ORIGINAL ARTICLE Efficacy of a red yeast rice based nutraceutical in large subgroups of hypercholesterolemic subjects in every day clinical practice A. F. G. Cicero • C. Benvenuti • ARMoweb study Group Received: 24 November 2009 / Accepted: 1 September 2010 Ó Springer-Verlag 2010 Abstract To verify the efficacy of a patented proprietary combination of nutraceuticals containing natural hypo- cholesterolemic and antioxidant agents as red yeast rice extract, policosanols, coenzyme Q 10 , 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, inde- pendently from age classes and administration time during the day, supporting its positive use for controlling hyper- cholesterolemia with a positive impact on CHD prevention in all categories of subjects. Keywords Lipid-lowering agents Á Red yeast rice Á Diet Á Menopause Á Elderly Á Administration time Introduction Lowering of low-density lipoprotein cholesterol (LDL-C) is clearly efficacious in the primary and secondary pre- vention of coronary artery disease and cerebrovascular disease [1], and pharmacologic therapy for treating dyslipidemias has always to be preceded by and parallel to changes in life-style and diet [2]. An increasing attention is now paid to the use of nutraceuticals in correcting dyslipidemias. An effective combination, dietetic recommendations and natural hypo- cholesterolemic principles could delay the turn to a pow- erful pharmacological therapy, thereby minimizing the adverse reaction risk, or represent an alternative treatment in hypolipemics intolerant patients [3]. A large number of nutraceutical are currently available in the market claiming an antihypercholesterolemic effect, but the pitfalls hidden in this selection are given first by the absence of guarantees on good manufacturing procedures, The members of the ARMoweb study group are mentioned in ‘‘Appendix’’. A. F. G. Cicero GC Descovich Atherosclerosis and Metabolic Disease Study Center; Alma Mater Studiorum, University of Bologna, Bologna, Italy C. Benvenuti Medical Department, Rottapharm|Madaus SpA, Monza, Italy A. F. G. Cicero (&) 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: afgcicero@cardionet.it 123 Mediterr J Nutr Metab DOI 10.1007/s12349-010-0028-5 (2010)3:239-246