A tolerability burden index in schizophrenia: incorporating patient perspective in clinical trial adverse event reporting.

: Adverse event (AE) reporting in clinical trials does not fully capture the patient-level perspective and comparing tolerability across treatments or among studies is difficult. : This study was designed to develop a treatment tolerability index algorithm that combines AE reporting with physician- and patient-level AE information into a global burden score to allow comparison of the overall tolerability of antipsychotic medications used in treating schizophrenia. : Data from a 4-arm, placebo-controlled clinical trial were used in the proposed tolerability index algorithm.

The use of adjunctive antipsychotics to treat depression in UK primary care.

Objective: Adjunctive antipsychotic therapy can be prescribed to patients with depression who have inadequate response to antidepressants. This study aimed to describe the use of adjunctive antipsychotics over a time period that includes the authorization in 2010 of prolonged-release quetiapine as the first adjunct antipsychotic to be used in major depressive disorder in the UK.

Research Design And Methods: Adults with an episode of depression between January 1, 2005 and July 31, 2013 were identified from antidepressant prescriptions and depression diagnoses in the UK Clinical Practice Research Datalink.

Clobazam and clonazepam use in epilepsy: Results from a UK database incident user cohort study.

Objective: To compare patient characteristics and treatment patterns among clobazam (CLB) and clonazepam (CZP)-treated patients with epilepsy in a longitudinal primary care database.

Methods: In this pharmacoepidemiological study, real-life usage data from the Clinical Practice Research Database (CPRD) were evaluated. The CPRD collects data from approximately 690 primary care practices throughout the UK.

Lack of tolerable treatment options for patients with schizophrenia.

Purpose: Atypical antipsychotics (AAs), an effective treatment for schizophrenia, have a range of pharmacologic properties leading to differences in tolerability as well as heterogeneity in treatment response. Individual patient characteristics must be considered when making treatment choices, especially from an adverse event (AE) or tolerability perspective. Despite the availability of numerous AAs, after appraising patient characteristics at the time of treatment selection, physicians may quickly run out of tolerable treatment options.

Cost-effectiveness of asenapine in the treatment of bipolar I disorder patients with mixed episodes.

Objective: Around one-third of patients with bipolar I disorder (BD-I) experience mixed episodes, characterized by both mania and depression, which tend to be more difficult and costly to treat. Atypical antipsychotics are recommended for the treatment of mixed episodes, although evidence of their efficacy, tolerability, and cost in these patients is limited. This study evaluates, from a UK National Health Service perspective, the cost-effectiveness of asenapine vs olanzapine in BD-I patients with mixed episodes.

Asenapine treatment and health-related quality of life in patients experiencing bipolar I disorder with mixed episodes: post-hoc analyses of pivotal trials.

Objective: To evaluate the baseline impact of episode type (manic vs. mixed), defined using DSM-IV-TR criteria, in bipolar I disorder (BD-I) on health-related quality of life (HRQoL), and to investigate the differential effect of asenapine vs. placebo and olanzapine on HRQoL in BD-I patients with mixed episodes.