Intravenous alfacalcidol once versus twice or thrice weekly in hemodialysis patients.Ther Apher Dial. 2013 Feb; 17(1):30-4.TA
Secondary hyperparathyroidism remains a serious problem in hemodialysis patients. The use of vitamin D analogs still constitutes a basis for its treatment. This study was carried out to evaluate the efficacy of intravenous administration of alfacalcidol once versus twice or thrice weekly in hemodialysis patients with secondary hyperparathyroidism. Twenty-nine end-stage renal disease patients maintained on hemodialysis for more than one year were included in this prospective study after signing the consent. These patients with secondary hyperparathyroidism had been on intravenous alfacalcidol twice or thrice per week and were followed up to 4 months (stage 1). Then they were shifted to intravenous alfacalcidol once weekly starting with the last total weekly intravenous dose for another 4 months (stage 2). The dose of alfacalcidol was adjusted according to intact parathyroid hormone, serum calcium and phosphorus levels, and calcium-phosphorus product. Intact parathyroid hormone, calcium, phosphorus, calcium-phosphorus product were measured monthly. Parathyroid ultrasound was done as a baseline and then repeated at the end of stage 1 and stage 2. The intact parathyroid hormone was reduced from 49.72 ± 2.72 pmol/L (mean ± standard error of the mean [SEM] during stage 1 to 42.13 ± 2.15 pmol/L during stage 2 (P = 0.005). Dose of alfacalcidol was reduced from 18.80 ± 1.15 µg/month (mean ± SEM) in stage 1 to 15.18 ± 1.27 µg/month in stage 2 (P = 0.008), and consequently the cost of alfacalcidol was reduced from 21.05 ± 1.25 US$/month (mean ± SEM) during stage 1 to 16.87 ± 1.40 US$/month during stage 2 (P = 0.008). Although the phosphorus level increased from 1.56 ± 0.36 mmol/L (mean ± SD) in stage 1 to 1.70 ± 0.46 mmol/ L in stage 2 (P = 0.003), and calcium-phosphorus product increased from 3.48 ± 0.82 mmol(2)/L(2) (mean ± SD) in stage 1 to 3.76 ± 1.00 mmol(2) /L(2) in stage 2 (P = 0.017), they remained in the target levels recommended by the Kidney Disease Outcomes Quality Initiative guidelines. No serious effects were observed during stage 1 and stage 2, respectively. Intravenous alfacalcidol once weekly is effective, safe and less costly in suppressing intact parathyroid hormone compared to twice or thrice weekly administration in chronic hemodialysis patients.