A meta-analysis of randomized controlled trials on levetiracetam in the treatment of pediatric patients with epilepsy

Figures & data

Figure 1 Study-selection process for this meta-analysis.

Table 1 Characteristics of RCTs included in this meta-analysis

Study	Country	Patients, n	Age, years (mean ± SD or mean [range])	Sex (M/F)	Type	Dose (mg/kg/day)	Follow-up (months)
Chen et al^Citation23	China	Lev 55 Oxc 48	9.8±3.5	58/45	All types	20–40 5–40	6
Sun and Zhou^Citation15	China	Lev 34 Vpa 34	7.26±1.62 7.19±1.59	20/14 21/13	Focal and general	20–60 15–45	6
Shan^Citation26	China	Lev 53 Oxc 51	8.58 (4.4–15) 8.45 (4.2–14.7)	29/24 29/22	BCECTS	10–40 10–30	12
Fattore et al^Citation17	Italy	Lev 38 Pbo 21	8.7±2.2 7.9±3.0	15/23 12/9	Absence of epilepsy	10–30 10–30	2 weeks
Zhang et al^Citation18	China	Lev 41 Oxc 48	6.82±2.79	56/52	Partial	5–50 5–40	12
Liu et al^Citation16	China	Lev 50 Vpa 50	7.6±2.6	ND	All types	10–40 5–30	3
Borggraefe et al^Citation19	Germany	Lev 21 Stm 22	8.7±1.7 9.0±1.5	15/6 12/10	BCECTS	10–30 2–6	24 weeks
Yu^Citation20	China	Lev 30 Vpa 30	8.5±2.8	37/23	BCECTS	20–40 10–30	16 weeks
Piña-Garza et al^Citation21	USA	Lev 60 Pbo 56	23.4 months 23.5 months	30/30 27/29	Partial	20–50 20–50	5 days
Huang and Zhu^Citation22	China	Lev 27 Cbz 26	6 7	11/16 16/10	Partial	10–40 5–20	6
Coppola et al^Citation14	Italy	Lev 21 Oxc 18	10.5 (5–13) 8.4 (3.3–14)	11/10 10/8	BCECTS	5–30 5–35	18
Hu et al^Citation24	China	Lev 40 Oxc 41	7.0±2.1 6.8±1.0	22/18 25/16	All types	5–60 10–60	6
Levisohn et al^Citation25	USA	Lev 64 Pbo 34	10.6±3.5 10.3±3.7	39/25 17/17	Partial	20–60 20–60	12 weeks

Abbreviations: RCTs, randomized controlled trials; Lev, levetiracetam; Oxc, oxcarbazepine; Vpa, valproate; Pbo, placebo; Stm, sulthiame; Cbz, carbamazepine; ND, no data; BCECTS, benign childhood epilepsy with centrotemporal spikes.

Figure 2 Risk-of-bias summary.

Note:

low risk;

high risk;

unclear risk.

Table 2 GRADE evidence profile

Quality assessment							Patients, n		Effect		Quality	Importance
Studies, n	Design	Limitations	Inconsistency	Indirectness	Imprecision	Other considerations	100%	Control	RR (95% CI)	Absolute
Seizure-free rate
13	Randomized trials	Very seriousa	No serious inconsistency	No serious indirectness	No serious imprecision	Strong associationb	258/534 (48.3%)	207/479 (43.2%) 57.7%	1.09 (0.92–1.3)	39 more per 1,000 (from 35 fewer to 130 more) 52 more per 1,000 (from 46 fewer to 173 more)	+− Moderate	Critical
≥50% reduction from baseline in seizure frequency
13	Randomized trials	Very serious	No serious inconsistency	No serious indirectness	No serious imprecision	Strong associationc	386/534	332/479 (69.3%) 78.4%	1.05 (0.95–1.15)	35 more per 1,000 (from 35 fewer to 104 more) 39 more per 1,000 (from 39 fewer to 118 more)	+− Moderate	Important
Adverse events
13	Randomized trials	Very serious	No serious inconsistency	No serious indirectness	No serious imprecision	None	167/534 (31.3%)	150/479 (31.3%) 25.5%	0.9 (0.77–1.06)	31 fewer per 1,000 (from 72 fewer to 19 more) 26 fewer per 1,000 (from 59 fewer to 15 more)	+− Moderate	Important

Notes:

a Four trials^15,23,24,26 were regarded as having a high risk of bias;

b three trials^17,21,25 compared levetiracetam with placebo for seizure-free rate (RR 4.26, 95% CI 1.90–9.45; P<0.05);

c three trials^17,21,25 compared levetiracetam with placebo for seizure-frequency reduction from baseline ≥50% (RR 1.79, 95% CI 1.26–2.53; P<0.05).

Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation.

Figure 3 Forest plot of seizure-free rate: levetiracetam versus other AEDs.

Abbreviations: MH, Mantel–Haenszel; AEDs, antiepileptic drugs.

Figure 4 Forest plot of seizure-frequency reduction ≥50% from baseline: levetiracetam versus other AEDs.

Abbreviations: MH, Mantel–Haenszel; AEDs, antiepileptic drugs.

Figure 5 Forest plot of adverse events: levetiracetam versus other AEDs.

Abbreviations: MH, Mantel–Haenszel; AEDs, antiepileptic drugs.

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