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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Drug: Fenofibrate 54mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30305
      • Kaiser Permanente of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Kendra Manigault, PharmD, Pharmacy Resident

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (Estimate): January 21, 2011

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: KPGA-10KMani-01