Combined Effects of Bioactive Compounds in Lipid Profile

Launched by ROTTAPHARM SPAIN · Mar 22, 2012

Keywords

ClinConnect Summary

Recently reported that the combination of extract of red yeast rice policosanol composed, berberine, folic acid and coenzyme Q10 (Armolipid Plus ®, Rottapharm) produced a significant improvement in lipid profile in patients with moderately elevated cholesterol levels of low density lipoprotein (LDL-C) plasma.

Taking into account the potential effect of Armolipid Plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients \> 18 years old
• • LDL-c plasma levels ≥130 mg/dL and ≤ 189 mg/dL
• • Patients not requiring lipid-lowering drug treatment according to ATPIII guidelines,that do not have cardiovascular disease, stroke or intermittent claudication, diabetes mellitus, renal or Patients who have demonstrated effects or contraindications to lipid-lowering drug therapy (in this case, treatment should be discontinued 1 month before baseline.
• • Signed and dated informed consent before any study specific procedure.
• Exclusion Criteria:
• • Patients on drug therapy to reduce LDL-C, for example, statins, bile acid sequestrants, nicotinic acid, fibrates or similar (up to 1 month before baseline).
• • History of cardiovascular disease, stroke or intermittent claudication.
• • Diabetes mellitus (at least 2 blood fasting glucose greater than 126 mg / dL).
• • Having taken any functional food with sterols, stanols or similar or any nutraceutical with lipid-lowering effects during the previous 7 days.
• • Plasma levels of triglycerides \> 350 mg/dl
• • Diagnosis of familial hypercholesterolemia