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Human safety of lamotrigine
T Betts1, G Goodwin, R M Withers
1Department of Psychiatry, University of Birmingham, England.
Epilepsia
|January 1, 1991
Summary
Lamotrigine (LTG) demonstrated comparable safety to placebo in short-term epilepsy trials. In longer open studies, common side effects like dizziness and rash occurred, but serious LTG-related issues were rare.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Refractory epilepsy requires effective and safe adjunctive treatments.
- Lamotrigine (LTG) is an antiepileptic drug (AED) used as add-on therapy.
Purpose of the Study:
- To evaluate the clinical safety of lamotrigine (LTG) in adult patients with refractory epilepsy.
- To assess adverse events associated with LTG when added to existing antiepileptic drugs (AEDs).
Main Methods:
- Pooled analysis of four randomized, double-blind, placebo-controlled crossover trials (n=92).
- Interim analysis of 27 open-label, 12-month studies (n=572).
- LTG administered twice daily as adjunctive therapy.
Main Results:
- Double-blind studies: No significant difference in adverse experiences between LTG and placebo. Two LTG withdrawals due to rash and nausea/vomiting.
- Open studies: Most common adverse experiences included dizziness, diplopia, somnolence, headache, ataxia, and asthenia (10-14% incidence).
- Overall, 8.6% of patients in open studies withdrew due to adverse events, primarily rash (2.3%). No LTG-attributable physical, neurological, or ECG abnormalities leading to withdrawal. No clinically significant changes in lab measures, vital signs, weight, or concomitant AED plasma concentrations.
Conclusions:
- Lamotrigine is generally well-tolerated as adjunctive therapy for refractory epilepsy.
- While common side effects like dizziness and rash can occur, serious LTG-related adverse events requiring withdrawal are infrequent.