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Clinical role of a fixed combination of standardized Berberis aristata and Silybum marianum extracts in diabetic and hypercholesterolemic patients intolerant to statins

Authors Di Pierro F, Bellone I, Rapacioli G, Putignano P

Received 8 December 2014

Accepted for publication 30 December 2014

Published 4 February 2015 Volume 2015:8 Pages 89—96


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Professor Ming-Hui Zou

Francesco Di Pierro,1 Iaele Bellone,2 Giuliana Rapacioli,3 Pietro Putignano4

1Scientific Department, Velleja Research, Milan, Italy; 2ASL TO1, Turin, Italy; 3AIOR, Pontenure, Province of Piacenza, Italy; 4University Hospital San Gerardo, Monza, Italy

Background: Statin intolerance is a medical condition often leading patients to nonadherence to the prescribed therapy or to a relevant reduction of the statin dosage. Both situations determine a totally or partially uncontrolled lipid profile, and these conditions unquestionably increase the risk of cardiovascular events.
Methods: We enrolled hypercholesterolemic, type 2 diabetic patients complaining of intolerance to statins. Some of them had reduced the statin dose ‘until the disappearance of symptoms’; others had opted for treatment with ezetimibe; and yet others were not undergoing any treatment at all. All patients of the three groups were then given a fixed combination of berberine and silymarin (Berberol®), known from previous papers to be able to control both lipidic and glycemic profiles.
Results: The tested product both as a single therapy and as add-on therapy to low-dose statin or to ezetimibe reduced triglycerides, low-density lipoprotein cholesterol, fasting blood glucose, and glycosylated hemoglobin in a significant manner without inducing toxicity conditions that might be somehow ascribed to a statin-intolerant condition.
Conclusion: Our study demonstrates that use of Berberol®, administered as a single or add-on therapy in statin-intolerant subjects affected by diabetes and hypercholesterolemia is a safe and effective tool capable of improving the patients' lipidic and glycemic profiles.

Keywords: berberine, silymarin, Berberol®, ezetimibe, cholesterol, type 2 diabetes

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