ECE2013 Poster Presentations Thyroid (non-cancer) (100 abstracts)
PRIMARA: a prospective descriptive observational study to review cinacalcet use in patients with primary hyperparathyroidism in clinical practice
Peter Schwartz 1 , Jean-Jacques Body 2 , Jan Cap 3 , Lorenz Hofbauer 4 , Mourad Farouk 5 , Alois Gessl 6 , Marc Kuhn 7 , Claudio Marcocci 8 , Caroline Mattin 9 , Manuel Munoz Torres 10 , Juraj Payer 11 , Annenienke van de Ven 12 , Maria Yavropoulou 13 & Peter Selby 14
1Research Center of Ageing and Osteoporosis, Glostrup, Denmark; 2University Hospital Brugmann (Universite Libre de Bruxelles), Brussels, Belgium; 3Carles University, Hradec Kralove, Czech Republic; 4Universitatsklinikum Carl Gustav Carus, Dresden, Germany; 5Amgen Europe, Zurich, Switzerland; 6Medical University of Vienna, Vienna, Austria; 7University Hospital of Rouen, Rouen, France; 8University of Pisa, Pisa, Italy; 9Amgen United Kingdom, Cambridge, UK; 10University Hospital San Cecilio, Granada, Spain; 11Cornelius University and University Hospital, Bratislava, Slovakia; 12Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands; 13AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece; 14Institute of Human Development, University of Manchester, Manchester, UK.
PRIMARA is the first observational study to describe the demographic and clinical profiles of adults with primary hyperparathyroidism (pHPT) receiving cinacalcet in daily clinics across European countries.
Patients with pHPT aged ≥18 years without prior cinacalcet treatment were eligible. Initial cinacalcet dosage and subsequent dose changes were at the investigator’s discretion. Information on dosing, biochemistry and adverse drug reactions (ADRs) were collected for up to 12 months from enrolment. Analysis was based on observed data.
Of 305 patients enrolled, 219 (72%) completed 12 months of cinacalcet treatment; the main reason for cinacalcet discontinuation was parathyroidectomy (40/86; 47%). 303 patients were evaluable for analysis. Forty-four percent were symptomatic with bone pains (43%) and renal stones (37%) reported as the most common symptoms. Reasons for prescribing cinacalcet included: surgery deemed inappropriate (35%), patient declined surgery (28%) or surgery had previously failed or was contraindicated (22%). Cinacalcet mean (S.D.) starting dose was 43.9 (15.8) mg/day. At month 12, 219 subjects (72%) were still receiving cinacalcet with mean (S.D.) dose of 51.3 (31.8) mg/day.
Median (Q1, Q3) iPTH concentration fell from 16.20 pmol/l (11.14, 27.91) at baseline to 13.85 (8.90, 23.66), 13.95 (8.49, 20.80) and 12.52 (7.97, 21.65) pmol/l at months 3, 6 and 12. At baseline, 22/223 (10%) had albumin-corrected serum calcium of ≤2.6 mmol/l; this rose to 63, 69 and 71% at 3, 6 and 12 months respectively. The percentage of subjects achieving reduction in albumin-corrected serum calcium ≥0.25 mmol/l was: 56, 63 and 60% at 3, 6 and 12 months post initiation of treatment. ADRs were reported in 81 patients (27%), most commonly nausea.
In conclusion, most patients received cinacalcet because surgery was inappropriate or they declined it. A clinically meaningful calcium decline of ≥0.25 mmol/l was observed in 60% of patients, 12 months post cinacalcet initiation without significant safety concerns.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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