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Int. J. Mol. Sci. 2017, 18(10), 2057; doi:10.3390/ijms18102057

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease Patients with Paricalcitol in German and Austrian Clinical Practice (TOP Study)

1
Division of Nephrology, III, Medical Clinic, University Hospital Frankfurt, Goethe-University, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany
2
Clinical Division of Nephrology, Department of Internal Medicine, Medical University Graz, Auenbruggerplatz 27, A-8036 Graz, Austria
3
AbbVie Deutschland GmbH & Co. KG, Mainzer Strasse 81, 65189 Wiesbaden, Germany
4
AbbVie GmbH, Lemböckgasse 61, A-1230 Wien, Austria
*
Author to whom correspondence should be addressed.
Received: 23 August 2017 / Revised: 19 September 2017 / Accepted: 21 September 2017 / Published: 28 September 2017
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Abstract

Paricalcitol is approved for prevention and therapy of secondary hyperparathyroidism (sHPT) in patients with chronic kidney disease (CKD), with only short-term data in clinical routine settings. A 12-month observational study was conducted in Germany and Austria (90 centers, 761 patients) from 2008 to 2013. Laboratory values, demographical, and clinical data were documented in 629 dialysis patients and 119 predialysis patients. In predialysis patients, median intact parathormone (iPTH) was 180.0 pg/mL (n = 105) at the start of the study, 115.7 pg/mL (n = 105) at last documentation, and 151.8 pg/mL (n = 50) at month 12, with 32.4% of the last documented iPTH values in the KDOQI (Kidney Disease Outcomes Quality Initiative) target range. In dialysis patients, median iPTH was 425.5 pg/mL (n = 569) at study start, 262.3 pg/mL (n = 569) at last documentation, and 266.1 pg/mL (n = 318) at month 12, with 36.5% of dialysis patients in the KDOQI target range. Intravenous paricalcitol showed more homogenous iPTH control than oral treatment. Combined analysis of all dialysis patients indicated comparable and stable mean serum calcium and phosphate levels throughout the study. Clinical symptoms, such as itching, bone pain, and fatigue, were improved compared with study entry. The spectrum and frequency of adverse events mirrored the known pattern for patients on dialysis. Paricalcitol is efficacious and has a consistent safety profile in sHPT over 12 months. View Full-Text
Keywords: parathormone (PTH); paricalcitol; secondary hyperparathyroidism (sHPT); chronic kidney disease (CKD); dialysis; predialysis parathormone (PTH); paricalcitol; secondary hyperparathyroidism (sHPT); chronic kidney disease (CKD); dialysis; predialysis
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

Obermüller, N.; Rosenkranz, A.R.; Müller, H.-W.; Hidde, D.; Veres, A.; Decker-Burgard, S.; Weisz, I.; Geiger, H. Long-Term Therapy Outcomes When Treating Chronic Kidney Disease Patients with Paricalcitol in German and Austrian Clinical Practice (TOP Study). Int. J. Mol. Sci. 2017, 18, 2057.

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