Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized controlled trial
Thadhani R, Appelbaum E, Pritchett Y, Chang Y, Wenger J, Tamez H, Bhan I, Agarwal R, Zoccali C, Wanner C, Lloyd-Jones D, Cannata J, Thompson BT, Andress D, Zhang W, Packham D, Singh B, Zehnder D, Shah A, Pachika A, Manning WJ, Solomon SD
JAMA · 390 citas
Etiquetas de revisión
Financiación no declaradaDatos 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
- Financiación no declarada
Publicación
- Publicado
- 2012-02-14 · JAMA · vol. 307 · número 7 · pág. 674
- Editorial
- American Medical Association
- Citado
- 567 citas · más que el 100% de estudios similares · 50.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 62 trabajos
- Acceso
- De pago
- Áreas de investigación
- Parathyroid Disorders and Treatments · Vitamin D Research Studies · Cardiovascular Function and Risk Factors
- Palabras clave
- paricalcitol, active vitamin D, chronic kidney disease, left ventricular hypertrophy, left ventricular mass, diastolic dysfunction, parathyroid hormone, hypercalcemia, cardiovascular magnetic resonance imaging, echocardiography, cardiovascular risk reduction, preserved ejection fraction, vitamin D receptor agonists, secondary prevention of cardiovascular disease, cardiovascular morbidity and mortality, cardiovascular risk stratification
- MeSH
- humans, kidney diseases, hypertrophy, left ventricular, hypercalcemia, vitamin d deficiency, hyperparathyroidism, secondary, chronic disease, ergocalciferols, parathyroid hormone, vitamins, glomerular filtration rate, treatment outcome, double-blind method, ventricular function, left, aged, middle aged, female, male
22 autores
- Ravi Thadhani🇺🇸 · autor de correspondenciaHarvard University; Massachusetts General Hospital
- Evan A. Appelbaum🇺🇸Harvard University
- Yili Pritchett🇺🇸Abbott (United States)
- Yuchiao Chang🇺🇸Harvard University
- Julia Wenger🇺🇸Harvard University
- Hector E. Tamez🇺🇸Harvard University
- Ishir Bhan🇺🇸Harvard University
- Rajiv Agarwal🇺🇸Indiana University
- Carmine Zoccali
- Christoph Wanner🇩🇪University of Würzburg
- Donald M. Lloyd‐Jones🇺🇸Northwestern University
- Jorge Benito Cannata-Andía🇪🇸Universidad de Oviedo
- Bruce Thompson🇺🇸Harvard University
- Dennis L. Andress🇺🇸Abbott (United States)
- Wuyan Zhang🇺🇸Abbott (United States)
- David Packham🇦🇺The Royal Melbourne Hospital; The University of Melbourne
- Bhupinder Singh🇺🇸Southwest Kidney Institute
- Daniel Zehnder🇬🇧University of Warwick
- Amil Shah🇺🇸Harvard University
- Ajay Pachika🇺🇸Harvard University
- Warren J. Manning🇺🇸Harvard University
- Scott David Solomon🇺🇸Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Context
Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking.
Objective
To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m(2).
Design, setting, and participants
Multinational, double-blind, randomized placebo-controlled trial among 227 patients with chronic kidney disease, mild to moderate left ventricular hypertrophy, and preserved left ventricular ejection fraction, conducted in 11 countries from July 2008 through September 2010.
Intervention
Participants were randomly assigned to receive oral paricalcitol, 2 μg/d (n =115), or matching placebo (n = 112).
Main outcome measures
Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging. Secondary end points included echocardiographic changes in left ventricular diastolic function.
Results
Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration. At 48 weeks, the change in left ventricular mass index did not differ between treatment groups (paricalcitol group, 0.34 g/m(2.7) [95% CI, -0.14 to 0.83 g/m(2.7)] vs placebo group, -0.07 g/m(2.7) [95% CI, -0.55 to 0.42 g/m(2.7)]). Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity (paricalcitol group, -0.01 cm/s [95% CI, -0.63 to 0.60 cm/s] vs placebo group, -0.30 cm/s [95% CI, -0.93 to 0.34 cm/s]) also did not differ. Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group.
Conclusion
Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease.
Trial registration
clinicaltrials.gov Identifier: NCT00497146.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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