Cinacalcet for managing secondary hyperparathyroidism in dialysis patients in clinical practice in Belgium: a 16-month observational study (ECHO-B).
In Belgium, the calcimimetic cinacalcet is initially reimbursed for < or = 4 months in dialysis patients with secondary hyperparathyroidism (SHPT) and intact parathyroid hormone (iPTH) > or = 800 pg/mL, or iPTH 300-800 pg/ mL and Ca x P > 55 mg 2/dL2 despite > or = 6 months' optimal treatment with vitamin D sterols and/or phosphate binders. The Belgian, multicentre, observational study ECHO-B evaluated cinacalcet in such patients. Patients who began cinacalcet treatment after March 1, 2007 were eligible. Data were collected retro/prospectively from 6 months before until 16 months after starting cinacalcet (whether or not cinacalcet was continued). Median iPTH was markedly elevated (816 [IQR 551-991] pg/mL) at baseline (the time of starting cinacalcet), but decreased continuously over the course of the study, reaching a value of 414 pg/mL (IQR 240-641; median change -41%) at 4 months, 335 pg/mL (IQR 159-616; -60%) at 12 months and 250 pg/mL (IQR 172-436; -64%) at 16 months. Reductions in serum calcium (-7%) and phosphorus (-13%) were already (near) maximal at 4 months. The primary outcome (iPTH 150-300 pg/mL and/or a > or = 30% reduction within 4 months of starting cinacalcet; criterion for continued reimbursement in Belgium) was achieved in 65/81 patients (80%; 95% CI 72-89%). Results show that in dialysis patients with SHPT in real-life clinical practice, mineral metabolism improves after starting cinacalcet: our study findings suggest that PTH levels may continue decreasing after 12 months' treatment in this setting.
Service de Néphrologie et Dialyse, CH EpiCURA Baudour, Baudour, Belgium. frederic.debelle@epicura.be
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Debelle
Dienst nefrologie, az Groeninge, Kortrijk, Belgium.
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Meeus
Clinique de Néphrologie-Dialyse, CHU Brugmann, Université Libre de Bruxelles, Bruxelles, Belgium.
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Dratwa
H.-Hartziekenhuis Roeselare-Menen, Roeselare, Belgium.
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Maes
Nephrology Section OK12, University Hospital, Gent, Belgium.
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Vanholder
Informatique médicale et Biostatistique, Université de Liège, Liège, Belgium.
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Albert
Amgen, Brussels, Belgium.
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Schutyser
Service de Néphrologie, Cliniques Universitaires Saint Luc, Université catholique de Louvain, Bruxelles, Belgium.
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Jadoul
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001530:Belgium; D057966:Calcimimetic Agents / Q000627:therapeutic use*; D002118:Calcium / Q000097:blood; D000069449:Cinacalcet; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D011446:Prospective Studies; D006435:Renal Dialysis; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D057966:Calcimimetic Agents; D009281:Naphthalenes; D010281:Parathyroid Hormone; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet