Table 2.
Comparison of main TEAEs between atogepant and placebo
| Outcome or Subgroup | Studies | Participants | Statistical Method | Effect Estimate | P | I 2 |
|---|---|---|---|---|---|---|
| TEAEs | 4 | 4256 | RR (M-H, Random, 95% CI) | 1.11 [1.02, 1.21] | 0.02 | 57% |
| Atogepant 10 mg QD | 2 | 722 | RR (M-H, Random, 95% CI) | 1.11 [0.78, 1.56] | 0.57 | 85% |
| Atogepant 30 mg QD | 2 | 819 | RR (M-H, Random, 95% CI) | 1.08 [0.79, 1.48] | 0.64 | 85% |
| Atogepant 60 mg QD | 4 | 1654 | RR (M-H, Random, 95% CI) | 1.09 [0.93, 1.26] | 0.28 | 65% |
| Atogepant 30 mg BID | 2 | 784 | RR (M-H, Random, 95% CI) | 1.17 [1.02, 1.34] | 0.02 | 0% |
| Atogepant 60 mg BID | 1 | 277 | RR (M-H, Random, 95% CI) | 1.18 [0.94, 1.48] | 0.16 | / |
| Treatment-related TEAEs | 4 | 4256 | RR (M-H, Random, 95% CI) | 1.09 [0.98, 1.21] | 0.12 | 51% |
| Atogepant 10 mg QD | 2 | 722 | RR (M-H, Random, 95% CI) | 0.95 [0.81, 1.12] | 0.53 | 0% |
| Atogepant 30 mg QD | 2 | 819 | RR (M-H, Random, 95% CI) | 1.05 [0.74, 1.48] | 0.80 | 60% |
| Atogepant 60 mg QD | 4 | 1654 | RR (M-H, Random, 95% CI) | 1.10 [0.91, 1.33] | 0.32 | 68% |
| Atogepant 30 mg BID | 2 | 784 | RR (M-H, Random, 95% CI) | 1.15 [0.99, 1.35] | 0.07 | 0% |
| Atogepant 60 mg BID | 1 | 277 | RR (M-H, Random, 95% CI) | 1.64 [1.02, 2.63] | 0.04 | / |
| Serious TEAEs | 4 | 4256 | RR (M-H, Fixed, 95% CI) | 1.13 [0.64, 2.01] | 0.67 | 0% |
| Atogepant 10 mg QD | 2 | 722 | RR (M-H, Fixed, 95% CI) | 1.00 [0.22, 4.54] | 1.00 | 0% |
| Atogepant 30 mg QD | 2 | 819 | RR (M-H, Fixed, 95% CI) | 0.56 [0.12, 2.58] | 0.45 | 0% |
| Atogepant 60 mg QD | 4 | 1654 | RR (M-H, Fixed, 95% CI) | 1.72 [0.73, 4.08] | 0.22 | 19% |
| Atogepant 30 mg BID | 2 | 784 | RR (M-H, Fixed, 95% CI) | 1.01 [0.28, 3.73] | 0.98 | 0% |
| Atogepant 60 mg BID | 1 | 277 | RR (M-H, Fixed, 95% CI) | 0.41 [0.02, 8.38] | 0.56 | / |
| Constipation | 4 | 4256 | RR (M-H, Fixed, 95% CI) | 2.55 [1.91, 3.41] | < 0.00001 | 0% |
| Atogepant 10 mg QD | 2 | 722 | RR (M-H, Fixed, 95% CI) | 1.98 [0.97, 4.04] | 0.06 | 0% |
| Atogepant 30 mg QD | 2 | 819 | RR (M-H, Fixed, 95% CI) | 2.14 [1.10, 4.18] | 0.03 | 0% |
| Atogepant 60 mg QD | 4 | 1654 | RR (M-H, Fixed, 95% CI) | 2.74 [1.74, 4.32] | < 0.0001 | 0% |
| Atogepant 30 mg BID | 2 | 784 | RR (M-H, Fixed, 95% CI) | 3.03 [1.54, 5.95] | 0.001 | 0% |
| Atogepant 60 mg BID | 1 | 277 | RR (M-H, Fixed, 95% CI) | 3.07 [0.89, 10.60] | 0.08 | / |
| Nausea | 4 | 4256 | RR (M-H, Fixed, 95% CI) | 2.19 [1.67, 2.87] | < 0.00001 | 0% |
| Atogepant 10 mg QD | 2 | 722 | RR (M-H, Fixed, 95% CI) | 1.77 [0.83, 3.78] | 0.14 | 25% |
| Atogepant 30 mg QD | 2 | 819 | RR (M-H, Fixed, 95% CI) | 1.77 [0.91, 3.44] | 0.09 | 0% |
| Atogepant 60 mg QD | 4 | 1654 | RR (M-H, Fixed, 95% CI) | 2.63 [1.71, 4.05] | < 0.0001 | 0% |
| Atogepant 30 mg BID | 2 | 784 | RR (M-H, Fixed, 95% CI) | 2.10 [1.16, 3.78] | 0.01 | 0% |
| Atogepant 60 mg BID | 1 | 277 | RR (M-H, Fixed, 95% CI) | 2.04 [0.84, 4.97] | 0.12 | / |
| Fatigue | 3 | 3943 | RR (M-H, Fixed, 95% CI) | 1.06 [0.75, 1.51] | 0.73 | 0% |
| Atogepant 10 mg QD | 2 | 722 | RR (M-H, Fixed, 95% CI) | 0.54 [0.16, 1.81] | 0.32 | 0% |
| Atogepant 30 mg QD | 2 | 819 | RR (M-H, Fixed, 95% CI) | 0.71 [0.32, 1.57] | 0.39 | 0% |
| Atogepant 60 mg QD | 3 | 1341 | RR (M-H, Fixed, 95% CI) | 1.02 [0.57, 1.84] | 0.94 | 0% |
| Atogepant 30 mg BID | 2 | 784 | RR (M-H, Fixed, 95% CI) | 1.27 [0.57, 2.79] | 0.56 | 0% |
| Atogepant 60 mg BID | 1 | 277 | RR (M-H, Fixed, 95% CI) | 3.07 [1.13, 8.35] | 0.03 | / |
| Urinary tract infection | 4 | 4256 | RR (M-H, Fixed, 95% CI) | 1.49 [1.05, 2.11] | 0.03 | 0% |
| Atogepant 10 mg QD | 2 | 722 | RR (M-H, Fixed, 95% CI) | 0.53 [0.19, 1.46] | 0.22 | 0% |
| Atogepant 30 mg QD | 2 | 819 | RR (M-H, Fixed, 95% CI) | 1.57 [0.77, 3.19] | 0.21 | 20% |
| Atogepant 60 mg QD | 4 | 1654 | RR (M-H, Fixed, 95% CI) | 1.45 [0.82, 2.57] | 0.21 | 0% |
| Atogepant 30 mg BID | 2 | 784 | RR (M-H, Fixed, 95% CI) | 2.54 [0.97, 6.62] | 0.06 | 0% |
| Atogepant 60 mg BID | 1 | 277 | RR (M-H, Fixed, 95% CI) | 3.07 [0.89, 10.60] | 0.08 | / |
| Nasopharyngitis | 4 | 4256 | RR (M-H, Fixed, 95% CI) | 1.12 [0.82, 1.52] | 0.47 | 10% |
| Atogepant 10 mg QD | 2 | 722 | RR (M-H, Fixed, 95% CI) | 0.75 [0.31, 1.84] | 0.53 | 22% |
| Atogepant 30 mg QD | 2 | 819 | RR (M-H, Fixed, 95% CI) | 1.57 [0.77, 3.19] | 0.21 | 49% |
| Atogepant 60 mg QD | 4 | 1654 | RR (M-H, Fixed, 95% CI) | 1.16 [0.74, 1.80] | 0.52 | 48% |
| Atogepant 30 mg BID | 2 | 784 | RR (M-H, Fixed, 95% CI) | 0.83 [0.38, 1.82] | 0.65 | 0% |
| Atogepant 60 mg BID | 1 | 277 | RR (M-H, Fixed, 95% CI) | 1.53 [0.35, 6.71] | 0.57 | / |
| Upper respiratory tract infection | 3 | 3943 | RR (M-H, Fixed, 95% CI) | 0.86 [0.65, 1.13] | 0.28 | 0% |
| Atogepant 10 mg QD | 2 | 722 | RR (M-H, Fixed, 95% CI) | 0.85 [0.45, 1.61] | 0.62 | 0% |
| Atogepant 30 mg QD | 2 | 819 | RR (M-H, Fixed, 95% CI) | 1.08 [0.64, 1.82] | 0.78 | 0% |
| Atogepant 60 mg QD | 3 | 1341 | RR (M-H, Fixed, 95% CI) | 0.67 [0.39, 1.14] | 0.14 | 0% |
| Atogepant 30 mg BID | 2 | 784 | RR (M-H, Fixed, 95% CI) | 0.91 [0.45, 1.85] | 0.80 | 0% |
| Atogepant 60 mg BID | 1 | 277 | RR (M-H, Fixed, 95% CI) | 0.82 [0.33, 2.04] | 0.67 | / |
TEAEs, treatment-emergent adverse events; QD, quaque die, once daily; BID, both in die, twice daily; RR, relative risk; M-H, Mantel-Haenszel; CI, confidence interval