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Title: Aripiprazole Shows Long-Term Treatment Efficacy in Bipolar Disorder: Presented at ECNP

"Aripiprazole Shows Long-Term Treatment Efficacy in Bipolar Disorder: Presented at ECNP"

By Joanna Lyford VIENNA, AUSTRIA -- October 15, 2007 -- Aripiprazole monotherapy is effective in preventing manic relapses in patients with bipolar disorder, long-term clinical data confirm. The study, which employed the most stringent criteria for stabilisation to date, provides strong support for the safety and efficacy of aripiprazole to maintain stability in patients with a recent manic or mixed episode of bipolar I disorder. Lead investigator Ronald Marcus, MD, Group Director, Global Clinical Development, Bristol-Myers Squibb, Wallingford, Connecticut, United States, presented the data in a poster session here at the 20th European College of Neuropsychopharmacology (ECNP) Congress. The study was an extension of a pivotal trial involving 567 patients with a recent manic or mixed episode of bipolar disorder. All patients were initially treated with open-label aripiprazole 15 to 30 mg/day for 6 to 18 weeks. In all, 161 patients achieved stabilisation, defined as a Young Mania Rating Scale score no greater than 10 and a Montgomery-Åsberg Depression Rating Scale score no greater than 13 for 6 consecutive weeks. Patients were then randomised to maintenance therapy with aripiprazole 15 to 30 mg/day (n = 77) or placebo (n = 83) for 100 weeks. Interim analysis at 26 weeks revealed that the time to relapse was significantly longer in patients treated with aripiprazole compared with those on placebo (hazard ratio [HR] 0.52; [P =.02). Importantly, this effect was sustained for 100 weeks (HR 0.53; P =.011)

Although the endpoint encompassed all mood symptoms, the benefit of aripiprazole was driven by a reduction in manic episodes. During the study period, 12% of aripiprazole-treated subjects experienced a manic relapse compared with 28% of placebo subjects, a highly significant difference (P <.05).

By contrast there was no difference between aripiprazole and placebo groups in the frequency or timing of depressive or mixed relapses.

"The safety and tolerability profile observed in this long-term study was consistent with that of other aripiprazole placebo-controlled studies," Marcus and coauthors report. The most common adverse events related to extrapyramidal syndrome were tremor, akathisia, and hypertonia in 9.1%, 7.8%, and 3.9% of subjects, respectively.

Other adverse effects associated with aripiprazole therapy were hypertension, dry mouth, weight gain, vaginitis, abnormal thinking, pharyngitis, and flu syndrome. Total discontinuation rates due to adverse events were 8% with aripiprazole versus 1% with placebo.

"To our knowledge, these are the first 2-year data in patients with bipolar I disorder since a lithium study published 30 years ago," Marcus and coauthors conclude (Am J Psychiatry. 1976;133:567-570).

"Over the course of the 100-week treatment period, aripiprazole monotherapy was shown to be effective in relapse prevention in patients with bipolar I disorder initially stabilised with aripiprazole for 6 consecutive weeks."

[Presentation title: Aripiprazole Maintenance Therapy In Bipolar Disorder: A Placebo-Controlled, 74-Week Extension of a 26-Week Study (CN138-010). Abstract P.3.c.051]

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