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The purpose of this study is to compare the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, in Chinese patients with moderate dyslipidemia.
Although lowering cholesterol and low-density lipoprotein-cholesterol (LDL-C) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentrations in the residual cardiovascular risk on statin treatment. Fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers TG and raises HDL-C through multifaceted mechanism by PPARα activation. However, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. Coenzyme A (CoA) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. Animal studies have proved its lipid-lowering effects. In a previous multicenter study we conducted in 2008, it was found that oral CoA 400U/d effectively lowered serum TG levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. So, the present study was performed to further investigate the lipid-lowing effects and safety of CoA capsule by comparing with fenofibrate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coenzyme A 400mg | Experimental | Coenzyme A 400mg per day |
|
| Fenofibrate 200mg | Active Comparator | Fenofibrate 200mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme A | Drug | Coenzyme A 400mg per day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| serum triglyceride level | The primary efficacy variable was the percentage change in serum lipid level from baseline to 4 and 8 weeks of treatment. | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| serum total cholesterol level | change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level. | 10 months |
| low-density lipoprotein cholesterol level | change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junzhu Chen | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D006951 | Hyperlipoproteinemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D003065 | Coenzyme A |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Fenofibrate 200mg | Drug | Fenofibrate 200mg per day |
|
|
| 10 months |
| serum high-density lipoprotein cholesterol level | change from baseline to 4 and 8 weeks of treatment in serum high-density lipoprotein cholesterol level. | 10 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |