Asenapine prescribing patterns in the treatment of manic in- and outpatients: Results from the MANACOR study

Abstract

BackgroundAsenapine is the most recent compound that has been FDA- and EMA-approved for treatment of mania. Its efficacy and safety have been assessed in placebo-controlled trials, but little is known about its performance in routine clinical conditions. In this study, we compared features of patients treated with adjunctive asenapine or other adjunctive antipsychotics and the costs of the treatment. MethodsA combined prospective and retrospective data collection and analysis was conducted from January 2011 to December 2013 following a clinical interview and assessment of manic and depressive symptoms (YMRS, HDRS-17), clinical state (CGI-BP-M), psychosocial functioning (FAST), sexual dysfunction (PRSexDQ) and health resource costs associated with treatment with adjunctive asenapine versus other adjunctive antipsychotics. ResultsHundred and fifty-two patients from different university hospitals were included. Fifty-three patients received adjunctive asenapine and 99 received other adjunctive antipsychotics concomitantly to mood stabilizers. Considering inpatients, those treated with adjunctive asenapine presented a significantly less severe manic episode (P=0.001), less psychotic symptoms (P=0.030) and more comorbid personality disorder (P=0.002). Regarding outpatients, those treated with adjunctive asenapine showed significantly less severe manic episode (P=0.046), more previous mixed episodes (P=0.013) and more sexual dysfunction at baseline (P=0.036). No significant differences were found in mean total costs per day. ConclusionClinicians tended to use adjunctive asenapine in patients with less severe manic symptoms but more complex clinical profile, including more mixed episodes in the past, concomitant personality disorder, and sexual problems. Treatment with adjunctive asenapine was not associated with higher costs when compared to other options.