
keywords = "Atherosclerosis, Cardiovascular diseases, Heart failure, Kidney, Sudden death",
author = "{Evaluation Of Cinacalcet HCl Therapy to Lower Cardio Vascular Events (EVOLVE) Trial Investigators} and Wheeler, {David C.} and London, {Gerard M.} and Parfrey, {Patrick S.} and Block, {Geoffrey A.} and Ricardo Correa-Rotter and Bastian Dehmel and Dr{\"u}eke, {Tilman B.} and J{\"u}rgen Floege and Yumi Kubo and Mahaffey, {Kenneth W.} and Goodman, {William G.} and Sharon Moe and Trotman, {Marie Louise} and Safa Abdalla and Chertow, {Glenn M.} and Herzog, {Charles A.}",
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T2 - The evaluation of cinacalcet hcl therapy to lower cardiovascular events (EVOLVE) trial

AU - Evaluation Of Cinacalcet HCl Therapy to Lower Cardio Vascular Events (EVOLVE) Trial Investigators

AU - Wheeler, David C.

AU - London, Gerard M.

AU - Parfrey, Patrick S.

AU - Block, Geoffrey A.

AU - Correa-Rotter, Ricardo

AU - Dehmel, Bastian

AU - Drüeke, Tilman B.

AU - Floege, Jürgen

AU - Kubo, Yumi

AU - Mahaffey, Kenneth W.

AU - Goodman, William G.

AU - Moe, Sharon

AU - Trotman, Marie Louise

AU - Abdalla, Safa

AU - Chertow, Glenn M.

AU - Herzog, Charles A.

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N2 - Background-Premature cardiovascular disease limits the duration and quality of life on long-term hemodialysis. The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms, risk factors for these events, and the effects of cinacalcet, using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial. Methods and Results-EVOLVE was a randomized, double-blind, placebo-controlled clinical trial that randomized 3883 hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to 64 months. For this post hoc analysis, the outcome measure was fatal and nonfatal cardiovascular events reflecting atherosclerotic and nonatherosclerotic cardiovascular diseases. During the trial, 1518 patients experienced an adjudicated cardiovascular event, including 958 attributable to nonatherosclerotic disease. Of 1421 deaths during the trial, 768 (54%) were due to cardiovascular disease. Sudden death was the most frequent fatal cardiovascular event, accounting for 24.5% of overall mortality. Combining fatal and nonfatal cardiovascular events, randomization to cinacalcet reduced the rates of sudden death and heart failure. Patients randomized to cinacalcet experienced fewer nonatherosclerotic cardiovascular events (adjusted relative hazard 0.84, 95% CI 0.74 to 0.96), while the effect of cinacalcet on atherosclerotic events did not reach statistical significance. Conclusions-Accepting the limitations of post hoc analysis, any benefits of cinacalcet on cardiovascular disease in the context of hemodialysis may result from attenuation of nonatherosclerotic processes.

AB - Background-Premature cardiovascular disease limits the duration and quality of life on long-term hemodialysis. The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms, risk factors for these events, and the effects of cinacalcet, using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial. Methods and Results-EVOLVE was a randomized, double-blind, placebo-controlled clinical trial that randomized 3883 hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to 64 months. For this post hoc analysis, the outcome measure was fatal and nonfatal cardiovascular events reflecting atherosclerotic and nonatherosclerotic cardiovascular diseases. During the trial, 1518 patients experienced an adjudicated cardiovascular event, including 958 attributable to nonatherosclerotic disease. Of 1421 deaths during the trial, 768 (54%) were due to cardiovascular disease. Sudden death was the most frequent fatal cardiovascular event, accounting for 24.5% of overall mortality. Combining fatal and nonfatal cardiovascular events, randomization to cinacalcet reduced the rates of sudden death and heart failure. Patients randomized to cinacalcet experienced fewer nonatherosclerotic cardiovascular events (adjusted relative hazard 0.84, 95% CI 0.74 to 0.96), while the effect of cinacalcet on atherosclerotic events did not reach statistical significance. Conclusions-Accepting the limitations of post hoc analysis, any benefits of cinacalcet on cardiovascular disease in the context of hemodialysis may result from attenuation of nonatherosclerotic processes.

KW - Atherosclerosis

KW - Cardiovascular diseases

KW - Heart failure

KW - Kidney

KW - Sudden death

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