Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results
Fishbane S, Shapiro WB, Corry DB, Vicks SL, Roppolo M, Rappaport K, Ling X, Goodman WG, Turner S, Charytan C
Clinical journal of the American Society of Nephrology : CJASN · 120 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- American Society of Nephrology
Según 1 financiador declarado.
Publicación
- Publicado
- 2008-10-22 · Clin J Am Soc Nephrol · vol. 3 · número 6 · págs. 1718–1725
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 171 citas · más que el 98% de estudios similares · 10.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 32 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 hydrochloride, vitamin D, secondary hyperparathyroidism, hemodialysis, chronic kidney disease, parathyroid hormone, calcium-phosphate product, KDOQI guidelines
- MeSH
- humans, kidney diseases, hyperparathyroidism, secondary, chronic disease, calcium, phosphorus, naphthalenes, parathyroid hormone, vitamins, vitamin d, treatment outcome, drug therapy, combination, renal dialysis, prospective studies, time factors, adult, aged, middle aged, female, male, practice guidelines as topic, cinacalcet
10 autores
- Steven N. Fishbane🇺🇸 · autor de correspondenciaWinthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
- Warren B. Shapiro🇺🇸Winthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
- Dalila B. Corry🇺🇸Winthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
- Steven L. Vicks🇺🇸Winthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
- Michael Roppolo🇺🇸Winthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
- Kenneth Rappaport🇺🇸Winthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
- Xiang Ling🇺🇸Winthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
- William G. Goodman🇺🇸Winthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
- Stewart A. Turner🇺🇸Winthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
- Chaim Charytan🇺🇸Winthrop-University Hospital; Amgen (United States); Palm Beach Gardens Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background and objectives
Patients with chronic kidney disease (CKD) receiving dialysis often develop secondary hyperparathyroidism with disturbed calcium and phosphorus metabolism. The National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (KDOQI) was established to guide treatment practices for these disorders. The ACHIEVE study was designed to test two treatment strategies for achieving KDOQI goals.
Design, setting, participants, measurements
Individuals on hemodialysis treated with vitamin D sterols were enrolled in this 33-week study. Subjects were randomly assigned to treatment with either cinacalcet and low-dose vitamin D (Cinacalcet-D) or flexible vitamin D alone (Flex-D) to achieve KDOQI-recommended bone mineral targets. ACHIEVE included a 6-week screening phase, including vitamin D washout, a 16-week dose-titration phase, and an 11-week assessment phase.
Results
Of 173 subjects enrolled, 83% of Cinacalcet-D and 67% of Flex-D subjects completed the study. A greater proportion of Cinacalcet-D versus Flex-D subjects had a >30% reduction in parathyroid hormone (PTH) (68% versus 36%, P < 0.001) as well as PTH <300 pg/ml (44% versus 23%, P = 0.006). The proportion of subjects simultaneously achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) was also greater (21% versus 14%), but this was not statistically significant. This was attributable to 19% of Cinacalcet-D subjects with a PTH value below the KDOQI target range.
Conclusions
Achievement of KDOQI targets was difficult, especially with Flex-D. Maintaining calcium and phosphorus target values precluded the use of vitamin D doses necessary to lower PTH to within the narrow target range and highlighted limitations inherent to the KDOQI treatment algorithm.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.