Efficacy and safety of intravenous paricalcitol treatment in Chinese hemodialysis patients: a real-world database analysis

Abstract

Background: The aim of this retrospective observational study based on real-world data was to evaluate the efficacy and safety profile of paricalcitol in Chinese hemodialysis (HD) patients with secondary hyperparathyroidism (SHPT) in routine clinical practice. Methods: From the Better Life for Future database, a total of 668 Chinese hemodialysis patients from 104 dialysis centers between January 2015 and May 2019 were included in the analysis set. Intact parathyroid hormone (iPTH), total serum calcium (Ca), phosphate (P), dosage of intravenous (IV) paricalcitol (Zemplar®) were analyzed and discussed via retrospective analysis of the database during the treatment. Results: Patients were divided into five groups according to the duration of follow-up. Median iPTH levels decreased from 1,183 pg/mL at baseline to 676 pg/mL at the final visit, or 30.88% (P<0.0001). A total of 56.14% of patients had a ≥30% decrease and 29.34% of patients had a ≥50% decrease in iPTH level. Serum Ca levels shown significantly increased in the group of Month 12–24 (P=0.0479). Serum phosphate levels remained stable in all follow-up groups. The average dose of paricalcitol was 20±9 µg/week. The total dose of paricalcitol and baseline iPTH were negatively correlated with the decrease in iPTH levels. Conclusions: This is the first national retrospective real-world observational study since intravenous paricalcitol is available in China since 2014. This study demonstrates the use of paricalcitol as an effective and well-tolerated treatment for the control of PTH during its use in routine practice.