title: Lamotrigine therapy in patients requiring a change in antiepileptic drug regimen.
abstract: BACKGROUND
  The tolerability of lamotrigine as adjunctive and monotherapy in patients requiring a change in antiepileptic drug (AED) therapy was assessed in this multicenter, open-label study. Open-label studies conducted in the clinic setting may provide additional drug tolerability and effectiveness information that may not be evident in pre-approval clinical trials.
  
  
  METHODS
  Adult patients with partial seizures received adjunctive lamotrigine for 16 weeks. Patients taking a single enzyme-inducing AED could convert to lamotrigine monotherapy for an additional 12 weeks. Patients were assessed at baseline, end of adjunctive therapy, and end of monotherapy using the Liverpool Adverse Experience Profile (AEP), Quality of Life in Epilepsy-31, a patient satisfaction rating, and a subjective investigator global assessment.
  
  
  RESULTS
  Of the 547 patients enrolled (mean age 42.7 years, 58% female), 421 (77%) completed adjunctive therapy. Upon completion of the adjunctive phase, mean improvement from baseline was 4.3 points on the AEP, and investigators rated 71% of patients as improved in global status. Overall score on the QOLIE 31 improved by 10 points from baseline. One hundred and seventy-eight patients entered and 143 (80%) patients completed the monotherapy phase. In patients completing lamotrigine monotherapy, mean improvement from baseline was 5.9 points on the AEP, and investigators rated 92% as improved in global status. Overall score on the QOLIE 31 score improved by 15 points from baseline.
  
  
  CONCLUSIONS
  Lamotrigine as adjunctive treatment and monotherapy may improve side effect burden and quality of life in patients requiring a change in AED therapy.
authors.affiliation: Epilepsy Clinical Development, GlaxoSmithKline, P.O. Box 13398, Research Triangle Park, NC 27709, USA. rob.p.kustra@gsk.com
authors.forename: Robert P
authors.initials: RP
authors.lastname: Kustra
authors.forename: Kimford J
authors.initials: KJ
authors.lastname: Meador
authors.forename: Bradley K
authors.initials: BK
authors.lastname: Evans
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Leschek-Gelman
authors.forename: Dawn A
authors.initials: DA
authors.lastname: Groenke
authors.forename: Anne E
authors.initials: AE
authors.lastname: Hammer
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Nanry
authors.forename: John A
authors.initials: JA
authors.lastname: Messenheimer
mesh_terms: D000293:Adolescent; D000328:Adult; D000339:Affect / Q000187:drug effects; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D004827:Epilepsy / Q000145:classification / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use*
chemical_list: D000927:Anticonvulsants; D014227:Triazines; D000077213:Lamotrigine