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The OPTIMA Study: Assessing a New Cinacalcet (Sensipar/Mimpara) Treatment Algorithm for Secondary Hyperparathyroidism

Piergiorgio Messa^*, Fernando Macário, Magdi Yaqoob, Koen Bouman, Johann Braun^||, Beat von Albertini^¶, Hans Brink^**, Francisco Maduell, Helmut Graf, João M. Frazão, Willem Jan Bos^||||, Vicente Torregrosa^¶¶, Heikki Saha^***, Helmut Reichel, Martin Wilkie, Valter J. Zani, Bart Molemans, Dave Carter, and Francesco Locatelli^||||||

^* Nephrology Division, CROFF Policlinico di Milano, Milan, Italy; Dialave, Diálise de Aveiro, Gambro Healthcare, Aveiro, Portugal; Royal London Hospital, London, United Kingdom; ZNA, Middelheim, Belgium; ^|| KfH Kuratorium fur Dialyse und Nierentransplantation, Nurnberg, Germany; ^¶ Centre de Dialyse Cecil, Lausanne, Switzerland; ^** Medisch Spectrum Twente, Enschede, The Netherlands; Hospital General de Castellón, Castellón de la Plana, Spain; Krankenanstalt der Stadt Wien-Rudolfstiftung, Wien, Austria; Nephrology Research and Development Unit and School of Medicine, Porto University, Porto, Portugal; ^|||| Antonius Hospital, The Netherlands; ^¶¶ Hospital Clínic i Provincial de Barcelona, Unitat de Transplantament Renal, Barcelona, Spain; ^*** Tampere University Hospital, Tampere, Finland; University of Heidelberg, Germany; Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK; Amgen GmbH, Zug, Switzerland; ^|||||| Department of Nephrology and Dialysis Ospedale A Manzoni, Lecco, Italy

Correspondence: Dr. Piergiorgio Messa, Nephrology Division, CROFF Policlinico di Milano, Via Della Commenda, 20122 Milano, Italy. Phone: +39-02-55034551; Fax: +39-02-55034550; E-mail: pmessa{at}policlinico.mi.it

Background and objectives: Cinacalcet, a novel calcimimetic, targets the calcium-sensing receptor to lower parathyroid hormone (PTH), calcium, and phosphorus levels in dialysis patients with secondary hyperparathyroidism (SHPT). This study compared the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.

Study design: In this multicenter, open-label study, hemodialysis patients with poorly controlled SHPT were randomized to receive conventional care (n = 184) or a cinacalcet-based regimen (n = 368). Doses of cinacalcet, vitamin D sterols, and phosphate binders were adjusted during a 16-wk dose-optimization phase with the use of algorithms that allowed cinacalcet to be used with adjusted doses of vitamin D. The primary end point was the proportion of patients with mean intact PTH 300 pg/ml during a 7-wk efficacy assessment phase.

Results: A higher proportion of patients receiving the cinacalcet-based regimen versus conventional care achieved the targets for PTH (71% versus 22%, respectively; P < 0.001), Ca x P (77% versus 58%, respectively; P < 0.001), calcium (76% versus 33%, respectively; P < 0.001), phosphorus (63% versus 50%, respectively; P = 0.002), and PTH and Ca x P (59% versus 16%, respectively, P < 0.001), and allowed a 22% reduction in vitamin D dosage in patients receiving vitamin D at baseline. Achievement of targets was greatest in patients with less severe disease (intact PTH range, 300 to 500 pg/ml) and the cinacalcet dose required was lower in these patients (median = 30 mg/d).

Conclusions: Compared with conventional therapy, a cinacalcet-based treatment algorithm increased achievement of KDOQI treatment targets in dialysis patients in whom conventional therapy was no longer effective in controlling this disease.