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. 2012 Sep 12;2012(9):CD001901. doi: 10.1002/14651858.CD001901.pub2

Comparison 1. Levetiracetam versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 50% Responders intention to treat 10   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
1.1 60 mg/kg/day 2 296 Risk Ratio (M‐H, Fixed, 95% CI) 1.91 [1.38, 2.63]
1.2 1000 mg 3 569 Risk Ratio (M‐H, Fixed, 95% CI) 2.49 [1.78, 3.50]
1.3 2000 mg 2 312 Risk Ratio (M‐H, Fixed, 95% CI) 4.91 [2.75, 8.77]
1.4 3000 mg 5 772 Risk Ratio (M‐H, Fixed, 95% CI) 2.59 [2.01, 3.33]
1.5 All doses 10 1742 Risk Ratio (M‐H, Fixed, 95% CI) 2.43 [2.04, 2.90]
2 Non‐responders (< 50% seizure frequency reduction) intention to treat 10   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
2.1 60 mg/kg/day 2 296 Risk Ratio (M‐H, Fixed, 95% CI) 0.68 [0.56, 0.81]
2.2 1000 mg 3 569 Risk Ratio (M‐H, Fixed, 95% CI) 0.78 [0.71, 0.85]
2.3 2000 mg 2 312 Risk Ratio (M‐H, Fixed, 95% CI) 0.68 [0.60, 0.77]
2.4 3000 mg 5 772 Risk Ratio (M‐H, Fixed, 95% CI) 0.67 [0.60, 0.74]
2.5 All doses 10 1742 Risk Ratio (M‐H, Fixed, 95% CI) 0.70 [0.66, 0.75]
3 50% responders best case 10   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
3.1 60 mg/kg/day 2 296 Risk Ratio (M‐H, Fixed, 95% CI) 1.91 [1.38, 2.63]
3.2 1000 mg 3 569 Risk Ratio (M‐H, Fixed, 95% CI) 2.63 [1.88, 3.67]
3.3 2000 mg 2 312 Risk Ratio (M‐H, Fixed, 95% CI) 5.09 [2.85, 9.06]
3.4 3000 mg 5 772 Risk Ratio (M‐H, Fixed, 95% CI) 2.63 [2.05, 3.38]
3.5 All doses 10 1742 Risk Ratio (M‐H, Fixed, 95% CI) 2.49 [2.09, 2.96]
4 50% Responders worst case 10   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
4.1 60 mg/kg/day 2 296 Risk Ratio (M‐H, Fixed, 95% CI) 1.91 [1.38, 2.63]
4.2 1000 mg 3 569 Risk Ratio (M‐H, Fixed, 95% CI) 2.37 [1.70, 3.29]
4.3 2000 mg 2 312 Risk Ratio (M‐H, Fixed, 95% CI) 4.54 [2.60, 7.94]
4.4 3000 mg 5 772 Risk Ratio (M‐H, Fixed, 95% CI) 2.33 [1.84, 2.96]
4.5 All doses 10 1742 Risk Ratio (M‐H, Fixed, 95% CI) 2.28 [1.92, 2.70]
5 Treatment withdrawal 11   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
5.1 60 mg/kg/day 2 296 Risk Ratio (M‐H, Fixed, 95% CI) 0.80 [0.43, 1.46]
5.2 1000 mg 3 569 Risk Ratio (M‐H, Fixed, 95% CI) 1.16 [0.72, 1.88]
5.3 2000 mg 3 393 Risk Ratio (M‐H, Fixed, 95% CI) 1.39 [0.88, 2.18]
5.4 3000 mg 5 772 Risk Ratio (M‐H, Fixed, 95% CI) 0.95 [0.62, 1.46]
5.5 4000 mg 1 77 Risk Ratio (M‐H, Fixed, 95% CI) 0.92 [0.42, 2.02]
5.6 Any dose levetiracetam 11 1861 Risk Ratio (M‐H, Fixed, 95% CI) 1.03 [0.80, 1.33]
6 Five most common adverse effects (any age) 10   Risk Ratio (M‐H, Fixed, 99% CI) Subtotals only
6.1 Somnolence 10 1831 Risk Ratio (M‐H, Fixed, 99% CI) 1.58 [1.14, 2.18]
6.2 Headache 10 1831 Risk Ratio (M‐H, Fixed, 99% CI) 0.95 [0.65, 1.39]
6.3 Fatigue (asthenia) 10 1831 Risk Ratio (M‐H, Fixed, 99% CI) 1.53 [0.98, 2.38]
6.4 Accidental injury 10 1831 Risk Ratio (M‐H, Fixed, 99% CI) 0.72 [0.49, 1.06]
6.5 Dizziness 10 1831 Risk Ratio (M‐H, Fixed, 99% CI) 1.63 [0.99, 2.66]
7 Most common adverse effects in adults 8   Risk Ratio (M‐H, Fixed, 99% CI) Subtotals only
7.1 Accidental injury 4 1023 Risk Ratio (M‐H, Fixed, 99% CI) 0.60 [0.39, 0.92]
7.2 Ataxia (unpublished data only) 4 1023 Risk Ratio (M‐H, Fixed, 99% CI) 1.50 [0.43, 5.26]
7.3 Dizziness 7 1249 Risk Ratio (M‐H, Fixed, 99% CI) 1.65 [0.96, 2.84]
7.4 Fatigue (asthenia) 4 1023 Risk Ratio (M‐H, Fixed, 99% CI) 1.47 [0.90, 2.40]
7.5 Headache 6 1360 Risk Ratio (M‐H, Fixed, 99% CI) 0.88 [0.59, 1.31]
7.6 Infection 4 1023 Risk Ratio (M‐H, Fixed, 99% CI) 1.76 [1.03, 3.02]
7.7 Nausea 3 599 Risk Ratio (M‐H, Fixed, 99% CI) 1.37 [0.47, 4.00]
7.8 Somnolence 8 1535 Risk Ratio (M‐H, Fixed, 99% CI) 1.51 [1.06, 2.17]
8 Most common adverse effects in children 2   Risk Ratio (M‐H, Fixed, 99% CI) Subtotals only
8.1 Accidental injury 1 198 Risk Ratio (M‐H, Fixed, 99% CI) 1.63 [0.63, 4.26]
8.2 Aggression (hostility) 2 296 Risk Ratio (M‐H, Fixed, 99% CI) 1.72 [0.64, 4.63]
8.3 Cough 2 296 Risk Ratio (M‐H, Fixed, 99% CI) 1.39 [0.49, 3.93]
8.4 Dizziness 2 296 Risk Ratio (M‐H, Fixed, 99% CI) 1.52 [0.47, 4.94]
8.5 Fatigue (asthenia) 2 296 Risk Ratio (M‐H, Fixed, 99% CI) 1.82 [0.62, 5.33]
8.6 Pharyngitis 2 296 Risk Ratio (M‐H, Fixed, 99% CI) 1.09 [0.47, 2.50]
8.7 Somnolence 2 296 Risk Ratio (M‐H, Fixed, 99% CI) 1.90 [0.88, 4.09]
8.8 Vomiting 2 296 Risk Ratio (M‐H, Fixed, 99% CI) 1.22 [0.55, 2.69]
9 Behavioural changes 6   Risk Ratio (M‐H, Fixed, 99% CI) Subtotals only
9.1 Hostility 1 198 Risk Ratio (M‐H, Fixed, 99% CI) 1.92 [0.56, 6.60]
9.2 Personality disorder 1 198 Risk Ratio (M‐H, Fixed, 99% CI) 1.10 [0.30, 3.95]
9.3 Nervousness 1 198 Risk Ratio (M‐H, Fixed, 99% CI) 4.80 [0.68, 34.14]
9.4 Depression 1 324 Risk Ratio (M‐H, Fixed, 99% CI) 1.41 [0.25, 7.85]
9.5 Aggression 1 98 Risk Ratio (M‐H, Fixed, 99% CI) 1.42 [0.27, 7.42]
9.6 Agitation 2 254 Risk Ratio (M‐H, Fixed, 99% CI) 6.17 [0.66, 57.79]
9.7 Emotional lability 1 198 Risk Ratio (M‐H, Fixed, 99% CI) 1.44 [0.28, 7.29]
9.8 Psychomotor hyperactivity 1 98 Risk Ratio (M‐H, Fixed, 99% CI) 0.43 [0.08, 2.19]
9.9 Irritability 1 156 Risk Ratio (M‐H, Fixed, 99% CI) 11.28 [0.26, 495.63]
9.10 Abnormal behaviour 1 98 Risk Ratio (M‐H, Fixed, 99% CI) 5.92 [0.14, 255.98]
9.11 Altered mood 1 98 Risk Ratio (M‐H, Fixed, 99% CI) 4.85 [0.11, 216.99]
9.12 Anxiety 1 98 Risk Ratio (M‐H, Fixed, 99% CI) 4.85 [0.11, 216.99]
9.13 Dissociation 1 94 Risk Ratio (M‐H, Fixed, 99% CI) 0.14 [0.00, 6.77]
9.14 Combined (regardless of age) 6 926 Risk Ratio (M‐H, Fixed, 99% CI) 1.87 [1.19, 2.95]
9.15 Combined (children) 2 296 Risk Ratio (M‐H, Fixed, 99% CI) 1.90 [1.16, 3.11]
9.16 Combined (adults) 4 630 Risk Ratio (M‐H, Fixed, 99% CI) 1.79 [0.59, 5.41]