Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy

Study Overview
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Brief Summary
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The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides.

Detailed Description
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Hypothesis: Study subjects receiving fenofibrate 54mg will maintain similar triglyceride levels as patients on 160mg of fenofibrate. The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. Secondary objectives include evaluating effect of the dosage change on low-density lipoprotein (LDL), HDL, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr), and the potential cost savings associated with prescribing 54mg instead of 160mg. Electronic medical records will be used to identify subjects and gather data on demographics, comorbid conditions, and concomitant lipid lowering therapy. Subjects will be recruited for enrollment via telephone by the principal investigator (PI), co-principal investigators (Co-PIs), or provider referral after eligibility screening and approval from their primary care physician. Subjects must provide written informed consent and Health Insurance Privacy and Accountability Act (HIPAA) privacy rule authorization prior to participation in this study. Subjects will be randomized to either the intervention arm (conversion to 54mg of fenofibrate) or to the control arm (remain on 160mg of fenofibrate). Subjects in both study arms will have fasting lipid panels, ALT/AST, and SCr evaluated at baseline. All subjects will have repeat labs approximately 8 weeks after enrollment. All subjects will continue to receive standard care based on lipid values. The study period will begin approximately October 29, 2010 and run to June 30, 2011.

Official Title
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Effects of Fenofibrate 160mg to 54mg Conversion on Triglyceride Levels in Patients on Statin Therapy

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Drug: Fenofibrate 54mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years of age or older Patients actively taking fenofibrate 160mg and statin therapy A fasting lipid panel within the past 9 months with most recent triglycerides levels less than 200mg/dL Primary care physician approves participation and fenofibrate conversion Exclusion Criteria: Impaired renal function defined as creatine clearance ≤ 50ml/min Current enrollment in other studies or clinical trials Previous fenofibrate 54mg use A history of pancreatitis or known previous triglyceride levels >1000mg/dL Pregnancy Members with plan benefits that include a deductible for lab services at Kaiser Permanente

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 'Fenofibrate 54mg'<br>Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks. | Drug: Fenofibrate 54mg<br>* Subjects will receive fenofibrate 54mg daily.<br>|
| No Intervention: Control 'Fenofibrate 160mg'<br>Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride Levels | Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low-density Lipoprotein (LDL) | LDL levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks | 
| High-density Lipoprotein,(HDL) | HDL levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks | 
| Alanine Aminotransferase(ALT) | ALT levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks | 
| Aspartate Aminotransferase (AST) | AST levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks | 
| Serum Creatinine(SCr) | SCr levels will be assessed in study participants 6-10 weeks after entry into study. | 6-10 weeks |