Table 2 Changes from baseline in cholesterol content of LDL subfractions
Study 565 | Study 566a | Study 1003 | |||||
|---|---|---|---|---|---|---|---|
Placebo | Alirocumab 150 mg Q2W | Placebo + ATV 80 mg | Alirocumab 150 mg Q2W + ATV 10 mg | Alirocumab 150 mg Q2W + ATV 80 mg | Placebo | Alirocumab 150 mg Q2W | |
n = 31 | n = 29 | n = 26 | n = 26 | n = 29 | n = 14 | n = 16 | |
Total LDL-C | |||||||
Baseline | 115.2 (27.3) | 109.6 (24.8) | 120.1 (24.4) | 123.0 (24.0) | 122.1 (33.4) | 141.4 (34.1) | 135.7 (28.2) |
Post-treatmentb | 111.1 (25.1) | 34.5 (14.9) | 97.7 (37.7) | 43.5 (15.3) | 44.6 (25.5) | 130.4 (32.0) | 53.4 (34.2) |
% change from baseline | −1.1 (21.3) | −67.5 (13.6)** | −17.3 (29.9) | −64.6 (11.9)** | −62.2 (22.5)** | −6.9 (13.7) | −60.3 (25.8)** |
LDLr-C | |||||||
Baseline | 90.5 (25.0) | 85.6 (22.5) | 95.0 (22.3) | 96.9 (21.7) | 96.0 (29.2) | 110.3 (28.9) | 103.6 (24.1) |
Post-treatmentb | 87.2 (21.6) | 21.5 (12.5) | 75.9 (32.4) | 27.7 (12.6) | 29.6 (22.5) | 100.6 (24.4) | 36.8 (29.9) |
% change from baseline | 0.1 (24.6) | −74.9 (14.4)** | −18.6 (32.5) | −71.6 (11.5)** | −68.7 (22.9)** | −7.1 (15.5) | −64.7 (28.6)** |
LDL1-C | |||||||
Baseline | 18.7 (6.3) | 16.2 (5.6) | 19.8 (7.0) | 19.2 (7.7) | 19.7 (9.2) | 23.3 (10.2) | 25.9 (9.9) |
Post-treatmentb | 17.0 (6.9) | 3.6 (2.8) | 14.7 (9.2) | 5.3 (3.5) | 4.9 (4.9) | 21.9 (10.8) | 6.8 (6.2) |
% change from baseline | −7.5 (24.4) | −76.9 (20.8)** | −18.4 (59.4) | −72.5 (16.4) | −40.7 (201.0) | 1.0 (39.1) | −68.9 (41.3)** |
LDL2-C | |||||||
Baseline | 22.3 (11.7) | 20.3 (10.9) | 29.4 (13.8) | 24.5 (12.3) | 27.6 (15.6) | 30.7 (17.5) | 31.5 (17.1) |
Post-treatmentb | 17.8 (12.5) | 3.0 (4.4) | 21.5 (16.1) | 4.5 (4.9) | 5.5 (8.4) | 27.5 (13.7) | 7.8 (11.9) |
% change from baseline | 2.9 (140.9) | −84.2 (26.2)* | −24.7 (48.5) | −83.7 (13.0)** | −83.4 (20.0)** | −2.6 (39.1) | −77.9 (26.1)** |
LDL3-C | |||||||
Baseline | 39.1 (15.2) | 37.1 (13.5) | 37.6 (14.8) | 40.6 (14.0) | 37.2 (16.4) | 43.7 (13.2) | 36.6 (12.5) |
Post-treatmentb | 38.2 (12.2) | 9.1 (6.6) | 30.5 (13.2) | 11.0 (6.3) | 11.7 (10.1) | 39.9 (12.0) | 15.2 (12.8) |
% change from baseline | 4.7 (31.6) | −74.8 (20.4)** | −5.5 (63.5) | −71.5 (18.0)** | −64.9 (29.7)** | −5.0 (25.9) | −58.1 (33.9)** |
LDL4-C | |||||||
Baseline | 10.4 (7.1) | 12.1 (9.0) | 8.3 (6.4) | 12.7 (8.5) | 11.6 (11.6) | 12.7 (9.7) | 9.7 (11.4) |
Post-treatmentb | 14.2 (9.2) | 5.8 (2.5) | 9.2 (5.0) | 7.0 (3.1) | 7.5 (4.0) | 11.2 (6.7) | 7.1 (3.5) |
Absolute change from baseline | 3.9 (8.5) | −6.2 (8.4)** | 0.9 (4.7) | −5.7 (6.5)* | −4.1 (9.3)* | −1.4 (7.5) | −2.6 (9.7)* |
% change from baseline | 84.7 (164.0) | −28.6 (56.4)* | 106.2 (236.9) | −5.6 (133.5) | 51.3 (352.1) | 12.8 (67.4) | 53.7 (156.8) |
LDL1+2-C | |||||||
Baseline | 40.9 (16.6) | 36.5 (13.9) | 49.1 (17.5) | 43.6 (17.9) | 47.2 (21.5) | 54.0 (25.2) | 57.4 (24.9) |
Post-treatmentb | 34.8 (17.8) | 6.6 (6.2) | 36.2 (24.2) | 9.8 (7.9) | 10.4 (12.0) | 49.4 (21.5) | 14.7 (17.6) |
% change from baseline | −10.3 (41.2) | −81.0 (18.9)** | −22.6 (51.5) | −78.8 (13.1) | −22.4 (312.6) | −1.8 (28.9) | −74.2 (30.6)** |
LDL3+4-C | |||||||
Baseline | 49.5 (18.1) | 49.2 (19.6) | 45.9 (18.0) | 53.2 (18.0) | 48.8 (26.1) | 56.4 (19.9) | 46.3 (22.7) |
Post-treatmentb | 52.4 (15.8) | 14.9 (8.1) | 39.7 (14.1) | 18.0 (7.8) | 19.2 (13.4) | 51.1 (16.1) | 22.3 (14.5) |
% change from baseline | 15.0 (41.4) | −68.5 (18.0)** | −0.9 (57.9) | −64.1 (18.8)** | −55.2 (30.8)** | −4.5 (27.3) | −48.8 (31.2)** |