Natural products to lower cholesterol

INTERVENTION: Randomsied, double‐blind, placebo controlled trial. Three interventional arms and 1 placebo/comparator arm. Participants are randomised to one treatment arm only and study is parallel in design. Arm 1: Ezetrol 10mg taken once daily for 8 weeks via oral tablet + Nutraceutical Placebo once daily for 8 weeks via oral tablets. Arm 2: Nutraceutical containing: 500mg Berberine (berberine hydrochloride) + 200mg Red Yeast Rice (equivalent to 3mg Monacolin K) + 2g Plant Sterols taken once daily for 8 weeks via oral tablets + Ezetrol Placebo taken once daily for 8 weeks via oral tablet Arm 3: Ezetrol 10mg taken once daily for 8 weeks via oral tablet + Nutraceutical containing: 500mg Berberine (berberine hydrochloride) + 200mg Red Yeast Rice (equivalent to 3mg Monacolin K) + 2g Plant Sterols taken once daily for 8 weeks via oral tablets Arm 4: Ezetrol Placebo taken once daily for 8 weeks via oral tablet + Nutraceutical Placebo taken once daily for 8 weeks via oral tablets For additional notes on placebo tablets, please see section below. Compliance will be monitored via drug tablet return. CONDITION: cardiovascular disease hyperlipidemia statin intolerance PRIMARY OUTCOME: Change in lipid profile (total cholesterol, low‐density lipoprotein (LDL) cholesterol, high‐density lipoprotein (HDL) cholesterol and triglycerides) as assessed via fasting blood sample following a 12 hour fast. SECONDARY OUTCOME: Development of side effects as assessed by plasma creatinine kinase measures as an indication of myopathy. Perceived quality of life as assessed by the validated EQUAL quality of life questionnaire. INCLUSION CRITERIA: Patients who are intolerant to statins and not currently achieving lipid targets (fasting LDL‐c >1.8 mmol/L and <7 mmol/L). Statin intolerance will be defined as an inability to tolerate 2 or more statins, one at a low dose, due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued. Low dose statin therapy is defined as an average daily dose of rosuvastatin 5mg, atorvastatin 10mg, simvastatin 10mg, lovastatin 20mg, pravastatin 40mg, fluvastatin 40mg or pitavastatin 2mg. Patients tolerating very low dose statin therapy (rosuvastatin <5mg, atorvastatin <10mg, simvastatin <10mg, lovastatin <20mg, pravastatin <40mg, fluvastatin <40mg or pitavastatin <2mg) are considered to be intolerant to that low dose statin.