Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 26, 2021; 9(33): 10172-10179
Published online Nov 26, 2021. doi: 10.12998/wjcc.v9.i33.10172
Paricalcitol in hemodialysis patients with secondary hyperparathyroidism and its potential benefits
Xiu Chen, Feng Zhao, Wei-Juan Pan, Jia-Mei Di, Wei-Nan Xie, Ling Yuan, Zhi Liu
Xiu Chen, Feng Zhao, Wei-Juan Pan, Jia-Mei Di, Wei-Nan Xie, Ling Yuan, Zhi Liu, Department of Nephrology, The First Affiliated Hospital of Anhui University of Science and Technology (The First People’s Hospital of Huainan), Huainan 232007, Anhui Province, China
Author contributions: Chen X and Liu Z designed the study and drafted the manuscript; Zhao F and Pan WJ collected the data and performed statistical analysis; Di JM and Xie WN participated in the data collection; Yuan L supervised the research and revised the draft; Liu Z participated in language editing of the draft; All authors have read and approved the final manuscript.
Supported by 2019 Anhui University Natural Science Research Project, No. KJ2019A0094, No. KJ2019A0095; Huainan City "50 Science and Technology Stars" Innovation Team Project; and Scientific Research Platform of Huainan Science and Technology Bureau, No. 2017G32.
Institutional review board statement: The study was reviewed and approved by The First People's Hospital of Huainan City Institutional Review Board (Approval No.2019-18).
Clinical trial registration statement: This study is not a clinical registration trial.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declared that they have no conflicts of interest to this work.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at hnsnk@163.com. Participants gave informed consent for data sharing.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Zhi Liu, MD, Chief Doctor, Department of Nephrology, The First Affiliated Hospital of Anhui University of Science and Technology (The First People’s Hospital of Huainan), No. 203 Huaibin Road, Tianjiaan District, Huainan 232007, Anhui Province, China. hnsnk@163.com
Received: July 7, 2021
Peer-review started: July 7, 2021
First decision: July 26, 2021
Revised: August 12, 2021
Accepted: October 14, 2021
Article in press: October 14, 2021
Published online: November 26, 2021
Abstract
BACKGROUND

Secondary hyperparathyroidism (SHPT) is a common complication in patients with end-stage renal disease and it is also common in hemodialysis patients. SHPT can increase bone fragility and calcification of blood vessels and soft tissues, which greatly increases the risk of death.

AIM

To discuss the outcome, safety and other potential benefits of paricalcitol injection in hemodialysis patients with SHPT.

METHODS

We recruited 40 patients who received hemodialysis at our hospital for chronic renal failure with SHPT between March and December 2019. They received paricalcitol injection for 24 wk (starting dose, 0.06–0.08 μg/kg), three times per week. They were followed up at the baseline (week 0), week 4, week 12 and week 24. The primary outcome indicator was the percentage of patients with a > 30% decrease in intact parathyroid hormone (iPTH) levels at week 24 compared with the baseline. The secondary outcome indicators included percentage decrease in iPTH levels at week 24, standard-reaching rate of iPTH (percentage of patients with iPTH down to 130–585 pg/mL), changes in serum levels of calcium (Ca), phosphate (P), Ca × P product, alkaline phosphatase (ALP), creatinine (Cre), hemoglobin (Hb), and C-reactive protein (CRP), and incidence of adverse events (AEs).

RESULTS

After 24 wk of treatment, iPTH levels decreased significantly (598.88 ± 381.29 pg/mL vs 888.84 ± 376.88 pg/mL, P < 0.05). More than 30% decrease of iPTH was found in 21 of 36 (58.33%) patients. The average decrease in iPTH levels was 32.16 ± 4.33%; the standard-reaching rate of iPTH levels was 66.67% (24/36); and ALP levels decreased significantly compared with the baseline (113.72 ± 41.73 IU/L vs 133.45 ± 56.86 IU/L) (t = 2.798, P < 0.05). There were no significant differences in the serum levels of calcium, Hb, Cre and CRP compared with the baseline (P > 0.05). After 24 wk of treatment, serum P levels decreased compared with the baseline (1.91 ± 0.40 mmol/L vs 2.16 ± 0.66 mmol/L) (t = 2.830, P < 0.05). Ca × P product decreased significantly compared with the baseline (56.38 ± 13.22 mg2/dL2vs 63.97 ± 20.30 mg2/dL2) (t = 2.717, P < 0.05). No serious adverse events occurred.

CONCLUSION

Paricalcitol was a safe and effective treatment for hemodialysis patients with SHPT. It decreased serum levels of iPTH, ALP and P and maintained stability of serum Ca levels.

Keywords: Paricalcitol, Hemodialysis, Secondary hyperparathyroidism, Drug efficacy, Drug safety

Core Tip: In this study, 40 patients with chronic renal failure were treated with paricalcitol for 24 wk. It was found that paricalcitol can significantly reduce intact parathyroid hormone, alkaline phosphatase and serum phosphate levels, and maintain a relatively stable serum calcium level. Therefore, paricalcitol is effective and safe in the treatment of hemodialysis patients with secondary hyperparathyroidism.