Clinical trial NCT01280604: Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy
Official title: Effects of Fenofibrate 160mg to 54mg Conversion on Triglyceride Levels in Patients on Statin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2011-01-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Triglyceride Levels
timeFrame: 6-10 weeks
Secondary outcomes:
measure: Low-density Lipoprotein (LDL)
timeFrame: 6-10 weeks
measure: High-density Lipoprotein,(HDL)
timeFrame: 6-10 weeks
measure: Alanine Aminotransferase(ALT)
timeFrame: 6-10 weeks
measure: Aspartate Aminotransferase (AST)
timeFrame: 6-10 weeks
measure: Serum Creatinine(SCr)
timeFrame: 6-10 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente of Georgia
state: Georgia
Study officials:
affiliation: Pharmacy Resident
name: Kendra Manigault, PharmD
role: PRINCIPAL_INVESTIGATOR
References: