Predictors of Response to Fenofibrate (PreFar)
Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there are no screening tests to identify poor responders. Genetic and environmental factors may explain the high variability in response. Although exploratory in nature, this study is of clinical and public health importance because prediction of drug response among those with hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large ($90 to $130/patient/month); targeting the responsive patients at the outset will help improve treatment outcomes at a lower cost. If successful, the investigators will propose to conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate response.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Pretreatment Genotyping at APOA5 and GCKR Loci and Response to Fenofibrate Therapy|
- Change in fasting triglyceride concentrations [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Changes in lipids and markers of insulin resistance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Participants will give a baseline blood sample and begin the 4 week course of fenofibrate. Patients will be given a 33-day dose of 145 mg of fenofibrate to be taken by mouth once a day. All doses of fenofibrate will be purchased in one batch, prepared at the pharmacy under supervision. A study nurse will collect each patient's 33-day dose of fenofibrate from the pharmacy and dispense to the study participants in the clinics. Patients will be given instructions on how to take the medication and given a 24-hr phone number to call in case of questions or need for additional care. Each patient will receive a phone call at least 2 times during the course of the trial to monitor the progress. Our co-investigators, who are also physicians will be available in case a study participant needs additional care. If not available, study participants will be able to reach the cardiologist or endocrinologist on call through an additional phone number we will provide.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023750
|United States, Alabama|
|UAB Kirklin Clinic|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Edmond K Kabagambe, DVM, PhD||University of Alabama at Birmingham|