Table 1.
Association between PCSK9 monoclonal antibodies and the risk of new-onset diabetes mentioned in the manuscript.
| Trail | N | Duration | Target population | Study groups | Change of lipid profile | Change of glucose spectrum | Risk of new-onset diabetes incidence VS placebo |
|---|---|---|---|---|---|---|---|
| Open-Label OSLER-1 Extension Study [75] |
1,324 | ≥208weeks | – | Evolocumab, 420 mg monthly |
LDL-C decreased by 58% | FPG did not change significantly | No significant difference |
| FOURIER randomized controlled trial [76] | 27,564 | 2.2 years | Patients with ASCVD and LDL-C ≥1.8 mmol/L | Evolocumab, 140 mg fortnightly or 420 mg monthly | LDL-C decreased by 59%, non-HDL decreased by 52% Apo B decreased by 49% |
HbA1c and FPG did not change significantly |
No significant Difference (HR of 1.05; 95% CI, 0.94 to 1.17) |
| GLAGOV Randomized Clinical Trial [77] |
968 | 78 weeks | Patients with angiographic coronary disease treating statins |
Evolocumab, 420 mg monthly | LDL-C decreased by 60.7% | Glucose and HbA1c did not change significantly |
No significant difference |
| FOURIER randomized controlled trial [78] | 2,341 | 78 weeks | Patients with LDL-C ≥1.8 mmol/L and a maximum tolerated dose of statins at high risk of cardiovascular events |
Alirocumab, 150 mg fortnightly | LDL-C decreased by 62% | No information | No significant Difference (P = 0.84) |
| ODYSSEY FH I and FH II [79] | 735 | 78 weeks | Patients with familial hypercholesterolemia and LDL-C ≥1.8 mmol/L | Alirocumab, 75 mg fortnightly | LDL-C decreased by 57.9% (FH I) and 51.4% (FH II) |
No significant difference | |
| Meta-analysis [80] | 26,123 | – | – | Alirocumab or Evolocumab | No information | FPG and HbA1c did not change significantly |
No significant difference(HR of 1.05; 95% CI, (0.95–1.16) |
| Meta-analysis [81] | 65,957 | ≥12 weeks | – | Alirocumab or Evolocumab | No information | No significant difference (HR of 0.97; 95% CI, 0.91–1.02; P = 0.22) |
|
| Meta-analysis [82] | 68,123 | 78 weeks | – | Alirocumab, Evolocumab, or Bococizumab |
No information | FPG and HbA1c increased | No significant difference (HR of 1.04; 95% CI, 0.96–1.13; P = 0.427) |