Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Effects of Fenofibrate 160mg to 54mg Conversion on Triglyceride Levels in Patients on Statin Therapy|
- Triglyceride Levels [ Time Frame: 6-10 weeks ]Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.
- Low-density Lipoprotein (LDL) [ Time Frame: 6-10 weeks ]LDL levels will be assessed in study participants 6-10 weeks after entry into study.
- High-density Lipoprotein,(HDL) [ Time Frame: 6-10 weeks ]HDL levels will be assessed in study participants 6-10 weeks after entry into study.
- Alanine Aminotransferase(ALT) [ Time Frame: 6-10 weeks ]ALT levels will be assessed in study participants 6-10 weeks after entry into study.
- Aspartate Aminotransferase (AST) [ Time Frame: 6-10 weeks ]AST levels will be assessed in study participants 6-10 weeks after entry into study.
- Serum Creatinine(SCr) [ Time Frame: 6-10 weeks ]SCr levels will be assessed in study participants 6-10 weeks after entry into study.
|Study Start Date:||October 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Intervention 'Fenofibrate 54mg'
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
Subjects will receive fenofibrate 54mg daily.
No Intervention: Control 'Fenofibrate 160mg'
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280604
|United States, Georgia|
|Kaiser Permanente of Georgia|
|Atlanta, Georgia, United States, 30305|
|Principal Investigator:||Kendra Manigault, PharmD||Pharmacy Resident|