Effect of Asenapine on Health-Related Quality of Life in patients with manic or mixed episodes associated with bipolar I disorder

摘要

Bipolar I disorder is a complex disease whose natural course frequently entails multiple relapses and impaired psychosocial functioning, resulting in a considerable reduction in patients' health-related quality of life (HRQoL) [1]. Even when patients are in euthymic state, their HRQoL is particularly impaired on both mental and social domains [2].Although HRQoL in patients suffering from bipolar disorders has received more interest in recent years, no comparative assessment of second-generation antipsychotics among acute manic and mixed patients suffering from bipolar I disorder is currently available [3].Asenapine is an antipsychotic with a unique pharmacologic profile [4] indicated in Europe for the treatment of moderate to severe manic episodes associated with bipolar I disorder. The clinical programme in monotherapy included two identically designed placebo-controlled, olanzapine-referenced 3-week randomised controlled trials (NCT00159744; NCT00159796) [5,6] followed by a 9-week olanzapine-referenced non-inferiority extension study in monotherapy (NCT00143182) [7]. In these studies HRQoL was assessed by the Medical Outcomes Study Short-Form 36-Item Health Survey, version 2 (SF-36) at baseline and study endpoint, allowing the assessment of functional health and well-being from a patient's perspective.The objective of these post-hoc analyses was to assess the differential effect of asenapine versus placebo and olanzapine on HRQoL among patients suffering from bipolar I disorder after 3 and 12 weeks of treatment.