Efficacy and Safety of Armolipid Plus®: An Updated PRISMA Compliant Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials

Nutrients
Q1
Feb 2021
Citations:16
Influential Citations:0
Systematic Reviews / Meta-Analyses
62
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Methods
Systematic review and meta-analysis of randomized, blinded, controlled trials in adults. Participants included individuals in primary prevention for CVD, those with documented coronary artery disease, individuals with metabolic syndrome, or generally healthy. Trials were parallel-group and multicenter or single-center.
Intervention
Armolipid Plus: red yeast rice extract 200 mg (monacolin K 3 mg) + policosanols 10 mg + berberine 500 mg + folic acid 0.2 mg + astaxanthin 0.5 mg + coenzyme Q10 2 mg; taken as a daily dietary supplement; duration varied by trial (follow-up 4 weeks to 12 months).
Results
Armolipid Plus significantly improved lipid and metabolic markers: total cholesterol −25.07 mg/dL; LDL-C −26.67 mg/dL; triglycerides −11.47 mg/dL; HDL-C +1.84 mg/dL; fasting plasma glucose −3.52 mg/dL; hs-CRP −0.61 mg/L; BMI −0.25 kg/m^2. No meaningful changes in weight, waist circumference, systolic/diastolic blood pressure, fasting insulin, or HOMA-IR. ALT rose modestly by +2.16 U/L; AST and CPK largely unchanged; no increased risk of musculoskeletal or gastrointestinal adverse events. Conclusion: When added to lifestyle modifications, Armolipid Plus can improve cardiometabolic risk markers with a favorable safety profile; direct cardiovascular outcomes require further long-term trials.
Limitations
Heterogeneity in TC and LDL-C effects (high I2); many eligible trials were excluded due to strict criteria; some outcomes had small sample sizes and limited power; follow-up durations varied across studies.

Abstract

Armolipid Plus® is a multi-constituent nutraceutical that claims to improve lipid profiles. The aim of this PRISMA compliant systematic review and meta-analysis was to globally evaluate the efficacy and safety of Armolipid Plus® on the basis of the a...