EARLIER: an observational study to evaluate the use of cinacalcet in incident hemodialysis patients with secondary hyperparathyroidism in daily clinical practice.

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.