Table 1.
Lipid changes in patients with diabetes treated with PCSK9 inhibitors in selected clinical trials
| References | Trial | No. of NCT | Anti-PCSK9 antibody | No. of patients | Duration (weeks) | LDL-C (%) | Non-HDL-C (%) | TC (%) | TG (%) | Lp(a) (%) | HDL-C (%) | Apo B (%) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taskinen et al.5 | Five phase 3 trials | Alirocumab | 675 DM with dyslipidemia | 24 | −57% | −45% | ||||||
| Leiter et al.6 | ODYSSEY COMB II | 01644188 | Alirocumab | 148 diabetes mellitus | 24 | −49% | −41% | −15% | −20% | +8% | −30% | |
| Muller-Wieland et al.8 | ODYSSEY DM-INSULIN | 02585778 | Alirocumab | 287 T1DM | 24 | −49%a | −38% | −27% | −6% | −19% | +8% | −33% |
| Muller-Wieland et al.8 | ODYSSEY DM-INSULIN | 02585778 | Alirocumab | 49 T1DM | 24 | −49%a | −46% | −14% | −30% | −23% | +11% | −39% |
| Sattar et al.9 | Three phase 3 trials | 01763866 | Evolocumab | 46 T2DM | 12 | −60% | −55% | −38% | −23% | −31% | +7% | |
| 01763918 | ||||||||||||
| 01763905 | ||||||||||||
| Sabatine et al.10 | FOURIER | 01764633 | Evolocumab | 11,031 DM | 48 | −57% |
PCSK9 indicates proprotein convertase subtilsin/kexin type 9; NCT, ClinicalTrials.gov number; LDL-C, low density lipoprotein cholesterol; non-HDL-C, non–high-density lipoprotein cholesterol; TC, total cholesterol; TG, total triglycerides; Lp(a), lipoprotein (a); HDL-C, high-density lipoprotein cholesterol; Apo B, apolipoprotein B; FOURIER, Further cardiovascular Outcomes Research with PCSK9 Inhibition in subjects with Elevated Risk; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus.
a
Data collected at week 12.