Abstracts

Rash has been reported in about 10% of patients receiving lamotrigine. An open, uncontrolled case series suggested that utilizing dermatology precautions (DP, precautions to decrease environmental sources of rash) may yield a lower (5/100, 5%) incidence of lamotrigine treatment-emergent rash. We assessed DP versus usual care precautions (UCP) in a randomized trial. Adult bipolar disorder patients were randomized to receive either blinded DP or UCP for 12 weeks while open lamotrigine was initiated, titrated adjusting for concomitant bipolar medications to a target dose of 200 mg/day, and maintained. Rates of rash, tolerability, and clinical responses (CGI-BP) were compared with DP versus UCP. 180 sites enrolled 1175 subjects. No serious rash was reported. Rates of non-serious rash were 50/584 (8.6%) with DP and 52/591 (8.8%) with UCP. Adverse events included headache (8%), dizziness (5%), and insomnia (5%). Mean CGI-BP scores improved or remained stable similarly in both groups. Lamotrigine was generally well-tolerated. DP and UCP had similar (8.6 [ndash] 8.8%) rates of non-serious rash, that were marginally lower than the approximately 10% rate reported previously. Possible reasons for the lack of replication of the even lower (5%) rate reported in an open, uncontrolled case series will be discussed. (Supported by GlaxoSmithKline.)