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.

Chronic KidneY Disease-Mineral Bone Disorder in the Elderly Peritoneal Dialysis Patient

“…Conventionally, fracture risk is associated with both high and low levels of PTH (20), but a recent large study showed no relationship below 900 ng/L. The present review is in accordance with the KDOQI guidelines (1) and recommends an upper limit of 300 ng/L, primarily using active vitamin D. There are no proven differences between the various drugs available (21) can be treated with cinacalcet, a calcimimetic, which reduces PTH by about 40%, even in patients with severe secondary hyperparathyroidism. For the elderly patient, medical treatment is preferred to surgical parathyroidectomy.…”

A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM)

“…Although numerous trials have documented the efficacy of cinacalcet (Sensipar/Mimpara; Amgen Inc., Thousand Oaks, CA) (1-10) and vitamin D analogs (11)(12)(13)(14)(15)(16)(17) in lowering PTH levels, no trial to date has directly compared these agents in the treatment of SHPT.…”

Lowering vascular calcification burden in chronic kidney disease: Is it possible?

“…Subsequent experimental study using different doses of active vitamin D demonstrated that both calcitriol and paricalcitol in high doses stimulated the development of vascular calcification whereas lower doses were protective [9] . Recent study in hemodialysis patients also revealed similar incidence of hypercalcemia and hyperphosphatemia in patients who received alfacalcidol and paricalcitol [36] . In a 2-year observational study in chronic hemodialysis patients, those who received higher prescribed dose of alfacalcidol experienced a slower rate of progression of aortic arch calcification [37] .…”