Unblinded, randomized multicenter trial comparing lamotrigine and valproate combination with controlled-release carbamazepine monotherapy as initial drug regimen in untreated epilepsy
- Authors
- Lee, Byung In; No, Soon Kee; Yi, Sang-Doe; Lee, Hyang Woon; Kim, Ok Joon; Kim, Sang Ho; Kim, Myeong Kyu; Kim, Sung Eun; Kim, Yo Sik; Kim, Jae Moon; Lee, Se-Jin; Shin, Dong Jin; Park, Sung Pa; Kim, Yeong In; Heo, Kyoung; Cho, Yong Won; Cho, Yang-Je; Kim, Youn Nam
- Issue Date
- Feb-2018
- Publisher
- W B SAUNDERS CO LTD
- Keywords
- Monotherapy; Combination therapy; CBZ-CR; LTG plus VPA; Initial drug regimen
- Citation
- SEIZURE-EUROPEAN JOURNAL OF EPILEPSY, v.55, pp.17 - 24
- Journal Title
- SEIZURE-EUROPEAN JOURNAL OF EPILEPSY
- Volume
- 55
- Start Page
- 17
- End Page
- 24
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/4115
- DOI
- 10.1016/j.seizure.2017.12.008
- ISSN
- 1059-1311
- 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. (C) 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
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