Hypertriglyceridemia
Conditions
Keywords
hypertriglyceridemia, Omega-3 Fatty Acids, Lipoprotein, Statin, Lovaza
Brief summary
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).
Detailed description
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).
Interventions
DRUGLovaza
1 gram gel capsule 4 capsules per day for 8 weeks
Sponsors
GlaxoSmithKline
Sanford Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 18-79 years * Stable does of statins ≥ 8 weeks prior to screening * Good health by medical history, physical exam, electrocardiogram, laboratory test (e.g., serum chem., urinalysis) * Mean fasting serum triglyceride of two most recent tests in medical record ≥ 200 and \< 500 mg/dL * Mean LDL-cholesterol of two most recent tests in medical record ≤ 1.1 × NCEP ATP III goal
Exclusion criteria
* Medications, vitamin pills, nutritional supplements or herbal preparations deemed exclusionary per primary investigator for possible interference * Poorly controlled diabetes mellitus (e.g. \[HbA1c\] \> 8.0%) * History of a cardiovascular event * Past revascularization procedure * Past aortic aneurysm or an aortic dissection \< 6 months prior to screening * History of pancreatitis * Sensitivity to any statin OR to omega-3 fatty acids or fish products * Poorly controlled hypertension (i.e.: \>=160 systolic (resting) and/or \>=100 diastolic (resting)) at 2 consecutive visits * Serum Creatinine ≥ 2.0 mg/dL * Serum transaminase \> 1.5 × upper limit of normal (ULN); including aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]; 31 U/L for AST, 45 U/L for ALT * Creatine Kinase (CK) \> 3.0 × ULN * Taking other triglyceride lowering drugs (e.g., niacin, fibrates) or fish oil supplements providing more than 500 mg of EPA+DHA per day * Contraindications for Lovaza per product insert * Women who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HDL 15-HEPE | 4 months | high density lipoprotein level of 15-HEPE |
Countries
United States
Participant flow
Recruitment details
Patients on statins with persistent hypertriglyceridemia were identified by EMR search of hospital records. Letters were sent to eligible and those responding were screened and if qualifying, enrolled.
Pre-assignment details
No run in or wash out
Participants by arm
| Arm | Count |
|---|---|
| Lovaza Lovaza was given as the only agent; there was no comparator agent or arm Lovaza: 1 gram gel capsule 4 capsules per day for 8 weeks | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Lovaza |
|---|---|
| Age, Continuous | 59 years |
| lipids HDL-C | 38 mg/dL |
| lipids LDL-C | 88 mg/dL |
| lipids TG | 237 mg/dL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
HDL 15-HEPE
high density lipoprotein level of 15-HEPE
Time frame: 4 months
Population: hypertriglyceridemic statin treated patients
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lovaza | HDL 15-HEPE | baseline | 3.7 nmol/mmol phospholipid |
| Lovaza | HDL 15-HEPE | final | 10.4 nmol/mmol phospholipid |