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. 2023 Aug 29;9(9):e19371. doi: 10.1016/j.heliyon.2023.e19371

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)