Table 2.
Safety summary (pool of DM-INSULIN and DM-DYSLIPIDEMIA; safety population)
| n (%) | Alirocumab (n = 213) | Control (n = 104) |
|---|---|---|
| TEAEs | 142 (66.7) | 70 (67.3) |
| Treatment-emergent SAEs | 28 (13.1) | 10 (9.6) |
| TEAEs leading to death | 1 (0.5) | 1 (1.0) |
| TEAEs occurring in ≥ 2% of individuals by preferred term | ||
| Urinary tract infection | 8 (3.8) | 6 (5.8) |
| Diarrhea | 8 (3.8) | 6 (5.8) |
| Hypertension | 8 (3.8) | 4 (3.8) |
| Influenza | 7 (3.3) | 4 (3.8) |
| Headache | 7 (3.3) | 1 (1.0) |
| Musculoskeletal pain | 7 (3.3) | 3 (2.9) |
| Nasopharyngitis | 6 (2.8) | 5 (4.8) |
| Back pain | 6 (2.8) | 2 (1.9) |
| Dizziness | 6 (2.8) | 3 (2.9) |
| Fatigue | 5 (2.3) | 3 (2.9) |
| Cataract | 5 (2.3) | 1 (1.0) |
| Myalgia | 5 (2.3) | 1 (1.0) |
| Nausea | 4 (1.9) | 3 (2.9) |
| Pain in extremity | 4 (1.9) | 3 (2.9) |
| Arthralgia | 3 (1.4) | 3 (2.9) |
| Bronchitis | 3 (1.4) | 3 (2.9) |
| Hypotension | 2 (0.9) | 3 (2.9) |
| Cough | 1 (0.5) | 3 (2.9) |
| Hyperglycemia | 0 (0.0) | 3 (2.9) |
SAE serious adverse event, TEAE treatment-emergent adverse event