Clinical trial NCT01010516: Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia
Official title: Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dyslipidemia
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2009-11-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in non-HDL-C levels
timeFrame: 6 months after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: University of Ioannina Medical School
Study officials:
affiliation: University of Ioannina Medical School
name: Moses S Elisaf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.