Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia

Launched by UNIVERSITY OF IOANNINA · Nov 9, 2009

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Eligibility criteria

• Inclusion Criteria:
• • Non-HDL-C above target goal according to NCEP-ATP III after 3 months of treatment with conventional statin doses, e.g. simvastatin 10-40 mg, atorvastatin 10-40 mg or rosuvastatin 5-20 mg
• Exclusion Criteria:
• • Known CVD, triglycerides \> 500 mg/dL, renal disease (serum creatinine levels \> 1.6 mg/dL), hypothyroidism \[thyroid stimulating hormone (TSH) \> 5 IU/mL\], liver disease (ALT and/or AST levels \> 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption \> 3 drinks/day for men and \> 2 drinks/day for women, and current or previous gout.
• • Patients with diabetes will be included in the study if they are adequately controlled (HbA1c \<7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period).
• • Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period).
• • Patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 4 weeks before study entry will be excluded.