Table 3 Changes from baseline in VLDL and remnant-related lipoprotein subfractions and triglycerides
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 VLDL-C | |||||||
Baseline | 25.0 (20.5 to 31.5) | 24.0 (18.0 to 30.0) | 24.0 (20.0 to 29.0) | 24.5 (21.0 to 31.0) | 21.0 (17.0 to 24.0) | 24.0 (18.0 to 33.0) | 26.0 (18.5 to 31.5) |
Post-treatmentb | 24.0 (19.5 to 32.0) | 17.0 (14.0 to 19.0) | 20.0 (17.0 to 26.0) | 20.0 (17.0 to 23.0) | 16.0 (14.0 to 19.0) | 27.0 (19.0 to 30.0) | 16.5 (15.0 to 20.0) |
% change from baseline | 5.6 (−19.4 to 19.4) | −32.4 (−37.1 to −17.4)** | −13.5 (−26.5 to 6.7) | −24.1 (−36.4 to 5.3) | −26.1 (−38.7 to −10.0)* | −3.6 (−12.8 to 21.4) | −32.2 (−46.5 to −19.6)* |
VLDL1+2-C | |||||||
Baseline | 10.2 (7.8 to 12.2) | 9.3 (6.9 to 13.8) | 9.9 (7.9 to 13.3) | 10.4 (8.3 to 13.9) | 7.5 (6.8 to 10.7) | 9.1 (6.3 to 14.4) | 10.5 (7.5 to 12.5) |
Post-treatmentb | 10.2 (7.9 to 14.0) | 6.2 (5.1 to 7.7) | 7.7 (6.5 to 11.7) | 8.8 (6.7 to 10.1) | 6.3 (5.3 to 8.5) | 9.8 (7.7 to 11.8) | 6.4 (5.4 to 8.7) |
% change from baseline | 12.1 (−21.9 to 27.9) | −34.6 (−41.7 to −20.4)** | −15.1 (−31.1 to 14.7) | −18.9 (−44.6 to 10.6) | −25.7 (−37.8 to −12.1)* | −8.0 (−16.7 to 24.4) | −33.9 (−49.5 to -–3.7)* |
VLDL3-C | |||||||
Baseline | 15.0 (12.5 to 18.5) | 14.0 (11.0 to 17.0) | 14.0 (12.0 to 17.0) | 14.0 (12.0 to 17.0) | 12.0 (11.0 to 15.0) | 14.5 (12.0 to 18.0) | 15.0 (12.0 to 18.5) |
Post-treatmentb | 14.0 (12.0 to 18.5) | 10.0 (8.0 to 12.0) | 13.0 (10.0 to 15.0) | 11.0 (10.0 to 13.0) | 10.0 (8.0 to 11.0) | 17.0 (11.0 to 18.0) | 10.0 (9.0 to 12.5) |
% change from baseline | 0.0 (−15.5 to 15.9) | −27.3 (−35.3 to −20.0)** | −14.3 (−21.4 to 6.7) | −28.7 (−33.3 to −9.1) | −23.1 (−36.4 to −16.7)* | 0.2 (−12.5 to 11.1) | −32.3 (−42.4 to −18.3)* |
IDL-C | |||||||
Baseline | 16.0 (13.0 to 20.0) | 15.0 (12.0 to 19.0) | 16.0 (13.0 to 20.0) | 17.5 (12.0 to 20.0) | 14.0 (11.0 to 20.0) | 21.0 (14.0 to 22.0) | 22.5 (17.5 to 26.0) |
Post-treatmentb | 15.0 (12.5 to 20.0) | 7.0 (4.0 to 9.0) | 11.5 (9.0 to 16.0) | 8.0 (6.0 to 10.0) | 6.0 (5.0 to 8.0) | 20.0 (16.0 to 24.0) | 8.0 (5.5 to 9.5) |
% change from baseline | −2.9 (−16.5 to 12.7) | −53.9 (−63.6 to −50.0)** | −22.5 (−42.1 to 7.1) | −51.5 (−63.6 to −37.5)* | −57.1 (−72.7 to −41.7)** | −10.0 (−27.3 to–15.8) | −68.6 (−73.1 to −49.2)** |
Triglycerides | |||||||
Baseline | 132.0 (104.0 to 204.5) | 148.0 (102.0 to 194.0) | 135.0 (102.0 to 154.0) | 149.5 (99.0 to 179.0) | 124.0 (90.0 to 149.0) | 140.5 (100.0 to 211.0) | 131.5 (109.5 to 179.0) |
Post-treatmentb | 143.0 (115.0 to 210.5) | 94.0 (78.0 to 152.0) | 119.0 (87.0 to 180.0) | 117.0 (86.0 to 162.0) | 92.0 (72.0 to 116.0) | 140.0 (93.0 to 162.0) | 114.5 (99.0 to 144.0) |
% change from baseline | 2.4 (−15.9 to 33.9) | −21.7 (−36.8 to 3.4)* | −11.6 (−29.8 to 22.5) | −13.5 (−31.3 to 18.6) | −24.6 (−39.0 to −8.4)* | −7.0 (−26.3 to 6.6) | −22.2 (−31.3 to −1.9) |
RLP-Cc | |||||||
Baseline | 30.0 (26.0 to 37.0) | 29.0 (24.0 to 35.0) | 32.5 (24.0 to 40.0) | 33.0 (24.0 to 36.0) | 25.0 (21.0 to 35.0) | 36.0 (28.0 to 43.0) | 37.5 (30.5 to 44.5) |
Post-treatmentb | 29.0 (25.0 to 38.0) | 18.0 (13.0 to 20.0) | 24.0 (18.0 to 32.0) | 19.0 (17.0 to 22.0) | 16.0 (14.0 to 18.0) | 36.0 (32.0 to 39.0) | 18.5 (15.0 to 22.0) |
% change from baseline | −4.4 (−14.5 to 9.3) | −42.1 (−50.0 to −34.5)** | −17.7 (−31.4 to 9.5) | −38.7 (−50.0 to −26.7)* | −42.1 (−55.0 to −29.4)** | −8.5 (−18.8 to 18.2) | −52.5 (−61.3 to −34.1)** |