Does EFSA statement on Monacolin content of nutraceutical combinations impair their lipid lowering effect? The LopiGLIK experience

Clin Diabetes Endocrinol. 2024 Nov 30;10(1):38. doi: 10.1186/s40842-024-00204-6.

Abstract

Background: Monacolin-K, the active component of red yeast rice (RYR), reduces cholesterol by inhibiting HMG-CoA reductase. Following safety concerns, the European Food Safety Authority (EFSA) recommended limiting Monacolin-K intake to less than 3 mg/day due to adverse effects at higher doses.

Case presentation: A study comparing Armolipid Plus® and LopiGLIK® found LopiGLIK® more effective in lowering LDL cholesterol, possibly due to slightly higher dosages of Berberine and Monacolin-K. Despite reducing Monacolin-K content to 2.99 mg following EFSA guidelines, LopiGLIK® maintained its cholesterol-lowering efficacy.

Conclusions: Taken together, our results indicate that other ingredients, such as Morus alba, may contribute to LopiGLIK®'s enhanced effectiveness, challenging the notion that minor differences in Monacolin-K dosage account for the observed efficacy.

Keywords: LDL cholesterol; Monacolin-K; Morus alba; Nuraceuticals; Red Yeast Rice (RYR).