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

NCT ID: NCT01280604

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-01-31

Brief Summary

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

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.

Conditions

Hyperlipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fenofibrate 54mg

Intervention Type: DRUG

Subjects will receive fenofibrate 54mg daily.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fenofibrate 54mg

Subjects will receive fenofibrate 54mg daily.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kendra Manigault, PharmD

Role: PRINCIPAL_INVESTIGATOR

Pharmacy Resident

Locations

Kaiser Permanente of Georgia

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

KPGA-10KMani-01

Identifier Type: -

Identifier Source: org_study_id