The effects of cinacalcet in older and younger patients on hemodialysis: The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial

Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial Investigators

Research output: Contribution to journalArticle

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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. 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. ResultsOlder patients had higher baseline prevalence of diabetesmellitus 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. 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.

Original languageEnglish (US)
Pages (from-to)791-799
Number of pages9
JournalClinical Journal of the American Society of Nephrology
Volume10
Issue number5
DOIs
StatePublished - Jan 1 2015

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Renal Dialysis
Hyperparathyroidism
Parathyroid Hormone
Therapeutics
Placebos
Parathyroidectomy
Secondary Hyperparathyroidism
Risk Reduction Behavior
Cinacalcet Hydrochloride
Kidney Transplantation
Confidence Intervals
Mortality

ASJC Scopus subject areas

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

Cite this

The effects of cinacalcet in older and younger patients on hemodialysis : The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial. / Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial Investigators.

In: Clinical Journal of the American Society of Nephrology, Vol. 10, No. 5, 01.01.2015, p. 791-799.

Research output: Contribution to journalArticle

Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial Investigators. / The effects of cinacalcet in older and younger patients on hemodialysis : The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial. In: Clinical Journal of the American Society of Nephrology. 2015 ; Vol. 10, No. 5. pp. 791-799.
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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. 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. ResultsOlder patients had higher baseline prevalence of diabetesmellitus 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. 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.",
author = "{Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial Investigators} and Parfrey, {Patrick S.} and Dr{\"u}eke, {Tilman B.} and Block, {Geoffrey A.} and Ricardo Correa-Rotter and J{\"u}rgen Floege and Herzog, {Charles A.} and London, {Gerard M.} and Mahaffey, {Kenneth W.} and Moe, {Sharon M.} and Wheeler, {David C.} and Yumi Kubo and Bastian Dehmel and Goodman, {William G.} and Chertow, {Glenn M.} and J. Santos and {Najun Zarazaga}, C. and I. Marin and N. Garrote and A. Cusumano and N. Pe{\~n}alba and {Del Valle}, E. and L. Juncos and {Martinez Saye}, J. and L. Lef and V. Altobelli and G. Petraglia and {Rosa Diez}, G. and W. Douthat and J. Lobo and C. Gallart and A. Lafalla and G. Diez and B. Linares and N. Lopez and N. Ramirez and R. Gonzalez and R. Valtuille and H. Beresan and O. Hermida and G. Rudolf and N. Marchetta and M. Rano and M. Ramirez and N. Garc{\'i}a and A. Gillies and B. Jones and E. Pedagogos and R. Walker and G. Talaulikar and K. Bannister",
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TY - JOUR

T1 - The effects of cinacalcet in older and younger patients on hemodialysis

T2 - The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial

AU - Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial Investigators

AU - Parfrey, Patrick S.

AU - Drüeke, Tilman B.

AU - Block, Geoffrey A.

AU - Correa-Rotter, Ricardo

AU - Floege, Jürgen

AU - Herzog, Charles A.

AU - London, Gerard M.

AU - Mahaffey, Kenneth W.

AU - Moe, Sharon M.

AU - Wheeler, David C.

AU - Kubo, Yumi

AU - Dehmel, Bastian

AU - Goodman, William G.

AU - Chertow, Glenn M.

AU - Santos, J.

AU - Najun Zarazaga, C.

AU - Marin, I.

AU - Garrote, N.

AU - Cusumano, A.

AU - Peñalba, N.

AU - Del Valle, E.

AU - Juncos, L.

AU - Martinez Saye, J.

AU - Lef, L.

AU - Altobelli, V.

AU - Petraglia, G.

AU - Rosa Diez, G.

AU - Douthat, W.

AU - Lobo, J.

AU - Gallart, C.

AU - Lafalla, A.

AU - Diez, G.

AU - Linares, B.

AU - Lopez, N.

AU - Ramirez, N.

AU - Gonzalez, R.

AU - Valtuille, R.

AU - Beresan, H.

AU - Hermida, O.

AU - Rudolf, G.

AU - Marchetta, N.

AU - Rano, M.

AU - Ramirez, M.

AU - García, N.

AU - Gillies, A.

AU - Jones, B.

AU - Pedagogos, E.

AU - Walker, R.

AU - Talaulikar, G.

AU - Bannister, K.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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. 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. ResultsOlder patients had higher baseline prevalence of diabetesmellitus 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. 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.

AB - 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. 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. ResultsOlder patients had higher baseline prevalence of diabetesmellitus 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. 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.

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