PT. Otsuka Indonesia

For many patients, the effectiveness of current treatments for bipolar disorder is suboptimal. Although mood-stabilizer, has been used widely for treatments for acute mania—show similar efficacy, clinical trials report nonresponse rates of up to 50% with these agents.
Antipsychotics are commonly used for the initial treatment of acute mania, both as monotherapy and as adjuncts to mood stabilizers. In acute mania, typical antipsychotics show similar efficacy to lithium, but they may have a faster onset of action and they appear more effective in treating psychomotor agitation.

Generally, atypical antipsychotics have a lower risk of neurological side effects compared with typical agents and may be less likely to exacerbate depressive symptoms.

However, currently available atypical antipsychotics are associated with unwanted side effects, including weight gain, hyperprolactinemia , QTc prolongation, hyperglycemia, and dyslipidemia, except Abilify^_®.

Abilify^_® is a novel antipsychotic with a pharmacodynamic profile that distinguishes it from other antipsychotics. Abilify^_® is a partial agonist at dopamine D2 receptors, a partial agonist at serotonin 5-HT1A receptors, and an antagonist at 5-HT2A receptors.

In a 3-week, multicenter, double-blind study randomly assigned 262 bipolar disorder patients in an acute manic or mixed episode to Abilify^_®, 30 mg/day (reduced to 15 mg/day if needed for tolerability), or placebo. Patients remained hospitalized for at least 2 of the weeks.
The primary efficacy measure was mean change from baseline in total score on the Young Mania Rating Scale; response was defined as a decrease in score of > 50%.

Results, Abilify^_® produced statistically significant mean improvements in total score on the Young Mania Rating Scale compared with placebo (–8.2 versus –3.4, respectively) and produced a significantly higher response rate (40% versus 19%). Forkey efficacy variables (response per Young Mania Rating Scale; Clinical Global Impression— Bipolar Version scores for severity of illness [mania] and change from preceding phase [mania]), Abilify® separated from placebo by day 4. The completion rate was significantly higher with Abilify^_® than with placebo (42% versus 21%).

Discontinuations due to adverse events did not differ significantly between the Abilify^_® and placebo groups. There were no significant changes in body weight versus placebo, and Abilify® was not associated with elevated serum prolactin or QTc prolongation.

Conclusions: Abilify^_® had significantly greater efficacy than placebo for the treatment of bipolar disorder patients in acute manic or mixed episodes and was safe and well tolerated in this randomized controlled trial.

Reference:

Jakarta, 28 Jan 2010

The Use of antipsychotics in acute bipolar mania