35 – Long-term safety of asenapine in patients with schizophrenia

Abstract

Background: Asenapine is a novel psychopharmacologic agent under development for treatment of schizophrenia and bipolar mania. This trial focused on the long-term safety of asenapine in patients with schizophrenia. Methods: In this double-blind, non-US, 1-year-long Phase III trial, patients were randomly assigned (3:1) to asenapine, 10–20 mg, or olanzapine, 20–40 mg, daily. Safety assessments included adverse events (AEs), body weight, and laboratory examinations. Other assessments included the Subjective Well-Being on Neuroleptics (SWN) scale, Short Form (SF-12) health survey, and PANSS (using mixed model for repeated measures). Results: Among 1219 treated patients, the final dose was 10 mg/day for 53% and 59% of patients in the asenapine and olanzapine groups, respectively. Drug-related AEs (mostly mild-to-moderate) occurred in 60% and 61% of patients on asenapine and olanzapine, respectively; withdrawals due to serious AEs were similar (6.3% and 6.8%). Incidence of EPS was 18% and 8%; mean weight gain was 1.6 kg and 5.6 kg; significant weight gain (≥7%) was 14.7% with asenapine and 36.1% with olanzapine. In both groups, the incidence of QTcFN500 ms or prolongation N60 ms was 0% and 0.3%. Both groups showed small mean declines in prolactin levels. Mean changes in fasting glucose, cholesterol, and triglycerides were small in both groups. Similar responses on SWN and SF-12 assessments were observed. The difference in PANSS total score between groups was 0.5 at week 6 and 4.2 points at week 52. Conclusions: Long-term treatment (1 year) with asenapine was well tolerated in patients with schizophrenia.