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

Wien Med Wochenschr. 2015 Oct;165(19-20):410-8. doi: 10.1007/s10354-015-0379-0. Epub 2015 Aug 25.

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.

Keywords: Calcimimetic; Cinacalcet; Dialysis; Incident dialysis; Secondary hyperparathyroidism.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Austria
  • Calcium / blood
  • Cinacalcet / therapeutic use*
  • Female
  • Humans
  • Hyperparathyroidism, Secondary / blood
  • Hyperparathyroidism, Secondary / drug therapy*
  • Male
  • Middle Aged
  • Parathyroid Hormone / blood
  • Phosphorus / blood
  • Product Surveillance, Postmarketing
  • Renal Dialysis / adverse effects*

Substances

  • Parathyroid Hormone
  • Phosphorus
  • Calcium
  • Cinacalcet