Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: A randomized controlled trial

Csaba P. Kovesdy, Jun L. Lu, Sandra M. Malakauskas, Dennis L. Andress, Kamyar Kalantar-Zadeh, Shahram Ahmadzadeh

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear. Randomized controlled trial. 80 patients with CKD stages 3 or 4, 25(OH)D level <30 ng/mL, and SHPT in a single medical center. Ergocalciferol, 50,000 units, titrated to achieve serum levels ≥30 ng/mL versus paricalcitol, 1 or 2 μg/d, for 16 weeks. The occurrence of 2 consecutive parathyroid hormone (PTH) levels decreased by at least 30% from baseline. All analyses were intention to treat. Baseline characteristics in the 2 groups were similar. 21 patients (53%) on paricalcitol and 7 patients (18%) on ergocalciferol treatment achieved the primary outcome measure (P = 0.002). After 16 weeks, PTH levels did not decrease significantly in patients receiving ergocalciferol, but were decreased significantly in those treated with paricalcitol (mean estimate of between-group difference over 16 weeks of therapy, 43.9 pg/mL; 95% CI, 11.2-76.6; P = 0.009). Serum 25(OH)D levels increased significantly after 16 weeks in only the ergocalciferol group, but not the paricalcitol group (mean estimate of between-group difference over 16 weeks of therapy, 7.08 ng/mL; 95% CI, 4.32-9.85; P < 0.001). Episodes of hyperphosphatemia and hypercalcemia were not significantly different between the 2 groups. Lack of blinding and use of surrogate end points. Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT.

Original languageEnglish (US)
Pages (from-to)58-66
Number of pages9
JournalAmerican Journal of Kidney Diseases
Volume59
Issue number1
DOIs
StatePublished - Jan 1 2012

Fingerprint

Ergocalciferols
Secondary Hyperparathyroidism
Chronic Renal Insufficiency
Randomized Controlled Trials
Parathyroid Hormone
Vitamin D Deficiency
Hyperphosphatemia
Calcitriol Receptors
Intention to Treat Analysis
Hypercalcemia
Therapeutics
Serum
paricalcitol
Biomarkers
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Nephrology

Cite this

Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4 : A randomized controlled trial. / Kovesdy, Csaba P.; Lu, Jun L.; Malakauskas, Sandra M.; Andress, Dennis L.; Kalantar-Zadeh, Kamyar; Ahmadzadeh, Shahram.

In: American Journal of Kidney Diseases, Vol. 59, No. 1, 01.01.2012, p. 58-66.

Research output: Contribution to journalArticle

Kovesdy, Csaba P. ; Lu, Jun L. ; Malakauskas, Sandra M. ; Andress, Dennis L. ; Kalantar-Zadeh, Kamyar ; Ahmadzadeh, Shahram. / Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4 : A randomized controlled trial. In: American Journal of Kidney Diseases. 2012 ; Vol. 59, No. 1. pp. 58-66.
@article{06b85e6af2ac4773b810245167eb2754,
title = "Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: A randomized controlled trial",
abstract = "The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear. Randomized controlled trial. 80 patients with CKD stages 3 or 4, 25(OH)D level <30 ng/mL, and SHPT in a single medical center. Ergocalciferol, 50,000 units, titrated to achieve serum levels ≥30 ng/mL versus paricalcitol, 1 or 2 μg/d, for 16 weeks. The occurrence of 2 consecutive parathyroid hormone (PTH) levels decreased by at least 30{\%} from baseline. All analyses were intention to treat. Baseline characteristics in the 2 groups were similar. 21 patients (53{\%}) on paricalcitol and 7 patients (18{\%}) on ergocalciferol treatment achieved the primary outcome measure (P = 0.002). After 16 weeks, PTH levels did not decrease significantly in patients receiving ergocalciferol, but were decreased significantly in those treated with paricalcitol (mean estimate of between-group difference over 16 weeks of therapy, 43.9 pg/mL; 95{\%} CI, 11.2-76.6; P = 0.009). Serum 25(OH)D levels increased significantly after 16 weeks in only the ergocalciferol group, but not the paricalcitol group (mean estimate of between-group difference over 16 weeks of therapy, 7.08 ng/mL; 95{\%} CI, 4.32-9.85; P < 0.001). Episodes of hyperphosphatemia and hypercalcemia were not significantly different between the 2 groups. Lack of blinding and use of surrogate end points. Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT.",
author = "Kovesdy, {Csaba P.} and Lu, {Jun L.} and Malakauskas, {Sandra M.} and Andress, {Dennis L.} and Kamyar Kalantar-Zadeh and Shahram Ahmadzadeh",
year = "2012",
month = "1",
day = "1",
doi = "10.1053/j.ajkd.2011.06.027",
language = "English (US)",
volume = "59",
pages = "58--66",
journal = "American Journal of Kidney Diseases",
issn = "0272-6386",
publisher = "W.B. Saunders Ltd",
number = "1",

}

TY - JOUR

T1 - Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4

T2 - A randomized controlled trial

AU - Kovesdy, Csaba P.

AU - Lu, Jun L.

AU - Malakauskas, Sandra M.

AU - Andress, Dennis L.

AU - Kalantar-Zadeh, Kamyar

AU - Ahmadzadeh, Shahram

PY - 2012/1/1

Y1 - 2012/1/1

N2 - The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear. Randomized controlled trial. 80 patients with CKD stages 3 or 4, 25(OH)D level <30 ng/mL, and SHPT in a single medical center. Ergocalciferol, 50,000 units, titrated to achieve serum levels ≥30 ng/mL versus paricalcitol, 1 or 2 μg/d, for 16 weeks. The occurrence of 2 consecutive parathyroid hormone (PTH) levels decreased by at least 30% from baseline. All analyses were intention to treat. Baseline characteristics in the 2 groups were similar. 21 patients (53%) on paricalcitol and 7 patients (18%) on ergocalciferol treatment achieved the primary outcome measure (P = 0.002). After 16 weeks, PTH levels did not decrease significantly in patients receiving ergocalciferol, but were decreased significantly in those treated with paricalcitol (mean estimate of between-group difference over 16 weeks of therapy, 43.9 pg/mL; 95% CI, 11.2-76.6; P = 0.009). Serum 25(OH)D levels increased significantly after 16 weeks in only the ergocalciferol group, but not the paricalcitol group (mean estimate of between-group difference over 16 weeks of therapy, 7.08 ng/mL; 95% CI, 4.32-9.85; P < 0.001). Episodes of hyperphosphatemia and hypercalcemia were not significantly different between the 2 groups. Lack of blinding and use of surrogate end points. Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT.

AB - The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear. Randomized controlled trial. 80 patients with CKD stages 3 or 4, 25(OH)D level <30 ng/mL, and SHPT in a single medical center. Ergocalciferol, 50,000 units, titrated to achieve serum levels ≥30 ng/mL versus paricalcitol, 1 or 2 μg/d, for 16 weeks. The occurrence of 2 consecutive parathyroid hormone (PTH) levels decreased by at least 30% from baseline. All analyses were intention to treat. Baseline characteristics in the 2 groups were similar. 21 patients (53%) on paricalcitol and 7 patients (18%) on ergocalciferol treatment achieved the primary outcome measure (P = 0.002). After 16 weeks, PTH levels did not decrease significantly in patients receiving ergocalciferol, but were decreased significantly in those treated with paricalcitol (mean estimate of between-group difference over 16 weeks of therapy, 43.9 pg/mL; 95% CI, 11.2-76.6; P = 0.009). Serum 25(OH)D levels increased significantly after 16 weeks in only the ergocalciferol group, but not the paricalcitol group (mean estimate of between-group difference over 16 weeks of therapy, 7.08 ng/mL; 95% CI, 4.32-9.85; P < 0.001). Episodes of hyperphosphatemia and hypercalcemia were not significantly different between the 2 groups. Lack of blinding and use of surrogate end points. Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT.

UR - http://www.scopus.com/inward/record.url?scp=83655191998&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=83655191998&partnerID=8YFLogxK

U2 - 10.1053/j.ajkd.2011.06.027

DO - 10.1053/j.ajkd.2011.06.027

M3 - Article

C2 - 21885174

AN - SCOPUS:83655191998

VL - 59

SP - 58

EP - 66

JO - American Journal of Kidney Diseases

JF - American Journal of Kidney Diseases

SN - 0272-6386

IS - 1

ER -