Paricalcitol-treated patients experience improved hospitalization outcomes compared with calcitriol-treated patients in real-world clinical settings

Dobrez, Deborah G.; Mathes, Ângelo do Carmo da Silva; Amdahl, Michael; Marx, Steven E.; Melnick, Joel Z.; Sprague, Stuart M.

doi:10.1093/ndt/gfh123

Cited by 103 publications

(74 citation statements)

References 15 publications

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“…The small mean decrease in calcium observed in the placebo group is consistent with the pathogenesis of SHPT and VDR inactivation and reflects the disease state in this population. Tissue and gene selectivity of paricalcitol thus allows for a greater therapeutic index for PTH reduction and may explain the previous observations of improved survival [16] and reduced morbidity [19]. …”

Section: Discussionmentioning

confidence: 92%

Oral Paricalcitol for the Treatment of Secondary Hyperparathyroidism in Patients on Hemodialysis or Peritoneal Dialysis

et al. 2007

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Background/Aims: Secondary hyperparathyroidism is a common complication of chronic kidney disease, resulting from inactivation of vitamin D receptor signaling and phosphate retention. Selective activation of vitamin D receptors with intravenous paricalcitol significantly reduced parathyroid hormone (PTH) levels with no significant hypercalcemia or hyperphosphatemia in predialysis and hemodialysis (HD) patients. This study investigates the effects of oral paricalcitol to reduce PTH in patients receiving chronic HD and peritoneal dialysis (PD). Methods: Eighty-eight patients were randomized in double-blind fashion to receive paricalcitol or placebo for 12 weeks. The dose of the study drug was adjusted weekly using the previous week’s intact PTH (iPTH) level as well as calcium and Ca × P product levels. The primary end points were efficacy (two consecutive iPTH decreases of ≧30%) and safety (two consecutive calcium measurements >11.0 mg/dl). Markers of biochemical bone activity were followed. Results: Demographic characteristics were similar between treatment groups. The mean paricalcitol doses (three times a week) over the entire treatment period for subjects with baseline iPTH ≤500 pg/ml and iPTH >500 pg/ml were 3.9 and 7.6 µg, respectively. A statistically significant decrease in iPTH was seen after week 1, with a mean 30% reduction occurring by week 3. A significantly greater proportion of both HD and PD paricalcitol subjects [83% (33/40) and 100% (18/18), respectively] achieved two consecutive ≧30% decreases in iPTH. The treatment groups were not statistically different in regard to the hypercalcemia safety end point. Phosphate binder use and mean serum phosphorus levels were not different between the treatment groups. The markers of bone activity improved in the treated subjects and worsened in those on placebo. Conclusion: Paricalcitol provides a rapid and sustained reduction of PTH in both HD and PD patients with minimal effect on serum calcium and phosphorus and no significant difference in adverse events as compared with placebo.

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Section: Discussionmentioning

confidence: 92%

Oral Paricalcitol for the Treatment of Secondary Hyperparathyroidism in Patients on Hemodialysis or Peritoneal Dialysis

et al. 2007

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“…An important observation in these studies was the fact that a survival benefit of VDRA was apparent across all quintiles of calcium, phosphate and PTH, which suggests that the use of vitamin-D receptor activators may possibly mitigate the deleterious effects of elevated phosphate, calcium and PTH on mortality (16,17). Both the mortality and morbidity data from these studies suggest that the benefit of paricalcitol was independent of baseline PTH, calcium or phosphorous levels, as a reduction in the risk of both death and the number of hospital admissions was apparent at all levels, when the data was stratified by variables (16)(17)(18). In contrast, data from the Dialysis Outcomes Practice Patterns Study (DOPPS) and from a notfor-profit dialysis provider in the United States demonstrated that differences in mortality risk between different vitamin-D receptor activators may be smaller than previously reported and that a prospective randomized controlled clinical trial is both needed and justified (19,20).…”

Section: Discussionmentioning

confidence: 91%

Achievement of recommended treatment targets for bone and mineral metabolism in haemodialysis patients using paricalcitol: An observational study

Fernström

Giaever

Granroth

et al. 2011

Scandinavian Journal of Urology and Nephrology

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“…These results were reproduced in other studies. 11,14 It has been shown that paricalcitol treatment may be associated with lower mortality, 20 lower hospitalization rates, and in-hospital stay 21 compared with calcitriol treatment. These beneficial effects on hard outcomes may not be related only to effects on calciumphosphorus metabolism but also depend on postreceptor differences between the molecules.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Tolerability of Intravenous Paricalcitol in Calcitriol-Resistant Hemodialysis Patients with Secondary Hyperparathyroidism: 12-Month Prospective Study

et al. 2012

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Rationale/objectives: Data are limited regarding the use of paricalcitol in calcitriol-resistant patients with secondary hyperparathyroidism (SHPT). We aimed to evaluate the effects of paricalcitol in calcitriol-resistant hemodialysis patients with SHPT. Methods: This is a 12-month, open-label, prospective study. Forty patients with calcitriol-resistant and/or calcitriol-intolerant SHPT were included. After a washout period, all patients converted to paricalcitol with a 1:3 conversion ratio. Serum calcium and phosphorus were monitored monthly, while serum intact parathyroid hormone (iPTH) once in every 3 months. Paricalcitol dose was reduced or discontinued in case of hypercalcemia and/or hyperphosphatemia. Pre-and posttreatment electrolyte and iPTH values were compared with Student's t-test and Wilcoxon signed-rank test, respectively. Main findings: Forty patients completed the study. Mean initiation dose of paricalcitol was 23 ± 7 µg/week. Mean serum calcium was 8.9 ± 0.8 mg/dL at baseline and 9.4 ± 0.7 mg/dL at study end (p = 0.07). Mean monthly serum phosphorus levels stayed stable. Paricalcitol was effective in reducing iPTH levels when compared with pretreatment values (747.9 ± 497.2 pg/mL, 307.3 ± 417.1 pg/mL, respectively; p < 0.001). Thirty-two patients had to discontinue intravenous (IV) paricalcitol at some time during their treatment. Main reasons for discontinuation were as follows: hyperphosphatemia (58%), hypercalcemia (25%), and iPTH < 150 pg/mL (17%). Principle conclusions: Paricalcitol was found to be effective in reducing iPTH levels in calcitriol-resistant patients with SHPT despite relatively frequent drug discontinuation rates.

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Paricalcitol-treated patients experience improved hospitalization outcomes compared with calcitriol-treated patients in real-world clinical settings

Cited by 103 publications

References 15 publications

Oral Paricalcitol for the Treatment of Secondary Hyperparathyroidism in Patients on Hemodialysis or Peritoneal Dialysis

Oral Paricalcitol for the Treatment of Secondary Hyperparathyroidism in Patients on Hemodialysis or Peritoneal Dialysis

Achievement of recommended treatment targets for bone and mineral metabolism in haemodialysis patients using paricalcitol: An observational study

Efficacy and Tolerability of Intravenous Paricalcitol in Calcitriol-Resistant Hemodialysis Patients with Secondary Hyperparathyroidism: 12-Month Prospective Study

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