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.

J Am Heart Assoc 2014 Nov 17;3(6):e001363. Epub 2014 Nov 17.

Hennepin County Medical Center, University of Minnesota, Minneapolis, MN (C.A.H.).

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.

Download full-text PDF

Source
http://dx.doi.org/10.1161/JAHA.114.001363DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4338730PMC
November 2014
42 Reads

Publication Analysis

Top Keywords

cardiovascular events
28
cardiovascular
13
atherosclerotic nonatherosclerotic
12
fatal nonfatal
12
nonatherosclerotic cardiovascular
12
nonfatal cardiovascular
12
cardiovascular disease
12
events
9
therapy lower
8
hcl therapy
8
cinacalcet hcl
8
lower cardiovascular
8
events evolve
8
cinacalcet
8
cardiovascular event
8
sudden death
8
evaluation cinacalcet
8
hoc analysis
8
post hoc
8
effects cinacalcet
8

References

(Supplied by CrossRef)

U.S. Renal Data System et al.
2012

Similar Publications