Table 3.
Response to PCSK9 inhibitor therapy.
| Variable | Usual Responders | All Unusual Responders | True Unusual Respondersa |
|---|---|---|---|
| N | 357 | 54 | 31 |
| Lipid parameters at baseline (median [IQR]) | |||
| LDL-Cb | 132 (102–170) | 121.5 (91.5–169.8) | 133 (104.5–191.5) (NS) |
| Lp(a)b | 30 (11–97) | 80 (23–127) | 73.5 (27.5–118.3) (NS) |
| PCSK9c | 361.1 (284.5–500.8) | 408 (267.3–523.3) | 358.5 (253.5–460) (NS) |
| Lipid parameters post 3rd dose (at 1 month) (median [IQR]) | |||
| LDL-Cb | 50 (31–74) | 95 (71–127) | 100 (80.3–160.8) (p < 0.001) |
| % change from baseline | −61.1 (−49, −72.4) | −24.7 (−14, −37.5) | −23.3 (−14.2, −26.9) (p < 0.001) |
| Lp(a)b | 28.5 (7–88.3) | 66 (32–109) | 81 (15–129) (NS) |
| % change from baseline | −16 (−0.3, −31.1) | −6.5 (2.3, −14.9) | 0 (14.7, −11.1) (p < 0.01) |
| PCSK9c | 3584.5 (2712–4613.9) | 3635.5 (2337.2–5165) | 3762.4 (2212.5–5161.3) (NS) |
| fold change from baseline | 9.9 (7.6, 12.4) | 9.5 (6.6, 13.3) | 10.4 (7.9, 14.4) (NS) |
| Lipid parameters at 6 months (median [IQR]) | |||
| LDL-Cb | 47 (30–69.3) | 69 (52–113) | 94 (68.5–167.5) (p < 0.001) |
| % change from baseline | −64.5 (−50.8, −74.6) | −35.2 (−21.9, −51.5) | −33.7 (−25.4, −49.5) (p < 0.001) |
| Lp(a)b | 52 (9–95) | 80 (23–115) | 82.5 (49.8–111.3) (NS) |
| % change from baseline | −21.1 (−10, −33.2) | −12.5 (1.8, −17.8) | −3 (3.1, −12.5) (p < 0.01) |
| PCSK9c | 3713.6 (2759.1–4519.4) | 3493.4 (2321.1–4196.7) | 1415.8 (1126.5–2170.4) (NS) |
| fold increase from baseline | 10.3 (7.7, 13.1) | 8.3 (4.6, 12.5) | 7 (3.4, 11.1) (NS) |
| Lipid parameters at 12 months (median [IQR]) | |||
| LDL-Cb | 51 (35–68) | 87 (60.5–110) | 96 (71–128) (p < 0.001) |
| % change from baseline | −62 (−51.4, −72.1) | −35 (−21.3, −49.3) | −34 (−27.6, −40.9) (p < 0.001) |
| Lp(a)b | 43.5 (7–109.8) | 83 (48–124) | 92.5 (83.8–128.5) (p < 0.05) |
| % change from baseline | −18.5 (−3.5, −33.3) | −10 (−3.6, −16.8) | −12.5 (3.5, −17.3) (NS) |
| PCSK9c | 3602.2 (2827.3–4903.9) | 3412.5 (2337.7–4067.4) | 2892 (1784.9–3563.9) (NS) |
| fold change from baseline | 10.5 (7.4, 12.9) | 5.8 (4.9, 11.3) | 7.3 (4.5, 12.4) (NS) |
IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol; Lp(a), lipoprotein (a); N, number; NS, not significant; PCSK9, protein convertase subtilisin/kexin type 9.
P values show significance of differences between true unusual responders and usual responders.
a
Without adherence complications: regression of lifestyle interventions, discontinuing background lipid-lowering therapy, discontinuing PCSK9i, and/or suboptimal dose. of PCSK9i.
b
mg/dL.
c
ng/dL.