Financiado en parte por Mitsubishi Tanabe Pharma Corporation
A Randomized Trial of Magnesium Oxide and Oral Carbon Adsorbent for Coronary Artery Calcification in Predialysis CKD
Sakaguchi Y, Hamano T, Obi Y, Monden C, Oka T, Yamaguchi S, Matsui I, Hashimoto N, Matsumoto A, Shimada K, Takabatake Y, Takahashi A, Kaimori JY, Moriyama T, Yamamoto R, Horio M, Yamamoto K, Sugimoto K, Rakugi H, Isaka Y
Journal of the American Society of Nephrology : JASN · 111 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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
- Organización sin fines de lucro
- American Society of Nephrology
- Empresa
- Mitsubishi Tanabe Pharma Corporation
Según 2 financiadores declarados.
Publicación
- Publicado
- 2019-04-29 · J Am Soc Nephrol · vol. 30 · número 6 · págs. 1073–1085
- Editorial
- American Society of Nephrology
- Citado
- 153 citas · más que el 99% de estudios similares · 11.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 66 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Parathyroid Disorders and Treatments · Magnesium in Health and Disease · Dialysis and Renal Disease Management
- Palabras clave
- Medicine, Internal medicine, Randomized controlled trial, Kidney disease, Diabetes mellitus, Coronary artery disease, Gastroenterology, Endocrinology
- MeSH
- humans, disease progression, oxides, carbon, magnesium oxide, prognosis, treatment outcome, administration, oral, severity of illness index, patient compliance, comorbidity, primary prevention, reference values, aged, middle aged, hospitals, university, female, male, renal insufficiency, chronic, coronary artery disease, vascular calcification
20 autores
- Yusuke Sakaguchi
- Takayuki Hamano · autor de correspondencia
- Yoshitsugu Obi🇺🇸University of California, Irvine
- Chikako Monden🇯🇵Osaka Kaisei Hospital
- Tatsufumi Oka🇺🇸Pediatric Nephrology of Alabama
- Satoshi Yamaguchi🇺🇸Pediatric Nephrology of Alabama
- Isao Matsui🇺🇸Pediatric Nephrology of Alabama
- Nobuhiro Hashimoto🇺🇸Pediatric Nephrology of Alabama
- Ayumi Matsumoto🇺🇸Pediatric Nephrology of Alabama
- Karin Shimada🇺🇸Pediatric Nephrology of Alabama
- Yoshitsugu Takabatake🇺🇸Pediatric Nephrology of Alabama
- Atsushi Takahashi🇺🇸Pediatric Nephrology of Alabama
- Jun-Ya Kaimori
- Toshiki Moriyama🇯🇵The University of Osaka
- Ryohei Yamamoto🇯🇵The University of Osaka
- Masaru Horio
- Koichi I. Yamamoto🇯🇵The University of Osaka
- Ken Sugimoto🇯🇵The University of Osaka
- Hiromi Rakugi🇯🇵The University of Osaka
- Yoshitaka Isaka🇺🇸Pediatric Nephrology of Alabama
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Developing strategies for managing coronary artery calcification (CAC) in patients with CKD is an important clinical challenge. Experimental studies have demonstrated that magnesium inhibits vascular calcification, whereas the uremic toxin indoxyl sulfate aggravates it.
Methods
To assess the efficacy of magnesium oxide (MgO) and/or the oral carbon adsorbent AST-120 for slowing CAC progression in CKD, we conducted a 2-year, open-label, randomized, controlled trial, enrolling patients with stage 3-4 CKD with risk factors for CAC (diabetes mellitus, history of cardiovascular disease, high LDL cholesterol, or smoking). Using a two-by-two factorial design, we randomly assigned patients to an MgO group or a control group, and to an AST-120 group or a control group. The primary outcome was percentage change in CAC score.
Results
We terminated the study prematurely after an interim analysis with the first 125 enrolled patients (of whom 96 completed the study) showed that the median change in CAC score was significantly smaller for MgO versus control (11.3% versus 39.5%). The proportion of patients with an annualized percentage change in CAC score of ≥15% was also significantly lower for MgO compared with control (23.9% versus 62.0%). However, MgO did not suppress the progression of thoracic aorta calcification. The MgO group's dropout rate was higher than that of the control group (27% versus 17%), primarily due to diarrhea. The percentage change in CAC score did not differ significantly between the AST-120 and control groups.
Conclusions
MgO, but not AST-120, appears to be effective in slowing CAC progression. Larger-scale trials are warranted to confirm these findings.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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