Asenapine in the Treatment of Bipolar Disorder: New Insights From the Expasen Study

Bipolar disorder is characterized by relapsing and remitting mood phases, such as manic or depressive episodes as well as periods of subsyndromal symptoms. Among the treatment options for acute manic episodes, most antipsychotics have a good level of evidence of effectiveness [1]. Asenapine is a new atypical antipsychotic which showed good effectiveness and tolerability [2] along with a reasonable cost-effectiveness [3] in placebo-controlled trials. However, few studies have tested this in real-world clinical settings so far. The aim of this study was to evaluate the effectiveness and tolerability of asenapine in bipolar patients in a naturalistic clinical setting. We retrospectively examined the clinical records of 94 systematically followed-up adult patients who received asenapine in four selected Spanish reference centers. We assessed sociodemographic variables, tolerability as well as clinical severity through routinely used evaluation scales. Half of the patients reported at least one adverse effect related to the asenapine (51%), being somnolence the most frequent (30%). Although none of the side effects reported was a cause to discontinue it. Asenapine showed good levels of effectiveness with a 61% reduction of manic and 44% of the depressive symptoms. Concerning mixed states, there was reduction of 30% and 39%, for both manic and depressive symptoms respectively. Though asenapine has an indication for acute manic episodes in bipolar disorder, the present study suggests that it can also have a role in treating depressive and mixed states in a real world setting. In addition, tolerability was consistent with clinical trial data.