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The PRIMARA study: a prospective, descriptive, observational study to review cinacalcet use in patients with primary
1Department of MedicineCopenhagen University Hospital Glostrup, Ndr. Ringvej 69, Building 88, 2600 Glostrup, DenmarkDepartment of MedicineCHU Brugmann, Université Libre de Bruxelles, Place Van Gehuchten 4, 1020 Brussels, Belgium4th Department of Internal MedicineUniversity Hospital of Hradec Králové, 500 05 Hradec Králové, Czech RepublicEndokrinologieDiabetes und Osteologie, Technische Universität Dresden, Fetscherstrasse 74, D-01307 Dresden, GermanyNephrology Therapeutic AreaAmgen Europe GmbH, Dammstrasse 23, CH-6301 Zug, SwitzerlandDivision of Endocrinology and MetabolismMedical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, AustriaService d'EndocrinologieDiabète et Maladies Métaboliques, University Hospital of Rouen, Hôpital de Bois Guillaume, 147 Avenue du Maréchal Juin, 76230 Bois-Guillaume Cedex, FranceDepartment of Clinical and Experimental MedicineUniversity of Pisa, Via Paradisa 2, 56124 Pisa, ItalyGlobal Biostatistical ScienceAmgen Ltd, 240 Cambridge Science Park, Milton Road, Cambridge CB4 0WD, UKEndocrinology DivisionUniversity Hospital San Cecilio, Avenida Dr Olóriz 16, 18012 Granada, Spain5th Department of Internal MedicineFaculty Hospital Bratislava, University Hospital of Bratislava, Ruzinovska 6, 826 06 Bratislava, SlovakiaDepartment of General Internal MedicineRadboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The NetherlandsDepartment of Endocrinology and MetabolismAHEPA University Hospital, Aristotle University of Thessaloniki, 1 Stilponos Kyriakidi Street, 54636 Thessaloniki, GreeceDepartment of MedicineInstitute of Human Development, Manchester Royal Infirmary, University of Manchester, Oxford Road, Manchester M13 9WL, UK peter.schwarz@regionh.dk.
Objective:
Medical management of primary hyperparathyroidism (PHPT) is important in patients for whom surgery is inappropriate. We aimed to describe clinical profiles of adults with PHPT receiving cinacalcet.
Design:
A descriptive, prospective, observational study in hospital and specialist care centres.
Methods:
For patients with PHPT, aged 23-92 years, starting cinacalcet treatment for the first time, information was collected on dosing pattern, biochemistry and adverse drug reactions (ADRs). Initial cinacalcet dosage and subsequent dose changes were at the investigator's discretion.
Results:
Of 303 evaluable patients with PHPT, 134 (44%) had symptoms at diagnosis (mostly bone pain (58) or renal stones (50)). Mean albumin-corrected serum calcium (ACSC) at baseline was 11.4 mg/dl (2.9 mmol/l). The reasons for prescribing cinacalcet included: surgery deemed inappropriate (35%), patient declined surgery (28%) and surgery failed or contraindicated (22%). Mean cinacalcet dose was 43.9 mg/day (s.d., 15.8) at treatment start and 51.3 mg/day (31.8) at month 12; 219 (72%) patients completed 12 months treatment. The main reason for cinacalcet discontinuation was parathyroidectomy (40; 13%). At 3, 6 and 12 months from the start of treatment, 63, 69 and 71% of patients, respectively, had an ACSC of ≤10.3 mg/dl vs 9.9% at baseline. Reductions from baseline in ACSC of ≥1 mg/dl were seen in 56, 63 and 60% of patients respectively. ADRs were reported in 81 patients (27%), most commonly nausea. A total of 7.6% of patients discontinued cinacalcet due to ADRs.
Conclusions:
Reductions in calcium levels of ≥1 mg/dl was observed in 60% of patients 12 months after initiation of cinacalcet, without notable safety concerns.
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