The Therapeutic Effects of Statins and Berberine on the Hyperlipemia

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Statins are cholesterol-lowering medications that are often prescribed for patients with high cholesterol and who are at risk for cardiovascular disease (CVD). But there are many patients whose hyperlipemia are not well controlled. If investigators are simply doubling the statins, that only 6% of the benefit can be received. And it often has significant side effects in elder patients. Several studies have suggested that the use of berberine can effectively lower blood lipids. The chemical structure and mechanisms of drug is clearly, and the side effects are seldom, the price of berberine is very cheap. The purpose of this study is to observe the therapeutic effects of combination of statins and berberine on the patients with hyperlipemia whose level of the lipid are not well controlled when only using statins.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wenzhou Medical University
• Treatments: Atorvastatin; Atorvastatin Calcium; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Current use of lipid-lowering medications;

2. Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization [percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)] and other arterial revascularization procedures, ischaemic stroke, peripheral arterial disease(PAD);

3. Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria); Patients with moderate to severe chronic kidney disease [glomerular filtration rate (GFR) < 60 mL/min/1.73㎡];

4. Markedly elevated single risk factors such as familial dyslipidaemias and severe hypertension;

5. A calculated SCORE ≥1% for 10 year risk of fatal CVD

Exclusion Criteria:

1. Cancer;

2. HIV infected;

3. Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis);

4. Active liver disease or unexplained persistent elevated transaminase levels；

5. Major surgery or hospitalization in the 3 months prior to study entry;

6. Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole" antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or protease inhibitors;

7. Female of childbearing potential;

8. Severe gastrointestinal disease;

9. With berberine using contraindications;

10. Secondary hyperlipidemia

11. Current participation in another clinical trial