Table 2. Safety of inclisiran.
N/A = not available
Author, Year | Trial name | Most common adverse events (number of events) | ||
Adverse events | Inclisiran Group | Placebo Group | ||
Fitzgerald et al., 2014 [6] | N/A | Infusion site hematoma | 1 | 1 |
Paresthesia | 3 | |||
Rash | 12 | 4 | ||
Headache | 5 | 2 | ||
Fitzgerald et al., 2016 [7] | N/A | Nasopharyngitis | 7 | N/A |
Diarrhea | 4 | |||
Back pain | 5 | |||
Headache | 6 | |||
Fitzgerald et al., 2017 [7,8] | ORION-1 | Injection site reaction | 19 | -- |
Myalgias | 27 | 6 | ||
Raal et al., 2019 [9] | ORION-2 | Paresthesia | 1 1 | N/A |
Unstable angina | 1 | |||
Wright et al., 2020 [10] | ORION-7 | Cough | 4 | N/A |
Nasopharyngitis | 1 | |||
Headache | 2 | |||
Fatigue | 2 | |||
Raal et al., 2020 [11] | ORION-9 | Nasopharyngitis | 28 | 20 |
Influenza | 13 | 21 | ||
Upper respiratory tract infections | 16 | 16 | ||
Back pain | 17 | 10 | ||
Injection site reaction | 22 | 0 | ||
Ray et al., 2020 [12] | ORION-10 | Death from cardiovascular events | 7 | 5 |
Diabetes mellitus | 120 | 108 | ||
Bronchitis | 46 | 30 | ||
Injection site reaction (mild and moderate) | 20 | 7 | ||
Ray et al., 2020 [12] | ORION-11 | Death from cardiovascular events | 9 | 10 |
Injection site reaction | 38 | 4 | ||
Nasopharyngitis | 91 | 90 | ||
Diabetes mellitus | 88 | 94 |