title: Usefulness of Nutraceuticals (Armolipid Plus) Versus Ezetimibe and Combination in Statin-Intolerant Patients With Dyslipidemia With Coronary Heart Disease.
abstract: Statins are extensively used to treat dyslipidemia, but, because of their low tolerability profile, they are discontinued in a significant proportion of patients. Ezetimibe and nutraceuticals have been introduced as alternative therapies and have proved to be effective and well tolerated. A single-blind, single-center, randomized, prospective, and parallel group trial comparing a combination of nutraceuticals (red yeast rice, policosanol, berberine, folic acid, coenzyme Q10 and astaxanthin), called Armolipid Plus, and ezetimibe for 3 months in terms of efficacy and tolerability. Patients who did not achieve their therapeutic target (low-density lipoprotein cholesterol <100 mg/dl) could add the alternative treatment on top of randomized treatment for another 12 months: 100 patients who are dyslipidemic with ischemic heart disease treated with percutaneous coronary intervention were enrolled (ezetimibe n = 50, nutraceutical n = 50). Efficacy (lipid profile) and tolerability (adverse events, transaminases, and creatine kinase) were assessed after 3 and 12 months. After 3 months, 14 patients in the nutraceutical group achieved their therapeutic target, whereas none of the patients in the ezetimibe group did. At 1-year follow-up, 58 patients (72.5%) of the combined therapy group (n = 86) and 14 (100%) of the nutraceutical group reached the therapeutic goal. No patients experienced important undesirable effects. In conclusion, nutraceuticals alone or in combination with ezetimibe are well tolerated and improve the lipid profile in statin-intolerant patients with coronary heart disease. Further studies are needed to assess long-term effects of nutraceuticals on mortality.
authors.affiliation: Istituto di Ricerca a Carattere Scientifico (IRCCS) San Raffaele Pisana, Rome, Italy. Electronic address: giuseppe.marazzi@sanraffaele.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Marazzi
authors.affiliation: Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pelliccia
authors.affiliation: Istituto di Ricerca a Carattere Scientifico (IRCCS) San Raffaele Pisana, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Campolongo
authors.affiliation: Istituto di Ricerca a Carattere Scientifico (IRCCS) San Raffaele Pisana, Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Quattrino
authors.affiliation: Institute of Cardiology, Madre Giuseppina Vannini Hospital, Rome, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Cacciotti
authors.affiliation: Istituto di Ricerca a Carattere Scientifico (IRCCS) San Raffaele Pisana, Rome, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Volterrani
authors.affiliation: Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Gaudio
authors.affiliation: Istituto di Ricerca a Carattere Scientifico (IRCCS) San Raffaele Pisana, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rosano
mesh_terms: D002784:Cholesterol / Q000097:blood; D003324:Coronary Artery Disease / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D019587:Dietary Supplements; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D000069438:Ezetimibe / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D002784:Cholesterol; D000069438:Ezetimibe