EFFECTS OF POLICOSANOL ON SERUM LIPID LEVELS IN HEALTHY SUBJECTS: AN EXPLORATORY POST HOC ANALYSIS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL COMPARATIVE STUDY.
Objective: Hypercholesterolemia is a major risk factor for coronary heart disease. There is evidence of the benefits of lowering cholesterol levels in subjects with borderline to mildly elevated serum total cholesterol (TC) levels (5.0-6.0mmol/L). Policosanol is a cholesterol-lowering drug made from...
| Publicado en: | Revista CENIC Ciencias Biológicas Vol. 56; pp. 119 - 128 |
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| Autores principales: | , , , |
| Formato: | Artículo |
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Centro Nacional de Investigaciones Cientificas
2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=lth&AN=192424598&site=ehost-live header: @attributes: shortDbName: lth uiTerm: 192424598 longDbName: MedicLatina uiTag: AN controlInfo: bkinfo: jinfo: jid: 02535688 UEZ jtl: Revista CENIC Ciencias Biológicas issn: 02535688 maglogo: N pubinfo: dt: 2025 vid: 56 pid: 21205 pub: Centro Nacional de Investigaciones Cientificas artinfo: ui: 192424598 ppf: 119 ppct: 9 formats: fmt: @attributes: type: P size: 1.4MB tig: atl: EFFECTS OF POLICOSANOL ON SERUM LIPID LEVELS IN HEALTHY SUBJECTS: AN EXPLORATORY POST HOC ANALYSIS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL COMPARATIVE STUDY. aug: au: Hitoe, Shoketsu Fernández Travieso, Julio César Mendoza Castaño, Sarahi Jung, Kwi Yeon affil: Regulation Affairs, Research & Development Department, Raydel Japan Corporation Ltd, Tokyo, Japan. Clinical Trials Unit, National Centre for Scientific Research, Havana, Cuba. Raydel Japan Corporation Ltd, Tokyo, Japan. su: Cholesterol Hypercholesteremia Functional foods Randomized controlled trials Blood lipids Antilipemic agents LDL cholesterol HDL cholesterol sug: subj: Cholesterol Hypercholesteremia Functional foods Randomized controlled trials Blood lipids Antilipemic agents LDL cholesterol HDL cholesterol keyword: borderline level cholesterol-lowering nutraceutical hypercholesterolemia policosanol colesterol LDL hipercolesterolemia nivel límitrofe nutracéutico para reducir el colesterol ab: Objective: Hypercholesterolemia is a major risk factor for coronary heart disease. There is evidence of the benefits of lowering cholesterol levels in subjects with borderline to mildly elevated serum total cholesterol (TC) levels (5.0-6.0mmol/L). Policosanol is a cholesterol-lowering drug made from purified sugar cane wax and now is also used as a cholesterol-lowering nutraceutical owing to its safety profile in some countries. The current exploratory post hoc analyses sought to investigate whether policosanol is efficacious to lower mildly elevated cholesterol levels at the normal ranges in healthy participants with borderline serum LDL-C levels, who previously participated in a randomized controlled trial. Methods: Data was obtained from a previous 14-week, single-center, prospective, double-blind, placebocontrolled, parallel-group, comparative study conducted in subjects with serum TC levels ≥ 4.8 to < 6.0mmol/L. After a six-week run-in period with instructions on lifestyle changes, participants were randomly assigned to two groups to receive either 5 mg of policosanol or placebo once daily with dinner for eight weeks. Lipid profile, safety indicators, adverse events (AEs), and treatment adherence were assessed. Data of thirty-nine participants were included in this analysis (policosanol = 16, placebo = 23). Results: After 8 weeks of supplementation, participants in the policosanol group exhibited statistically significant decreases in serum TC (-13.84%), LDL-C (-23.89%), LDL-C/HDL-C (high-density lipoprotein cholesterol) ratio (-30.45%) and increase in HDL-C (10.80%) versus baseline (week 0) while no significant changes were observed in the placebo group. The reductions on policosanol group were also significant compared to placebo. There were no significant changes observed on triglyceride. Conclusion: From the above results, it is concluded that policosanol supplementation has the potential to lower mildly elevated cholesterol levels at the normal ranges in healthy subjects and to be used as a cholesterol-lowering nutraceutical to improve the risk factor of hypercholesterolemia for coronary heart disease. Objetivo: La hipercolesterolemia es un factor de riesgo importante para la enfermedad coronaria. Existe evidencia de los beneficios de reducir los niveles de colesterol en sujetos con niveles de colesterol total (CT) sérico entre limítrofes y ligeramente elevados (5,0-6,0 mmol/L). El policosanol es un fármaco hipocolesterolemiante elaborado a partir de cera purificada de caña de azúcar y, debido a su perfil de seguridad, también se utiliza actualmente como nutracéutico hipocolesterolemiante en algunos países. Los análisis exploratorios post hoc actuales buscaron investigar si el policosanol es eficaz para reducir los niveles de colesterol ligeramente elevados dentro de los rangos normales en participantes sanos con niveles séricos de c-LDL limítrofes, que participaron previamente en un ensayo controlado aleatorizado. Métodos: Los datos se obtuvieron de un estudio comparativo de 14 semanas, unicéntrico, prospectivo, doble ciego, controlado con placebo, de grupos paralelos, realizado en sujetos con niveles séricos de CT ≥ 4,8 a < 6,0 mmol/L. Tras un período de preinclusión de seis semanas con instrucciones sobre cambios en el estilo de vida, los participantes fueron asignados aleatoriamente a dos grupos para recibir 5 mg de policosanol o placebo una vez al día con la cena durante ocho semanas. Se evaluaron el perfil lipídico, los indicadores de seguridad, los eventos adversos (EA) y la adherencia al tratamiento. Se incluyeron los datos de treinta y nueve participantes en este análisis (policosanol = 16, placebo = 23). Resultados: Tras 8 semanas de suplementación, los participantes del grupo de policosanoles mostraron disminuciones estadísticamente significativas en el CT sérico (-13,84%), el C-LDL (-23,89%), la relación C-LDL/C-HDL (-30,45%) y un aumento del CHDL (10,80%) en comparación con el valor inicial (semana 0), mientras que no se observaron cambios significativos en el grupo placebo. Las reducciones en el grupo de policosanoles también fueron significativas en comparación con el placebo. No se observaron cambios significativos en los triglicéridos. Conclusión: De los resultados anteriores, se concluye que el tratamiento con policosanol tiene el potencial de reducir los niveles de colesterol levemente elevados en rangos normales en sujetos sanos y de usarse como un nutracéutico reductor del colesterol para mejorar el factor de riesgo de hipercolesterolemia para la enfermedad cardíaca coronaria. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: Y custom: Copyright of Revista CENIC Ciencias Biológicas is the property of Centro Nacional de Investigaciones Cientificas and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. item: Revista CENIC Ciencias Biológicas holder: Centro Nacional de Investigaciones Cientificas dt: @attributes: year: 2025 holdings: @attributes: islocal: N |
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