Paricalcitol Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients: A German-Austrian, Single-Arm, Open-Label, Prospective, Noninterventional, Observational Study

Background: Safety and efficacy of paricalcitol in hemodialysis patients with secondary hyperparathyroidism (sHPT) was investigated under routine clinical practice in German and Austrian dialysis centers. Methods: Hemodialysis patients with sHPT initiating intravenous paricalcitol were enrolled in this noninterventional study regardless of concomitant sHPT treatment. Prior active vitamin D therapy was discontinued. Clinical laboratory values, including intact parathyroid hormone (iPTH), total serum calcium (Ca), phosphorus ( P), Ca x P product, and alkaline phosphatase (AP), were recorded for 6 months following initiation of paricalcitol treatment. Results: 1,313 patients ( Austria, n = 280; Germany, n = 1,033) from 169 dialysis centers were enrolled. Most patients ( n = 932; 79.1%) had received dialysis for = 1 year. Median iPTH fell from 518.9 pg/ml [55.0 pmo vertical bar/vertical bar] at baseline to 264.0 pg/ml [28.0 pmo vertical bar/vertical bar] after 6 months (p < 0.0001). After 6 months of treatment, >= 30 and >= 60% reductions in iPTH were observed in 63.0 and 35.9% of patients, respectively. At 6 months, 27.2% of patients achieved iPTH levels between 150 and < 300 pg/ ml [15.9 and < 31.8 pmo vertical bar/vertical bar] compared with 9.7% at baseline. Ca, P, and Ca x P levels remained stable in the majority of patients. AP levels declined from a median of 98 U/vertical bar at baseline to 83 U/ vertical bar ( p < 0.0001) at 6 months. Monitoring of adverse events and clinical laboratory assessments identified no unexpected safety signals for paricalcitol. Conclusions: Paricalcitol is an effective and well-tolerated treatment option for the control of iPTH levels in hemodialysis patients with sHPT. The results of this study support the results of previous trials under real-time clinical practice conditions in Austria and Germany. (C) 2014 S. Karger AG, Basel