title: Management of secondary hyperparathyroidism: practice patterns and outcomes of cinacalcet treatment with or without active vitamin D in Austria and Switzerland - the observational TRANSIT Study.
abstract: Secondary hyperparathyroidism is a complex disorder requiring an individualized multicomponent treatment approach. This study was conducted to identify treatment combinations used in clinical practice in Austria and Switzerland and the potential to control this disorder. A total of 333 adult hemodialysis and peritoneal dialysis patients were analyzed. All patients received conventional care prior to initiation of a cinacalcet-based regimen. During the study, treatment components, e.g. cinacalcet, active vitamin D analogues and phosphate binders, were adapted to individual patient requirements and treatment dynamics were documented. Overall, the mean intact parathyroid hormone (iPTH) increased from 64.2 pmol/l to 79.6 pmol/l under conventional therapy and decreased after cinacalcet initiation to 44.0 pmol/l after 12 months (mean decrease between baseline and 12 months -45%). Calcium remained within the normal range throughout the study and phosphorus ranged around the upper limit of normal. The Kidney Disease: Improving Global Outcomes (KDIGO) target achievement for iPTH increased from 44.5% of patients at baseline to 65.7% at 12 months, corrected calcium from 58.9% to 51.9% and phosphorus from 18.4% to 24.4%. On average, approximately 30% of patients adapted their regimen from one observation period to the next. The reasons for changing a given regimen were to attain or maintain any of the bone mineral markers within recommended targets and to avoid developments to extreme values. Some regional differences in practice patterns were identified. No new safety signals emerged. In conclusion, cinacalcet appears to be a necessary treatment component to achieve recommended targets. The detailed composition of the treatment mix should be adapted to patient requirements and reassessed on a regular basis.
authors.affiliation: Department of Internal Medicine, Dialysis Unit, Hospital of the Brothers of Saint John of God, Johannes von Gott Platz 1, 7001, Eisenstadt, Austria. Wolfgang.Pronai@bbeisen.at.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Pronai
authors.affiliation: Department of Internal Medicine, Clinical Division of Nephrology, Medical University of Graz, Graz, Austria.
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Rosenkranz
authors.affiliation: Abteilung Nephrologie, Kantonsspital Aarau, Aarau, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Bock
authors.affiliation: Sozialmedizinisches Zentrum Ost - Donauspital, Vienna, Austria.
authors.forename: Renate
authors.initials: R
authors.lastname: Klauser-Braun
authors.affiliation: Amgen GmbH, Vienna, Austria.
authors.forename: Christine
authors.initials: C
authors.lastname: Jäger
authors.affiliation: Amgen AG, Zug, Switzerland.
authors.forename: Gunther
authors.initials: G
authors.lastname: Pendl
authors.affiliation: hemetsberger medical services, Vienna, Austria.
authors.forename: Margit
authors.initials: M
authors.lastname: Hemetsberger
authors.affiliation: Department of Nephrology and Dialysis, Academic Teaching Hospital Feldkirch, Feldkirch, Austria.
authors.forename: Karl
authors.initials: K
authors.lastname: Lhotta
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001317:Austria / Q000453:epidemiology; D057966:Calcimimetic Agents / Q000008:administration & dosage; D015984:Causality; D000069449:Cinacalcet / Q000008:administration & dosage*; D015897:Comorbidity; D004359:Drug Therapy, Combination / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D015995:Prevalence; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy* / Q000453:epidemiology; D012307:Risk Factors; D013557:Switzerland / Q000453:epidemiology; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage*
chemical_list: D057966:Calcimimetic Agents; D014807:Vitamin D; D000069449:Cinacalcet
keywords: Cinacalcet; Clinical practice; Observational study; Secondary hyperparathyroidism; Treatment pattern