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Statin therapy does not fully eliminate the cardiovascular disease (CVD) risk associated with low high density lipoprotein-C (HDL-C) and high triglyceride levels. It is currently unknown what would be the best treatment option for patients with mixed hyperlipidemia who fail to meet their lipid targets with statin monotherapy at conventional does, i.e. high dose rosuvastatin or conventional statin dose plus micronized fenofibrate or conventional statin dose plus niacin/laropiprant. The aim of the present study is to compare the efficacy of high-dose rosuvastatin vs conventional statin dose plus micronized fenofibrate vs conventional statin dose plus extended-release niacin/laropiprant on lipid profile in patients with mixed hyperlipidemia. The primary efficacy endpoint will be changes in non-HDL-C levels at 6 months after treatment initiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose rosuvastatin | Active Comparator | 40 mg of rosuvastatin |
|
| Stain plus fenofibrate | Active Comparator | existing statin plus micronized fenofibrate 200 mg |
|
| Statin plus niacin ER/laropiprant | Active Comparator | existing statin plus extended-release niacin/laropiprant (1 g/day for the first month which will be uptitrated to 2 g/day for the next months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose rosuvastatin | Drug | 40 of rosuvastatin daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in non-HDL-C levels | 6 months after treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moses S Elisaf, MD | Contact | +302651007509 | egepi@cc.uoi.gr |
| Name | Affiliation | Role |
|---|---|---|
| Moses S Elisaf, MD | University of Ioannina Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ioannina Medical School | Recruiting | Ioannina | 45 110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24618208 | Derived | Kei A, Tellis C, Liberopoulos E, Tselepis A, Elisaf M. Effect of switch to the highest dose of rosuvastatin versus add-on-statin fenofibrate versus add-on-statin nicotinic acid/laropiprant on oxidative stress markers in patients with mixed dyslipidemia. Cardiovasc Ther. 2014 Aug;32(4):139-46. doi: 10.1111/1755-5922.12072. | |
| 24379928 |
| Label | URL |
|---|---|
| 2nd Department of Internal Medicine, University Hospital of Ioannina | View source |
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 2, 2015 | |
| Reset | Jan 6, 2016 | |
| Release | Jul 20, 2016 |
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| Statin plus fenofibrate |
| Drug |
Existing statin plus micronised fenofibrate 200 mg daily |
|
| Statin plus niacin ER/laropiprant | Drug | Existing statin plus extended-release niacin/laropiprant (1 g/day for the first month which will be uptitrated to 2 g/day for the next months) |
|
| Kei A, Liberopoulos E, Elisaf M. Effect of hypolipidemic treatment on glycemic profile in patients with mixed dyslipidemia. World J Diabetes. 2013 Dec 15;4(6):365-71. doi: 10.4239/wjd.v4.i6.365. |
| 23600368 | Derived | Kei A, Liberopoulos E, Tellis K, Rizzo M, Elisaf M, Tselepis A. Effect of hypolipidemic treatment on emerging risk factors in mixed dyslipidemia: a randomized pilot trial. Eur J Clin Invest. 2013 Jul;43(7):698-707. doi: 10.1111/eci.12095. Epub 2013 Apr 20. |
| University of Ioannina. Greece | View source |
| University Hospital of Ioannina, Greece | View source |
| Reset | Aug 31, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 2, 2015 | Jan 6, 2016 | |||
| Jul 20, 2016 | Aug 31, 2016 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D010636 | Phenols |
| D007659 | Ketones |
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