Musculoskeletal Adverse Events Associated with PCSK9 Inhibitors: Disproportionality Analysis of the FDA Adverse Event Reporting System
Table 1
Characteristics of reports of interest reported by health professionals in FAERS from 2015 quarter 4 to 2021 quarter 2 of PCSK9 inhibitors.
PCSK9 inhibitors regimen
All reports
PCSK9 inhibitors monotherapy
Statin+PCSK9
Statin monotherapy
Cases
Noncases
Cases
Noncases
Cases
Noncases
Number
53979
3088
50502
97
292
7817
37516
Sex
T\I
3 (0.01%)
—
3
—
—
1
—
Missing
2949 (5.46%)
218
2694
8
29
696
3966
Female
29386 (54.44%)
1507
27744
32
103
2956
16357
Male
21641 (40.09%)
1363
20061
57
160
4164
17193
Age, years
Median
68
67
67
55
61
67
68
Interquartile range
60-75
61-74
60-74
51-65
45.25-71
58-74
59-76
0-18 years
32 (0.06%)
2
25
1
4
39
216
19-44 years
864 (1.60%)
44
781
10
29
286
1409
45-64 years
14399 (26.68%)
762
13514
44
79
2382
10041
65-74 years
14354 (26.59%)
751
13538
11
54
2130
9261
≥75 years
8871 (16.43%)
449
8375
9
38
1564
8996
Missing
15459 (28.64%)
1080
14269
22
88
1416
7593
Reporter occupation
Missing
831 (1.54%)
45
781
3
2
598
2442
Pharmacist
5460 (10.12%)
304
5043
24
89
2101
10057
Physician
39214 (72.65%)
2195
36809
51
159
2996
15528
Other health professionals
8474 (15.70%)
544
7869
19
42
2122
9489
Reporting year
2015
548 (1.02%)
43
505
—
—
234
1266
2016
4047 (7.50%)
359
3673
3
12
1096
5212
2017
4420 (8.19%)
311
4058
16
35
1109
4538
2018
26657 (49.38%)
1639
24929
23
66
1452
6304
2019
7684 (14.24%)
385
7239
13
47
1549
7866
2020
6915 (12.81%)
263
6546
27
79
1718
8318
2021 (Q1,Q2)
3708 (6.87%)
88
3552
15
53
659
4012
Top 5 reporter countries
USA (51634, 95.65%)
USA (2896)
USA (48615)
USA (29)
USA (94)
USA (2316)
USA (10379)
Germany (394, 0.73%)
Germany (50)
Germany (289)
Germany (25)
Canada (53)
England (953)
France (6937)
Canada (390, 0.72%)
Canada (34)
Canada (284)
Canada (19)
Japan (36)
France (695)
England (4447)
Japan (281, 0.55%)
Netherlands (14)
Japan (224)
Japan (9)
Germany (30)
Germany (592)
Canada (2645)
England (204, 0.37%)
Japan (12)
England (184)
Belgium (4)
ES (15)
Italy (534)
Germany (1541)
Outcome$
DE#
695 (7.36%)
5
665
—
25
366
3278
LT#
208 (2.20%)
6
162
1
39
582
1960
HO#
2977 (31.54%)
99
2807
15
56
2809
12075
DS#
156 (1.65%)
29
122
1
4
416
1127
CA#
5 (0.05%)
0
1
—
4
2
131
RI#
12 (0.13%)
2
10
—
—
21
16
OT#
5448 (57.72%)
463
4820
59
106
2341
12582
Missing#
44478 (82.40%)
2484
41915
21
58
1280
6347
$Since there are more than one outcomes of seriousness in a single report, the final level of seriousness for the single report was as the following orders: death > life threatening > hospitalization > disability > congenital anomaly > required intervention > other serious. The percentage of individual income is calculated based on the available data. #DE: death; LT: life-threatening; HO: required hospitalization or prolongation of existing hospitalization; DS: disability; CA: congenital anomaly or birth defect; RI: required intervention to prevent permanent impairment/damage; OT: other serious medical events.
