Rapidity of Action, Effectiveness and Adherence to Treatment with Asenapine: a Real-world, Observational Study

Abstract

Asenapine (ASE) is a second-generation antipsychotic with a unique pharmacological profile, that was recently approved for the treatment of moderate/severe manic episodes (ME). Real-world data on rapidity of action in inpatient settings are lacking. 1) rating scale variation after 7 days (T0-T1) of treatment with ASE in patients hospitalized for ME during Bipolar I Disorder or a Schizoaffective Disorder 2) follow-up on continuity of treatment at 6 months Determination of short-term effects of ASE and continuity of treatment in an observational, real-world study. All inpatients who met DSM-IV-TR criteria for ME treated with ASE were recruited in the 2 years after the drug was available. YMRS and BPRS were administered at T0 and T1. 6 months follow-up data were collected from patients taking ASE at discharge. The mean total YMRS score decreased by 12.6 (SD ±10.3; t(17)=5.2, p<.005), implying a mean 37.8% improvement. A statistically significant reduction was observed for all YMRS items, except for 'sexual interest”. The mean total BPRS score decreased by 17.2 (SD ±14.9; t(17)=4.9, p<.005). A statistically significant reduction was observed for several items, including 'conceptual disorganization”, 'grandiosity”, 'unusual thought content”, 'excitement”. At hospital discharge, ASE was confirmed in 55% of patients, 18% of which were still taking the drug at 6 months: lack of efficacy and poor adherence were found to influence continuity of treatment rather than specific side effects. ASE is rapidly effective in the first week of treatment, but is subject to a high discontinuation rate on the long term.