PMID- 37775363
OWN - NLM
STAT- MEDLINE
DCOM- 20240116
LR  - 20240116
IS  - 1873-7862 (Electronic)
IS  - 0924-977X (Linking)
VI  - 78
DP  - 2024 Jan
TI  - Lamotrigine efficacy, safety, and tolerability for women of childbearing age with 
      bipolar I disorder: Meta-analysis from four randomized, placebo-controlled 
      maintenance studies.
PG  - 81-92
LID - S0924-977X(23)00671-5 [pii]
LID - 10.1016/j.euroneuro.2023.09.001 [doi]
AB  - This meta-analysis investigated the efficacy, safety, and tolerability of 
      lamotrigine versus placebo in preventing relapse and recurrence of mood episodes 
      in women of childbearing age with bipolar I disorder. Following up to 16 weeks' 
      open-label lamotrigine treatment, responders were randomized to double-blind 
      treatment, including lamotrigine 100-400 mg/day or placebo, in four trials of up 
      to 76 weeks. Women aged 18-45 years who received >/= 1 dose of study treatment and 
      had >/= 1 efficacy assessment in the double-blind phase were pooled for efficacy 
      analysis. The primary outcome was median time to intervention for any mood 
      episode (TIME). Of 717 eligible women in the open-label phase, 287 responded and 
      were randomized to lamotrigine (n = 153) or placebo (n = 134). The randomized 
      group had a mean (SD) of 2.0(2.02) manic and 2.5(2.02) depressive episodes in the 
      3 years before screening. Median TIME was 323 days with lamotrigine and 127 days 
      with placebo (HR 0.69; 95% CI 0.49, 0.96; p = 0.030). Lamotrigine delayed time to 
      intervention for any depressive episode (HR 0.59; 95% CI 0.39, 0.90; p = 0.014) 
      with no treatment difference for manic episodes (HR 0.91; 95% CI 0.52, 1.58; 
      p = 0.732). 2/717 (< 1%) participants experienced serious rash-related adverse 
      events (AEs) during the open-label phase, and 52/717 (7%) had non-serious 
      rash-related events leading to study withdrawal. Incidence of AEs and AEs leading 
      to withdrawal were similar between lamotrigine and placebo groups. Lamotrigine 
      delayed relapse and recurrence of mood episodes, largely by preventing depressive 
      episodes, and was well tolerated in women of childbearing age.
CI  - Copyright (c) 2023 The Author(s). Published by Elsevier B.V. All rights reserved.
FAU - Vieta, Eduard
AU  - Vieta E
AD  - Hospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, 
      CIBERSAM, Barcelona, Catalonia, Spain.
FAU - Ghorpade, Sanman
AU  - Ghorpade S
AD  - Global Medical Affairs, GSK, Mumbai, India. Electronic address: 
      sanman.a.ghorpade@gsk.com.
FAU - Biswas, Arunangshu
AU  - Biswas A
AD  - Development Biostatistics, GSK, Mumbai, India.
FAU - Sarkar, Angshuman
AU  - Sarkar A
AD  - Development Biostatistics, GSK, Mumbai, India.
FAU - Phansalkar, Abhay
AU  - Phansalkar A
AD  - Regional Medical Affairs, GSK, Mumbai, India.
FAU - Cooper, James
AU  - Cooper J
AD  - General Medicines, GSK, Brentford, UK.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20230927
PL  - Netherlands
TA  - Eur Neuropsychopharmacol
JT  - European neuropsychopharmacology : the journal of the European College of 
      Neuropsychopharmacology
JID - 9111390
RN  - U3H27498KS (Lamotrigine)
RN  - 0 (Triazines)
RN  - 0 (Anticonvulsants)
SB  - IM
MH  - Humans
MH  - Female
MH  - Lamotrigine/adverse effects
MH  - *Bipolar Disorder/diagnosis
MH  - Triazines/adverse effects
MH  - Anticonvulsants/therapeutic use
MH  - Mania/chemically induced/drug therapy
MH  - Double-Blind Method
MH  - Recurrence
MH  - *Exanthema/chemically induced/drug therapy
MH  - Treatment Outcome
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - Anticonvulsants
OT  - Bipolar Depression
OT  - Relapse
OT  - Reproductive Health
OT  - Teratogens
OT  - Unplanned Pregnancy
COIS- Conflict of interest Eduard Vieta, has received grants from AB-Biotics, Dainippon 
      Sumitomo Pharma, Janssen, Lundbeck, Novartis, Otsuka, Sage, Sanofi-Aventis, 
      Sunovion, and Takeda; has received payment or honoraria from Abbott, Angelini, 
      Cambridge University Press, Casen-Recordati, Elsevier, Galenica, GSK, Janssen, 
      Lundbeck, Oxford University Press, Organon, Otsuka, and Sage; and has served on a 
      Data Safety Monitoring Board or Advisory Board for AbbVie, Angelini, Biogen, 
      Celon, Gedeon Richter, GH Research, Janssen, Lundbeck, Novartis, Otsuka, Sage, 
      Sanofi-Aventis, Shire, Sunovion, and Takeda (all outside the submitted work). 
      Sanman Ghorpade, Angshuman Sarkar, Abhay Phansalkar, and James Cooper are 
      employees of, and hold stocks in, GSK group of companies. Arunangshu Biswas is an 
      employee of GSK.
EDAT- 2023/09/30 09:42
MHDA- 2024/01/16 06:42
CRDT- 2023/09/29 21:54
PHST- 2022/12/13 00:00 [received]
PHST- 2023/08/17 00:00 [revised]
PHST- 2023/09/04 00:00 [accepted]
PHST- 2024/01/16 06:42 [medline]
PHST- 2023/09/30 09:42 [pubmed]
PHST- 2023/09/29 21:54 [entrez]
AID - S0924-977X(23)00671-5 [pii]
AID - 10.1016/j.euroneuro.2023.09.001 [doi]
PST - ppublish
SO  - Eur Neuropsychopharmacol. 2024 Jan;78:81-92. doi: 
      10.1016/j.euroneuro.2023.09.001. Epub 2023 Sep 27.