Table 2. Outcomes in Major Clinical Trials for Atogepant.
Study | Doses | CFB in MMDs after 12 weeks (95% CI)a | CFB in MHDs after 12 weeks (95% CI)a | ≥ 50% reduction in MMDs (%) (OR, 95% CI) | CFB in acute medication use days (95% CI)a | Incidence of TRAEs (%) | Incidence of SAEs (%) | Drug discontinuation rate (%) |
---|---|---|---|---|---|---|---|---|
Ankrom et al.9 | 60 mg OD | - | - | - | - | 23.3 | 0 | 15.3 |
Goadsby et al.10 | 10 mg OD | − 1.2* (− 1.9 to − 0.4) | − 1.4* (− 2.2 to – 0.5) | 1.5 (1 to 2.3) | − 1.3 (− 2.0 to − 0.6) | 18 | 0 | 4 |
30 mg OD | − 0.9* (− 1.6 to − 0.3) | − 1.2* (− 1.9 to − 0.6 | 1.5 (1 to 2.1) | − 1.4 (− 2.0 to − 0.9) | 21 | 0 | 6 | |
60 mg OD | − 0.7* (− 1.4 to − 0.1) | − 0.9* (− 1.6 to − 0.2) | 1.4 (1 to 2) | − 1.1 (− 1.7 to − 0.5) | 23 | 0 | 3 | |
30 mg BID | − 1.4* (− 2.2 to − 0.6) | − 1.3* (− 2.2 to − 0.4) | 1.8* (1.2 to 2.9) | − 1.4* (− 2.1 to − 0.6) | 21 | 0 | 6 | |
60 mg BID | − 1.3* (− 2.1 to − 0.5) | − 1.4* (− 2.3 to − 0.5) | 2.0* (1.3 to 3.2) | − 1.2* (− 1.9 to − 0.5) | 26 | 0 | 8 | |
Placebo | - | - | - | - | 16 | 0 | 3 | |
Min et al.11 | 170 mg OD | - | - | - | - | 87 | 0 | 8.7 |
Placebo | - | - | - | - | 72.7 | 0 | 0 | |
Boinpally et al.12 | 300 mg SD | - | - | - | - | 1.7 | 0 | 0 |
Placebo | - | - | - | - | - | - | - | |
Ailani et al.13, Schwedt et al.14, and Lipton et al.15 | 10 mg OD | − 1.2** (− 1.8 to − 0.6) | − 1.4** (− 2.0 to − 0.8) | 3.1** (2 to 4.6) | − 1.3** (− 1.8 to − 0.8) | 23.1 | 0.5 | 4.1 |
30 mg OD | − 1.9** (− 1.9 to –0.8) | − 1.5** (− 2.1 to− 1.1) | 3.5** (2. 4 to 5.3) | − 1.3** (− 1.8 to − 0.8) | 14.9 | 0 | 1.8 | |
60 mg OD | − 1.7** (− 2.3 to − 1.2) | − 1.7** (− 2.3 to − 1.1) | 3.8** (2.6 to 5.7) | − 1.5** (− 2.0 to − 1.0) | 19.5 | 0 | 2.6 | |
Placebo | - | - | - | - | 9 | 0 | 2.7 | |
Klein et al.16 | 60 mg OD | - | - | - | - | 8.8 | 3.4 | 25.4 (after open label treatment period) and 27.7 (at safety follow-up period) |
Ashina et al.17 | 60 mg OD | - | - | 84.2 | - | 18 | 4.4 | 31.6 |
Placebo | - | - | - | - | 36.2 | 3.6 | 31.2 |