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Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism
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Urena-Torres, P., Bridges, I., Christiano, C., Cournoyer, S. H., Cooper, K., Farouk, M., Kopyt, N. P., Rodriguez, M., Zehnder, Daniel and Covic, A. (2013) Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism. Nephrology Dialysis Transplantation, Volume 28 (Number 5). pp. 1241-1254. doi:10.1093/ndt/gfs568 ISSN 0931-0509.
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Official URL: http://dx.doi.org/10.1093/ndt/gfs568
Abstract
Treatment with cinacalcet improves the control of secondary hyperparathyroidism (SHPT) and the achievement of calcium and phosphorus targets. Most data come from subjects receiving cinacalcet after several years of dialysis treatment. We therefore compared the efficacy of treatment with cinacalcet and low doses of active vitamin D to flexible doses of active vitamin D alone for the management of SHPT in patients recently initiating haemodialysis.
This open-label trial randomized subjects (n 309) with parathyroid hormone (PTH) 300 pg/mL on dialysis for 312 months to either cinacalcet with low-dose active vitamin D, if prescribed (cinacalcet); or usual care without cinacalcet (control). Randomized subjects were stratified by PTH at screening (300450, 450600, 600 pg/mL) and by the use of active vitamin D at enrolment. Treatment duration was 12 months, with primary efficacy endpoint (mean PTH reduction 30 from baseline) assessed at 6 months.
The mean [standard deviation (SD)] haemodialysis vintage at enrolment was 7.2 (2.7) months; 53 of subjects were not receiving active vitamin D at enrolment. There was a significant difference in the achievement of the primary endpoint (30 PTH reduction at 6 months) between cinacalcet-treated subjects and controls in both the entire cohort (63 versus 38; n 304; P 0.0001) and the subgroup of subjects not receiving active vitamin D at enrolment (70 versus 44; n 161; P 0.01). Hypocalcaemia and gastrointestinal adverse events were more commonly observed in cinacalcet-treated subjects.
These results indicate that cinacalcet with low-dose active vitamin D, if prescribed, provides a more effective treatment approach than usual care without cinacalcet for SHPT in incident haemodialysis patients, even in relatively treatment-naive patients.
| Item Type: | Journal Article | ||||
|---|---|---|---|---|---|
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Biomedical Sciences > Translational & Experimental Medicine > Metabolic and Vascular Health (- until July 2016) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Journal or Publication Title: | Nephrology Dialysis Transplantation | ||||
| Publisher: | Oxford University Press | ||||
| ISSN: | 0931-0509 | ||||
| Official Date: | May 2013 | ||||
| Dates: |
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| Volume: | Volume 28 | ||||
| Number: | Number 5 | ||||
| Page Range: | pp. 1241-1254 | ||||
| DOI: | 10.1093/ndt/gfs568 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
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