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

• ClinicalTrials.gov Identifier: NCT01280604
• Recruitment Status: Completed
• First Posted: January 21, 2011
• Results First Posted: June 8, 2015
• Last Update Posted: June 8, 2015
• Sponsor: Kaiser Permanente
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemias	Drug: Fenofibrate 54mg	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• 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
• Study Start Date: October 2010
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. Triglyceride Levels [ Time Frame: 6-10 weeks ]
   Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.

Secondary Outcome Measures :

1. Low-density Lipoprotein (LDL) [ Time Frame: 6-10 weeks ]
   LDL levels will be assessed in study participants 6-10 weeks after entry into study.
2. High-density Lipoprotein,(HDL) [ Time Frame: 6-10 weeks ]
   HDL levels will be assessed in study participants 6-10 weeks after entry into study.
3. Alanine Aminotransferase(ALT) [ Time Frame: 6-10 weeks ]
   ALT levels will be assessed in study participants 6-10 weeks after entry into study.
4. Aspartate Aminotransferase (AST) [ Time Frame: 6-10 weeks ]
   AST levels will be assessed in study participants 6-10 weeks after entry into study.
5. Serum Creatinine(SCr) [ Time Frame: 6-10 weeks ]
   SCr levels will be assessed in study participants 6-10 weeks after entry into study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Georgia

Kaiser Permanente of Georgia

Atlanta, Georgia, United States, 30305

Sponsors and Collaborators

Kaiser Permanente

Investigators

• Principal Investigator: Kendra Manigault, PharmD; Pharmacy Resident

More Information

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT01280604
• Other Study ID Numbers: KPGA-10KMani-01
• First Posted: January 21, 2011
• Results First Posted: June 8, 2015
• Last Update Posted: June 8, 2015
• Last Verified: June 2015

Additional relevant MeSH terms:

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Fenofibrate; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents