Treatment of Secondary Hyperparathyroidism

Control of secondary hyperparathyroidism (HPT) laboratory parameters over time1

A historical cohort analysis of pooled data of 29,021 patients on paricalcitol showed reductions in parathyroid hormone (PTH) with paricalcitol diminished over 1 year while serum calcium and serum phosphorus levels increased.2 In contrast, phase 3 results from three 6-month studies in chronic kidney disease (CKD) patients with secondary HPT on dialysis (N = 1,136) indicated that adding Sensipar® to traditional therapy sustained PTH reductions over 1 year while serum calcium and phosphorus levels decreased.1 Traditional therapy included vitamin D and phosphate binders, if prescribed.3

With paricalcitol, reductions in PTH diminished over time while calcium and phosphorus increased2

Results shown for patients treated with paricalcitol only. Results based on a historical cohort analysis in a dialysis chain. Most patients also received phosphate binders.
Data from Teng et al, N Engl J Med, 2003.2
*For each point vs baseline beween groups.

This analysis included data pooled from the database of a large dialysis provider. The total database included 69,492 patients on IV vitamin D therapy, of whom 67,399 were prescribed either calcitriol (n = 38,378) or paricalcitol (n = 29,021). Results are based on a historical cohort analysis of patients initiated on paricalcitol between 1999 and 2001. The percentage change from baseline was calculated for each patient at 3, 6, and 12 months. Target value for iPTH was < 300 pg/mL. Most patients also received phosphate binders. No specific therapies were suggested. At 3, 6, and 12 months, the mean doses of paricalcitol per administration were 4.2 mcg, 4.3 mcg, and 4.3 mcg, respectively.2

Adding Sensipar® to traditional therapy, reductions in secondary HPT laboratory parameters—PTH, calcium, and phosphorus—were sustained over time1

Data on file, Amgen.1 Pooled phase 3 studies published in: Moe et al, Kidney Int, 2005.3 Results shown for patients treated with Sensipar® only. ||n numbers vary for each laboratory parameter at each time point. n numbers at month 3, 6, and 12, respectively, were: 547, 473, and 98 for PTH; 555, 471, and 98 for calcium; and 547, 466, and 97 for phosphorus.1

Phase 3 results were obtained from three 6-month, multicenter, randomized, double-blind, placebo-controlled clinical studies conducted in CKD patients with secondary HPT on dialysis (N = 1,136). Sensipar® doses of 30 to 180 mg or placebo were administered once daily to achieve a mean iPTH ≤ 250 pg/mL. A majority of Sensipar® patients were also treated with phosphate binders (93%) and vitamin D (66%). A comparable percentage of patients on placebo also received phosphate binders and vitamin D: 93% and 68%, respectively. Pooled median baseline iPTH concentrations were 596 pg/mL and 564 pg/mL for the Sensipar® and control groups, respectively.3

Sensipar® lowers serum calcium, and therefore patients should be carefully monitored for the occurrence of hypocalcemia.4

  • Sensipar® treatment should not be initiated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL)
  • Serum calcium should be measured within 1 week after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium should be measured approximately monthly
  • If serum calcium falls below 8.4 mg/dL but remains above 7.5 mg/dL, or if symptoms of hypocalcemia occur, calcium-containing phosphate binders and/or vitamin D sterols can be used to raise serum calcium
  • If serum calcium falls below 7.5 mg/dL, or if symptoms of hypocalcemia persist and the dose of vitamin D cannot be increased, withhold administration of Sensipar® until serum calcium levels reach 8.0 mg/dL, and/or symptoms of hypocalcemia have resolved. Treatment should be re-initiated using the next lowest dose of Sensipar®
  • In clinical studies, less than 1% of patients discontinued Sensipar® due to hypocalcemia

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