Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia

Francesco Di Pierro,1 Pietro Putignano,2 Tarcisio Ferrara,3 Carmela Raiola,4 Giuliana Rapacioli,5 Nicola Villanova6 1Scientific Department, Velleja Research, Milan, Italy; 2Outpatient Diabetic Clinic, University Hospital San Gerardo, Monza, Italy; 3District 63, Cava de’ Tirreni-Costa d&...

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Autores principales: Di Pierro F, Putignano P, Ferrara T, Raiola C, Rapacioli G, Villanova N
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Publicado: Dove Medical Press 2016
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spelling oai:doaj.org-article:00dc716845f146ea9f628f35637121aa2021-12-02T04:02:55ZRetrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia1179-1438https://doaj.org/article/00dc716845f146ea9f628f35637121aa2016-12-01T00:00:00Zhttps://www.dovepress.com/retrospective-analysis-of-the-effects-of-a-highly-standardized-mixture-peer-reviewed-article-CPAAhttps://doaj.org/toc/1179-1438Francesco Di Pierro,1 Pietro Putignano,2 Tarcisio Ferrara,3 Carmela Raiola,4 Giuliana Rapacioli,5 Nicola Villanova6 1Scientific Department, Velleja Research, Milan, Italy; 2Outpatient Diabetic Clinic, University Hospital San Gerardo, Monza, Italy; 3District 63, Cava de’ Tirreni-Costa d’Amalfi, Salerno, Italy; 4Outpatient Clinic “Ordine di Malta”, Naples, Italy; 5AIOR, Piacenza, Italy; 6Metabolic Disorders, S. Orsola Malpighi Hospital, Bologna, Italy Background: Berberis aristata, because of its berberine content, and Monascus purpureus fermented rice, because of the presence of monacolins (naturally derived statins), are widely investigated food-grade ingredients used to formulate cholesterol-lowering supplements. Although they are extensively used, berberine is poorly absorbed and monacolins are poorly chemically characterized, not standardized, and possibly contaminated with toxic compounds. Silymarin is reported to enhance berberine absorption, while Monakopure™-K20 (MK-20) is a highly standardized red yeast rice containing monacolins K and KA in the ratio of 1:1 but not secondary monacolins, dehydromonacolins, or citrinin.Aim: The effects of a cholesterol-lowering supplement (Berberol®K) containing berberine, silymarin, and MK-20 (BSM) in patients with dyslipidemia were clinically analyzed.Methods: The clinical role of BSM in naïve and in statin-intolerant patients was retrospectively evaluated and the effects observed were compared with those obtained in patients without treatment or treated with lovastatin.Results: Total cholesterol, low density lipoprotein, and triglyceride levels were approximately 4%, 6%, and 11% lower, respectively, and the creatine phosphokinase increase was reduced in patients treated with BSM compared to those treated with lovastatin. Similar results were also obtained in statin-intolerant subjects where BSM was administered as add-on therapy to ezetimibe or fenofibrate. Conclusion: BSM is a food supplement potentially useful 1) as a primary intervention in low-cardiovascular-risk subjects with dyslipidemia; 2) as add-on therapy in mildly statin-intolerant patients; and 3) in dyslipidemic patients with a negative perception of statins who prefer a treatment seen as natural. Keywords: berberine, Berberol®K, silymarin, P-glycoprotein, cholesterol, triglycerides, Monascus purpureus, Monakopure™-K20Di Pierro FPutignano PFerrara TRaiola CRapacioli GVillanova NDove Medical PressarticleberberineBerberol®KsilymarinP-glycoproteincholesteroltriglyceridesMonascus purpureusMonakopure™-K20.Therapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol Volume 9, Pp 1-7 (2016)
institution DOAJ
collection DOAJ
language EN
topic berberine
Berberol®K
silymarin
P-glycoprotein
cholesterol
triglycerides
Monascus purpureus
Monakopure™-K20.
Therapeutics. Pharmacology
RM1-950
spellingShingle berberine
Berberol®K
silymarin
P-glycoprotein
cholesterol
triglycerides
Monascus purpureus
Monakopure™-K20.
Therapeutics. Pharmacology
RM1-950
Di Pierro F
Putignano P
Ferrara T
Raiola C
Rapacioli G
Villanova N
Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia
description Francesco Di Pierro,1 Pietro Putignano,2 Tarcisio Ferrara,3 Carmela Raiola,4 Giuliana Rapacioli,5 Nicola Villanova6 1Scientific Department, Velleja Research, Milan, Italy; 2Outpatient Diabetic Clinic, University Hospital San Gerardo, Monza, Italy; 3District 63, Cava de’ Tirreni-Costa d’Amalfi, Salerno, Italy; 4Outpatient Clinic “Ordine di Malta”, Naples, Italy; 5AIOR, Piacenza, Italy; 6Metabolic Disorders, S. Orsola Malpighi Hospital, Bologna, Italy Background: Berberis aristata, because of its berberine content, and Monascus purpureus fermented rice, because of the presence of monacolins (naturally derived statins), are widely investigated food-grade ingredients used to formulate cholesterol-lowering supplements. Although they are extensively used, berberine is poorly absorbed and monacolins are poorly chemically characterized, not standardized, and possibly contaminated with toxic compounds. Silymarin is reported to enhance berberine absorption, while Monakopure™-K20 (MK-20) is a highly standardized red yeast rice containing monacolins K and KA in the ratio of 1:1 but not secondary monacolins, dehydromonacolins, or citrinin.Aim: The effects of a cholesterol-lowering supplement (Berberol®K) containing berberine, silymarin, and MK-20 (BSM) in patients with dyslipidemia were clinically analyzed.Methods: The clinical role of BSM in naïve and in statin-intolerant patients was retrospectively evaluated and the effects observed were compared with those obtained in patients without treatment or treated with lovastatin.Results: Total cholesterol, low density lipoprotein, and triglyceride levels were approximately 4%, 6%, and 11% lower, respectively, and the creatine phosphokinase increase was reduced in patients treated with BSM compared to those treated with lovastatin. Similar results were also obtained in statin-intolerant subjects where BSM was administered as add-on therapy to ezetimibe or fenofibrate. Conclusion: BSM is a food supplement potentially useful 1) as a primary intervention in low-cardiovascular-risk subjects with dyslipidemia; 2) as add-on therapy in mildly statin-intolerant patients; and 3) in dyslipidemic patients with a negative perception of statins who prefer a treatment seen as natural. Keywords: berberine, Berberol®K, silymarin, P-glycoprotein, cholesterol, triglycerides, Monascus purpureus, Monakopure™-K20
format article
author Di Pierro F
Putignano P
Ferrara T
Raiola C
Rapacioli G
Villanova N
author_facet Di Pierro F
Putignano P
Ferrara T
Raiola C
Rapacioli G
Villanova N
author_sort Di Pierro F
title Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia
title_short Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia
title_full Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia
title_fullStr Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia
title_full_unstemmed Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia
title_sort retrospective analysis of the effects of a highly standardized mixture of berberis aristata, silybum marianum, and monacolins k and ka in patients with dyslipidemia
publisher Dove Medical Press
publishDate 2016
url https://doaj.org/article/00dc716845f146ea9f628f35637121aa
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