Unblinded, randomized multicenter trial comparing lamotrigine and valproate combination with controlled-release carbamazepine monotherapy as initial drug regimen in untreated epilepsy
- 주제(키워드) Monotherapy , Combination therapy , CBZ-CR , LTG plus VPA , Initial drug regimen
- 주제(기타) Clinical Neurology; Neurosciences
- 설명문(일반) [Lee, Byung In; Heo, Kyoung; Cho, Yang-Je] Yonsei Univ, Coll Med, Dept Neurol, Seoul, South Korea; [No, Soon Kee] Bong Seng Mem Hosp, Dept Neurol, Busan, South Korea; [Yi, Sang-Doe; Cho, Yong Won] Keimyung Univ, Sch Med, Dept Neurol, Daegu, South Korea; [Lee, Hyang Woon] Ewha Womans Univ, Sch Med, Dept Neurol, Seoul, South Korea; [Kim, Ok Joon] CHA Univ, Dept Neurol, Seongnam, South Korea; [Kim, Sang Ho] Dong A Univ, Coll Med, Dept Neurol, Busan, South Korea; [Kim, Myeong Kyu] Chonnam Natl Univ, Med Sch, Dept Neurol, Gwangju, South Korea; [Kim, Sung Eun] Inje Univ, Coll Med, Dept Neurol, Busan, South Korea; [Kim, Yo Sik] Wonkwang Univ, Sch Med, Dept Neurol, Iksan, South Korea; [Kim, Jae Moon] Chungnam Natl Univ, Sch Med, Dept Neurol, Daejeon, South Korea; [Lee, Se-Jin] Yeungnam Univ, Coll Med, Dept Neurol, Daegu, South Korea; [Shin, Dong Jin] Gachon Univ, Med Ctr, Dept Neurol, Incheon, South Korea; [Park, Sung Pa] Kyungpook Natl Univ, Sch Med, Dept Neurol, Daegu, South Korea; [Kim, Yeong In] Catholic Univ Korea, Coll Med, Dept Neurol, Seoul, South Korea; [Kim, Youn Nam] Yonsei Univ Hlth Syst, Severance Hosp, Clin Trial Ctr, Seoul, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 W B SAUNDERS CO LTD
- 발행년도 2018
- URI http://www.dcollection.net/handler/ewha/000000151547
- 본문언어 영어
- Published As http://dx.doi.org/10.1016/j.seizure.2017.12.008
초록/요약
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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