The calcimimetic etelcalcetide may be more effective in suppressing calcification compared with the vitamin D receptor activator (VDRA) maxacalcitol in patients with secondary hyperparathyroidism (SHPT) undergoing hemodialysis (HD), according to new research findings.
In the VICTORY (VDRA vs Intravenous Calcimimetics in the Treatment Of Renal patients with secondary hYperparathyroidism) trial, investigators randomly assigned 326 Japanese patients (median age 66 years; 35% female) to receive intravenous (IV) etelcalcetide (5 mg thrice weekly) or IV maxacalcitol (5 or 10 mg thrice weekly) for 12 months. Patients also were taking phosphate binders and magnesium. The primary endpoint was the change in serum calcification propensity (T50). A shorter T50 time reflects higher calcification propensity and correlates with arterial calcification, arterial stiffness, and death, the investigators explained. The researchers reported the results of the 321 patients who were included in an intent-to-treat analysis: 165 in the etelcalcetide group and 156 in the maxacalcitol group.
Over 12 months, median T50 increased significantly from 123 to 166 minutes in the etelcalcetide group and from 116 to 131 minutes in the maxacalcitol group. Etelcalcetide treatment significantly prolonged T50 by an extra 20 minutes using least square means, Tetsuo Shoji, MD, of the vascular medicine department at Osaka City University Graduate School of Medicine in Osaka, Japan, and colleagues reported in the Clinical Journal of the American Society of Nephrology.
T50 inversely correlated with serum phosphate and calcium levels. Serum phosphate and corrected calcium levels at 3, 6, and 12 months differed significantly between groups in post hoc analyses. The investigators found no notable differences in serum magnesium or fetuin-A.
Dr Shoji’s team concluded that their study “showed that treatment with etelcalcetide was more effective in increasing T50, namely in suppressing calcification propensity, than treatment with maxacalcitol in patients with secondary hyperparathyroidism undergoing hemodialysis.”
Among the study’s limitations, some patients in the etelcalcetide group briefly ceased treatment to receive oral alfacalcidol for hypocalcemia and some patients in the maxacalcitol group ceased treatment to receive oral cinacalcet or evocalcet for hypercalcemia.
With respect to safety, 19.4% of the etelcalcetide group and 27.7% of the maxacalcitol group experienced serious adverse events.
The investigators examined handgrip strength and change in dementia score as secondary endpoints but found no significant differences between groups. Future studies are needed to clarify any drug effects on muscle strength and cognition, according to the team.
Disclosure: This clinical trial was supported by Ono Pharmaceutical. Please see the original reference for a full list of authors’ disclosures.
Shoji T, Nakatani S, Kabata D, et al. Comparative effects of etelcalcetide and maxacalcitol on serum calcification propensity in secondary hyperparathyroidism: a randomized clinical trial. Published online March 8, 2021. Clin J Am Soc Nephrol. doi:10.2215/CJN.16601020