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

Phase 4

• Conditions: Dyslipidemia
• Interventions: Drug: High-dose rosuvastatin; Drug: Statin plus fenofibrate; Drug: Statin plus niacin ER/laropiprant

• Registration Number: NCT01010516
• Lead Sponsor: University of Ioannina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Status Verified: 2009-11
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Last Update Submitted: 2011-08-09
• Last Update Posted: 2011-08-10
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose rosuvastatin	High-dose rosuvastatin	40 mg of rosuvastatin
Stain plus fenofibrate	Statin plus fenofibrate	existing statin plus micronized fenofibrate 200 mg
Statin plus niacin ER/laropiprant	Statin plus niacin ER/laropiprant	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)

Primary Outcome Measures

Name	Time	Method
Changes in non-HDL-C levels	6 months after treatment initiation

Trial Locations

Locations (1)

University of Ioannina Medical School; 🇬🇷 Ioannina, Greece