Summary of findings 2. Lamotrigine compared to valproate for absence seizures in children and adolescents.
| Lamotrigine compared to valproate for absence seizures in children and adolescents | ||||||
| Patient or population: absence seizures in children and adolescents Setting: outpatients Intervention: lamotrigine Comparison: valproate | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with valproate | Risk with Lamotrigine | |||||
| Seizure freedom at 12 months | Study population | ‐ | 405 (4 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | Higher proportion seizure free at 1 month in patients receiving valproate compared to those receiving lamotrigine (2 studies). No difference between valproate and lamotrigine for seizure freedom at 3 and 6 months (3 and 4 studies, respectively). Length of follow‐up in included studies: 12 months |
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| see comment | see comment | |||||
| 80% or greater reduction in seizure frequency ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | |
| 50% or greater reduction in seizure frequency ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Normalization of the EEG | Study population | RR 2.39 (1.14 to 5.04) | 45 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 2,3 | Length of follow‐up: 12 months | |
| 273 per 1,000 | 652 per 1,000 (311 to 1,000) | |||||
| Adverse effects (Table 7; Table 9) The most common adverse effects of treatment with lamotrigine were fatigue, and behavioural/psychiatric changes. The most common adverse effects of treatment with valproate were fatigue, nausea, vomiting, increased appetite with weight gain, behavioural/psychiatric changes (decreased concentration, personality change, hyperactivity, attention problems, hostility), and thrombocytopenia | ||||||
| *The risk in the intervention group (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 certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Most information comes from studies at low or unclear risk of bias; plausible bias is likely to seriously alter the results.
2 Information comes from a small study at unclear and high risk of bias.
3 Information comes from a single study conducted in a small number of patients.