A randomised open multicentre comparative trial of lamotrigine and carbamazepine as monotherapy in patients with newly diagnosed or recurrent epilepsy

Reunanen, Mauri; Dam, M.; Yuen, Alan W.C.

doi:10.1016/0920-1211(95)00085-2

Cited by 131 publications

(78 citation statements)

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“…The seizure-free rate (95% CI) in the maintenance phase by seizure type was 40.0% (27.02-54.09) in patients with partial seizures and 80.0% (44.39-97.48) in patients with generalized tonic-clonic seizures. Although the lower limit of 95% CI interval in this study did not reach the threshold value of 0.40, three past comparative studies [5,6,7] of lamotrigine showed point estimates of seizure-free rates for the last 24 weeks ranging from 35% to 60.4%. Results for both all seizure types and partial seizures therefore suggest that the efficacy in this study is consistent with that reported by three previous comparative studies [5,6,7].…”

Section: Discussionmentioning

confidence: 95%

“…Given the efficacy and safety evidence reported in several countries, the approval of lamotrigine monotherapy in Japan has been awaited by the Japan Epilepsy Society, the Japan Neurosurgical Society, and the Japanese Society of Child Neurology. To establish evidence, this study was started in 2011, using an earlier comparative study of lamotrigine and carbamazepine as reference [5,6,7]. The seizure-free rate (95% CI) in the maintenance phase (the primary efficacy endpoint) for all seizure types was 43.1% (30.85-55.96).…”

Section: Discussionmentioning

confidence: 99%

“…To calculate the sample size in this study, the results from previous comparative studies of lamotrigine [5,6,7] were used, in which seizure-free rates for the last 24 weeks of the treatment period were 35% to 60.4%. Therefore, a seizure-free rate of 0.60 as point estimates was estimated for lamotrigine treatment.…”

Section: Discussionmentioning

confidence: 99%

“…At a dose up to 200 mg, lamotrigine tablets were administered once daily (QD) in the evening in accordance with the previous comparative monotherapy study of lamotrigine and carbamazepine [7]. If tolerability issues were observed with evening dosing, administration in the morning was an option.…”

Section: Methodsmentioning

confidence: 99%

“…The effectiveness of monotherapy with lamotrigine was established in three randomized comparative studies conducted in adults with newly diagnosed or recurrent epilepsy [5,6,7]. Various guidelines [1,2,8] recommend lamotrigine as a first-line treatment for partial and generalized seizures.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Lamotrigine monotherapy in newly diagnosed epilepsy or recurrent epilepsy:A multi-center, open-label study

Yamamoto

Hong

Shimizu

et al. 2014

E&S

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Purpose:To evaluate the efficacy and safety of lamotrigine monotherapy in patients with newly diagnosed partial seizures including secondarily generalized seizures or generalized tonic-clonic seizures, and those with recurrent seizures in Japan and South Korea. Methods: The study was a multi-center, open-label, evaluation of lamotrigine monotherapy in patients with newly diagnosed epilepsy or epilepsy with recurrent seizures. The primary endpoint was the seizure-free rate in the maintenance phase. Results: A total of 67 patients were enrolled; 52 patients completed 6 weeks of treatment (the escalation phase) and 42 patients completed 30 weeks of treatment (the escalation phase and the maintenance phase). The seizure-free rate in the maintenance phase for all seizure types was 43.1%. Adverse events (AEs) were reported in 82% (53/65) of patients. The most common AEs were headache (14/65, 22%), nasopharyngitis (12/65, 18%) and rash (7/65, 11%). Conclusion:The seizure-free rate with lamotrigine monotherapy in the maintenance phase was 43.1% for all seizure types. Lamotrigine monotherapy appears to be effective in patients with newly diagnosed epilepsy and those with recurrent seizures in Japan and South Korea. The safety profile of lamotrigine in this monotherapy study was similar to that observed in patients with adult bipolar disorder treated with lamotrigine monotherapy.

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