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Healio
December 11, 2014
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Cinacalcet reduced fracture risk in patients receiving hemodialysis

Cinacalcet to treat secondary hyperparathyroidism in patients with chronic kidney disease who are receiving hemodialysis appears to reduce clinical fracture rates, according to research published in the Journal of the American Society of Nephrology.

In the EVOLVE trial, cinacalcet (Sensipar, Amgen) showed a protective effect against fractures after adjusting for baseline characteristics, multiple fractures and/or events prompting drug discontinuation.

“Our results showed a reduction in fracture risk by 16% to 29% in the patients receiving cinacalcet when adjusted for other fracture risk factors like age,” Sharon M. Moe, MD, of Indiana University School of Medicine and Roudebush Veterans Administration Medical Center, said in a press release.

Sharon Moe

Sharon M. Moe

In EVOLVE, hemodialysis patients with secondary hyperparathyroidism were randomly assigned cinacalcet (n=1,948; mean age, 55 years) or placebo (n=1,935; mean age, 54 years) for up to 64 months. All-cause mortality and nonfatal cardiovascular events were primary endpoints, with first clinical fractures a key secondary outcome.

Moe and colleagues tested the hypothesis “that secondary hyperparathyroidism is a major cause of bone loss and increased bone fragility, and therefore treatment with cinacalcet would reduce clinical fractures.”

Clinical fractures were observed in 238 patients (12.2%) assigned cinacalcet vs. 255 patients (13.2%) on placebo.

The relative hazard for fracture, based on unadjusted intention-to-treat analysis, for cinacalcet vs. placebo was 0.89 (95% CI, 0.75-1.07). With adjustments for baseline characteristics and multiple fractures, the relative hazard dropped to 0.83 (95% CI, 0.72-0.98).

Using prespecified lag-censoring analysis, a measure of drug exposure, the relative hazard for fracture decreased to 0.72 (95% CI, 0.58-0.9) and further diminished when participants were censored at the time of cointerventions (parathyroidectomy, transplant or provision of commercial cinacalcet) to 0.71 (95% CI, 0.58-0.87).

“Fracture rates were much higher in older compared with younger patients, as virtually all other studies in the general population and chronic kidney disease and end-stage renal disease populations have shown,” the researchers wrote.

Disclosure: Two researchers are employees and stockholders of Amgen Inc.

Sources/Disclosures

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Source:

Moe SM. J Am Soc Nephrol. 2014;doi:10.1681/ASN.2014040414.