Trial Outcomes & Findings for Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects (NCT NCT00903409)
NCT ID: NCT00903409
Last Updated: 2017-10-09
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
188 participants
Primary outcome timeframe
Month 4 (LOV111818)
Results posted on
2017-10-09
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
100
|
|
Overall Study
COMPLETED
|
62
|
73
|
|
Overall Study
NOT COMPLETED
|
26
|
27
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
9
|
|
Overall Study
Non-compliance with Protocol
|
1
|
1
|
|
Overall Study
Laboratory Abnormality
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
8
|
|
Overall Study
Other
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
6
|
Baseline Characteristics
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Baseline characteristics by cohort
| Measure |
Non-switcher
n=85 Participants
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).
|
Switcher
n=97 Participants
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).
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 10.80 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
80 Number of participants
n=5 Participants
|
95 Number of participants
n=7 Participants
|
175 Number of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Number of participants
n=5 Participants
|
0 Number of participants
n=7 Participants
|
2 Number of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Number of participants
n=5 Participants
|
1 Number of participants
n=7 Participants
|
3 Number of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Number of participants
n=5 Participants
|
1 Number of participants
n=7 Participants
|
2 Number of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Non-switcher
n=80 Participants
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).
|
Switcher
n=92 Participants
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).
|
Total Non-switcher and Switcher
n=172 Participants
Non-switcher and Switcher groups combined
|
|---|---|---|---|
|
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
Interval -47.5 to 60.0
|
-9.4 Percent change
Interval -35.7 to 33.9
|
-3.3 Percent change
Interval -47.5 to 60.0
|
SECONDARY outcome
Timeframe: Months 4, 12, and 24 (LOV111818) of the open-label extension trialPopulation: ITT Population
Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial
Outcome measures
| Measure |
Non-switcher
n=85 Participants
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).
|
Switcher
n=96 Participants
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).
|
Total Non-switcher and Switcher
n=181 Participants
Non-switcher and Switcher groups combined
|
|---|---|---|---|
|
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
Interval -39.6 to 139.5
|
-4.7 Percent change
Interval -38.3 to 42.2
|
-4.0 Percent change
Interval -39.6 to 139.5
|
|
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
Interval -39.3 to 154.9
|
-3.8 Percent change
Interval -44.5 to 60.8
|
-3.5 Percent change
Interval -44.5 to 154.9
|
|
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
Interval -52.1 to 43.8
|
-10.3 Percent change
Interval -38.7 to 53.8
|
-8.3 Percent change
Interval -52.1 to 53.8
|
|
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
Interval -51.9 to 115.6
|
-8.1 Percent change
Interval -58.6 to 39.4
|
-7.3 Percent change
Interval -58.6 to 115.6
|
|
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
Interval -47.0 to 97.4
|
-9.0 Percent change
Interval -43.4 to 39.4
|
-8.9 Percent change
Interval -47.0 to 97.4
|
|
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
Interval -71.0 to 130.5
|
-31.5 Percent change
Interval -64.6 to 59.7
|
-29.8 Percent change
Interval -71.0 to 130.5
|
|
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
Interval -75.9 to 189.6
|
-35.7 Percent change
Interval -71.8 to 59.7
|
-34.6 Percent change
Interval -75.9 to 189.6
|
|
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
Interval -86.1 to 138.7
|
-35.7 Percent change
Interval -74.5 to 59.7
|
-33.3 Percent change
Interval -86.1 to 138.7
|
|
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
Interval -41.6 to 32.3
|
-7.7 Percent change
Interval -27.7 to 46.9
|
-6.5 Percent change
Interval -41.6 to 46.9
|
|
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
Interval -31.5 to 83.9
|
-7.7 Percent change
Interval -52.6 to 34.6
|
-6.5 Percent change
Interval -52.6 to 83.9
|
|
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
Interval -40.6 to 69.6
|
-6.8 Percent change
Interval -32.2 to 34.6
|
-6.7 Percent change
Interval -40.6 to 69.6
|
|
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
Interval -65.2 to 86.4
|
-29.3 Percent change
Interval -64.6 to 47.6
|
-27.9 Percent change
Interval -65.2 to 86.4
|
|
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
Interval -75.8 to 62.2
|
-31.9 Percent change
Interval -71.8 to 45.2
|
-30.7 Percent change
Interval -75.8 to 62.2
|
|
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
Interval -68.8 to 213.6
|
-33.1 Percent change
Interval -74.1 to 45.2
|
-31.5 Percent change
Interval -74.1 to 213.6
|
|
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
Interval -38.4 to 77.4
|
-0.4 Percent change
Interval -30.3 to 88.1
|
1.7 Percent change
Interval -38.4 to 88.1
|
|
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
Interval -34.6 to 73.4
|
6.3 Percent change
Interval -33.8 to 63.4
|
6.2 Percent change
Interval -34.6 to 73.4
|
|
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
Interval -34.1 to 186.2
|
2.6 Percent change
Interval -32.0 to 70.9
|
3.0 Percent change
Interval -34.1 to 186.2
|
|
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
Interval -29.4 to 39.8
|
0.0 Percent change
Interval -22.2 to 31.9
|
0.0 Percent change
Interval -29.4 to 39.8
|
|
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
Interval -33.3 to 50.0
|
-3.1 Percent change
Interval -23.2 to 44.1
|
-0.9 Percent change
Interval -33.3 to 50.0
|
|
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
Interval -44.8 to 50.0
|
-5.6 Percent change
Interval -37.7 to 36.0
|
-4.6 Percent change
Interval -44.8 to 50.0
|
|
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
Interval -39.6 to 78.0
|
-7.9 Percent change
Interval -35.8 to 30.2
|
-6.9 Percent change
Interval -39.6 to 78.0
|
SECONDARY outcome
Timeframe: LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trialPopulation: ITT Population
Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial
Outcome measures
| Measure |
Non-switcher
n=85 Participants
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).
|
Switcher
n=96 Participants
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).
|
Total Non-switcher and Switcher
n=181 Participants
Non-switcher and Switcher groups combined
|
|---|---|---|---|
|
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
Interval -58.6 to 194.2
|
-27.0 Percentage change
Interval -71.8 to 97.2
|
-17.1 Percentage change
Interval -71.8 to 194.2
|
|
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
Interval -81.2 to 390.1
|
-27.0 Percentage change
Interval -74.7 to 97.2
|
-19.5 Percentage change
Interval -81.2 to 390.1
|
|
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
Interval -37.7 to 40.4
|
-7.1 Percentage change
Interval -29.3 to 25.3
|
-2.5 Percentage change
Interval -37.7 to 40.4
|
|
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
Interval -23.2 to 58.9
|
-3.4 Percentage change
Interval -53.2 to 23.9
|
-2.7 Percentage change
Interval -53.2 to 58.9
|
|
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
Interval -52.9 to 122.7
|
-23.1 Percentage change
Interval -69.2 to 38.0
|
-13.5 Percentage change
Interval -69.2 to 122.7
|
|
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
Interval -44.1 to 76.7
|
-6.4 Percentage change
Interval -58.6 to 29.2
|
-1.5 Percentage change
Interval -58.6 to 76.7
|
|
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
Interval -39.0 to 102.8
|
-6.3 Percentage change
Interval -35.0 to 40.7
|
-3.8 Percentage change
Interval -39.0 to 102.8
|
|
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
Interval -52.1 to 134.1
|
-25.8 Percentage change
Interval -69.5 to 39.4
|
-15.8 Percentage change
Interval -69.5 to 134.1
|
|
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
Interval -30.2 to 53.5
|
-5.6 Percentage change
Interval -31.1 to 34.2
|
-3.0 Percentage change
Interval -31.1 to 53.5
|
|
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
Interval -58.6 to 113.6
|
-21.3 Percentage change
Interval -69.8 to 97.2
|
-13.7 Percentage change
Interval -69.8 to 113.6
|
|
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
Interval -80.7 to 113.6
|
-26.4 Percentage change
Interval -71.1 to 97.2
|
-17.5 Percentage change
Interval -80.7 to 113.6
|
|
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
Interval -45.7 to 64.3
|
6.3 Percentage change
Interval -35.4 to 56.7
|
3.7 Percentage change
Interval -45.7 to 64.3
|
|
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
Interval -28.2 to 64.7
|
10.1 Percentage change
Interval -32.1 to 69.8
|
6.3 Percentage change
Interval -32.1 to 69.8
|
|
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
Interval -28.6 to 105.9
|
5.5 Percentage change
Interval -32.2 to 80.1
|
3.8 Percentage change
Interval -32.2 to 105.9
|
|
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
Interval -33.3 to 31.1
|
1.7 Percentage change
Interval -22.8 to 34.8
|
-1.2 Percentage change
Interval -33.3 to 34.8
|
|
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
Interval -34.1 to 30.8
|
-1.8 Percentage change
Interval -30.7 to 40.4
|
-2.8 Percentage change
Interval -34.1 to 40.4
|
|
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
Interval -41.8 to 30.8
|
-4.8 Percentage change
Interval -40.6 to 21.9
|
-4.9 Percentage change
Interval -41.8 to 30.8
|
|
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
Interval -33.4 to 110.5
|
-7.5 Percentage change
Interval -31.8 to 35.5
|
-3.5 Percentage change
Interval -33.4 to 110.5
|
|
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
Interval -35.5 to 96.1
|
-5.4 Percentage change
Interval -34.9 to 53.4
|
-0.1 Percentage change
Interval -35.5 to 96.1
|
|
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
Interval -36.7 to 116.3
|
-1.9 Percentage change
Interval -31.4 to 58.8
|
1.1 Percentage change
Interval -36.7 to 116.3
|
Adverse Events
Non-switcher
Serious events: 17 serious events
Other events: 67 other events
Deaths: 0 deaths
Switcher
Serious events: 11 serious events
Other events: 79 other events
Deaths: 0 deaths
Total Non-switcher and Switcher
Serious events: 28 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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).
|
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).
|
Total Non-switcher and Switcher
Non-switcher and Switcher groups combined
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
2/85
|
0.00%
0/97
|
1.1%
2/182
|
|
Cardiac disorders
Coronary artery disease
|
2.4%
2/85
|
0.00%
0/97
|
1.1%
2/182
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/85
|
2.1%
2/97
|
1.1%
2/182
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
|
Cardiac disorders
Pericardial infusion
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
|
Infections and infestations
Cellulitis
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
|
Infections and infestations
Pneumonia
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
|
Endocrine disorders
Hyperparathyroidism
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
General disorders
Chest discomfort
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
|
Psychiatric disorders
Bipolar disorder
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.2%
1/85
|
0.00%
0/97
|
0.55%
1/182
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/85
|
1.0%
1/97
|
0.55%
1/182
|
Other adverse events
| Measure |
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).
|
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).
|
Total Non-switcher and Switcher
Non-switcher and Switcher groups combined
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
8.2%
7/85
|
13.4%
13/97
|
11.0%
20/182
|
|
Infections and infestations
Bronchitis
|
5.9%
5/85
|
10.3%
10/97
|
8.2%
15/182
|
|
Infections and infestations
Sinusitis
|
10.6%
9/85
|
5.2%
5/97
|
7.7%
14/182
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
6/85
|
6.2%
6/97
|
6.6%
12/182
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
5/85
|
7.2%
7/97
|
6.6%
12/182
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
5/85
|
5.2%
5/97
|
5.5%
10/182
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
2/85
|
7.2%
7/97
|
4.9%
9/182
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
6/85
|
3.1%
3/97
|
4.9%
9/182
|
|
Infections and infestations
Urinary tract infection
|
3.5%
3/85
|
6.2%
6/97
|
4.9%
9/182
|
|
Psychiatric disorders
Anxiety
|
5.9%
5/85
|
3.1%
3/97
|
4.4%
8/182
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
3/85
|
5.2%
5/97
|
4.4%
8/182
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
5/85
|
2.1%
2/97
|
3.8%
7/182
|
|
Psychiatric disorders
Depression
|
5.9%
5/85
|
2.1%
2/97
|
3.8%
7/182
|
|
Investigations
Weight increased
|
1.2%
1/85
|
5.2%
5/97
|
3.3%
6/182
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER