Table 4.
Adverse events for atogepant versus placebo
| Outcome or subgroup | Number of studies [References] | Number of pooled events/participants | I2 | Risk ratio (95% CI) | p value | |
|---|---|---|---|---|---|---|
| Atogepant | Placebo | |||||
| Atogepant 10 mg | ||||||
| Any AE | 2 [23, 24] | 178/314 | 218/408 | 85.1% | 1.11 (0.78–1.56)a | 0.566 |
| Any SAE | 3/314 | 4/408 | 0.0% | 1.00 (0.22–4.54) | 0.997 | |
| Discontinuation due to AEs | 13/314 | 11/408 | 0.0% | 1.54 (0.69–3.42) | 0.289 | |
| Constipation | 19/314 | 5/408 | 80.5% | 3.93 (0.20–76.09)a | 0.365 | |
| Nasopharyngitis | 7/314 | 12/408 | 22.2% | 0.75 (0.31–1.84) | 0.532 | |
| Nausea | 16/314 | 13/408 | 24.9% | 1.77 (0.83–3.78) | 0.139 | |
| Upper respiratory tract infection | 15/314 | 25/408 | 0.0% | 0.85 (0.45–1.61) | 0.620 | |
| Urinary tract infection | 5/314 | 12/408 | 0.0% | 0.53 (0.19–1.46) | 0.221 | |
| Atogepant 30 mg | ||||||
| Any AE | 2 [23, 24] | 234/411 | 218/408 | 84.5% | 1.08 (0.79–1.48)a | 0.639 |
| Any SAE | 2/411 | 4/408 | 0.0% | 0.56 (0.12–2.58) | 0.453 | |
| Discontinuation due to AEs | 15/411 | 11/408 | 55.0% | 1.36 (0.63–2.92) | 0.428 | |
| Constipation | 26/411 | 5/408 | 62.3% | 5.19 (2.00–13.46) | 0.001 | |
| Nasopharyngitis | 19/411 | 12/408 | 48.9% | 1.57 (0.77–3.19) | 0.211 | |
| Nausea | 23/411 | 13/408 | 0.0% | 1.77 (0.91–3.44) | 0.093 | |
| Upper respiratory tract infection | 27/411 | 25/408 | 0.0% | 1.08 (0.64–1.82) | 0.782 | |
| Urinary tract infection | 20/411 | 12/408 | 36.8% | 1.65 (0.82–3.34) | 0.160 | |
| Atogepant 60 mg | ||||||
| Any AE | 2 [23, 24] | 231/417 | 218/408 | 61.1% | 1.04 (0.91–1.17) | 0.575 |
| Any SAE | 2/417 | 4/408 | 0.0% | 0.55 (0.12–2.54) | 0.441 | |
| Discontinuation due to AEs | 12/417 | 11/408 | 0.0% | 1.07 (0.48–2.39) | 0.872 | |
| Constipation | 25/417 | 5/408 | 66.4% | 4.92 (1.89–12.79) | 0.001 | |
| Nasopharyngitis | 22/417 | 12/408 | 67.3% | 1.80 (0.90–3.58) | 0.096 | |
| Nausea | 36/417 | 13/408 | 0.0% | 2.73 (1.47–5.06) | 0.001 | |
| Upper respiratory tract infection | 19/417 | 25/408 | 0.0% | 0.75 (0.42–1.33) | 0.324 | |
| Urinary tract infection | 14/417 | 12/408 | 0.0% | 1.14 (0.53–2.43) | 0.740 | |
AE adverse event, CI confidence interval, SAE serious adverse event
aRisk ratio from random-effect model.