No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial

Ditte Hansen; Knud Rasmussen; Henning Danielsen; Helmut Meyer-Hofmann; Egidijus Bacevicius; Thomas Guldager Lauridsen; Jens Kristian Madsen; Birgitte G Tougaard; Peter Marckmann; Peter Thye-Roenn; Jørgen Erik Nielsen; Svend Kreiner; Lisbet Brandi

doi:10.1038/ki.2011.226

No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial

Ditte Hansen, Knud Rasmussen, Henning Danielsen, Helmut Meyer-Hofmann, Egidijus Bacevicius, Thomas Guldager Lauridsen, Jens Kristian Madsen, Birgitte G Tougaard, Peter Marckmann, Peter Thye-Roenn, Jørgen Erik Nielsen, Svend Kreiner, Lisbet Brandi

56 Citationer (Scopus)

Abstract

Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium or phosphate levels reached an upper threshold. Unfortunately, due to a period effect, only the initial 16-week intervention period for 80 patients was statistically analyzed. The proportion of patients achieving a 30% decrease in parathyroid hormone levels over the last four weeks of study was statistically indistinguishable between the two groups. Paricalcitol was more efficient at correcting low than high baseline parathyroid hormone levels, whereas alfacalcidol was equally effective at all levels. There were no differences in the incidence of hypercalcemia and hyperphosphatemia. Thus, alfacalcidol and paricalcitol were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range

Originalsprog	Engelsk
Tidsskrift	Kidney International
Vol/bind	80
Udgave nummer	8
Sider (fra-til)	841-850
Antal sider	10
ISSN	0085-2538
DOI	https://doi.org/10.1038/ki.2011.226
Status	Udgivet - 2 okt. 2011

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10.1038/ki.2011.226

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Hansen, D., Rasmussen, K., Danielsen, H., Meyer-Hofmann, H., Bacevicius, E., Lauridsen, T. G., Madsen, J. K., Tougaard, B. G., Marckmann, P., Thye-Roenn, P., Nielsen, J. E., Kreiner, S., & Brandi, L. (2011). No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial. Kidney International, 80(8), 841-850. https://doi.org/10.1038/ki.2011.226

Hansen, D, Rasmussen, K, Danielsen, H, Meyer-Hofmann, H, Bacevicius, E, Lauridsen, TG, Madsen, JK, Tougaard, BG, Marckmann, P, Thye-Roenn, P, Nielsen, JE , Kreiner, S & Brandi, L 2011, 'No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial', Kidney International, bind 80, nr. 8, s. 841-850. https://doi.org/10.1038/ki.2011.226

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title = "No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial",

abstract = "Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium or phosphate levels reached an upper threshold. Unfortunately, due to a period effect, only the initial 16-week intervention period for 80 patients was statistically analyzed. The proportion of patients achieving a 30% decrease in parathyroid hormone levels over the last four weeks of study was statistically indistinguishable between the two groups. Paricalcitol was more efficient at correcting low than high baseline parathyroid hormone levels, whereas alfacalcidol was equally effective at all levels. There were no differences in the incidence of hypercalcemia and hyperphosphatemia. Thus, alfacalcidol and paricalcitol were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range",

author = "Ditte Hansen and Knud Rasmussen and Henning Danielsen and Helmut Meyer-Hofmann and Egidijus Bacevicius and Lauridsen, {Thomas Guldager} and Madsen, {Jens Kristian} and Tougaard, {Birgitte G} and Peter Marckmann and Peter Thye-Roenn and Nielsen, {J{\o}rgen Erik} and Svend Kreiner and Lisbet Brandi",

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AU - Hansen, Ditte

AU - Rasmussen, Knud

AU - Danielsen, Henning

AU - Meyer-Hofmann, Helmut

AU - Bacevicius, Egidijus

AU - Lauridsen, Thomas Guldager

AU - Madsen, Jens Kristian

AU - Tougaard, Birgitte G

AU - Marckmann, Peter

AU - Thye-Roenn, Peter

AU - Nielsen, Jørgen Erik

AU - Kreiner, Svend

AU - Brandi, Lisbet

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N2 - Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium or phosphate levels reached an upper threshold. Unfortunately, due to a period effect, only the initial 16-week intervention period for 80 patients was statistically analyzed. The proportion of patients achieving a 30% decrease in parathyroid hormone levels over the last four weeks of study was statistically indistinguishable between the two groups. Paricalcitol was more efficient at correcting low than high baseline parathyroid hormone levels, whereas alfacalcidol was equally effective at all levels. There were no differences in the incidence of hypercalcemia and hyperphosphatemia. Thus, alfacalcidol and paricalcitol were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range

AB - Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium or phosphate levels reached an upper threshold. Unfortunately, due to a period effect, only the initial 16-week intervention period for 80 patients was statistically analyzed. The proportion of patients achieving a 30% decrease in parathyroid hormone levels over the last four weeks of study was statistically indistinguishable between the two groups. Paricalcitol was more efficient at correcting low than high baseline parathyroid hormone levels, whereas alfacalcidol was equally effective at all levels. There were no differences in the incidence of hypercalcemia and hyperphosphatemia. Thus, alfacalcidol and paricalcitol were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range

U2 - 10.1038/ki.2011.226

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M3 - Journal article

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JO - Kidney International

JF - Kidney International

IS - 8

ER -

No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial

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