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Unblinded, randomized multicenter trial comparing lamotrigine and valproate combination with controlled-release carbamazepine monotherapy as initial drug regimen in untreated epilepsy

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Author(s)
Byung In LeeSoon Kee NoSang-Doe YiHyang Woon LeeOk Joon KimSang Ho KimMyeong Kyu KimSung Eun KimYo Sik KimJae Moon KimSe-Jin LeeDong Jin ShinSung Pa ParkYeong In KimKyoung HeoYong Won ChoYang-Je ChoYoun Nam Kim
Keimyung Author(s)
Cho, Yong WonYi, Sang Do
Department
Dept. of Neurology (신경과학)
Journal Title
Seizure
Issued Date
2018
Volume
55
Keyword
CBZ-CRCombination therapyInitial drug regimenLTG + VPAMonotherapy
Abstract
PURPOSE:
To compare controlled-release carbamazepine monotherapy (CBZ-CR) with lamotrigine and valproate combination therapy (LTG + VPA) in equivalent total drug load, as initial drug regimen in untreated patients with partial and/or generalized tonic-clonic seizures (GTCS).

METHODS:
This unblinded, randomized, 60-week superiority trial recruited patients having two or more unprovoked seizures with at least one seizure during previous three months. After randomization into CBZ-CR or LTG + VPA, patients entered into eight-week titration phase (TP), followed by 52-week maintenance phase (MP). Median doses of CBZ-CR and LTG + VPA were 600 mg/day and 75 mg/day + 500 mg/day, respectively. Primary outcome measure was completion rate (CR), a proportion of patients who have completed the 60-week study as planned. Secondary efficacy measures included seizure-free rate (SFR) for 52-week of MP and time to first seizure (TTFS) during MP.

RESULTS:
Among 207 randomized patients, 202 underwent outcome analysis (104 in CBZ-CR, 98 in LTG + VPA). CR was 62.5% in CBZ-CR and 65.3% in LTG + VPA (p = 0.678). SFR during MP was higher in LTG + VPA (64.1%) than CBZ-CR (47.8%) (P = 0.034). TTFS was shorter with CBZ-CR (p = 0.041). Incidence of adverse effects (AEs) were 57.7% in CBZ-CR and 60.2% in LTG + VPA and premature drug withdrawal rates due to AEs were 12.5% and 7.1%, respectively, which were not significantly different.

CONCLUSION:
CR was comparable between LTG + VPA and CBZ-CR, however, both SFR for 52-week MP and TTFS during MP were in favor of LTG + VPA than CBZ-CR. The study suggested that LTG + VPA can be an option as initial drug regimen for untreated patients with partial seizures and/or GTCS except for women of reproductive age.
Keimyung Author(s)(Kor)
조용원
이상도
Publisher
School of Medicine (의과대학)
Citation
Byung In Lee et al. (2018). Unblinded, randomized multicenter trial comparing lamotrigine and valproate combination with controlled-release carbamazepine monotherapy as initial drug regimen in untreated epilepsy. Seizure, 55, 17–24. doi: 10.1016/j.seizure.2017.12.008
Type
Article
ISSN
1059-1311
DOI
10.1016/j.seizure.2017.12.008
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41569
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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