Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial

Glenn M. Chertow, Ricardo Correa-Rotter, Geoffrey A. Block, Tilman B. Drueke, Jürgen Floege, William G. Goodman, Charles A. Herzog, Yumi Kubo, Gerard M. London, Kenneth W. Mahaffey, Thomas Christian Mix, Sharon Moe, David C. Wheeler, Patrick S. Parfrey

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Background Secondary hyperparathyroidism (sHPT) and other abnormalities associated with chronic kidney diseasemineral bone disorder can contribute to dystrophic (including vascular) calcification. Dietary modification and variety of medications can be used to attenuate the severity of sHPT. However, it is unknown whether any of these approaches can reduce the high risks of death and cardiovascular disease in patients with end-stage renal disease. Methods The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial was designed to test the hypothesis that treatment with the calcimimetic agent cinacalcet compared with placebo (on a Background of conventional therapy including phosphate binders/-vitamin D sterols) reduces time to death or non-fatal cardiovascular events (specifically myocardial infarction, unstable angina, heart failure and peripheral arterial disease events) among patients on hemodialysis with sHPT. This report describes baseline characteristics of enrolled subjects with a focus on regional variation. Results There were 3883 subjects randomized from 22 countries, including the USA, Canada, Australia, three Latin American nations, Russia and 15 European nations. The burden of overt cardiovascular disease at baseline was high (e.g. myocardial infarction 12.4%, heart failure 23.3%). The median plasma parathyroid hormone concentration at baseline was 692 pg/mL (10%, 90% range, 363-1694 pg/mL). At baseline, 87.2% of subjects were prescribed phosphate binders and 57.5% were prescribed activated vitamin D derivatives. Demographic data, comorbid conditions and baseline laboratory data varied significantly across regions. Conclusions EVOLVE enrolled 3883 subjects on hemodialysis with moderate to severe sHPT. Inclusion of subjects from multiple global regions with varying degrees of disease severity will enhance the external validity of the trial results.

Original languageEnglish
Pages (from-to)2872-2879
Number of pages8
JournalNephrology Dialysis Transplantation
Volume27
Issue number7
DOIs
StatePublished - Jul 2012

Fingerprint

Secondary Hyperparathyroidism
Vitamin D
Calcimimetic Agents
Renal Dialysis
Cardiovascular Diseases
Heart Failure
Phosphates
Myocardial Infarction
Vascular Calcification
Diet Therapy
Peripheral Arterial Disease
Russia
Unstable Angina
Sterols
Therapeutics
Parathyroid Hormone
Reproducibility of Results
Chronic Kidney Failure
Canada
Placebos

Keywords

  • cinacalcet
  • clinical trial
  • end-stage renal disease
  • hemodialysis
  • secondary hyperparathyroidism

ASJC Scopus subject areas

  • Nephrology
  • Transplantation

Cite this

Chertow, G. M., Correa-Rotter, R., Block, G. A., Drueke, T. B., Floege, J., Goodman, W. G., ... Parfrey, P. S. (2012). Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial. Nephrology Dialysis Transplantation, 27(7), 2872-2879. https://doi.org/10.1093/ndt/gfr777

Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial. / Chertow, Glenn M.; Correa-Rotter, Ricardo; Block, Geoffrey A.; Drueke, Tilman B.; Floege, Jürgen; Goodman, William G.; Herzog, Charles A.; Kubo, Yumi; London, Gerard M.; Mahaffey, Kenneth W.; Mix, Thomas Christian; Moe, Sharon; Wheeler, David C.; Parfrey, Patrick S.

In: Nephrology Dialysis Transplantation, Vol. 27, No. 7, 07.2012, p. 2872-2879.

Research output: Contribution to journalArticle

Chertow, GM, Correa-Rotter, R, Block, GA, Drueke, TB, Floege, J, Goodman, WG, Herzog, CA, Kubo, Y, London, GM, Mahaffey, KW, Mix, TC, Moe, S, Wheeler, DC & Parfrey, PS 2012, 'Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial', Nephrology Dialysis Transplantation, vol. 27, no. 7, pp. 2872-2879. https://doi.org/10.1093/ndt/gfr777
Chertow, Glenn M. ; Correa-Rotter, Ricardo ; Block, Geoffrey A. ; Drueke, Tilman B. ; Floege, Jürgen ; Goodman, William G. ; Herzog, Charles A. ; Kubo, Yumi ; London, Gerard M. ; Mahaffey, Kenneth W. ; Mix, Thomas Christian ; Moe, Sharon ; Wheeler, David C. ; Parfrey, Patrick S. / Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial. In: Nephrology Dialysis Transplantation. 2012 ; Vol. 27, No. 7. pp. 2872-2879.
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abstract = "Background Secondary hyperparathyroidism (sHPT) and other abnormalities associated with chronic kidney diseasemineral bone disorder can contribute to dystrophic (including vascular) calcification. Dietary modification and variety of medications can be used to attenuate the severity of sHPT. However, it is unknown whether any of these approaches can reduce the high risks of death and cardiovascular disease in patients with end-stage renal disease. Methods The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial was designed to test the hypothesis that treatment with the calcimimetic agent cinacalcet compared with placebo (on a Background of conventional therapy including phosphate binders/-vitamin D sterols) reduces time to death or non-fatal cardiovascular events (specifically myocardial infarction, unstable angina, heart failure and peripheral arterial disease events) among patients on hemodialysis with sHPT. This report describes baseline characteristics of enrolled subjects with a focus on regional variation. Results There were 3883 subjects randomized from 22 countries, including the USA, Canada, Australia, three Latin American nations, Russia and 15 European nations. The burden of overt cardiovascular disease at baseline was high (e.g. myocardial infarction 12.4{\%}, heart failure 23.3{\%}). The median plasma parathyroid hormone concentration at baseline was 692 pg/mL (10{\%}, 90{\%} range, 363-1694 pg/mL). At baseline, 87.2{\%} of subjects were prescribed phosphate binders and 57.5{\%} were prescribed activated vitamin D derivatives. Demographic data, comorbid conditions and baseline laboratory data varied significantly across regions. Conclusions EVOLVE enrolled 3883 subjects on hemodialysis with moderate to severe sHPT. Inclusion of subjects from multiple global regions with varying degrees of disease severity will enhance the external validity of the trial results.",
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