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. 2021 Jul 27;13(7):e16664. doi: 10.7759/cureus.16664

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