Mixed Hyperlipidemia
Conditions
Interventions
Experimental Group:Atorvastatin: Take orally once a day, 10-40mg per day
? -3 Fatty Acid Ethyl Ester 90 Soft Capsules: Take 2 capsules orally each time, twice a day or 4 capsules each time, once a day, with meals or after meals.
Conventional starting dose of atorvastatin:
Control Group:Atorvastatin: Take orally once a day, 10-40mg per day
Fenofibrate Capsules: 200mg per day (with a 12-hour interval from statins. It is recommended to take fibrates in the morning and statins before going to bed).
Sponsors
Beiing Anzhen Hospital. Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for the study, patients had to meet all of the following eligibility criteria: 1. Age >=18 years old; 2. Have the ability to sign the informed consent form, voluntarily participate in this study, and have good compliance; 3. Participants receiving treatment for mixed hyperlipidemia according to local guidelines (including appropriate diet, exercise, or medical therapy) with baseline fasting serum triglyceride levels >200 mg/dL and <2000 mg/dL(2.26 mmol/L <= fasting TG < 22.60 mmol/L); 4. If they had been receiving a statin, they should have been receiving stable therapy (without a new or changed active ingredient or change in treatment dose) for at least 3 months before enrollment. 5. Any circumstances in which the patient was judged by the investigator to be suitable for enrollment.
Exclusion criteria
Exclusion criteria: Patients with any of the following were not eligible for the study: 1. Subjects with known allergies to fish or shellfish, or to the active ingredients ?-3 fatty acids, fish oil; 2. For the disease is receiving niacin and its derivatives, cholesterol absorption inhibitor drugs and other treatment without stopping the drug; 3. Patients who are participating in other intervention studies; 4. Women with confirmed pregnancy or lactation; 5. Conditions with a known increased risk of bleeding, such as recent surgery or gastrointestinal bleeding disorders; 6. Major liver disease detected at visit 1 (screening) (ALT and AST measured at the central laboratory were twice the upper limit of normal); 7. Bleeding creatinine > 176 µmol/L at the first visit (screening); 8, platelet count =160mmHg or diastolic blood pressure >=100mmHg in sitting position at rest); 10. Those who had undergone major surgery within 3 months before the screening period, had major trauma, or needed major surgery during the trial (planned elective surgery); 11. A history of drug abuse or excessive alcohol consumption (> 2 drinks/day: 1 drink = 340g beer, 142g red wine or 42.5g white wine) within 1 year before the start of the screening period; 12. According to the investigator's judgment, those who have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or those who are considered to be unsuitable for enrollment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Triglyceride; | — |
Secondary
| Measure | Time frame |
|---|---|
| High-Density Lipoprotein Cholesterol;Low-Density Lipoprotein Cholesterol;Low-Density Lipoprotein Cholesterol;Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol Ratio;Creatine Kinase;Adverse Raction;Evaluation of Health Economics; | — |
Countries
China
Contacts
Public ContactYang Lin
Beiing Anzhen Hospital. Capital Medical University
Outcome results
None listed