Endocrine Abstracts

Objectives: Main: To assess the effect on the 10-year risk of cardiovascular events (RCVE) of daily supplementation with a fixed combination of red yeast rice extract (250 mg), berberin 525 mg and coenzyme Q₁₀ (50 mg) in patients with self-reported statin intolerance. Secondary: effects on anthropometric (BMI, SBP, DBP, HR) and laboratory (lipids, fasting glucose and HbA_1C in diabetic patients, eGFR, AST, ALT, GGT, CK); self-reported compliance and tolerance.

Methods: We recruited 30–75 year-old patients with LDL-cholesterol >130 mg/dl and triglycerides <300 mg/dl, without established coronary heart disease, cerebrovascular disease or heart failure, who had withdrawn statin therapy due to self-reported intolerance, without evidence of myolysis or hepatotoxicity. Data were obtained initially (>2 months after statin withdrawal) and after 3 months of therapy with the supplement. The study was open and uncontrolled. RCVE was estimated by the ASCVD Risk Estimator (AHA-ACC 2013). Statistical analysis were made with Kruskall-Wallis’ H-test and Student’s T-test.

Results: 24 patients were recruited (age 59.2±11.6, 17 women, 8 diabetic). 21 patients (87.5%) had adequate compliance (>80%). No adverse effects were attributed to the supplement, and in no case AST, ALT or CK were >3xUNL.

RCVE: 12.4%→9.3% (−25%, P=0.0071).

LDL-cholesterol (mg/dL): 166.3±31.2→131.4±22.7 (−21%, P<0.0001).

Total cholesterol (mg/dL): 248.6±48.4→212.1±39.2 (−15%, P=0.0077).

HDL-cholesterol (mg/dL): 41.4±8.3→43.1±9.2

Triglycerides (mg/dL): 204.5±69.8→188.0±73.1

AST (U/L): 39.7±11.7→33.9±9.7

ALT (U/L): 36.4±8.8→32.7±9.2

GGT (U/L): 67.6±18.7→63.4±17.6

CK (U/L): 87.4±16.8→88.3±15.7

BMI (kg/m²): 29.6±5.2→28.9±4.7

SBP (mmHg): 144±11→141±10

DBP (mmHg): 83±9→80±7

HR (lpm): 78±8→77±8

Fasting glucose (mg/dL) in diabetic patients: 139±21→132±17

HbA_1C (%) in diabetic patients: 7.3±1.2→6.9±1.0

CKD-EPI eGFR (ml/min/1.73m²): 68.5±11.3→69.7±11.0

Conclusions: The supplement was well tolerated in this group of hypercholesterolemic patients with self-diagnosed statin intolerance (without evidence of myopathy or liver disease); after 3 months the patients had marked reductions in total and LDL-cholesterol. and their RCVE was significantly reduced.