The Reduction of Monacolin K Dosage From 10 to 2.9 Mg Results in a Loss of Effectiveness of the Lipid-Lowering Therapy

Objective: Nutraceuticals can be a valid therapeutic alternative in certain classes of patients. Since June 2023, European Union has mandated a reduction in the dosage of monacolin (<3 mg/day). There is currently no literature data regarding maintenance of therapeutic effectiveness on LDL levels with this dosage. Design and method: We evaluated efficacy [percentage reduction in LDL and percentage of achieving the therapeutic goal (<100 mg/dl) of a nutraceutical containing 2.9 mg of monacolin K (MK) in patients with moderate cardiovascular risk (SCORE >0.9 <5% at 10 years)], who were unwilling to take statins, compared to treatment with nutraceutical containing 10 mg. We evaluated 55 patients (35 females) consecutively attending outpatient clinic for dyslipidemia. All patients had been under treatment, for at least nine months (average 14.4±4.8 months), with a nutraceutical containing 10 mg of MK (Colenorm Plus®) and, since June 2022, they started taking nutraceutical containing 2.9 mg of MK. Before any lipid-lowering treatment, the values were: mean age 62.2±8.5 years, BMI 25.5±0.7, TC 202.6±29.3, HDL 53.2±10.7, LDL 125.4±31.7, TG 123±39.2. Results: At baseline: BMI 26.7±3.7, TC 167.5±37.2, HDL 50.9±13.4, LDL 92.4±37.5 (-26% compared to no therapy), TG 120.3±59.7. The 63.64% of patients reached target <100 mg/dl. Six weeks after starting new therapy: BMI 26.9±3.5, TC 185.5±43.4, HDL 52.4±10.1, LDL 111.5±33.8, TG 126.5±31.8. LDL values decreased by 11.2% compared to no therapy but increased by 20.7% compared to 10 mg. Patients reaching the goal decreased to 27.27%. Conclusions: Reduction of MK to 2.9 mg results in a significant lost in the efficacy on LDL levels and the achievement of the therapeutic goal compared to 10 mg. A new strategy for lipid-lowering nutraceuticals, based on the combination of 2.9 mg of MK with other lipid-lowering molecules, is necessary to achieve a good therapeutic response.