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Cinacalcet treatment and serum FGF23 levels in haemodialysis patients with secondary hyperparathyroidism.
Nephrol Dial Transplant. 2012 Feb; 27(2):784-90.ND

Abstract

BACKGROUND

Elevated fibroblast growth factor 23 (FGF23) is associated with adverse clinical outcomes and development of secondary hyperparathyroidism (SHPT) refractory to active vitamin D. Cinacalcet hydrochloride is effective in treating SHPT, but little is known as to whether treatment with cinacalcet alters these levels and whether pretreatment FGF23 levels predict response to this therapy.

METHODS

We measured serum full-length FGF23 levels in 55 haemodialysis patients, who participated and completed the 52-week, multicentre, open-label single-arm trial that examined the effectiveness of cinacalcet for treating SHPT. In the study, alteration of vitamin D dosage was not permitted except for the case in which serum calcium could not be managed by calcium carbonate adjustment alone.

RESULTS

After 12 weeks of cinacalcet treatment, FGF23 levels decreased significantly concomitantly with a significant reduction in intact parathyroid hormone (PTH) levels. These responses were sustained >52 weeks. In multivariate regression analyses, changes from baseline in serum FGF23 were associated with changes in serum calcium and phosphorus but not with intact PTH at each time point of measurements (Week-12, Week-24 and Week-52). Baseline FGF23 was not associated with the likelihood of achieving an intact PTH <180 pg/mL at the study end.

CONCLUSIONS

Cinacalcet lowers serum FGF23 in haemodialysis patients with SHPT independently of the effects of active vitamin D. Pretreatment FGF23 cannot predict treatment response to cinacalcet in this setting. The precise mechanism of FGF23 reduction by cinacalcet and its clinical impact on outcomes in patients remain to be investigated.

Authors+Show Affiliations

Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21730210

Citation

Koizumi, Masahiro, et al. "Cinacalcet Treatment and Serum FGF23 Levels in Haemodialysis Patients With Secondary Hyperparathyroidism." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 27, no. 2, 2012, pp. 784-90.
Koizumi M, Komaba H, Nakanishi S, et al. Cinacalcet treatment and serum FGF23 levels in haemodialysis patients with secondary hyperparathyroidism. Nephrol Dial Transplant. 2012;27(2):784-90.
Koizumi, M., Komaba, H., Nakanishi, S., Fujimori, A., & Fukagawa, M. (2012). Cinacalcet treatment and serum FGF23 levels in haemodialysis patients with secondary hyperparathyroidism. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 27(2), 784-90. https://doi.org/10.1093/ndt/gfr384
Koizumi M, et al. Cinacalcet Treatment and Serum FGF23 Levels in Haemodialysis Patients With Secondary Hyperparathyroidism. Nephrol Dial Transplant. 2012;27(2):784-90. PubMed PMID: 21730210.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cinacalcet treatment and serum FGF23 levels in haemodialysis patients with secondary hyperparathyroidism. AU - Koizumi,Masahiro, AU - Komaba,Hirotaka, AU - Nakanishi,Shohei, AU - Fujimori,Akira, AU - Fukagawa,Masafumi, Y1 - 2011/07/05/ PY - 2011/7/7/entrez PY - 2011/7/7/pubmed PY - 2012/9/14/medline SP - 784 EP - 90 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 27 IS - 2 N2 - BACKGROUND: Elevated fibroblast growth factor 23 (FGF23) is associated with adverse clinical outcomes and development of secondary hyperparathyroidism (SHPT) refractory to active vitamin D. Cinacalcet hydrochloride is effective in treating SHPT, but little is known as to whether treatment with cinacalcet alters these levels and whether pretreatment FGF23 levels predict response to this therapy. METHODS: We measured serum full-length FGF23 levels in 55 haemodialysis patients, who participated and completed the 52-week, multicentre, open-label single-arm trial that examined the effectiveness of cinacalcet for treating SHPT. In the study, alteration of vitamin D dosage was not permitted except for the case in which serum calcium could not be managed by calcium carbonate adjustment alone. RESULTS: After 12 weeks of cinacalcet treatment, FGF23 levels decreased significantly concomitantly with a significant reduction in intact parathyroid hormone (PTH) levels. These responses were sustained >52 weeks. In multivariate regression analyses, changes from baseline in serum FGF23 were associated with changes in serum calcium and phosphorus but not with intact PTH at each time point of measurements (Week-12, Week-24 and Week-52). Baseline FGF23 was not associated with the likelihood of achieving an intact PTH <180 pg/mL at the study end. CONCLUSIONS: Cinacalcet lowers serum FGF23 in haemodialysis patients with SHPT independently of the effects of active vitamin D. Pretreatment FGF23 cannot predict treatment response to cinacalcet in this setting. The precise mechanism of FGF23 reduction by cinacalcet and its clinical impact on outcomes in patients remain to be investigated. SN - 1460-2385 UR - https://wwww.unboundmedicine.com/medline/citation/21730210/Cinacalcet_treatment_and_serum_FGF23_levels_in_haemodialysis_patients_with_secondary_hyperparathyroidism_ DB - PRIME DP - Unbound Medicine ER -