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. 2020 Dec 22;44(3):337–349. doi: 10.1007/s40264-020-01021-3

Table 3.

Distribution of Individual Case Safety Reports having alirocumab or evolocumab as the suspected drugs, by therapeutic indication

Variable Level All ICSRs [n = 2041] ICSRs reporting alirocumab as the suspect drug [n = 856] ICSRs reporting evolocumab as the suspect drug [n = 1231]
Therapeutic indication Lipid metabolism disorder 1423b (69.7) 579b (67.6) 870b (70.7)
Cardiovascular disorders 176b (8.6) 55b (6.4) 123b (10)
Product used for unknown indication 635b (31.1) 271b (31.6) 386b (31.3)
Other therapeutic indicationsa 18b (0.8) 7b (0.8) 11b (0.9)

Data are expressed as (%)

ICSRs Individual Case Safety Reports

aOther therapeutic indications: clinical trial participant; diabetes mellitus; disease risk factor; drug intolerance/drug hypersensitivity; hypolipidaemia; ill-defined disorder; intentional overdose; multiple sclerosis; plasmacytoma; product use in unapproved indication; routine health maintenance; dyspnea

bThe sum of therapeutic indications reported in ICSRs is higher than the total number of ICSRs, since more than one therapeutic indication can be reported in each ICSR