ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Endocrine Abstracts (2008) 16 P750

Impact of Cinacalcet treatment on health related quality of life (HRQOL) in patients with primary hyperparathyroidism (PHPT) who have failed or in whom parathyroidectomy (PTX) is contraindicated

Philippe Chanson1, Dolores Shoback2, John Lu3, Sunfa Cheng3, Lulu Ren3 & John Bilezikian4

1Hôpital de Bicêtre and Université Paris-Sud, Paris, France; 2Veterans Affairs Medical Center, University of California, San Francisco, California, USA; 3Amgen Inc, Thousand Oaks, California, USA; 4College of Physicians and Surgeons, Columbia University, New York, New York, USA.

Hypercalcemic complications of PHPT include renal, cardiovascular, gastrointestinal, neuromuscular and neuropsychiatric issues, all potentially impacting negatively on HRQOL. As control of the hypercalcemia associated with PHPT might improve HRQOL, the SF-36 and a 6-item scale on cognitive functioning (CF) were included in a phase 2, single-arm study evaluating the ability of cinacalcet to control serum calcium levels in 17 patients with intractable PHPT. Mean±S.E.M. calcium in these patients fell significantly from 3.2±0.05 to 2.6±0.08 mmol/l after up to a 16-week titration phase. The SF-36 scales are standardized so that the general population mean is 50. The CF scale is scored from 0 to 100. Higher numbers indicate better HRQOL. Mean change from baseline to end of the treatment phase for these patients was calculated for each scale. Numerically scores for all scales improved during treatment. For the SF-36, the gain ranged from 3.0 to 7.7 points. For the CF, it was 11.8 (Table).

HRQOL scalesMean (S.E.M.) score at baselineMean change from baseline (95% confidence interval)
Physical functioning (PF)34.3 (3.2)4.6 (2.0, 7.2)
Body pain (BP)42.8 (3.1)5.1 (0.7, 9.6)
Role limitations-physical (RP)35.0 (2.6)3.3 (−1.1, 7.7)
General health (GH) 40.9 (2.5)3.0 (−2.3, 8.3)
Social functioning (SF)36.7 (3.6)6.9 (−2.1, 15.9)
Vitality (VT)37.8 (2.6)5.6 (−2.7, 13.8)
Role limitations-emotional (RE)37.4 (3.4)7.7 (0.6, 14.9)
Emotional well being (EW)38.5 (3.3)7.5 (−0.1, 15.1)
Cognitive functioning (CF)61.2 (5.7)11.8 (−2.4, 25.9)

Treatment with cinacalcet may lead to improvement in HRQOL and functioning in patients with PHPT who have failed parathyroidectomy or in whom surgery is contraindicated. Larger, randomized studies are needed to confirm these findings.

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