Affiliations: [a] GC Descovich Atherosclerosis and Metabolic Disease Study Center; Alma Mater Studiorum, University of Bologna, Bologna, Italy | [b] Medical Department, Rottapharm|Madaus SpA, Monza, Italy | [c] Atherosclerosis and Metabolic Diseases Research Unit, Internal Medicine, Aging and Kidney diseases Department, Sant'Orsola-Malpighi Hospital, University of Bologna, Poliambulatorio Pad. 2-Via Albertoni, 15-40138 Bologna, Italy. e-mail: firstname.lastname@example.org
Abstract: To verify the efficacy of a patented proprietary combination of nutraceuticals containing natural hypocholesterolemic and antioxidant agents as red yeast rice extract, policosanols, coenzyme Q10, astaxanthin, and folic acid in the following subgroups of hyperlipidemic subjects: fertile (F) versus menopause (M) women, adults versus elderly (>65 years), lunch versus dinner administration time. A randomised, multicenter study in 411 Italians units compared Armolipid-Rottapharm|Madaus (ARM) one tablet/day plus diet versus diet alone (D) for 16 weeks in hyperlipidemic patients [serum total cholesterol (tot-C) >200 mg/dL or LDL-cholesterol (LDL-C) >150 mg/dL at admission]. Efficacy parameters were measured at baseline and every 4 weeks. In 2,408 eligible subjects, 1,665 adults and 743 elderly, total and LDL-cholesterol were likewise reduced by ARM + D in both age classes and significantly versus D. In 1,246 cases, 302 F and 946 M, tot-C gradually and significantly decreased up to 18.7 and 16.8% in F and M treated groups versus 9% in D group. Similar reduction was observed in LDL-C. In 907 cases, the time of administration of ARM was detailed: 733 received ARM + D at dinner and 174 at lunch. Cholesterolemia improved equally in the two groups. The association of ARM with an appropriate diet is more effective than diet alone in reducing abnormal cholesterolemia, independently from age classes and administration time during the day, supporting its positive use for controlling hypercholesterolemia with a positive impact on CHD prevention in all categories of subjects.
Keywords: Lipid-lowering agents, Red yeast rice, Diet, Menopause, Elderly, Administration time