Table 4.
Summary results ‐ biomarker analyses at 1 year
|
Number of studies |
Number of PCSK9 participants |
Number of comparator arm participants |
Fixed‐effect (95% CI) |
Random‐effects (95% CI) |
Between‐study heterogeneity P value |
|
| Placebo comparison | ||||||
| LDL‐C % change | 6 | 29865 | 28694 | ‐52.80 (‐53.46 to 52.14) | ‐52.87 (‐60.03 to ‐45.72) | < 0.001 |
| HDL‐C % change | 4 | 14528 | 14127 | 5.55 (5.07 to 6.03) | 6.06 (4.30 to 7.82) | 0.102 |
| Triglycerides % change | 3 | 14319 | 14020 | ‐12.53 (‐15.45 to ‐9.61) | ‐12.53 (‐15.45 to ‐9.61) | 0.679 |
| Total cholesterol % change | 2 | 808 | 409 | ‐31.33 (‐33.80 to ‐28.86) | ‐28.47 (‐38.85 to ‐18.10) | < 0.001 |
| Apolipoprotein A1 % change | 1 | 599 | 302 | 3.00 (1.31 to 4.69) | ||
| Apolipoprotein B % change | 4 | 14528 | 14127 | ‐47.18 (‐48.29 to ‐48.29) | ‐43.51 (‐48.88 to ‐38.13) | < 0.001 |
| Lipoprotein(a) % change | ||||||
| Non‐HDL‐C % change | 2 | 808 | 409 | ‐47.16 (‐50.77 to ‐43.55) | ‐43.46 (‐57.45 to ‐29.47) | 0.001 |
| Glucose (mg/dL) absolute change* | 2 | 13720 | 13718 | 1.80 (0.61 to 2.99) | ||
| HbA1c absolute change* | 2 | 13720 | 13718 | 0.02 (‐0.01 to 0.05) | ||
| Ezetimibe and statin comparison | ||||||
| LDL‐C % change | 1 | 2976 | 1489 | ‐58.40 (‐60.40 to ‐56.40) | ||
| HDL‐C % change | 1 | 736 | 368 | 5.40 (3.09 to 7.71) | ||
| Triglycerides % change | 1 | 736 | 368 | ‐10.00 (‐13.59 to ‐6.41) | ||
| Total cholesterol % change | ||||||
| Apolipoprotein A1 % change | 1 | 736 | 368 | 4.30 (2.61 to 5.99) | ||
| Apolipoprotein B % change | 1 | 736 | 368 | ‐38.80 (‐41.18 to ‐36.42) | ||
| Lipoprotein(a) % change | 1 | 736 | 368 | ‐20.80 (‐23.95 to ‐17.65) | ||
| Non‐HDL‐C % change | 1 | 736 | 368 | ‐44.00 (‐46.77 to ‐41.23) | ||
| Glucose (mg/dL) absolute change* | ||||||
| HbA1c absolute change | ||||||
*On the basis of the combined analysis of SPIRE‐1 and SPIRE‐2, study‐specific estimates were unavailable, hence no random‐effects or between‐study heterogeneity estimates could be calculated