Dipartimento di Scienza e Tecnologia del Farmaco

Descrizione del progetto

Members of other units:
Dr. M. Giaccone (Dip. Scienze della Sanità Pubblica e Pediatriche)
Dr. G. Imperiale (Scuola di Medicina)
Dr. S. Rosso (Dip. Scienze Mediche)
General Practitioners of the Province of Turin

Partners:
Order of Pharmacists of Turin, Italy
Local Health Authority ASL-TO2
SSD Medicina Interna, Ospedale Evangelico Valdese, Torino
Centro di Riferimento Regionale per l’Epidemiologia e la Prevenzione dei Tumori, Struttura Complessa Epidemiologia dei Tumori D.O., Registro Tumori Piemonte

Description

This study, which full title is “valutazione dell’attività ipocolesterolemizzante di un preparato galenico assimilabile ad un integratore alimentare contenente monacolina k e policosanoli in soggetti con ipercolesterolemia lieve-moderata non complicata non familiare”, started in 2010. It’s a phase II randomized double-blind controlled clinical trial.

The yeast Monascus purpureus, as a result of fermentation on rice, produces metabolically active components known as monacolins, the most representative one is the monacolin k, equipped with high affinity towards the enzyme HMG-CoA reductase. Meanwhile in literature it is widely reported as treatment with policosanol allows a reduction in blood of cholesterol (LDL/tot), triglycerides and, on the other hand, an increased level of HDL. Given these circumstances and considering the fact that the action of fermented rice by Monascus purpureus is given by a set of factors not strictly related to monacolin k itself, the objective of the MONAPOL clinical trial is to verify the profiles of effectiveness and tolerability of a galenic comparable to a dietary supplement containing a dry extract of red rice fermented by Monascus purpureus associated with another one titrated in policosanol. The study is aimed, in a period of 3 months, for a representative cohort of 210 subjects presenting mild to moderate hypercholesterolemia uncomplicated non-familiar (subjects currently outside indication comparing to the start of treatment with inhibitors of HMG-CoA reductase). At the Faculty of Pharmacy of University of Turin, the study of the formulation, the verification of stability of molecules present in the galenic and the preparation thereof, were conducted. Galenics present advantages such as the ability to use specific ingredients in order, firstly not to incur in dietary intolerances, secondly the possibility to select the source of supply that best ensures the high quality of raw materials.

The analytical HPLC method necessary for the evaluation of the plasmatic concentration of monacolin k, already on going for enrolled patients, was set up. The benefit derived from treatment is considered as both absolute and percentage reduction compared to levels resulting in hematic withdrawal before the start of the study, of lipid metabolic disorder pathologies indexes; blood analysis of subjects were performed both by venipuncture and self-diagnostics device. Considering the new regulations on “Services Pharmacy” it seems appropriate and relevant to assess the reliability of self-diagnostics tools comparing the results obtained with those ones resulting from analyses carried out in authorized laboratories.

Keywords:
Galenics, Dietary supplements , Monascus purpureus, Monacolin k, Cholesterol-lowering activity, Policosanol