Treatment of secondary hyperparathyroidism with paricalcitol in patients with end-stage renal disease undergoing hemodialysis in Turkey: an observational study
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To evaluate monthly percentage changes of intact parathyroid hormone (iPTH) and other major bone marker levels in patients with secondary hyperparathyroidism (SHPT) undergoing hemodialysis (HD) and receiving paricalcitol.
A total of 493 (F/M 244/249) adult patients with SHPT who were undergoing HD in 22 HD units and receiving paricalcitol treatment, with iPTH > 300 mg/mL, adjusted serum levels of calcium (Ca) < 10.2 mg/dL, and serum levels of inorganic phosphorus (iP) < 6 mg/dL were included in this multi-center, national, prospective, observational study. Data regarding efficacy, safety, and adverse events of paricalcitol treatment were collected during a 12-month follow-up period through monthly visits along with serum iPTH, Ca, iP, alkaline phosphatase (ALP) and other required biochemistry tests as necessary. Mortality data until 6 months after the end of the study were also investigated.
The mean age was 58.3 ± 15.8 years and the mean duration of HD was 6.2 ± 5.5 years, respectively. As of 12th month, mean iPTH values decreased from 646 ± 424 pg/mL to 473 ± 387 pg/mL (p < 0.001); no statistically significant changes were observed in Ca levels (p > 0.05). Serum ALP levels also significantly decreased (p = 0.001) and serum phosphorus levels significantly increased (p < 0.001) during the study observation period. Reasons for early terminations were being lost to follow-up (n = 119, 24.1%), hyperphosphatemia (iP > 6 mg/dL, n = 108, 21.9%), low iPTH levels (iPTH < 150 mg/dL, n = 97, 19.7%), and withdrawal of consent (n = 41, 8.3%). In total 32 patients (6.5%) were prematurely terminated the study with hypercalcemia (Ca > 10.2 mg/dL). 46.9% of those hypercalcemic patients had other anomalies with iP and iPTH levels along with hypercalcemia.
Paricalcitol treatment, resulted in successful iPTH control. In approximately 6.5% of the patients paricalcitol treatment was discontinued since Ca levels reached > 10.2 mg/dL in those patients. No unfavorable effects on serum phosphorus and Ca–phosphorus (Ca × P) product were observed.
KeywordsParicalcitol Chronic kidney disease End-stage renal disease Hemodialysis Hyperparathyroidism
The authors would like to thank to MONITOR CRO, Istanbul, Turkey (funded by AbbVie) for the statistical analysis and assistance in medical writing.
This study was funded by AbbVie.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
This study was sponsored by AbbVie. AbbVie contributed to the study design, research, and interpretation of data, writing, reviewing, and approving the publication. The design, study conduct, and financial support for the Zemplar PMOS study (protocol number P12-314) were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication. All authors received payments from AbbVie to participate in this study. In addition, F. Fevzi Ersoy has received speaker and/or consultancy fees from AbbVie, Sanofi, Abdi Ibrahim and Roche. Hasan Hoser, Hasan Koc, Yalcin Akdag and Cemaliye Kendir have not received speaker and/or consultancy fees from AbbVie or any other pharmaceutical companies. The authors would like to acknowledge the other participants of the P12-314 Study Team.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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