Recently, concerns regarding the safety of red yeast rice (RYR) have been raised after the publication of some case reports claiming toxicity. Since the previous meta-analyses on the effects of RYR were mainly focused on its efficacy to improve lipid profile and other cardiovascular parameters, we carried out a meta-analysis on safety data derived from the available randomized controlled clinical trials (RCTs). Primary outcomes were musculoskeletal disorders (MuD). Secondary outcomes were non-musculoskeletal adverse events (Non-MuD) and serious adverse events (SAE). Subgroups analyses were carried out considering the intervention (RYR alone or in association with other nutraceutical compounds), monacolin K administered daily dose (≤3, 3.1-5 or >5 mg/day), follow-up (>12 or ≤12 weeks), with statin therapy or statin-intolerance and type of control treatment (placebo or statin treatment). Data were pooled from 53 RCTs comprising 112 treatment arms, which included 8535 subjects, with 4437 in the RYR arm and 4303 in the control one. Monacolin K administration was not associated with increased risk of MuD (odds ratio (OR) = 0.94, 95% confidence interval (CI) 0.53,1.65). Moreover, we showed reduced risk of Non-MuD (OR = 0.59, 95%CI 0.50, 0.69) and SAE (OR = 0.54, 95%CI 0.46, 0.64) vs. control. Subgroups analyses confirmed the high tolerability profile of RYR. Furthermore, increasing daily doses of monacolin K were negatively associated with increasing risk of Non-MuD (slope: -0.10; 95%CI: -0.17, -0.03; two-tailed p < 0.01). Based on our data, RYR use as lipid-lowering dietary supplement seems to be overall tolerable and safe in a large kind of moderately hypercolesterolaemic subjects.

1st Department of Internal Medicine Faculty of Medicine Pavol Jozef Safarik University Košice Slovakia

3rd Department of Internal Medicine 1st Medical Faculty Charles University Prague Czech Republic

Biomedical Department of Internal Medicine and Medical Specialties University of Palermo Palermo Italy

Biotechnology Research Center Pharmaceutical Technology Institute Mashhad University of Medical Sciences Mashhad Iran; Neurogenic Inflammation Research Center Mashhad University of Medical Sciences Mashhad Iran

Cardiometabolic Service Department of Cardiology Royal Perth Hospital School of Medicine University of Western Australia Perth Western Australia Australia

Department of Clinical Biochemistry Royal Free Campus University College London Medical School University College London London UK

Department of Hypertension Chair of Nephrology and Hypertension Medical University of Lodz Poland; Polish Mother's Memorial Hospital Research Institute Lodz Poland; Cardiovascular Research Centre University of Zielona Gora Zielona Gora Poland

Department of Medicine and Surgery Sciences University of Bologna Bologna Italy

Department of Medicine Division of Cardiology University of British Columbia Vancouver British Columbia Canada

Dyslipidaemia Department Institute of Cardiology AMS of Ukraine Ukraine

Institute of Cardiometabolism and Nutrition Endocrinology Department Hopital Pitié Salpetrière Paris France

Preventive Cardiology Unit Department of Vascular Medicine Division of Internal Medicine University Medical Centre Ljubljana Slovenia

The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease Baltimore MD USA; Preventive Cardiology CGH Medical Center Sterling IL USA

University Hospital Centre Zagreb School of Medicine University of Zagreb Department of Internal Medicine Zagreb Croatia

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