Long-term therapy outcomes when treating chronic kidney disease patients with paricalcitol in German and Austrian clinical practice (TOP study)

  • 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.

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Author:Nicholas Obermüller, Alexander R. Rosenkranz, Hans-Walter Müller, Dennis Hidde, András Veres, Sabine Decker-Burgard, Isolde Weisz, Helmut GeigerGND
URN:urn:nbn:de:hebis:30:3-465029
DOI:https://doi.org/10.3390/ijms18102057
ISSN:1422-0067
ISSN:1661-6596
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/28956807
Parent Title (English):International journal of molecular sciences
Publisher:Molecular Diversity Preservation International
Place of publication:Basel
Document Type:Article
Language:English
Year of Completion:2017
Date of first Publication:2017/09/28
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2018/05/29
Tag:chronic kidney disease (CKD); dialysis; parathormone (PTH); paricalcitol; predialysis; secondary hyperparathyroidism (sHPT)
Volume:18
Issue:10, Art. 2057
Page Number:20
First Page:1
Last Page:20
Note:
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).
HeBIS-PPN:433870575
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung 4.0