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Table 4 Secondary efficacy outcomes were not significantly different between patients using and not using migraine preventive medications, for all doses of lasmiditan

From: Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials

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

  1. 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
  2. aOdds ratio compared to patients who received placebo in the same subgroup
  3. bInteraction p-value comparing patients using and patients not using migraine preventive medications