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Long-Term Therapy Outcomes When Treating Chronic Kidney Disease Patients with
Paricalcitol in German and Austrian Clinical Practice (TOP Study)
#MMPMID28956807
Obermüller N
; Rosenkranz AR
; Müller HW
; Hidde D
; Veres A
; Decker-Burgard S
; Weisz I
; Geiger H
Int J Mol Sci
2017[Sep]; 18
(10
): ? PMID28956807
show ga
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.
|Adult
[MESH]
|Aged
[MESH]
|Aged, 80 and over
[MESH]
|Austria
[MESH]
|Biomarkers
[MESH]
|Bone Density Conservation Agents/therapeutic use
[MESH]
free
free
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