title: Investigation into the long-term metabolic effects of aripiprazole adjunctive to lithium, valproate, or lamotrigine.
abstract: BACKGROUND
  Bipolar I disorder (BPD) patients are often overweight or obese, and likely to have metabolic syndrome. Several medications used to treat BPD are associated with increased body weight and/or worsening metabolic parameters.
  
  
  METHODS
  Metabolic data were analyzed from two efficacy studies of aripiprazole plus the mood stabilizers, lithium/valproate (Study CN138-189), or lamotrigine (Study CN138-392), in the long-term treatment (52 weeks) of BPD. Changes in body weight, individual metabolic parameters, and incidence of metabolic syndrome were assessed.
  
  
  RESULTS
  In the lithium/valproate study, modest increases in body weight were observed at Week 52 in both groups: 1.7 ± 0.8 kg in the lithium/valproate group, and 1.6 ± 0.7 kg in the adjunctive aripiprazole group; this difference was nonsignificant. In the lamotrigine study, decreases in body weight were observed at Week 52 with lamotrigine alone (-2.2 ± 1.0 kg), whereas a modest increase was observed when combined with aripiprazole (0.4 ± 1.0 kg). In both studies, rates of metabolic syndrome at 52 weeks did not increase from baseline with aripiprazole, and median changes from baseline in individual metabolic syndrome parameters were similar with both mood stabilizer monotherapy and the addition of aripiprazole as an adjunctive therapy.
  
  
  CONCLUSIONS
  This was a post-hoc analysis, and a low percentage of patients completed the lamotrigine study.
  
  
  CONCLUSIONS
  Aripiprazole plus a mood stabilizer has minimal impact on metabolic changes in predominantly overweight/obese BPD patients over a 52-week period. In both studies, modest mean increases in weight with the addition of aripiprazole were not accompanied by increased rates of metabolic syndrome or changes in metabolic parameters.
authors.affiliation: University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH, USA. kemp.david@gmail.com
authors.forename: David E
authors.initials: DE
authors.lastname: Kemp
authors.forename: Marc
authors.initials: M
authors.lastname: De Hert
authors.forename: Zia
authors.initials: Z
authors.lastname: Rahman
authors.forename: Paula
authors.initials: P
authors.lastname: Fyans
authors.forename: James M
authors.initials: JM
authors.lastname: Eudicone
authors.forename: Sabrina V
authors.initials: SV
authors.lastname: Marler
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker
authors.forename: Berit X
authors.initials: BX
authors.lastname: Carlson
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000188:drug therapy*; D001835:Body Weight; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077213:Lamotrigine; D008094:Lithium / Q000627:therapeutic use*; D008297:Male; D024821:Metabolic Syndrome / Q000453:epidemiology; D008875:Middle Aged; D009765:Obesity / Q000453:epidemiology; D050177:Overweight / Q000453:epidemiology; D010879:Piperazines / Q000627:therapeutic use*; D015363:Quinolones / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use*; D014635:Valproic Acid / Q000627:therapeutic use*
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D014227:Triazines; D014635:Valproic Acid; D000068180:Aripiprazole; D008094:Lithium; D000077213:Lamotrigine