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The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism.
Clin J Am Soc Nephrol. 2008 Jan; 3(1):36-45.CJ

Abstract

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 < or =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.

Authors+Show Affiliations

Nephrology Division, CROFF Policlinico di Milano, Via Della Commenda, 20122 Milano, Italy. pmessa@policlinico.mi.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

18178780

Citation

Messa, Piergiorgio, et al. "The OPTIMA Study: Assessing a New Cinacalcet (Sensipar/Mimpara) Treatment Algorithm for Secondary Hyperparathyroidism." Clinical Journal of the American Society of Nephrology : CJASN, vol. 3, no. 1, 2008, pp. 36-45.
Messa P, Macário F, Yaqoob M, et al. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008;3(1):36-45.
Messa, P., Macário, F., Yaqoob, M., Bouman, K., Braun, J., von Albertini, B., Brink, H., Maduell, F., Graf, H., Frazão, J. M., Bos, W. J., Torregrosa, V., Saha, H., Reichel, H., Wilkie, M., Zani, V. J., Molemans, B., Carter, D., & Locatelli, F. (2008). The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clinical Journal of the American Society of Nephrology : CJASN, 3(1), 36-45. https://doi.org/10.2215/CJN.03591006
Messa P, et al. The OPTIMA Study: Assessing a New Cinacalcet (Sensipar/Mimpara) Treatment Algorithm for Secondary Hyperparathyroidism. Clin J Am Soc Nephrol. 2008;3(1):36-45. PubMed PMID: 18178780.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. AU - Messa,Piergiorgio, AU - Macário,Fernando, AU - Yaqoob,Magdi, AU - Bouman,Koen, AU - Braun,Johann, AU - von Albertini,Beat, AU - Brink,Hans, AU - Maduell,Francisco, AU - Graf,Helmut, AU - Frazão,João M, AU - Bos,Willem Jan, AU - Torregrosa,Vicente, AU - Saha,Heikki, AU - Reichel,Helmut, AU - Wilkie,Martin, AU - Zani,Valter J, AU - Molemans,Bart, AU - Carter,Dave, AU - Locatelli,Francesco, PY - 2008/1/8/pubmed PY - 2008/1/31/medline PY - 2008/1/8/entrez SP - 36 EP - 45 JF - Clinical journal of the American Society of Nephrology : CJASN JO - Clin J Am Soc Nephrol VL - 3 IS - 1 N2 - 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 < or =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. SN - 1555-905X UR - https://www.unboundmedicine.com/medline/citation/18178780/The_OPTIMA_study:_assessing_a_new_cinacalcet__Sensipar/Mimpara__treatment_algorithm_for_secondary_hyperparathyroidism_ L2 - https://cjasn.asnjournals.org/cgi/pmidlookup?view=long&amp;pmid=18178780 DB - PRIME DP - Unbound Medicine ER -