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 n (%)
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