title: Combined treatment with Dif1stat and diet reduce plasma lipid indicators of moderate hypercholesterolemia more effectively than diet alone: a randomized trial in parallel groups.
abstract: An open-labeled randomized trial with parallel groups was carried out to study the effects of Dif1stat (Monascus purpureus-Linear aliphatic alcohols-Niacin) in the treatment of primary moderate hypercholesterolemia. The trial lasted 8 months. The patients, males and females, were assigned to two groups: A (#130), treated with diet, and B (#110) submitted to diet + Dif1stat. After 4 months, group A did not show significant changes in Total cholesterol (TC), LDL-cholesterol (LDLC), HDL-cholesterol (HDLC) or non-HDL-cholesterol (non-HDLC). The same group, showed a reduction in TC (-22%), LDLC (-30%) and non-HDLC (-27%) after 8 months (P < or = 0.001). After 4 months, TC (-21.3%), LDLC (-29%), and non-HDLC (-26%) were significantly lowered in group B (P < or = 0.001). In group B, TC, LDLC and non-HDLC showed a further reduction after 8 months: -29.4, -38 and -37%, respectively (P < or = 0.001). Even triglycerides (TG) decreased significantly (-33%) (P < or = 0.001). After 8 months, group B showed a significant reduction of TG (-33%) (P < or = 0.001), when compared to group A. Some safety parameters were significantly reduced in both groups: AST and gamma-GT in group A after 4 and 8 months, as well as ALT, AST and gamma-GT in group B after 8 months (P < or = 0.001). Dif1stat, given with a suitable diet, was well tolerated in the long-term and induced an anti-atherogenic plasma lipid and lipoprotein profile, in patients with moderate hypercholesterolemia.
authors.affiliation: Clinical and Medical Therapy Department, Umberto I Hospital Rome I-EU, University of Rome La Sapienza, Rome, Italy. plasmaferesi@tin.it
authors.forename: Claudia
authors.initials: C
authors.lastname: Stefanutti
authors.forename: Fabio
authors.initials: F
authors.lastname: Mazza
authors.forename: Antonio
authors.initials: A
authors.lastname: Vivenzio
authors.forename: Serafina
authors.initials: S
authors.lastname: Di Giacomo
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Perrone
authors.forename: Mariarosaria
authors.initials: M
authors.lastname: Serra
authors.forename: Antonello
authors.initials: A
authors.lastname: Bucci
mesh_terms: D000284:Administration, Oral; D015992:Body Mass Index; D004032:Diet; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000627:therapeutic use*
chemical_list: D000960:Hypolipidemic Agents; D008055:Lipids; D009525:Niacin