Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl
Therapy to Lower Cardiovascular Events (EVOLVE) trial.
Author(s): Chertow GM, Correa-Rotter R, Block GA, Drueke TB, Floege J, Goodman WG, Herzog
CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Wheeler DC, Parfrey PS.
Affiliation(s): Stanford University School of Medicine, Palo Alto, CA, USA. gchertow@stanford.edu
Publication date & source: 2012, Nephrol Dial Transplant. , 27(7):2872-9
BACKGROUND: Secondary hyperparathyroidism (sHPT) and other abnormalities
associated with chronic kidney disease-mineral 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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