Table 3 Summary of mean fasting serum lipid concentrations at baseline and after 4 weeks by treatment. Analysis is for the modified intent-to-treat population, defined as all participants who received at least one dose of study drug and provided at least one post-randomization efficacy value
Lipid parameter | OM3-CA 2 g (n = 7) | OM3-CA 4 g (n = 6) | OM3-EE 4 g (n = 14a) |
|---|---|---|---|
Fasting TG (mmol/L) | |||
Baseline | |||
Mean (SD) | 22.4 (36.2) | 8.5 (5.7) | 9.6 (10.0) |
4-week endpoint | |||
Mean (SD) | 15.8 (18.3) | 5.7 (3.3) | 8.2 (9.0) |
Mean change from baseline (SD) | −6.6 (18.6) | −2.8 (3.2) | −1.4 (4.1) |
Mean % change from baseline (SD) | −1.0 (41.0) | −25.6 (28.7) | −7.8 (40.0) |
Fasting TC (mmol/L) | |||
Baseline | |||
Mean (SD) | 7.2 (3.8) | 4.9 (1.1) | 5.6 (1.8) |
4-week endpoint | |||
Mean (SD) | 5.8 (2.2) | 4.5 (0.8) | 4.9 (1.4) |
Mean change from baseline (SD) | −1.5 (1.8) | −0.4 (0.7) | −0.7 (1.2) |
Mean % change from baseline (SD) | −15.9 (11.2) | −6.2 (11.0) | −9.3 (16.6) |
Fasting direct LDL-C (mmol/L) | |||
Baseline | |||
Mean (SD) | 1.5 (0.9) | 1.5 (0.8) | 1.8 (0.8) |
4-week endpoint | |||
Mean (SD) | 1.5 (0.7) | 1.8 (0.5) | 1.9 (1.0) |
Mean change from baseline (SD) | −0.1 (0.2) | 0.3 (0.6) | 0.1 (0.5) |
Mean % change from baseline (SD) | 21.2 (71.6) | 36.9 (51.6) | 6.0 (29.4) |
Fasting HDL-C (mmol/L) | |||
Baseline | |||
Mean (SD) | 0.6 (0.2) | 0.6 (0.1) | 0.6 (0.2) |
4-week endpoint | |||
Mean (SD) | 0.5 (0.2) | 0.6 (0.1) | 0.6 (0.2) |
Mean change from baseline (SD) | −0.04 (0.14) | 0.05 (0.04) | −0.02 (0.12) |
Mean % change from baseline (SD) | −2.7 (24.7) | 8.3 (7.3) | −1.0 (21.1) |
Fasting VLDL-C (mmol/L) | |||
Baseline | |||
Mean (SD) | 5.1 (4.7) | 2.8 (1.5) | 3.2 (2.3) |
4-week endpoint | |||
Mean (SD) | 3.8 (2.8) | 2.1 (1.1) | 2.5 (1.7) |
Mean change from baseline (SD) | −1.3 (2.0) | −0.7 (0.8) | −0.7 (1.2) |
Mean % change from baseline (SD) | −17.8 (15.2) | −21.8 (22.5) | −13.3 (33.5) |
Fasting non-HDL-C (mmol/L) | |||
Baseline | |||
Mean (SD) | 6.7 (4.0) | 4.3 (1.2) | 5.0 (1.9) |
4-week endpoint | |||
Mean (SD) | 5.2 (2.4) | 3.9 (0.9) | 4.3 (1.5) |
Mean change from baseline (SD) | −1.4 (1.8) | −0.4 (0.7) | −0.6 (1.3) |
Mean % change from baseline (SD) | −16.3 (12.9) | −7.9 (11.7) | −9.7 (18.9) |
Fasting TC:HDL-C | |||
Baseline | |||
Mean (SD) | 19.0 (22.3) | 9.0 (3.1) | 9.9 (4.7) |
4-week endpoint | |||
Mean (SD) | 14.2 (11.6) | 7.7 (1.9) | 9.0 (4.5) |
Mean change from baseline (SD) | −4.8 (12.9) | −1.3 (1.9) | −0.9 (2.8) |
Mean % change from baseline (SD) | −6.8 (32.2) | −12.6 (12.7) | −4.6 (26.9) |