Table 3.

Meta‐analyses of reduction from baseline in primary seizures and ≥50% responder rates for DS populations, overall and on clobazam (intention‐to‐treat population)

Trial	Treatment arm vs placebo	Overall			On clobazam
		Interaction p‐value	Treatment/odds ratio a (95% CI)	p‐value	Interaction p‐value	Treatment/odds ratio a (95% CI)	p‐value
Reduction in convulsive seizure frequency
GWPCARE2	CBD10		0.70 (0.54‐0.92)	0.0095	0.1691	0.63 (0.46‐0.86)	0.0042
	CBD20		0.74 (0.57‐0.97)	0.0299	0.5702	0.69 (0.50‐0.96)	0.0297
GWPCARE1	CBD20		0.67 (0.50‐0.90)	0.0082		0.57 (0.40‐0.83)	0.0032
Meta‐analysis	CBD10 + CBD20	0.8808	0.71 (0.60‐0.83)	<0.0001	0.7490	0.63 (0.52‐0.77)	<0.0001
	CBD20	0.6170	0.71 (0.58‐0.86)	0.0006	0.4490	0.64 (0.50‐0.81)	0.0003
≥50% responder rate
GWPCARE2	CBD10		2.24 (1.06‐4.73)	0.0346	0.9722	2.33 (0.96‐5.68)	0.0623
	CBD20		2.77 (1.32‐5.82)	0.0073	0.8188	3.26 (1.28‐8.26)	0.0130
GWPCARE1	CBD20		2.04 (0.93‐4.51)	0.0768	0.2517	2.88 (1.06‐7.84)	0.0382
Meta‐analysis	CBD10 + CBD20	0.8512	2.34 (1.51‐3.63)	0.0001	0.8763	2.78 (1.62‐4.77)	0.0002
	CBD20	0.5837	2.40 (1.40‐4.13)	0.0015	0.8612	3.08 (1.56‐6.08)	0.0012

Results are based on a fixed‐effects meta‐analysis. The interaction p‐value tested the null hypothesis of homogeneity of the treatment effect across trials/dose comparisons.

Abbreviations: CBD10, cannabidiol 10 mg/kg/day; CBD20, cannabidiol 20 mg/kg/day; CI, confidence interval; DS, Dravet syndrome.

^aReductions in convulsive seizure frequency are displayed using treatment ratios; ≥50% responder rates are displayed using odds ratios.