title: EARLIER: an observational study to evaluate the use of cinacalcet in incident hemodialysis patients with secondary hyperparathyroidism in daily clinical practice.
abstract: The EARLIER (Evaluation of MimpARa in incident hemodiaLysis patIEnts with secondaRy hyperparathyroidism; SHPT) observational postmarketing surveillance study evaluated incident hemodialysis patients (< 1 year dialysis vintage; n = 146) receiving cinacalcet in Austrian clinical practice. Despite intervention with vitamin D sterols and phosphate binders, 24 % had already developed severe SHPT (intact parathyroid hormone (iPTH) > 800 pg/mL) at baseline. After cinacalcet was started, median iPTH decreased substantially, from 611 pg/mL to 251 pg/mL (median decrease 58 % [IQR - 36 to - 78 %] at 12 months. Overall, 36 % of patients achieved the Kidney Disease Outcomes Quality Initiative (K/DOQI) target range (150-300 pg/mL) for iPTH; this included 35 % of those with severe SHPT at baseline. Serum phosphorus (P), calcium (Ca) (corr), and Ca (corr) × P also decreased, with 43, 34, and 62 % of patients, respectively, reaching K/DOQI targets at 12 months. Thus, in this observational study, mineral metabolism in incident dialysis patients with SHPT improved after starting cinacalcet.
authors: hemetsberger medical services, Vienna, Austria.
authors: Margit
authors: M
authors: Hemetsberger
authors: 3rd Internal Department -Kidney diseases and high pressure conditions, transplant medicine, rheumatology, Elisabethinen Hospital, Linz, Austria.
authors: Rainer
authors: R
authors: Oberbauer
authors: Clinical Trials Management GmbH, Vienna, Austria.
authors: Helmut
authors: H
authors: Erb
authors: Department of Internal Medicine, Dialysis Unit, Krankenhaus der Barmherzigen Brüder, Johannes von Gott Platz 1, 7001, Eisenstadt, Austria. Wolfgang.Pronai@bbeisen.at.
authors: Wolfgang
authors: W
authors: Pronai
mesh_terms: D000328:Adult; D000368:Aged; D001317:Austria; D002118:Calcium / Q000097:blood; D000069449:Cinacalcet / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D011358:Product Surveillance, Postmarketing; D006435:Renal Dialysis / Q000009:adverse effects*
chemical_list: D010281:Parathyroid Hormone; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet
keywords: Calcimimetic; Cinacalcet; Dialysis; Incident dialysis; Secondary hyperparathyroidism