Losigamone add‐on therapy for partial epilepsy

Yousheng Xiao; Man Luo; Jin Wang; Hongye Luo

doi:10.1002/14651858.CD009324.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgments about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Losigamone versus placebo: 50% or greater reduction in seizure frequency, Outcome 1 All doses.

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Analysis 1.2

Comparison 1 Losigamone versus placebo: 50% or greater reduction in seizure frequency, Outcome 2 1500 mg/day.

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Analysis 1.3

Comparison 1 Losigamone versus placebo: 50% or greater reduction in seizure frequency, Outcome 3 1200 mg/day.

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Analysis 2.1

Comparison 2 Losigamone versus placebo: treatment withdrawal, Outcome 1 All doses.

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Analysis 2.2

Comparison 2 Losigamone versus placebo: treatment withdrawal, Outcome 2 1500 mg/day.

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Analysis 2.3

Comparison 2 Losigamone versus placebo: treatment withdrawal, Outcome 3 1200 mg/day.

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Analysis 3.1

Comparison 3 Losigamone versus placebo: adverse events, Outcome 1 The proportion of participants experiencing any adverse events (random model).

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Analysis 3.2

Comparison 3 Losigamone versus placebo: adverse events, Outcome 2 The proportion of participants experiencing any adverse events (fixed model).

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Analysis 3.3

Comparison 3 Losigamone versus placebo: adverse events, Outcome 3 Dizziness.

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Analysis 3.4

Comparison 3 Losigamone versus placebo: adverse events, Outcome 4 Headache.

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Analysis 3.5

Comparison 3 Losigamone versus placebo: adverse events, Outcome 5 Somnolence.

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Analysis 3.6

Comparison 3 Losigamone versus placebo: adverse events, Outcome 6 Fatigue.

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Analysis 3.7

Comparison 3 Losigamone versus placebo: adverse events, Outcome 7 Ataxia.

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Analysis 3.8

Comparison 3 Losigamone versus placebo: adverse events, Outcome 8 Nausea.

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Analysis 3.9

Comparison 3 Losigamone versus placebo: adverse events, Outcome 9 Diplopia.

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Analysis 3.10

Comparison 3 Losigamone versus placebo: adverse events, Outcome 10 Abnormal vision.

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Analysis 3.11

Comparison 3 Losigamone versus placebo: adverse events, Outcome 11 Vertigo.

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Analysis 3.12

Comparison 3 Losigamone versus placebo: adverse events, Outcome 12 Depression.

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Summary of findings for the main comparison. Losigamone compared to placebo for partial epilepsy

Losigamone compared to placebo for partial epilepsy
Patient or population: partial epilepsy Settings: multicenter Intervention: losigamone Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Placebo	Losigamone
50% or greater reduction in seizure frequency Follow‐up: mean 8 to 12 weeks	Study population		RR 1.76 (1.14 to 2.72)	467 (2 studies)	⊕⊕⊕⊝ moderate¹
	132 per 1000	233 per 1000 (151 to 360)
	Moderate
	131 per 1000	231 per 1000 (149 to 356)
Treatment withdrawal Follow‐up: mean 8 to 12 weeks	Study population		RR 2.16 (1.28 to 3.67)	467 (2 studies)	⊕⊕⊕⊝ moderate¹
	90 per 1000	194 per 1000 (115 to 330)
	Moderate
	88 per 1000	190 per 1000 (113 to 323)
The proportion of participants experiencing any adverse events Follow‐up: mean 8 to 12 weeks	Study population		RR 1.34 (1.00 to 1.80)	467 (2 studies)	⊕⊕⊕⊝ moderate¹
	471 per 1000	631 per 1000 (471 to 848)
	Moderate
	482 per 1000	646 per 1000 (482 to 868)
Adverse event (dizziness) Follow‐up: mean 8 to 12 weeks	Study population		RR 3.82 (1.69 to 8.64)	467 (2 studies)	⊕⊕⊕⊝ moderate¹
	63 per 1000	243 per 1000 (107 to 549)
	Moderate
	60 per 1000	229 per 1000 (101 to 518)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ One of the two included trials did not describe the method used to generate the random list and did not mention allocation concealment

Summary of findings for the main comparison. Losigamone compared to placebo for partial epilepsy

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Table 1. Outcome reporting matrix

Study ID (author, date of publication)	Review's primary outcomes		Review's secondary outcomes		Other study outcomes
Study ID (author, date of publication)	50% or greater reduction in seizure frequency	Seizure freedom	Treatment withdrawal	Adverse events	Change in seizure frequency	The percentage reduction in seizure frequency
Bauer 2001	√	×	√	√	√	×
Baulac 2003	√	×	√	√	×	√
√Full reporting of outcomes for treatment comparison × No reporting of outcomes for treatment comparison

Table 1. Outcome reporting matrix

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Comparison 1. Losigamone versus placebo: 50% or greater reduction in seizure frequency

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All doses Show forest plot	2	467	Risk Ratio (M‐H, Fixed, 95% CI)	1.76 [1.14, 2.72]

2 1500 mg/day Show forest plot	2	380	Risk Ratio (M‐H, Fixed, 95% CI)	1.94 [1.25, 3.01]

3 1200 mg/day Show forest plot	1	172	Risk Ratio (M‐H, Fixed, 95% CI)	1.47 [0.70, 3.08]

Comparison 1. Losigamone versus placebo: 50% or greater reduction in seizure frequency

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Comparison 2. Losigamone versus placebo: treatment withdrawal

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All doses Show forest plot	2	467	Risk Ratio (M‐H, Fixed, 95% CI)	2.16 [1.28, 3.67]

2 1500 mg/day Show forest plot	2	380	Risk Ratio (M‐H, Fixed, 95% CI)	2.34 [1.38, 3.99]

3 1200 mg/day Show forest plot	1	172	Risk Ratio (M‐H, Fixed, 95% CI)	1.79 [0.69, 4.63]

Comparison 2. Losigamone versus placebo: treatment withdrawal

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Comparison 3. Losigamone versus placebo: adverse events

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 The proportion of participants experiencing any adverse events (random model) Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 All doses	2	467	Risk Ratio (M‐H, Random, 95% CI)	1.34 [1.00, 1.80]
1.2 1200 mg/day	1	172	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.83, 1.34]
1.3 1500 mg/day	2	380	Risk Ratio (M‐H, Random, 95% CI)	1.40 [1.14, 1.71]
2 The proportion of participants experiencing any adverse events (fixed model) Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 All doses	2	467	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [1.12, 1.57]
3 Dizziness Show forest plot	2		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

3.1 All doses	2	467	Risk Ratio (M‐H, Fixed, 99% CI)	3.82 [1.69, 8.64]
3.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	5.37 [0.77, 37.42]
3.3 1500 mg/day	2	380	Risk Ratio (M‐H, Fixed, 99% CI)	3.96 [1.79, 8.76]
4 Headache Show forest plot	1		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.1 All doses	1	264	Risk Ratio (M‐H, Fixed, 99% CI)	1.19 [0.43, 3.30]
4.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	0.85 [0.24, 3.06]
4.3 1500 mg/day	1	177	Risk Ratio (M‐H, Fixed, 99% CI)	1.50 [0.50, 4.47]
5 Somnolence Show forest plot	1		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

5.1 All doses	1	264	Risk Ratio (M‐H, Fixed, 99% CI)	2.26 [0.57, 8.93]
5.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	1.71 [0.36, 8.19]
5.3 1500 mg/day	1	177	Risk Ratio (M‐H, Fixed, 99% CI)	2.77 [0.66, 11.65]
6 Fatigue Show forest plot	1		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

6.1 All doses	1	264	Risk Ratio (M‐H, Fixed, 99% CI)	2.26 [0.57, 8.93]
6.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	1.71 [0.36, 8.19]
6.3 1500 mg/day	1	177	Risk Ratio (M‐H, Fixed, 99% CI)	2.77 [0.66, 11.65]
7 Ataxia Show forest plot	1		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

7.1 All doses	1	264	Risk Ratio (M‐H, Fixed, 99% CI)	10.03 [0.24, 411.20]
7.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	10.75 [0.24, 473.22]
7.3 1500 mg/day	1	177	Risk Ratio (M‐H, Fixed, 99% CI)	10.17 [0.23, 448.02]
8 Nausea Show forest plot	1		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

8.1 All doses	1	264	Risk Ratio (M‐H, Fixed, 99% CI)	0.85 [0.21, 3.45]
8.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	0.39 [0.05, 3.25]
8.3 1500 mg/day	1	177	Risk Ratio (M‐H, Fixed, 99% CI)	1.29 [0.30, 5.56]
9 Diplopia Show forest plot	1		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

9.1 All doses	1	264	Risk Ratio (M‐H, Fixed, 99% CI)	2.85 [0.59, 13.70]
9.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	2.28 [0.40, 12.90]
9.3 1500 mg/day	1	177	Risk Ratio (M‐H, Fixed, 99% CI)	3.39 [0.66, 17.33]
10 Abnormal vision Show forest plot	1		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

10.1 All doses	1	264	Risk Ratio (M‐H, Fixed, 99% CI)	2.37 [0.48, 11.68]
10.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	1.63 [0.26, 10.25]
11 Vertigo Show forest plot	1		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

11.1 All doses	1	264	Risk Ratio (M‐H, Fixed, 99% CI)	6.17 [0.44, 87.50]
11.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	5.86 [0.37, 92.10]
11.3 1500 mg/day	1	177	Risk Ratio (M‐H, Fixed, 99% CI)	6.47 [0.42, 98.79]
12 Depression Show forest plot	1		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

12.1 All doses	1	264	Risk Ratio (M‐H, Fixed, 99% CI)	0.63 [0.09, 4.40]
12.2 1200 mg/day	1	172	Risk Ratio (M‐H, Fixed, 99% CI)	0.98 [0.12, 7.71]
12.3 1500 mg/day	1	177	Risk Ratio (M‐H, Fixed, 99% CI)	0.92 [0.12, 7.30]

Comparison 3. Losigamone versus placebo: adverse events

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