Safety and efficacy of pulse and daily calcitriol in patients on CAPD

A randomized trial

Sharon Moe, Michael Kraus, Christine M. Gassensmith, Naomi S. Fineberg, Francis H. Gannon, Munro Peacock

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

Background. Calcitriol therapy is the mainstay of therapy for the treatment of secondary hyperparathyroidism. Oral administration of calcitriol is necessary in CAPD patients, but no studies have directly compared different routes of administration in this patient population. Methods. To determine if the peak serum calcitriol level (pulse therapy) is more important than the total delivered dose, we randomized CAPD patients with mild to moderate secondary hyperparathyroidism to receive either pulse (3.0 μg twice a week, n = 10) or daily (0.75 μg a day, n = 8) oral calcitriol in comparable weekly doses. The main comparison was the rate of decline of serum intact parathyroid hormone (PTH) levels to reach the desired end-point of 100 pg/ml. The patients were dialysed with low-calcium dialysate and received only calcium-containing phosphate binders. Results. Pharmacokinetic analysis after a single dose of 3.0 μg (pulse) vs 0.75 μg (daily) revealed 1,25(OH)2-vitamin D levels to be higher in the pulse group at 3 and 6 h, but equivalent by 12 h. The area under the curve for 1 week of daily and 1 week of pulse therapy was equal. The patients in the 2 arms had equivalent basal serum levels of PTH (pulse = 562 ± 291 vs daily = 454 ± 113 pg/ml), calcium (pulse = 2.32 ± 0.20 vs daily = 2.32 ± 0.12 mmol/l) and phosphorus (pulse = 1.32 ± 0.52 vs daily = 1.35 ± 0.26 mmol/l). The time required for the PTH to decrease to 100 pg/ml and the rate of decline in PTH were similar (time: pulse = 14.2 ± 6.8 weeks, daily = 12.2 ± 7 weeks; rate: pulse = 7.4 ± 4.2 vs daily = 8.4 ± 4.2% PTH/week; P = NS). The serum calcium increased similarly in both groups. Hypercalcaemia (> 2.9 mmol/l) was rare (pulse = 3, daily = 2 episodes). Conclusions. This study demonstrates that pulse and daily calcitriol are similarly effective and safe for the treatment of mild to moderate secondary hyperparathyroidism in CAPD patients despite higher peak levels of 1,25(OH)2-vitamin D with pulse therapy.

Original languageEnglish
Pages (from-to)1234-1241
Number of pages8
JournalNephrology Dialysis Transplantation
Volume13
Issue number5
DOIs
StatePublished - May 1998

Fingerprint

Continuous Ambulatory Peritoneal Dialysis
Calcitriol
Parathyroid Hormone
Safety
Secondary Hyperparathyroidism
Ergocalciferols
Calcium
Serum
Therapeutics
Dialysis Solutions
Hypercalcemia
Phosphorus
Area Under Curve
Oral Administration
Pharmacokinetics
Heart Rate
Population

Keywords

  • Calcitriol
  • Calcium balance
  • CAPD
  • Dialysis
  • Hyperparathyroidism
  • Renal osteodystrophy

ASJC Scopus subject areas

  • Nephrology
  • Transplantation

Cite this

Safety and efficacy of pulse and daily calcitriol in patients on CAPD : A randomized trial. / Moe, Sharon; Kraus, Michael; Gassensmith, Christine M.; Fineberg, Naomi S.; Gannon, Francis H.; Peacock, Munro.

In: Nephrology Dialysis Transplantation, Vol. 13, No. 5, 05.1998, p. 1234-1241.

Research output: Contribution to journalArticle

Moe, Sharon ; Kraus, Michael ; Gassensmith, Christine M. ; Fineberg, Naomi S. ; Gannon, Francis H. ; Peacock, Munro. / Safety and efficacy of pulse and daily calcitriol in patients on CAPD : A randomized trial. In: Nephrology Dialysis Transplantation. 1998 ; Vol. 13, No. 5. pp. 1234-1241.
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abstract = "Background. Calcitriol therapy is the mainstay of therapy for the treatment of secondary hyperparathyroidism. Oral administration of calcitriol is necessary in CAPD patients, but no studies have directly compared different routes of administration in this patient population. Methods. To determine if the peak serum calcitriol level (pulse therapy) is more important than the total delivered dose, we randomized CAPD patients with mild to moderate secondary hyperparathyroidism to receive either pulse (3.0 μg twice a week, n = 10) or daily (0.75 μg a day, n = 8) oral calcitriol in comparable weekly doses. The main comparison was the rate of decline of serum intact parathyroid hormone (PTH) levels to reach the desired end-point of 100 pg/ml. The patients were dialysed with low-calcium dialysate and received only calcium-containing phosphate binders. Results. Pharmacokinetic analysis after a single dose of 3.0 μg (pulse) vs 0.75 μg (daily) revealed 1,25(OH)2-vitamin D levels to be higher in the pulse group at 3 and 6 h, but equivalent by 12 h. The area under the curve for 1 week of daily and 1 week of pulse therapy was equal. The patients in the 2 arms had equivalent basal serum levels of PTH (pulse = 562 ± 291 vs daily = 454 ± 113 pg/ml), calcium (pulse = 2.32 ± 0.20 vs daily = 2.32 ± 0.12 mmol/l) and phosphorus (pulse = 1.32 ± 0.52 vs daily = 1.35 ± 0.26 mmol/l). The time required for the PTH to decrease to 100 pg/ml and the rate of decline in PTH were similar (time: pulse = 14.2 ± 6.8 weeks, daily = 12.2 ± 7 weeks; rate: pulse = 7.4 ± 4.2 vs daily = 8.4 ± 4.2{\%} PTH/week; P = NS). The serum calcium increased similarly in both groups. Hypercalcaemia (> 2.9 mmol/l) was rare (pulse = 3, daily = 2 episodes). Conclusions. This study demonstrates that pulse and daily calcitriol are similarly effective and safe for the treatment of mild to moderate secondary hyperparathyroidism in CAPD patients despite higher peak levels of 1,25(OH)2-vitamin D with pulse therapy.",
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T2 - A randomized trial

AU - Moe, Sharon

AU - Kraus, Michael

AU - Gassensmith, Christine M.

AU - Fineberg, Naomi S.

AU - Gannon, Francis H.

AU - Peacock, Munro

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N2 - Background. Calcitriol therapy is the mainstay of therapy for the treatment of secondary hyperparathyroidism. Oral administration of calcitriol is necessary in CAPD patients, but no studies have directly compared different routes of administration in this patient population. Methods. To determine if the peak serum calcitriol level (pulse therapy) is more important than the total delivered dose, we randomized CAPD patients with mild to moderate secondary hyperparathyroidism to receive either pulse (3.0 μg twice a week, n = 10) or daily (0.75 μg a day, n = 8) oral calcitriol in comparable weekly doses. The main comparison was the rate of decline of serum intact parathyroid hormone (PTH) levels to reach the desired end-point of 100 pg/ml. The patients were dialysed with low-calcium dialysate and received only calcium-containing phosphate binders. Results. Pharmacokinetic analysis after a single dose of 3.0 μg (pulse) vs 0.75 μg (daily) revealed 1,25(OH)2-vitamin D levels to be higher in the pulse group at 3 and 6 h, but equivalent by 12 h. The area under the curve for 1 week of daily and 1 week of pulse therapy was equal. The patients in the 2 arms had equivalent basal serum levels of PTH (pulse = 562 ± 291 vs daily = 454 ± 113 pg/ml), calcium (pulse = 2.32 ± 0.20 vs daily = 2.32 ± 0.12 mmol/l) and phosphorus (pulse = 1.32 ± 0.52 vs daily = 1.35 ± 0.26 mmol/l). The time required for the PTH to decrease to 100 pg/ml and the rate of decline in PTH were similar (time: pulse = 14.2 ± 6.8 weeks, daily = 12.2 ± 7 weeks; rate: pulse = 7.4 ± 4.2 vs daily = 8.4 ± 4.2% PTH/week; P = NS). The serum calcium increased similarly in both groups. Hypercalcaemia (> 2.9 mmol/l) was rare (pulse = 3, daily = 2 episodes). Conclusions. This study demonstrates that pulse and daily calcitriol are similarly effective and safe for the treatment of mild to moderate secondary hyperparathyroidism in CAPD patients despite higher peak levels of 1,25(OH)2-vitamin D with pulse therapy.

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KW - Calcium balance

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