Table 4.
Secondary efficacy outcomes were not significantly different between patients using and not using migraine preventive medications, for all doses of lasmiditan
| Outcome | Lasmiditan dose (mg) | Using preventives | Not using preventives | Interaction p-valueb | ||
|---|---|---|---|---|---|---|
| n/N (%) | Odds ratioa (CI) | n/N (%) | Odds ratioa (CI) | |||
| Pain relief, n/N (%) | PBO | 88/207 (42.5) | 420/922 (45.6) | |||
| 50 | 61/113 (54.0) | 1.5 (0.9, 2.5) | 292/485 (60.2) | 1.6 (1.3, 2.1) | 0.630 | |
| 100 | 109/189 (57.7) | 1.8 (1.2, 2.7) | 595/944 (63.0) | 2.0 (1.7, 2.5) | 0.712 | |
| 200 | 114/189 (60.3) | 2.1 (1.4, 3.1) | 583/931 (62.6) | 2.0 (1.7, 2.4) | 0.567 | |
| Sustained pain freedom at 24 h, n/N (%) | PBO | 11/196 (5.6) | 99/867 (11.4) | |||
| 50 | 12/104 (11.5) | 1.7 (0.6, 4.4) | 85/452 (18.8) | 1.4 (1.0, 2.0) | 0.660 | |
| 100 | 25/175 (14.3) | 2.8 (1.3, 5.8) | 150/860 (17.4) | 1.6 (1.2, 2.2) | 0.326 | |
| 200 | 30/167 (18.0) | 3.7 (1.8, 7.7) | 192/879 (21.8) | 2.2 (1.7, 2.8) | 0.293 | |
| Total migraine freedom, n/N (%) | PBO | 18/196 (9.2) | 159/867 (18.3) | |||
| 50 | 23/104 (22.1) | 3.1 (1.3, 7.4) | 121/452 (26.8) | 1.3 (1.0, 1.8) | 0.437 | |
| 100 | 39/175 (22.3) | 2.8 (1.6, 5.2) | 241/860 (28.0) | 1.7 (1.4, 2.2) | 0.534 | |
| 200 | 43/167 (25.7) | 3.4 (1.9, 6.2) | 287/879 (32.7) | 2.2 (1.7, 2.7) | 0.604 | |
| PGIC very much better or much better, n/N (%) | PBO | 39/207 (18.8) | 243/923 (26.3) | |||
| 50 | 36/113 (31.9) | 2.0 (1.1, 3.8) | 183/485 (37.7) | 1.4 (1.1, 1.9) | 0.830 | |
| 100 | 62/189 (32.8) | 2.1 (1.3, 3.3) | 382/944 (40.5) | 1.9 (1.6, 2.3) | 0.830 | |
| 200 | 69/189 (36.5) | 2.5 (1.6, 3.9) | 381/931 (40.9) | 1.9 (1.6, 2.4) | 0.421 | |
| Disability-free at 2 h, n/N (%) | PBO | 34/201 (16.9) | 222/912 (24.3) | |||
| 50 | 29/113 (25.7) | 1.6 (0.8, 3.2) | 155/480 (32.3) | 1.3 (1.0, 1.8) | 0.751 | |
| 100 | 47/189 (24.9) | 1.6 (1.0, 2.7) | 320/934 (34.3) | 1.6 (1.3, 2.0) | 0.669 | |
| 200 | 54/187 (28.9) | 2.0 (1.2, 3.2) | 327/916 (35.7) | 1.7 (1.4, 2.1) | 0.631 | |
Abbreviations: CI confidence interval, MBS most bothersome symptom, N number of patients in the subgroup of ITT population, n number of patients achieving outcome, PBO placebo, PGIC patient global impression of change
aOdds ratio compared to patients who received placebo in the same subgroup
bInteraction p-value comparing patients using and patients not using migraine preventive medications