From 7 732 656 screened FAERS cases, we omitted 7 713 888 and qualified 18 768 events, which included 5398 cardiac, 4594 haemorrhagic, 634 thrombotic, 1689 all-cause death, and 6453 other adverse events. Of the 13 234 cases qualified for clopidogrel, 3839 (29.0%) were cardiac, 2777 (21.0%) were haemorrhagic, 386 (2.9%) were thrombotic, 1156 (8.7%) were all-cause death, and 5076 (38.4%) were other (Table 1). Of the 2927 cases qualified for prasugrel, 505 (17.3%) were cardiac, 1312 (44.8%) were haemorrhagic, 61 (2.1%) were thrombotic, 151 (5.2%) were all-cause death, and 898 (30.6%) were kept as other. Of the 2607 cases qualified for ticagrelor, 1054 (40.4%) were cardiac, 505 (19.4%) were haemorrhagic, 187 (7.2%) were thrombotic, 382 (14.7%) were all-cause death, and 479 (18.3%) were other (Table 1). Comparing ticagrelor to clopidogrel, reported cardiac (relative odds ratio (ROR) = 1.66, proportional reporting ratio (PRR) = 1.39, =132.55, P = NS), haemorrhagic (ROR = 0.91, PRR = 0.92, =3.35, P = NS), were not significantly different, while all-cause death events (ROR = 1.79, PRR = 1.68, =86.30, P = 1.52e−20) and thrombotic events (ROR = 2.57, PRR = 2.46, =112.00, P = 3.66 × 10−26) were significantly worse for ticagrelor compared to clopidogrel (Table 2). Comparing ticagrelor to prasugrel, reported cardiac (ROR = 3.25, PRR = 2.34, =364.8, P = 2.43 × 10−81), thrombotic (ROR = 3.63, PRR = 3.44, =82.20, P = 1.21 × 10−19), and all-cause death events (ROR = 3.16, PRR = 2.84, =141.7, P = 1.13e−32) were significantly worse for ticagrelor, while reported haemorrhagic events (ROR = 0.30, PRR = 0.43, =403.9, P = 7.71 × 10−90) were significantly lower for ticagrelor. Comparing clopidogrel to prasugrel, reported cardiac (ROR = 1.96, PRR = 1.68, =167.90, P = NS), thrombotic (ROR = 1.41, PRR = 1.40, =5.87, P = NS), and all-cause death (ROR = 1.76, PRR = 1.69, =40.76, P = NS) were not significantly different, while reported haemorrhagic events (ROR = 0.33, PRR = 0.47, =719.50, P < 0.0001) significantly favoured clopidogrel.
The 2015 adverse event profile co-reported with oral P2Y12 platelet inhibitors in FDA Adverse Event Reporting System
Adverse event . | Clopidogrel (%) . | Prasugrel (%) . | Ticagrelor (%) . |
---|---|---|---|
Cardiac | 3839 (29.0%) | 505 (17.3%) | 1054 (40.4%) |
Haemorrhagic | 2777 (21.0%) | 1312 (44.8%) | 505 (19.4%) |
Thrombotic | 386 (2.9%) | 61 (2.1%) | 187 (7.2%) |
All-cause death | 1156 (8.7%) | 151 (5.2%) | 382 (14.7%) |
Other | 5076 (38.4%) | 898 (30.6%) | 479 (18.3%) |
Total events | 13 234 (100%) | 2927 (100%) | 2607 (100%) |
Adverse event . | Clopidogrel (%) . | Prasugrel (%) . | Ticagrelor (%) . |
---|---|---|---|
Cardiac | 3839 (29.0%) | 505 (17.3%) | 1054 (40.4%) |
Haemorrhagic | 2777 (21.0%) | 1312 (44.8%) | 505 (19.4%) |
Thrombotic | 386 (2.9%) | 61 (2.1%) | 187 (7.2%) |
All-cause death | 1156 (8.7%) | 151 (5.2%) | 382 (14.7%) |
Other | 5076 (38.4%) | 898 (30.6%) | 479 (18.3%) |
Total events | 13 234 (100%) | 2927 (100%) | 2607 (100%) |
The 2015 adverse event profile co-reported with oral P2Y12 platelet inhibitors in FDA Adverse Event Reporting System
Adverse event . | Clopidogrel (%) . | Prasugrel (%) . | Ticagrelor (%) . |
---|---|---|---|
Cardiac | 3839 (29.0%) | 505 (17.3%) | 1054 (40.4%) |
Haemorrhagic | 2777 (21.0%) | 1312 (44.8%) | 505 (19.4%) |
Thrombotic | 386 (2.9%) | 61 (2.1%) | 187 (7.2%) |
All-cause death | 1156 (8.7%) | 151 (5.2%) | 382 (14.7%) |
Other | 5076 (38.4%) | 898 (30.6%) | 479 (18.3%) |
Total events | 13 234 (100%) | 2927 (100%) | 2607 (100%) |
Adverse event . | Clopidogrel (%) . | Prasugrel (%) . | Ticagrelor (%) . |
---|---|---|---|
Cardiac | 3839 (29.0%) | 505 (17.3%) | 1054 (40.4%) |
Haemorrhagic | 2777 (21.0%) | 1312 (44.8%) | 505 (19.4%) |
Thrombotic | 386 (2.9%) | 61 (2.1%) | 187 (7.2%) |
All-cause death | 1156 (8.7%) | 151 (5.2%) | 382 (14.7%) |
Other | 5076 (38.4%) | 898 (30.6%) | 479 (18.3%) |
Total events | 13 234 (100%) | 2927 (100%) | 2607 (100%) |
Statistical comparison of clopidogrel, prasugrel, and ticagrelor and co-reported adverse reactions
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Cells highlighted in red or green reach the threshold criteria for a significant signal specified by Evans et al.9 Cells highlighted in tan have a PRR that approaches, but does not reach, the threshold for a significant signal, and thus represent a trend towards significance.
NS, not significant; PRR, proportional reporting ratio; ROR, relative odds ratio.
Statistical comparison of clopidogrel, prasugrel, and ticagrelor and co-reported adverse reactions
![]() |
![]() |
Cells highlighted in red or green reach the threshold criteria for a significant signal specified by Evans et al.9 Cells highlighted in tan have a PRR that approaches, but does not reach, the threshold for a significant signal, and thus represent a trend towards significance.
NS, not significant; PRR, proportional reporting ratio; ROR, relative odds ratio.
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