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.
['Obermüller|Nicholas|N|', 'Rosenkranz|Alexander R|AR|', 'Müller|Hans-Walter|HW|', 'Hidde|Dennis|D|', 'Veres|András|A|', 'Decker-Burgard|Sabine|S|', 'Weisz|Isolde|I|', 'Geiger|Helmut|H|']
D000328:Adult D000368:Aged D000369:Aged, 80 and over D001317:Austria D015415:Biomarkers D050071:Bone Density Conservation Agents D002118:Calcium D004872:Ergocalciferols D005260:Female D005858:Germany D006801:Humans D006962:Hyperparathyroidism, Secondary D007676:Kidney Failure, Chronic D007677:Kidney Function Tests D008297:Male D008875:Middle Aged D010758:Phosphorus D006435:Renal Dialysis D051436:Renal Insufficiency, Chronic D013997:Time Factors D016896:Treatment Outcome
paricalcitol secondary hyperparathyroidism (sHPT) chronic kidney disease (CKD) dialysis predialysis parathormone (PTH)