NDT Advance Access originally published online on March 29, 2007
Nephrology Dialysis Transplantation 2007 22(7):2102-2103; doi:10.1093/ndt/gfm172
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Six cases of successful cinacalcet cessation in haemodialysis patients treated for secondary hyperparathyroidism
Email: guillaume-jean-crat{at}wanadoo.frSir,
Cinacalcet acts as an allosteric activator of calcium-sensing receptor (CaR) and diminishes Parathyroid hormone (PTH) secretion [1]. For more than 2 years, it has been successfully used for the treatment of secondary hyperparathyroidism (SHPT) [2], and has been shown to facilitate achievement of the KDOQI-recommended targets for PTH, calcium, phosphorus and Ca x P product [3], with a sustained effect lasting for >2–3 years [4]. This expensive treatment is thought to be for life and the possibility of complete weaning had not been reported.
Among the 59 Haemodialysis (HD) patients who have been treated with cinacalcet for SHPT since 2004, we report here six successful cases of complete weaning after 12 months: four females and two males, 63 ± 20 years old, diabetics in 2/6 cases, dialysed for 41 ± 42 months, with a mean 3 x 6 h 15 min schedule achieving a mean 2.2 ± 0.6 Kt/V, using a standard dialysate calcium of 1.5 mmol/l. Serum levels of calcium, phosphorus and iPTH (Roche Elecsys) were recorded monthly before dialysis, and bone turnover markers every 3 months: bone alkaline phosphatases (BALP, chemiluminescence Mérieux) and ß cross-laps (C-Terminal Telopeptide collagen type I (CTX), Roche Elecsys). Cinacalcet, 30 mg tablets were taken at least 8 h before dialysis and on alternate days when prescribed at a dose <30 mg/day. All patients received daily oral cholecalciferol in order to correct 25-OH vitamin D deficiency. Serum levels of 25-OH vitamin D remained stable at baseline and after 12 months (81 ± 50, range 40–166 nmol/l vs 108 ± 52, range 40–176 nmol/l). The standard phosphate binder was sevelamer and no oral calcium was given. Alfacalcidol dose was tapered according to PTH, Ca x P and bone markers level. Criteria for cinacalcet weaning were PTH < 100 pg/ml, BALP < 25 µg/l, CTX < 2 µg/l and Ca x P level <4.0 mmol2/l achieved with the lowest dose of cinacalcet, i.e. 30 mg on alternate days for a period of 3 months.
The biological and therapeutic evolution is displayed in Table 1. Six months after cinacalcet cessation, serum level of PTH, calcium, phosphate and bone markers slightly increased but remained within the desirable targets, with an increase need for phosphate binder and alfacalcidol. Dialysis prescription remained stable during the study period, especially the 1.5 mmol/l dialysate calcium.
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Cinacalcet is a very efficient treatment of SHPT in dialysis patients, to a degree that allows, under specific conditions, for a complete weaning trial in certain cases. Out of the great and rapid initial biological improvement, we found no baseline characteristics predicting the possibility for tapering both alfacalcidol and cinacalcet and eventually leading to cessation of cinacalcet after 1 year. The underlying explanation for such an evolution remains to be elucidated. Parathyroid cell CaR and Vitamin D Receptor (VDR) expression would be interesting to measure, but it is difficult to obtain in clinical practice. Besides, we do not systematically follow-up ultrasound parathyroid gland size and a possible decrease in gland hyperplasia. Very close biological monitoring, including bone markers in these vitamin D-replete patients, seems a very helpful strategy. Long-term evolution is unknown, especially in case of future kidney transplantation. Due to its high cost, cinacalcet should be used under close follow-up, evaluation criteria leading, in some cases, to a complete weaning trial.
Conflict of interest statement. All the authors declare that they are the scientific consultants for Fresenius Medical Care.
Centre de Rein Artificiel,
Tassin la demi-lune, France
References
- Goodman WG. Calcimimetic agents for the treatment of secondary hyperparathyroidism. Seminars in Nephrology (2004) 24:460–463.[Web of Science][Medline]
- Block GA, Martin KJ, de Francisco AL, et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med (2004) 350:1516–1525.
[Abstract/Free Full Text] - Moe SM, Chertow GM, Coburn JW, et al. Achieving NKF-K/DOQI bone metabolism and disease treatment goals with cinacalcet HCl. Kidney Int (2005) 67:760–771.[CrossRef][Web of Science][Medline]
- Moe SM, Cunningham J, Bommer J, et al. Long-term treatment of secondary hyperparathyroidism with the calcimimetic cinacalcet HCl. Nephrol Dial Transplant (2005) 20:2186–2193.
[Abstract/Free Full Text]
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