Financiado en parte por Amgen
Effects of cinacalcet and concurrent low-dose vitamin D on FGF23 levels in ESRD
Wetmore JB, Liu S, Krebill R, Menard R, Quarles LD
Clinical journal of the American Society of Nephrology : CJASN · 110 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Amgen
- Gobierno
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- Gobierno
- NIAMS NIH HHS
- Subvenciones
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR045955); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01-AR-45955); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R56AR045955)
Según 3 financiadores declarados.
Publicación
- Publicado
- 2009-11-05 · Clin J Am Soc Nephrol · vol. 5 · número 1 · págs. 110–116
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 153 citas · más que el 99% de estudios similares · 11.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 36 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Parathyroid Disorders and Treatments · Dialysis and Renal Disease Management · Vitamin D Research Studies
- Palabras clave
- cinacalcet, vitamin D, fibroblast growth factor 23, end-stage renal disease, secondary hyperparathyroidism, calcitriol analogs, phosphate, serum calcium, parathyroid hormone, ACHIEVE trial
- MeSH
- humans, kidney failure, chronic, naphthalenes, fibroblast growth factors, vitamins, vitamin d, drug therapy, combination, single-blind method, middle aged, female, male, cinacalcet, fibroblast growth factor-23
5 autores
- James B. Wetmore🇺🇸 · autor de correspondenciaUniversity of Kansas Medical Center
- Shiguang Liu · autor de correspondencia
- Ron Krebill🇺🇸University of Kansas Medical Center
- Rochelle Menard
- L. Darryl Quarles · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background and objectives
Fibroblast growth factor-23 (FGF23) levels are elevated in ESRD and have been associated with adverse outcomes. The effects of various treatments for secondary hyperparathyroidism on FGF23 levels in ESRD have not been examined in a clinical trial.
Design, setting, participants, & measurements
We assessed intact FGF23 levels in 91 subjects over the course of the ACHIEVE trial, which was designed to compare escalating doses of Cinacalcet plus fixed low-dose calcitriol analogs (Cinaclcet-D) with titration of calcitriol analogs alone (Flex-D) to suppress parathyroid hormone. Between-group and within-group changes in log-transformed FGF23 levels were analyzed. Factors associated with change in FGF23 were assessed using a multiple regression model.
Results
Intact FGF23 levels were markedly elevated in subjects at baseline. A statistically significant difference in percent change in log FGF23 levels was observed between treatment groups (P < 0.002). The Cinacalcet-D group had a significant decrease in percent change in log FGF23 levels (corrected P = 0.021), whereas FGF23 levels trended toward an increase in the Flex-D group. Change in FGF23 level was significantly associated with changes in levels of phosphate (P < 0.0001) and calcium (P = 0.0002) but not parathyroid hormone.
Conclusions
Treatment with Cinacalcet plus low-dose calcitriol analogs results in lower FGF23 levels compared with a treatment regimen using calcitriol analogs alone in ESRD. The mechanisms underlying the differential effects of these treatment regimens on FGF23 levels and the clinical impact of these changes on FGF23 remain to be defined.
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