Cinacalcet's Cardiovascular Benefits Modest in Dialysis Patients
Cinacalcet treatment is associated with a modest decrease in the risk of death or major cardiovascular events among hemodialysis (HD) patients suffering from moderate-to-severe secondary hyperparathyroidism (SHPT), according to researchers.
In a study, that risk was decreased by a nonsignificant 7% in cinacalcet-treated patients compared with those who received placebo in unadjusted analyses. After adjustment for baseline characteristics, cinacalcet treatment was associated with a “nominally significant” 12% decreased risk, investigators reported in The New England Journal of Medicine (2012;367:2482-2494).
SHPT and other disorders of mineral metabolism are thought to contribute to vascular calcification among patients with chronic kidney disease. Researchers had hypothesized that treatment with cinacalcet, a calcimimetic agent, might decrease the risk of death or nonfatal cardiovascular events in this patient population.
In the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial, Glenn M. Chertow, MD, of Stanford University School of Medicine in Palo Alto, Calif., and colleagues randomly assigned 3,883 HD patients with moderate-to-severe SHPT to receive either cinacalcet or placebo. Subjects were followed for up to 64 months. The median duration of study-drug exposure was 21.2 months in the cinacalcet group and 17.5 months in the placebo group. The primary composite end point—time until death, myocardial infarction, hospitalization for unstable angina, heart failure, or a peripheral vascular event—was reached in 938 (48.2%) of the 1,948 patients in the cinacalcet arm and 952 (49.2%) of the 1,935 patients in the placebo arm.
Cinacalcet recipients experienced a significantly greater frequency of hypocalcemia and gastrointestinal adverse events.
The study was funded by Amgen, which makes cinacalcet and markets it under the name Sensipar.