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Combined Treatment with Dif1stat® and Diet Reduce Plasma Lipid Indicators of Moderate Hypercholesterolemia More Effectively than Diet Alone: A Randomized Trial in Parallel Groups

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Lipids

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 ≤ 0.001). After 4 months, TC (–21.3%), LDLC (–29%), and non-HDLC (–26%) were significantly lowered in group B (P ≤ 0.001). In group B, TC, LDLC and non-HDLC showed a further reduction after 8 months: –29.4, –38 and –37%, respectively (P ≤ 0.001). Even triglycerides (TG) decreased significantly (–33%) (P ≤ 0.001). After 8 months, group B showed a significant reduction of TG (–33%) (P ≤ 0.001), when compared to group A. Some safety parameters were significantly reduced in both groups: AST and γ-GT in group A after 4 and 8 months, as well as ALT, AST and γ-GT in group B after 8 months (P ≤ 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.

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Abbreviations

LAAs:

Linear aliphatic alcohols

MP:

Monascus purpureus

N:

Niacin

TC:

Total cholesterol

LDLC:

LDL-cholesterol

HDLC:

HDL-cholesterol

non-HDLC:

non-HDL-cholesterol

TG:

Triglycerides

ATPIII:

Adult treatment panel III

BMI:

Body mass index

Lp(a):

lipoprotein (a)

CYP3A4:

Cytochrome P450 3A4

ALT:

Alanine aminotransferase

AST:

Aspartate aminotransferase

γGT:

Gamma-glutamyl-transpeptidase

CK:

Creatine kinase

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Conflict of interest statement

The author(s) certify that they have no affiliation with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in this manuscript.

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Authors and Affiliations

  1. Clinical and Medical Therapy Department, ‘Umberto I’ Hospital Rome I-EU, University of Rome ‘La Sapienza’, Rome, Italy

    Claudia Stefanutti, Fabio Mazza, Antonio Vivenzio, Serafina Di Giacomo, Giuseppina Perrone, Mariarosaria Serra & Antonello Bucci

  2. Department of Obstetrics and Gynecology, ‘Umberto I’ Hospital Rome I-EU, University of Rome ‘La Sapienza’, Rome, Italy

    Giuseppina Perrone

Authors
  1. Claudia Stefanutti
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  2. Fabio Mazza
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  3. Antonio Vivenzio
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  4. Serafina Di Giacomo
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  6. Mariarosaria Serra
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  7. Antonello Bucci
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Correspondence to Claudia Stefanutti.

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Stefanutti, C., Mazza, F., Vivenzio, A. et al. Combined Treatment with Dif1stat® and Diet Reduce Plasma Lipid Indicators of Moderate Hypercholesterolemia More Effectively than Diet Alone: A Randomized Trial in Parallel Groups. Lipids 44, 1141–1148 (2009). https://doi.org/10.1007/s11745-009-3368-5

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  • DOI: https://doi.org/10.1007/s11745-009-3368-5

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