Table 1.
The characteristics of GLP-1 RAs-associated gastrointestinal reports.
| Characteristics | All GLP-1 RAs N = 21,281 | Exenatide N = 1,956 | Liraglutide N = 2,819 | Dulaglutide N = 10,757 | Lixisenatide N = 182 | Semaglutide N = 5,567 |
|---|---|---|---|---|---|---|
| Demographics | ||||||
| Gender, n (%) | ||||||
| Female | 7,384 (34.70%) | 682 (34.87%) | 891 (31.61%) | 3,547 (32.97%) | 54 (29.67%) | 2,210 (39.70%) |
| Male | 11,532 (54.19%) | 1,209 (61.81%) | 1,884 (66.83%) | 5,172 (48.08%) | 95 (52.20%) | 3,172 (56.98%) |
| Unknown | 2,365 (11.11%) | 65 (3.32%) | 44 (1.56%) | 2,038 (18.95%) | 33 (18.13%) | 185 (3.32%) |
| Age, n (%) | ||||||
| 0–18 | 15 (0.07%) | 1 (0.05%) | 6 (0.21%) | 5 (0.05%) | 0 (0.00%) | 3 (0.05%) |
| 18–44 | 1,031 (4.84%) | 74 (3.78%) | 286 (10.15%) | 329 (3.06%) | 11 (6.04%) | 331 (5.95%) |
| 45–65 | 4,913 (23.09%) | 533 (27.25%) | 978 (34.69%) | 1,772 (16.47%) | 50 (27.47%) | 1,580 (28.38%) |
| 65+ | 4,446 (20.89%) | 544 (27.81%) | 712 (25.26%) | 1,585 (14.73%) | 46 (25.27%) | 1,559 (28.00%) |
| Unknown | 10,876 (51.11%) | 804 (41.10%) | 837 (29.69%) | 7,066 (65.69%) | 75 (41.21%) | 2,094 (37.61%) |
| Median (IQR) | 62 (54–70) | 64 (56–70) | 60 (50–68) | 62 (54–70) | 63 (53–70) | 63 (54–71) |
| Reporting characteristics | ||||||
| Reporting region, n (%) | ||||||
| North America | 19,450 (91.40%) | 1,834 (93.76%) | 2,331 (82.69%) | 10,041 (93.34%) | 149 (81.87%) | 5,095 (91.52%) |
| Europe | 872 (4.10%) | 68 (3.48%) | 148 (5.25%) | 240 (2.23%) | 13 (7.14%) | 73 (1.31%) |
| Asia | 542 (2.55%) | 35 (1.79%) | 163 (5.78%) | 367 (3.41%) | 6 (3.30%) | 301 (5.41%) |
| Oceania | 233 (1.09%) | 18 (0.92%) | 17 (0.60%) | 32 (0.30%) | 0 (0.00%) | 29 (0.52%) |
| South America | 96 (0.45%) | 1 (0.05%) | 119 (4.22%) | 49 (0.46%) | 8 (4.40%) | 56 (1.01%) |
| Africa | 9 (0.04%) | 0 (0.00%) | 2 (0.07%) | 6 (0.06%) | 0 (0.00%) | 1 (0.02%) |
| Unknown | 79 (0.37%) | 0 (0.00%) | 39 (1.38%) | 22 (0.20%) | 6 (3.30%) | 12 (0.22%) |
| Reporting year, n (%) | ||||||
| 2018 | 4,163 (19.56%) | 608 (31.08%) | 1,128 (40.01%) | 1,925 (17.90%) | 57 (31.32%) | 445 (7.99%) |
| 2019 | 4,468 (21.00%) | 624 (31.90%) | 561 (19.90%) | 2,547 (23.68%) | 56 (30.77%) | 680 (12.21%) |
| 2020 | 4,642 (21.81%) | 412 (21.06%) | 480 (17.03%) | 2,300 (21.38%) | 27 (14.84%) | 1,423 (25.56%) |
| 2021 | 5,048 (23.72%) | 236 (12.07%) | 362 (12.84%) | 2,696 (25.06%) | 30 (16.48%) | 1,724 (30.97%) |
| 2022Q1–Q2* | 2,952 (13.87%) | 76 (3.89%) | 283 (10.04%) | 1,287 (11.96%) | 12 (6.59%) | 1,294 (23.24%) |
| Unknown | 8 (0.04%) | 0 (0.00%) | 5 (0.18%) | 2 (0.02%) | 0 (0.00%) | 1 (0.02%) |
| Occupation of reporters, n (%) | ||||||
| Physician | 2,349 (11.04%) | 200 (10.22%) | 422 (14.97%) | 689 (6.41%) | 55 (30.22%) | 983 (17.66%) |
| Pharmacist | 896 (4.21%) | 26 (1.33%) | 147 (5.21%) | 205 (1.91%) | 1 (0.55%) | 517 (9.29%) |
| Health professional | 1,263 (5.93%) | 29 (1.48%) | 159 (5.64%) | 563 (5.23%) | 16 (8.79%) | 496 (8.91%) |
| Other health-professional | 552 (2.59%) | 22 (1.12%) | 201 (7.13%) | 137 (1.27%) | 14 (7.69%) | 178 (3.20%) |
| Consumer | 15,807 (74.28%) | 1,320 (67.48%) | 1,871 (66.37%) | 9,148 (85.04%) | 96 (52.75%) | 3,372 (60.57%) |
| Lawyer | 14 (0.07%) | 0 (0.00%) | 11 (0.39%) | 2 (0.02%) | 0 (0.00%) | 1 (0.02%) |
| Unknown | 400 (1.88%) | 359 (18.35%) | 8 (0.28%) | 13 (0.12%) | 0 (0.00%) | 20 (0.36%) |
| Indications, n (%) | ||||||
| Diabetes mellitus | 8,741 (41.07%) | 1,154 (59.00%) | 1,202 (42.64%) | 3,926 (36.50%) | 105 (57.69%) | 2,354 (42.28%) |
| Others | 1,822 (8.56%) | 358 (18.30%) | 563 (19.97%) | 357 (3.32%) | 8 (4.40%) | 536 (9.63%) |
| Unknown | 10,718 (50.36%) | 444 (22.70%) | 1,054 (37.39%) | 6,474 (60.18%) | 69 (37.91%) | 2,677 (48.09%) |
| Outcomes, n (%) | ||||||
| Death (Grade 5) | 160 (0.75%) | 24 (1.23%) | 30 (1.06%) | 69 (0.64%) | 4 (2.20%) | 33 (0.59%) |
| Life-Threatening (Grade 4) | 191 (0.90%) | 21 (1.07%) | 45 (1.60%) | 77 (0.72%) | 0 (0.00%) | 48 (0.86%) |
| Those causing hospitalization, disability, or congenital anomaly (Grade 3) | 2,933 (13.78%) | 239 (12.22%) | 582 (20.65%) | 1,176 (10.93%) | 35 (19.23%) | 901 (16.18%) |
| Required Intervention to Prevent (Grade 2) | 160 (0.75%) | 24 (1.23%) | 30 (1.06%) | 69 (0.64%) | 4 (2.20%) | 33 (0.59%) |
| Other Medical Event (Grade 1) | 191 (0.90%) | 21 (1.07%) | 45 (1.60%) | 77 (0.72%) | 0 (0.00%) | 48 (0.86%) |
| The time to onset (days) | ||||||
| [0,30) | 3,234 (15.20%) | 228 (11.66%) | 448 (0.00%) | 1,381 (12.84%) | 32 (17.58%) | 1,145 (20.57%) |
| [30,60) | 299 (1.41%) | 18 (0.92%) | 49 (0.00%) | 58 (0.54%) | 1 (0.55%) | 173 (3.11%) |
| [60,90) | 180 (0.85%) | 11 (0.56%) | 20 (0.00%) | 41 (0.38%) | 1 (0.55%) | 107 (1.92%) |
| [90,120) | 102 (0.48%) | 4 (0.20%) | 14 (0.00%) | 20 (0.19%) | 0 (0.00%) | 64 (1.15%) |
| [120,150) | 54 (0.25%) | 1 (0.05%) | 11 (0.00%) | 14 (0.13%) | 1 (0.55%) | 27 (0.49%) |
| [150,180) | 54 (0.25%) | 4 (0.20%) | 5 (0.00%) | 13 (0.12%) | 1 (0.55%) | 31 (0.56%) |
| [180,360) | 123 (0.58%) | 5 (0.26%) | 29 (0.00%) | 32 (0.30%) | 1 (0.55%) | 56 (1.01%) |
| 360+ | 130 (0.61%) | 11 (0.56%) | 46 (0.00%) | 44 (0.41%) | 0 (0.00%) | 29 (0.52%) |
| Median (IQR) | 1 (0–24) | 1 (0–19.5) | 3 (0–37.75) | 1 (0–7) | 0 (0–11) | 4 (0–40) |
*The first and second quarters of 2022. N, number of total gastrointestinal adverse event reports.