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
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...
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| Vydané v: | Journal of the American Heart Association Ročník 3; číslo 6; s. e001363 - n/a |
|---|---|
| Hlavní autori: | , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
| Vydavateľské údaje: |
England
Wiley-Blackwell
17.12.2014
Blackwell Publishing Ltd |
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| ISSN: | 2047-9980, 2047-9980 |
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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.
Clinical Trials Registration
Unique identifier: NCT00345839. URL: ClinicalTrials.gov. |
|---|---|
| AbstractList | 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.BACKGROUNDPremature 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.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.METHODS AND RESULTSEVOLVE 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.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.CONCLUSIONSAccepting 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.Unique identifier: NCT00345839. URL: ClinicalTrials.gov.CLINICAL TRIALS REGISTRATIONUnique identifier: NCT00345839. URL: ClinicalTrials.gov. 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 HC l 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. Clinical Trials Registration Unique identifier: NCT00345839. URL: ClinicalTrials.gov . 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. Clinical Trials Registration Unique identifier: NCT00345839. URL: ClinicalTrials.gov. 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. 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. 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. Unique identifier: NCT00345839. URL: ClinicalTrials.gov. |
| Author | Parfrey, Patrick S. Chertow, Glenn M. Dehmel, Bastian Herzog, Charles A. Drüeke, Tilman B. Abdalla, Safa Floege, Jürgen Moe, Sharon M. Goodman, William G. Trotman, Marie‐Louise Block, Geoffrey A. Kubo, Yumi Mahaffey, Kenneth W. London, Gerard M. Wheeler, David C. Correa‐Rotter, Ricardo |
| Author_xml | – sequence: 1 givenname: David C. surname: Wheeler fullname: Wheeler, David C. organization: University College London – sequence: 2 givenname: Gerard M. surname: London fullname: London, Gerard M. organization: Hôpital Manhès – sequence: 3 givenname: Patrick S. surname: Parfrey fullname: Parfrey, Patrick S. organization: Health Sciences Center St. John's – sequence: 4 givenname: Geoffrey A. surname: Block fullname: Block, Geoffrey A. organization: Denver Nephrology – sequence: 5 givenname: Ricardo surname: Correa‐Rotter fullname: Correa‐Rotter, Ricardo organization: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán – sequence: 6 givenname: Bastian surname: Dehmel fullname: Dehmel, Bastian organization: Amgen, Inc – sequence: 7 givenname: Tilman B. surname: Drüeke fullname: Drüeke, Tilman B. organization: Inserm Unit 1088, UFR Médecine/Pharmacie, Université de Picardie – sequence: 8 givenname: Jürgen surname: Floege fullname: Floege, Jürgen organization: Universitätsklinikum der RWTH Aachen – sequence: 9 givenname: Yumi surname: Kubo fullname: Kubo, Yumi organization: Amgen, Inc – sequence: 10 givenname: Kenneth W. surname: Mahaffey fullname: Mahaffey, Kenneth W. organization: Stanford University School of Medicine – sequence: 11 givenname: William G. surname: Goodman fullname: Goodman, William G. organization: Amgen, Inc – sequence: 12 givenname: Sharon M. surname: Moe fullname: Moe, Sharon M. organization: Roudebush Veterans Administration Medical Center – sequence: 13 givenname: Marie‐Louise surname: Trotman fullname: Trotman, Marie‐Louise organization: Amgen, Inc – sequence: 14 givenname: Safa surname: Abdalla fullname: Abdalla, Safa organization: Stanford University School of Medicine – sequence: 15 givenname: Glenn M. surname: Chertow fullname: Chertow, Glenn M. organization: Stanford University School of Medicine – sequence: 16 givenname: Charles A. surname: Herzog fullname: Herzog, Charles A. organization: University of Minnesota |
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| Copyright | 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell. Distributed under a Creative Commons Attribution 4.0 International License 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell. 2014 |
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| Keywords | atherosclerosis heart failure kidney sudden death cardiovascular diseases |
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| Snippet | Background
Premature cardiovascular disease limits the duration and quality of life on long‐term hemodialysis. The objective of this study was to define the... 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... Background Premature cardiovascular disease limits the duration and quality of life on long‐term hemodialysis. The objective of this study was to define the... |
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| SubjectTerms | atherosclerosis Atherosclerosis - diagnosis Atherosclerosis - etiology Atherosclerosis - mortality Atherosclerosis - prevention & control Calcimimetic Agents - therapeutic use Cardiology and cardiovascular system cardiovascular diseases Cinacalcet Hydrochloride Death, Sudden, Cardiac - etiology Death, Sudden, Cardiac - prevention & control Double-Blind Method Female heart failure Heart Failure - diagnosis Heart Failure - etiology Heart Failure - mortality Heart Failure - prevention & control Human health and pathology Humans Hyperparathyroidism, Secondary - diagnosis Hyperparathyroidism, Secondary - drug therapy Hyperparathyroidism, Secondary - etiology Hyperparathyroidism, Secondary - mortality Intention to Treat Analysis kidney Kidney Failure, Chronic - complications Kidney Failure, Chronic - diagnosis Kidney Failure, Chronic - mortality Kidney Failure, Chronic - therapy Life Sciences Male Naphthalenes - therapeutic use Original Research Renal Dialysis - adverse effects Renal Dialysis - mortality Risk Factors Severity of Illness Index sudden death Time Factors Treatment Outcome Urology and Nephrology |
| 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 |
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