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The Effects of Cinacalcet in Older and Younger Patients on Hemodialysis: The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial.
- Source :
-
Clinical journal of the American Society of Nephrology : CJASN [Clin J Am Soc Nephrol] 2015 May 07; Vol. 10 (5), pp. 791-9. Date of Electronic Publication: 2015 Feb 20. - Publication Year :
- 2015
-
Abstract
- Background and Objectives: The calcimimetic cinacalcet reduced the risk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older (≥65 years, n=1005) and younger (<65 years, n=2878) patients.<br />Design, Setting, Participants, & Measurements: Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified.<br />Results: Older patients had higher baseline prevalence of diabetes mellitus and CV comorbidity. Annualized rates of kidney transplantation and parathyroidectomy were >3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups.<br />Conclusions: In the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone.<br /> (Copyright © 2015 by the American Society of Nephrology.)
- Subjects :
- Adult
Age Factors
Aged
Aged, 80 and over
Female
Humans
Hyperparathyroidism, Secondary etiology
Hyperparathyroidism, Secondary surgery
Kidney Failure, Chronic complications
Kidney Failure, Chronic therapy
Kidney Transplantation statistics & numerical data
Male
Middle Aged
Parathyroidectomy statistics & numerical data
Renal Dialysis
Severity of Illness Index
Calcimimetic Agents therapeutic use
Cardiovascular Diseases prevention & control
Cinacalcet therapeutic use
Hyperparathyroidism, Secondary drug therapy
Kidney Failure, Chronic mortality
Subjects
Details
- Language :
- English
- ISSN :
- 1555-905X
- Volume :
- 10
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Clinical journal of the American Society of Nephrology : CJASN
- Publication Type :
- Academic Journal
- Accession number :
- 25710802
- Full Text :
- https://doi.org/10.2215/CJN.07730814