The drug cinacalet, which is sold under the trade name Sensipar by Amgen Inc., may help prevent bone fractures in dialysis patients, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology.
Sharon Moe, MD, from Indiana University School of Medicine and Roudebush Veterans Administration Medical Center, and her colleagues conducted a study to see whether cinacalet, a drug that lowers parathyroid hormone (PTH), can reduce the risk of fractures in patients receiving dialysis. In animals, lowering the level of PTH improves bone structure and reduces fractures.
The investigators conducted a planned secondary analysis of the EVOLVE trial, the largest study in hemodialysis patients to date. This study compared cinacalcet vs. placebo, on a background of standard of care. Clinical fractures were observed in 255 of 1,935 (13.2%) dialysis patients randomized to placebo and 238 of 1,948 (12.2%) patients randomized to cinacalcet. While cinacalcet did not reduce the rate of clinical fractures in unadjusted analyses, it had a protective effect against fractures after the researchers accounted for differences in patient characteristics and events that prompted patients to discontinue treatment.
Amgen sponsored the study, and several of the authors report receiving grants or consulting fees from Amgen. Two study authors are employed by Amgen.
“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,” said Moe.
Study co-authors include Safa Abdalla, Glenn M. Chertow, Patrick S. Parfrey, Geoffrey A. Block, Ricardo Correa-Rotter, Jürgen Floege, Charles A. Herzog, Gerard M. London, Kenneth W. Mahaffey, David C. Wheeler, Bastian Dehmel, William G. Goodman, and Tilman B. Drüeke.
The article, entitled “Effects of Cinacalcet on Fracture Events in Patients Receiving Hemodialysis: The EVOLVE Trial,” appears online at http://jasn.asnjournals.org.