Table 2.
Overview of TEAEs (safety population)
| n (%) | Alirocumab (n = 128) | Usual carea (n = 58) |
|---|---|---|
| Any TEAE | 86 (67.2) | 41 (70.7) |
| Any treatment-emergent SAE | 8 (6.3) | 3 (5.2) |
| Any TEAE leading to death | 0 | 0 |
| Any TEAE leading to permanent treatment discontinuation | 4 (3.1) | 2 (3.4) |
| TEAEs occurring in ≥ 2% of individuals (preferred level term)b | ||
| Anemia | 3 (2.3) | 0 |
| Arthralgia | 2 (1.6) | 4 (6.9) |
| Back pain | 1 (0.8) | 2 (3.4) |
| Bronchitis | 1 (0.8) | 5 (8.6) |
| Cellulitis | 3 (2.3) | 0 |
| Cough | 1 (0.8) | 3 (5.2) |
| Diarrhea | 6 (4.7) | 4 (6.9) |
| Dizziness | 2 (1.6) | 2 (3.4) |
| Dyspnea | 1 (0.8) | 2 (3.4) |
| Fall | 3 (2.3) | 2 (3.4) |
| Fatigue | 5 (3.9) | 1 (1.7) |
| Headache | 2 (1.6) | 3 (5.2) |
| Hyperinsulinemic hypoglycemia | 3 (2.3) | 0 |
| Hypoglycemia | 2 (1.6) | 2 (3.4) |
| Hypotension | 1 (0.8) | 2 (3.4) |
| Influenza | 6 (4.7) | 2 (3.4) |
| Injection-site bruising | 3 (2.3) | 0 |
| Injection-site pruritus | 4 (3.1) | 0 |
| Injection-site reaction | 5 (3.9) | 0 |
| Muscle spasms | 3 (2.3) | 1 (1.7) |
| Musculoskeletal pain | 4 (3.1) | 2 (3.4) |
| Myalgia | 3 (2.3) | 1 (1.7) |
| Nausea | 4 (3.1) | 2 (3.4) |
| Osteoarthritis | 0 | 2 (3.4) |
| Pain in extremity | 1 (0.8) | 2 (3.4) |
| Sinusitis | 1 (0.8) | 2 (3.4) |
| Type 2 diabetes mellitus | 1 (0.8) | 2 (3.4) |
| Upper respiratory tract infection | 5 (3.9) | 2 (3.4) |
| Urinary tract infection | 11 (8.6) | 2 (3.4) |
| Viral upper respiratory tract infection | 7 (5.5) | 1 (1.7) |
| Vitamin D deficiency | 0 | 2 (3.4) |
SAE serious adverse event, TEAE treatment-emergent adverse event
aOptions included ezetimibe, fenofibrate, no additional lipid-lowering therapy, omega-3 fatty acid, and nicotinic acid
bGiven in alphabetical order