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

Table 5 Pain freedom at 0.5, 1, 1.5, and 2 h did not differ significantly between groups using and not using migraine preventive medications

Hours after dosing	Lasmiditan dose (mg)	Using preventives		Not using preventives		Interaction p-value^b
Hours after dosing	Lasmiditan dose (mg)	Pain freedom n/N (%)	Odds ratio^a (CI)	Pain freedom n/N (%)	Odds ratio^a (CI)	Interaction p-value^b
0.5	PBO	2/196 (1.0)		13/867 (1.5)
	50	2/104 (1.9)	1.9 (0.2, 20.9)	9/452 (2.0)	1.3 (0.5,3.4)	0.714
	100	2/175 (1.1)	1.2 (0.2, 8.2)	14/860 (1.6)	1.1 (0.5,2.3)	0.904
	200	3/167 (1.8)	1.8 (0.3, 10.7)	22/879 (2.5)	1.7 (0.8, 3.4)	0.920
1.0	PBO	7/196 (3.6)		67/867 (7.7)
	50	7/104 (6.7)	2.2 (0.6, 8.9)	33/452 (7.3)	0.9 (0.5, 1.5)	0.316
	100	13/175 (7.4)	2.2 (0.8, 5.6)	91/860 (10.6)	1.4 (1.0, 2.0)	0.854
	200	18/167 (10.8)	3.3 (1.3, 8.0)	144/879 (16.4)	2.3 (1.7, 3.2)	0.889
1.5	PBO	13/196 (6.6)		114/867 (13.1)
	50	17/104 (16.3)	2.5 (1.0, 6.3)	83/452 (18.4)	1.3 (0.9, 1.8)	0.196
	100	28/175 (16.0)	2.7 (1.3, 5.3)	188/860 (21.9)	1.8 (1.4, 2.4)	0.732
	200	31/167 (18.6)	3.2 (1.6, 6.4)	249/879 (28.3)	2.6 (2.0, 3.3)	0.656
2.0	PBO	23/196 (11.7)		172/867 (19.8)
	50	25/104 (24.0)	2.2 (1.0, 4.7)	134/452 (29.6)	1.4 (1.0, 1.9)	0.715
	100	44/175 (25.1)	2.5 (1.4, 4.4)	265/860 (30.8)	1.8 (1.4, 2.2)	0.654
	200	51/167 (30.5)	3.3 (1.9, 5.7)	321/879 (36.5)	2.3 (1.9, 2.9)	0.550

Abbreviations CI confidence interval, N number of patients in the subgroup of mITT population, n, number of patients achieving outcome, PBO placebo
^aOdds ratio compared to patients who received placebo in the same subgroup
^bComparing subgroups of patients who were using and not using migraine preventive medications for the stated time point and treatment group

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