Investigation into the Long-term Metabolic Effects of Aripiprazole Adjunctive to Lithium, Valproate, or Lamotrigine

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. LIMITATIONS: 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.file:///C|/Users/Marc/Desktop/dx.doi.org/10.1016/j.jad.2012.11.054status: publishe