Hypertriglyceridemia
Conditions
Keywords
High triglycerides, Lovaza, simvastatin, omega-3-acid ethyl esters
Brief summary
In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) \[formerly known as Omacor\] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.
Detailed description
Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this posting.
Interventions
DRUGSimvastatin + Lovaza® (omega-3-acid ethyl esters)
Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/
Exclusion criteria
prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8. FYI - entry criteria for LOV111818/OM6 (double-blind study) Inclusion Criteria: * Men and women ages 18-79 years, inclusive * Current therapy with a statin drug * Triglyceride levels between 200 and 499 mg/dL * Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests * Provide written informed consent and authorization for protected health information disclosure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | Month 4 (LOV111818) | Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Months 4, 12, and 24 (LOV111818) of the open-label extension trial | Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial |
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial | Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-switcher Open-label Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor®\] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409). | 85 |
| Switcher Open-label Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor®\] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409). | 97 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 9 |
| Overall Study | Laboratory Abnormality | 2 | 0 |
| Overall Study | Lost to Follow-up | 2 | 6 |
| Overall Study | Non-compliance with Protocol | 1 | 1 |
| Overall Study | Other | 2 | 3 |
| Overall Study | Withdrawal by Subject | 8 | 8 |
Baseline characteristics
| Characteristic | Non-switcher | Switcher | Total |
|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 10.32 | 60.0 years STANDARD_DEVIATION 10.8 | 59.9 years STANDARD_DEVIATION 10.55 |
| Race/Ethnicity, Customized Asian | 2 Number of participants | 0 Number of participants | 2 Number of participants |
| Race/Ethnicity, Customized Black or African American | 2 Number of participants | 1 Number of participants | 3 Number of participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Number of participants | 1 Number of participants | 2 Number of participants |
| Race/Ethnicity, Customized White | 80 Number of participants | 95 Number of participants | 175 Number of participants |
| Sex: Female, Male Female | 36 Participants | 38 Participants | 74 Participants |
| Sex: Female, Male Male | 49 Participants | 59 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 67 / — | 79 / — | 146 / — |
| serious Total, serious adverse events | 17 / — | 11 / — | 28 / — |
Outcome results
Primary
Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818)
Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)
Time frame: Month 4 (LOV111818)
Population: Intent-to-Treat (ITT) Population: Comprised of data for all participants who were enrolled and received at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-switcher | Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | 0.9 Percent change |
| Switcher | Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | -9.4 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | -3.3 Percent change |
p-value: <0.001Kruskal-Wallis
Secondary
Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial
Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial
Time frame: LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial
Population: ITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | HDL-C, Month 4 | -2.9 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C, Month 12 | -1.7 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C:HDL-C Ratio, Month 12 | 2.7 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LDL-C, Month 24 | 1.9 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C, Month 24 | -1.0 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | TG Month, 4 | 1.8 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LDL-C, Month 12 | 1.9 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Calculated VLDL-C, Month 4 | 2.1 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Calculated VLDL-C, Month 24 | -5.8 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LDL-C, Month 4 | 0.6 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Calculated VLDL-C, Month 12 | -4.6 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C:HDL-C Ratio, Month 4 | 1.3 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | TG Month, 12 | -3.2 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C:HDL-C Ratio, Month 24 | 5.7 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | HDL-C, Month 24 | -5.4 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | TG Month, 24 | -6.4 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Non-HDL-C, Month 24 | 1.6 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | HDL-C, Month 12 | -3.1 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C, Month 4 | 0.6 Percentage change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Non-HDL-C, Month 12 | -0.2 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C:HDL-C Ratio, Month 24 | -1.9 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Calculated VLDL-C, Month 24 | -26.4 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Non-HDL-C, Month 12 | -6.4 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Non-HDL-C, Month 24 | -6.3 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | TG Month, 4 | -25.8 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | TG Month, 12 | -27.0 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | TG Month, 24 | -27.0 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C, Month 4 | -7.1 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C, Month 12 | -3.4 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C, Month 24 | -5.6 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Calculated VLDL-C, Month 4 | -23.1 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Calculated VLDL-C, Month 12 | -21.3 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LDL-C, Month 4 | 6.3 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LDL-C, Month 12 | 10.1 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LDL-C, Month 24 | 5.5 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | HDL-C, Month 4 | 1.7 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | HDL-C, Month 12 | -1.8 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | HDL-C, Month 24 | -4.8 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C:HDL-C Ratio, Month 4 | -7.5 Percentage change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C:HDL-C Ratio, Month 12 | -5.4 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C, Month 12 | -2.7 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C:HDL-C Ratio, Month 4 | -3.5 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LDL-C, Month 24 | 3.8 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C, Month 4 | -2.5 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Non-HDL-C, Month 24 | -3.8 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | HDL-C, Month 4 | -1.2 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | TG Month, 24 | -19.5 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C:HDL-C Ratio, Month 24 | 1.1 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | HDL-C, Month 12 | -2.8 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | TG Month, 12 | -17.1 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C:HDL-C Ratio, Month 12 | -0.1 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | HDL-C, Month 24 | -4.9 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Calculated VLDL-C, Month 12 | -13.7 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Calculated VLDL-C, Month 24 | -17.5 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Calculated VLDL-C, Month 4 | -13.5 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | TG Month, 4 | -15.8 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LDL-C, Month 4 | 3.7 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Total-C, Month 24 | -3.0 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Non-HDL-C, Month 12 | -1.5 Percentage change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | LDL-C, Month 12 | 6.3 Percentage change |
Secondary
Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers
Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial
Time frame: Months 4, 12, and 24 (LOV111818) of the open-label extension trial
Population: ITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C:HDL-C Ratio, Month 12 | -3.6 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Low Density (LD)L-C, Month 4 | 2.4 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-Cholesterol (Total-C), Month 4 | -4.2 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-HDL-C, Month 12 | -6.6 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Calculated Very Low Density (VLD)L-C, Month 24 | -25.0 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C, Month 12 | -5.4 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C:HDL-C Ratio, Month 4 | -5.3 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Calculated Very Low Density (VLD)L-C, Month 12 | -29.8 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C, Month 24 | -6.4 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | HDL-C, Month 24 | -2.9 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Calculated Very Low Density (VLD)L-C, Month 4 | -24.3 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-HDL-C, Month 24 | -7.8 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | HDL-C, Month 12 | 0.0 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | HDL-C, Month 4 | 0.8 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Triglycerides (TG), Month 4 | -26.2 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-HDL-C, Month 4 | -5.4 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Low Density (LD)L-C, Month 24 | 3.4 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | TG, Month 12 | -30.4 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C:HDL-C Ratio, Month 24 | -1.9 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Low Density (LD)L-C, Month 12 | 5.9 Percent change |
| Non-switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | TG, Month 24 | -28.2 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Low Density (LD)L-C, Month 24 | 2.6 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C:HDL-C Ratio, Month 4 | -7.9 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-HDL-C, Month 4 | -10.3 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-HDL-C, Month 12 | -8.1 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-HDL-C, Month 24 | -9.0 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Triglycerides (TG), Month 4 | -31.5 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | TG, Month 12 | -35.7 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | TG, Month 24 | -35.7 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-Cholesterol (Total-C), Month 4 | -7.7 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C, Month 12 | -7.7 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C, Month 24 | -6.8 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Calculated Very Low Density (VLD)L-C, Month 4 | -29.3 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Calculated Very Low Density (VLD)L-C, Month 12 | -31.9 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Calculated Very Low Density (VLD)L-C, Month 24 | -33.1 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Low Density (LD)L-C, Month 4 | -0.4 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Low Density (LD)L-C, Month 12 | 6.3 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | HDL-C, Month 4 | 0.0 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | HDL-C, Month 12 | -3.1 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | HDL-C, Month 24 | -5.6 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C:HDL-C Ratio, Month 12 | -4.7 Percent change |
| Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C:HDL-C Ratio, Month 24 | -3.8 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C:HDL-C Ratio, Month 4 | -6.9 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Low Density (LD)L-C, Month 4 | 1.7 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | TG, Month 12 | -34.6 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-HDL-C, Month 4 | -8.3 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Low Density (LD)L-C, Month 12 | 6.2 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Triglycerides (TG), Month 4 | -29.8 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | HDL-C, Month 4 | 0.0 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Low Density (LD)L-C, Month 24 | 3.0 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-HDL-C, Month 24 | -8.9 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C:HDL-C Ratio, Month 24 | -3.5 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C:HDL-C Ratio, Month 12 | -4.0 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C, Month 24 | -6.7 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | HDL-C, Month 12 | -0.9 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Calculated Very Low Density (VLD)L-C, Month 4 | -27.9 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-C, Month 12 | -6.5 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Non-HDL-C, Month 12 | -7.3 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Calculated Very Low Density (VLD)L-C, Month 12 | -30.7 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Total-Cholesterol (Total-C), Month 4 | -6.5 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | HDL-C, Month 24 | -4.6 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Calculated Very Low Density (VLD)L-C, Month 24 | -31.5 Percent change |
| Total Non-switcher and Switcher | Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | TG, Month 24 | -33.3 Percent change |