Table 2.
Safety data for patients with DM and ASCVD in placebo‐controlled and ezetimibe‐controlled pools
| Placebo‐controlled pools (n = 656) | Ezetimibe‐controlled pool (n = 322) | |||
|---|---|---|---|---|
| n (%) | Alirocumab (n = 437) | Placebo (n = 222) | Alirocumab (n = 199) | Ezetimibe (n = 123) |
| TEAEs | 358 (81.9) | 179 (80.6) | 162 (81.4) | 93 (75.6) |
| Treatment‐emergent SAEs | 110 (25.2) | 67 (30.2) | 45 (22.6) | 22 (17.9) |
| TEAEs leading to death | 5 (1.1) | 4 (1.8) | 2 (1.0) | 2 (1.6) |
| TEAEs leading to discontinuation | 33 (7.6) | 13 (5.9) | 22 (11.1) | 18 (14.6) |
| TEAEs in ≥5% of individuals | ||||
| Nasopharyngitis | 53 (12.1) | 21 (9.5) | 8 (4.0) | 5 (4.1) |
| Upper respiratory tract infection | 38 (8.7) | 25 (11.3) | 11 (5.5) | 11 (8.9) |
| Urinary tract infection | 30 (6.9) | 16 (7.2) | 6 (3.0) | 2 (1.6) |
| Hypertension | 22 (5.0) | 7 (3.2) | 13 (6.5) | 5 (4.1) |
| Influenza | 22 (5.0) | 11 (5.0) | 10 (5.0) | 9 (7.3) |
| Injection‐site reaction | 22 (5.0) | 6 (2.7) | 5 (2.5) | 1 (0.8) |
| Bronchitis | 23 (5.3) | 19 (8.6) | 9 (4.5) | 7 (5.7) |
| Arthralgia | 16 (3.7) | 16 (7.2) | 7 (3.5) | 4 (3.3) |
| Myalgia | 14 (3.2) | 8 (3.6) | 8 (4.0) | 8 (6.5) |
| Osteoarthritis | 13 (3.0) | 7 (3.2) | 7 (3.5) | 7 (5.7) |
| Pain in extremity | 13 (3.0) | 13 (5.9) | 5 (2.5) | 4 (3.3) |
| Fatigue | 12 (2.7) | 13 (5.9) | 6 (3.0) | 1 (0.8) |
| Accidental overdosea | 7 (1.6) | 4 (1.8) | 17 (8.5) | 5 (4.1) |
| Muscle‐related TEAEs | ||||
| Myalgia | 14 (3.2) | 8 (3.6) | 8 (4.0) | 8 (6.5) |
| Musculoskeletal pain | 12 (2.7) | 4 (1.8) | 0 | 1 (0.8) |
| Muscle spasms | 12 (2.7) | 6 (2.7) | 5 (2.5) | 3 (2.4) |
| Muscle strain | 2 (0.5) | 5 (2.3) | 1 (0.5) | 2 (1.6) |
| Injection‐site reactions | ||||
| Leading to treatment discontinuation | 1/22 (4.5) | 1/6 (16.7) | 1/5 (20.0) | 1/1 (100.0) |
| Severityb | ||||
| Mild | 20/22 (90.9) | 5/6 (83.3) | 4/5 (80.0) | 0/1 (0.0) |
| Moderate | 2/22 (9.1) | 1/6 (16.7) | 1/5 (20.0) | 0/1 (0.0) |
| Severe | 0/22 (0.0) | 0/6 (0.0) | 0/5 (0.0) | 1/1 (100.0) |
Abbreviations: ASCVD, atherosclerotic cardiovascular disease; DM, diabetes mellitus; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.
a
Accidental or intentional administration of study drug at a frequency higher than that allowed by study protocol, if associated with an adverse event.
b
Local injection‐site reactions were graded by severity and were characterized by related signs and symptoms such as (but not limited to) redness and pain. Severity was highest if an individual experienced several local injection site reactions.