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 - Friedman, E.
N1 - Publisher Copyright:
© 2015 by the American Society of Nephrology.
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.
UR - http://www.scopus.com/inward/record.url?scp=84929171843&partnerID=8YFLogxK
U2 - 10.2215/CJN.07730814
DO - 10.2215/CJN.07730814
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C2 - 25710802
AN - SCOPUS:84929171843
SN - 1555-9041
VL - 10
SP - 791
EP - 799
JO - Clinical Journal of the American Society of Nephrology
JF - Clinical Journal of the American Society of Nephrology
IS - 5
ER -