DENVER—Oral paricalcitol (OP) appears to have similar efficacy and safety compared with oral calcitriol (OC) in dialysis patients with secondary hyperparathyroidism (SHPT), according to results from a randomized, controlled trial.
To date, there have no published studies comparing OP with OC in the treatment of SHPT in dialysis patients. Loke Meng Ong, MD, of Penange Hospital, Malaysia, and colleagues compared the efficacy and safety of OP versus OC in this patient population. The Malaysian investigators conducted a multi-center, open-label, parallel group, randomized, controlled trial over 24 weeks. The initial thrice weekly dose of OP and OC was titrated three times a week to serum intact parathyroid hormone (iPTH), calcium (Ca) and calcium × phosphorous product (CaP). The primary endpoint was time to a 30% or greater reduction from baseline PTH.
A total of 36 patients were randomized to OP and 30 to OC. Baseline characteristics were similar between the two groups. The primary endpoint did not different between the two arms: 86.1% in the OP group and 86.7% in the OC group at 24 weeks. The mean time to first event was 7.7 months for OP versus 6.9 months of OC. The mean time to maximal reduction in PTH was 16.1 weeks for OP and 15.5 weeks for OC.
The two groups had comparable drug compliance. A total of 23 episodes of hypercalcemia in six patients (17%) in the OP group and 16 episodes of hypercalcemia in six patients (20%) in the OC group were reported. All other adverse events were similar in both groups.