TY - JOUR
T1 - No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients
T2 - A randomized crossover trial
AU - Hansen, Ditte
AU - Rasmussen, Knud
AU - Danielsen, Henning
AU - Meyer-Hofmann, Helmut
AU - Bacevicius, Egidijus
AU - Lauridsen, Thomas G.
AU - Madsen, Jens K.
AU - Tougaard, Birgitte G.
AU - Marckmann, Peter
AU - Thye-Roenn, Peter
AU - Nielsen, Jørgen E.
AU - Kreiner, Svend
AU - Brandi, Lisbet
PY - 2011/10/2
Y1 - 2011/10/2
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.
KW - activated vitamin D
KW - hemodialysis
KW - hyperparathyroidism
KW - mineral metabolism
UR - http://www.scopus.com/inward/record.url?scp=80053562092&partnerID=8YFLogxK
U2 - 10.1038/ki.2011.226
DO - 10.1038/ki.2011.226
M3 - Article
C2 - 21832979
AN - SCOPUS:80053562092
VL - 80
SP - 841
EP - 850
JO - Kidney International
JF - Kidney International
SN - 0085-2538
IS - 8
ER -