Hyperlipidemias
Conditions
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.
Interventions
DRUGFenofibrate 54mg
Subjects will receive fenofibrate 54mg daily.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride Levels | 6-10 weeks | Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low-density Lipoprotein (LDL) | 6-10 weeks | LDL levels will be assessed in study participants 6-10 weeks after entry into study. |
| High-density Lipoprotein,(HDL) | 6-10 weeks | HDL levels will be assessed in study participants 6-10 weeks after entry into study. |
| Alanine Aminotransferase(ALT) | 6-10 weeks | ALT levels will be assessed in study participants 6-10 weeks after entry into study. |
| Aspartate Aminotransferase (AST) | 6-10 weeks | AST levels will be assessed in study participants 6-10 weeks after entry into study. |
| Serum Creatinine(SCr) | 6-10 weeks | SCr levels will be assessed in study participants 6-10 weeks after entry into study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily. | 25 |
| Control Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks). | 29 |
| Total | 54 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 8.67 | 57.41 years STANDARD_DEVIATION 8.36 | 57.55 years STANDARD_DEVIATION 9.26 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 22 Participants | 47 Participants | 25 Participants |
| Region of Enrollment United States | 25 participants | 54 participants | 29 participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Male | 17 Participants | 39 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 29 |
| serious Total, serious adverse events | 0 / 25 | 0 / 29 |
Outcome results
Primary
Triglyceride Levels
Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Triglyceride Levels | Baseline Triglyceride Levels | 135.5 milligram/deciliter | Standard Deviation 36.22 |
| Intervention | Triglyceride Levels | Follow-Up Triglyceride Levels | 152.7 milligram/deciliter | Standard Deviation 42.61 |
| Control | Triglyceride Levels | Baseline Triglyceride Levels | 108.3 milligram/deciliter | Standard Deviation 37.41 |
| Control | Triglyceride Levels | Follow-Up Triglyceride Levels | 109 milligram/deciliter | Standard Deviation 39.7 |
Secondary
Alanine Aminotransferase(ALT)
ALT levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Alanine Aminotransferase(ALT) | Baseline Alanine aminotransferase | 29.76 international units/liter | Standard Deviation 26.2 |
| Intervention | Alanine Aminotransferase(ALT) | Follow-up Alanine aminotransferase | 27.38 international units/liter | Standard Deviation 9.13 |
| Control | Alanine Aminotransferase(ALT) | Baseline Alanine aminotransferase | 30.66 international units/liter | Standard Deviation 26.61 |
| Control | Alanine Aminotransferase(ALT) | Follow-up Alanine aminotransferase | 29.96 international units/liter | Standard Deviation 11.03 |
Secondary
Aspartate Aminotransferase (AST)
AST levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Aspartate Aminotransferase (AST) | Baseline Aspartate Aminotransferase | 27.48 international units/liter | Standard Deviation 6.14 |
| Intervention | Aspartate Aminotransferase (AST) | Follow-up Aspartate Aminotransferase | 25.5 international units/liter | Standard Deviation 5.41 |
| Control | Aspartate Aminotransferase (AST) | Baseline Aspartate Aminotransferase | 27.59 international units/liter | Standard Deviation 8.57 |
| Control | Aspartate Aminotransferase (AST) | Follow-up Aspartate Aminotransferase | 26.36 international units/liter | Standard Deviation 6.49 |
Secondary
High-density Lipoprotein,(HDL)
HDL levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | High-density Lipoprotein,(HDL) | Baseline High-density lipoprotein | 41.88 milligram/deciliter | Standard Deviation 9.58 |
| Intervention | High-density Lipoprotein,(HDL) | Follow-up High-density lipoprotein | 43.21 milligram/deciliter | Standard Deviation 38.99 |
| Control | High-density Lipoprotein,(HDL) | Baseline High-density lipoprotein | 41.79 milligram/deciliter | Standard Deviation 14.24 |
| Control | High-density Lipoprotein,(HDL) | Follow-up High-density lipoprotein | 38.79 milligram/deciliter | Standard Deviation 33.61 |
Secondary
Low-density Lipoprotein (LDL)
LDL levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Low-density Lipoprotein (LDL) | Baseline Low-density lipoprotein | 95.32 milligram/deciliter | Standard Deviation 21.32 |
| Intervention | Low-density Lipoprotein (LDL) | Follow-up Low-density lipoprotein | 84.42 milligram/deciliter | Standard Deviation 21.05 |
| Control | Low-density Lipoprotein (LDL) | Baseline Low-density lipoprotein | 83.29 milligram/deciliter | Standard Deviation 22.99 |
| Control | Low-density Lipoprotein (LDL) | Follow-up Low-density lipoprotein | 78.71 milligram/deciliter | Standard Deviation 21.93 |
Secondary
Serum Creatinine(SCr)
SCr levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Serum Creatinine(SCr) | Baseline Serum Creatinine | 0.9880 milligram/deciliter | Standard Deviation 0.2571 |
| Intervention | Serum Creatinine(SCr) | Follow-up Serum Creatinine | 1 milligram/deciliter | Standard Deviation 0.23 |
| Control | Serum Creatinine(SCr) | Baseline Serum Creatinine | 1.14 milligram/deciliter | Standard Deviation 0.24 |
| Control | Serum Creatinine(SCr) | Follow-up Serum Creatinine | 1.13 milligram/deciliter | Standard Deviation 0.23 |