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This study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fluvastatin: daily 80 mg, oral |
|
| 2 | Experimental | Valsartan |
|
| 3 | Experimental | Hydrochlorothiazide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluvastatin | Drug | Fluvastatin: daily 80 mg, oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables) | 9 month | |
| Proportion of patients with controlled glycemia | 9 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Rossi, MD | ASL Terni 4, Narni (TR) - Italy | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23334870 | Result | Ambrosioni E, Cicero AF, Parretti D, Filippi A, Rossi A, Peruzzi E, Borghi C. Global cardiovascular disease risk management in italian patients with metabolic syndrome in the clinical practice setting. High Blood Press Cardiovasc Prev. 2008 Apr;15(2):37-45. doi: 10.2165/00151642-200815020-00001. Epub 2013 Jan 3. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077340 | Fluvastatin |
| D000068756 | Valsartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Valsartan | Drug | Valsartan: daily 160 mg, oral |
|
|
| Hydrochlorothiazide | Drug | Hydrochlorothiazide: daily 12.5mg, oral |
|
| Percentage of patients no longer classifiable as having metabolic syndrome |
| 9 months |
| D009750 | Nutritional and Metabolic Diseases |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |