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Cinacalcet May Protect Against Fracture in Dialysis

Mortality, cardiovascular disease risk remains same for patient with secondary hyperparathyroidism…

After further review, adjusted findings from the EVOLVE Trial showed that cinacalcet may reduce the risk of fracture among patients on dialysis. In a pre-specified subgroup analysis, cinacalcet was associated with reduced fracture risk after taking baseline characteristics and multiple fractures into account (HR 0.83, 95% CI 0.72-0.98).

Fractures frequently occur in patients on dialysis and worse breaks such as hip fracture increase the risk of death. To assess whether giving cinacalcet to dialysis patients would reduce fracture rates, Dr. Sharon Moe and colleagues conducted a pre-specified secondary analysis of data from the EVOLVE Trial looking at 3,883 patients. The trial originally found that cinacalcet didn’t reduce the risk of mortality or major cardiovascular disease among dialysis patients with secondary hyperparathyroidism, although a post-hoc analysis found that the drug could diminish the need to parathyoidectomy.

Overall, fracture rates were similar between cinacalcet and placebo in patients (12.2% vs. 13.2%). However, in a pre-specified lag-censoring analysis, which is meant to provide a measure of actual drug exposure, they also found a protective effect (HR 0.72, 95% CI 0.58-0.90) as did a time-censored analysis (HR 0.71, 95% CI 0.58-0.87).

The researchers noted that fracture rates were higher in older patients, and the benefit of cinacalcet was more noticeable in this population.

Practice Pearls:

  • Fractures frequently occur in patients on dialysis and worse breaks such as hip fracture increase the risk of death.
  • Cinacalcet was associated with reduced fracture risk after taking baseline characteristics and multiple fractures into account (HR 0.83, 95% CI 0.72-0.98).
  • They also found a protective effect (HR 0.72, 95% CI 0.58-0.90) as did a time-censored analysis (HR 0.71, 95% CI 0.58-0.87).

Journal of the American Society of Nephrology. Moe SM, et al “Effects of cinacalcet on fracture events in patients receiving hemodialysis: The EVOLVE trial” J Am Soc Nephrol 2014; DOI: 10.1681/ASN.2014040414.