Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE): Rationale and design overview

Glenn M. Chertow, Lara B. Pupim, Geoffrey A. Block, Ricardo Correa-Rotter, Tilman B. Drueke, Jürgen Floege, William G. Goodman, Gerard M. London, Kenneth W. Mahaffey, Sharon M. Moe, David C. Wheeler, Moetaz Albizem, Kurt Olson, Preston Klassen, Patrick Parfrey

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Abstract

Background and Objectives: The dramatically high rates of mortality and cardiovascular morbidity observed among dialysis patients highlights the importance of identifying and implementing strategies to lower cardiovascular risk in this population. Results from clinical trials undertaken thus far, including trials on lipid reduction, normalization of hematocrit, and increased dialysis dosage, have been unsuccessful. Available data indicate that abnormalities in calcium and phosphorus metabolism, as a result of either secondary hyperparathyroidism alone or the therapeutic measures used to manage secondary hyperparathyroidism, are associated with an increased risk for death and cardiovascular events. However, no prospective trials have evaluated whether interventions that modify these laboratory parameters result in a reduction in adverse cardiovascular outcomes. Design, Setting, Participants, & Measurements: Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events is a global, phase 3, double-blind, randomized, placebo-controlled trial evaluating the effects of cinacalcet on mortality and cardiovascular events in hemodialysis patients with secondary hyperparathyroidism. Approximately 3800 patients from 22 countries will be randomly assigned to cinacalcet or placebo. Flexible use of traditional therapies will be permitted. The primary end point is the composite of time to all-cause mortality or first nonfatal cardiovascular event (myocardial infarction, hospitalization for unstable angina, heart failure, or peripheral vascular disease, including lower extremity revascularization and nontraumatic amputation). Results: The study will be event driven (terminated at 1882 events) with an anticipated duration of approximately 4 yr. Conclusions: Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events will determine whether management of secondary hyperparathyroidism with cinacalcet reduces the risk for mortality and cardiovascular events in hemodialysis patients.

Original languageEnglish (US)
Pages (from-to)898-905
Number of pages8
JournalClinical Journal of the American Society of Nephrology
Volume2
Issue number5
DOIs
StatePublished - Sep 1 2007

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ASJC Scopus subject areas

  • Epidemiology
  • Critical Care and Intensive Care Medicine
  • Nephrology
  • Transplantation

Cite this

Chertow, G. M., Pupim, L. B., Block, G. A., Correa-Rotter, R., Drueke, T. B., Floege, J., Goodman, W. G., London, G. M., Mahaffey, K. W., Moe, S. M., Wheeler, D. C., Albizem, M., Olson, K., Klassen, P., & Parfrey, P. (2007). Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE): Rationale and design overview. Clinical Journal of the American Society of Nephrology, 2(5), 898-905. https://doi.org/10.2215/CJN.04381206