Efficacy and tolerability of asenapine for acute mania in bipolar I disorder: meta-analyses of randomized-controlled trials.

The aim of this study was to quantitatively review, using
a meta-analytic approach, randomized-controlled trials
analyzing the efficacy and safety profiles of asenapine
in the treatment of bipolar disorder (BD). MEDLINE
(1966 to August 2012) and EMBASE (1980 to August
2012) databases were systematically searched to identify
relevant papers. Data from four randomized-controlled
trials were analyzed. For continuous data (Young Mania
Rating Scale, Clinical Global Impression Scale for Bipolar
Disorder, and Montgomery-Asberg Depression Rating
Scale scores), the Hedges g was adopted as a measure
of the effect size; for dichotomous outcome measures
(discontinuation and rates of adverse events), the risk ratio
was calculated. In short-term trials, asenapine was found
to be significantly superior to placebo in the treatment
of manic symptoms of BD. There is also evidence of the
positive effects of asenapine compared with placebo
on depressive symptoms in mixed bipolar states. In the
medium-term and long-term studies, asenapine showed
comparable efficacy with the well-established comparator
olanzapine in the treatment of manic and depressive
symptoms of BD. Adverse events such as somnolence,
weight gain, and extrapyramidal symptom, which have an
impact on treatment adherence, are scarcely or moderately
elicited by asenapine, which shows a better profile than
olanzapine on metabolic parameters. On the basis of these
results, asenapine can be considered as an effective
and tolerable treatment for manic and mixed episodes
of BD.