Etelcalcetide Shows Efficacy, Safety Over 52 Weeks
By 52 weeks, 87.5% of patients had reached an intact parathyroid hormone target range of 60 to 240 pg/mL.
The intravenous calcimimetic etelcalcetide achieves and maintains serum intact parathyroid hormone levels (iPTH) within target range for at least 1 year in hemodialysis (HD) patients with secondary hyperparathyroidism (SHPT), Japanese researchers reported. The treatment is associated with modest risks for hypocalcemia and hyperphosphatemia with concomitant therapies.
Takashi Shigematsu, MD, PhD, of Wakayama Medical University in Japan, and colleagues studied etelcalcetide's longer-term safety and efficacy in 191 maintenance HD patients with SHPT (iPTH above 240 pg/mL). Etelcalcetide was administered 3 times per week after HD sessions for 52 weeks at an initial dose of 5 mg, then adjusted to 2.5 and 15 mg with dosing of other medications, such as calcium formulations and phosphate binders.
By 52 weeks, 87.5% of patients had reached the iPTH target range of 60 to 240 pg/mL. Serum calcium (Ca) and phosphate (P) levels were maintained within goal with a combination of therapies. In addition, etelcalcetide reduced tartrate-resistant acid phosphatase-5b, bone alkaline phosphatase, and intact fibroblast growth factor 23.
“Our results demonstrated that etelcalcetide, together with concomitant medications, can be adjusted for the ideal efficacy in individual patients,” Dr Shigematsu and his team reported online ahead of print in Clinical and Experimental Nephrology. “The well-controlled serum iPTH, Ca, and P levels may have been partially based on the dose adjustment of these concomitant medications, including active vitamin D preparations, Ca preparations, and Ca-free or Ca-containing P binders.”
About 97% of patients reported adverse events (AEs). These were mostly mild to moderate and led to study discontinuation by 7.4% of patients. Nausea and vomiting occurred in 4.7% and 9.5% of patients overall, respectively, but just 0.5% and 1.1% experienced these AEs from the calcimimetic, according to researchers.
The study was funded by Ono Pharmaceutical Co., Ltd, which produces etelcalcetide in Japan.
Shigematsu T, Fukagawa M, Yokoyama K, et al. Long-term effects of etelcalcetide as intravenous calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism. Clin Exp Nephrol. doi: 10.1007/s10157-017-1442-5