The TARGET study was originally supported by Amgen, Inc. Disclosures: Dr Goodman is an employee of Amgen, Inc. Dr Lu was previously an employee of Amgen, Inc. Dr Xu and Mr Knight were employed by Amgen, Inc. during the conduct of this study. Drs Chertow, Bushinsky, and Block have received research funding and honoraria from Amgen, Inc.
Self-reported symptoms in patients on hemodialysis with moderate to severe secondary hyperparathyroidism receiving combined therapy with cinacalcet and low-dose vitamin D sterols
Article first published online: 28 NOV 2011
© 2011 The Authors; Hemodialysis International © 2011 International Society for Hemodialysis
Volume 16, Issue 2, pages 188–197, April 2012
How to Cite
Chertow, G. M., Lu, Z. J., Xu, X., Knight, T. G., Goodman, W. G., Bushinsky, D. A. and Block, G. A. (2012), Self-reported symptoms in patients on hemodialysis with moderate to severe secondary hyperparathyroidism receiving combined therapy with cinacalcet and low-dose vitamin D sterols. Hemodialysis International, 16: 188–197. doi: 10.1111/j.1542-4758.2011.00642.x
- Issue published online: 10 APR 2012
- Article first published online: 28 NOV 2011
- Manuscript Revised: OCT 2011
- Manuscript Received: JUL 2011
- Amgen, Inc
- Secondary hyperparathyroidism;
Patients with secondary hyperparathyroidism experience a variety of clinical symptoms which may adversely affect physical and mental function. As part of a multicenter, open-label clinical trial, subjects completed a questionnaire that included the Medical Outcomes Study Short Form-36 and 14 kidney disease-related symptoms at multiple time points during the study. Out of the 567 subjects who received at least one dose of cinacalcet, 528 to 535 (93.8–94.4%) completed all or portions of the questionnaire at baseline. The median bioactive parathyroid hormone (PTH) was 294 pg/mL (10%, 90% range, 172–655 pg/mL). Following treatment with cinacalcet and low-dose vitamin D sterols, subjects reported significant improvement in the frequency of pain in muscles, joints and bones, stiff joints, dry skin, itchy skin, excessive thirst, and trouble with memory. At end of the efficacy assessment phase (Weeks 16 to 22), the magnitude of improvement was the greatest in joint pain, bone pain, dry skin, and excessive thirst (>5 on a 0–100 scale; P < 0.001). There were no clinically or statistically significant changes in any of the Short Form-36 subscales or in the physical or mental health composite scores. Among patients on hemodialysis with moderate to severe secondary hyperparathyroidism, treatment with cinacalcet and low-dose vitamin D sterols results in significant improvement in pain in the muscles, joints and bones, joint stiffness, dry and itchy skin, excessive thirst, and trouble with memory.