Sandeep Dhanda, Flavien Coukan, Lesley Wise, Saad Shakir

Background

Asenapine is approved in the EU for the treatment of manic episodes associated with bipolar I disorder in adults. A PASS was carried out to monitor the use and safety of asenapine using real-world primary care data in England; targeted safety outcomes were oral hypoaesthesia, oropharyngeal swelling, somnolence and sedation, acute allergic reactions and weight gain (defined as weight (kg) and/or BMI (kg/m2) increase of ≥7% at end of study vs. index).

Objectives

To describe the utilisation and safety of asenapine in primary care in England.

Methods

A cohort study identified patients from dispensed prescriptions of asenapine in England from January 2012-June 2016. Patient characteristics, drug utilisation and outcome data were collected from prescribing general practitioners via questionnaires sent at ≥3, and ≥12 months after the 1st prescription issued for each patient. Summary descriptive statistics were calculated.

Results

The cohort consisted of 122 patients with 3-month data of whom 56 patients had corresponding 12-month data (median age 44 years [IQR 35-55]; 66.4% female). The most frequent indication was bipolar disorder (n=81, 66.4%); for 10 patients (12.3%), the indication was specifically reported as bipolar I disorder. There were also a number of off-label indications e.g., schizophrenia (n=21, 17.2%). Asenapine was prescribed in accordance with the product label for 61 patients (50.0%) who were started on 5mg bd; 19 patients (15.6%) were prescribed 10mg bd.

For the 3-month cohort, incidence of targeted events was; oral hypoaesthesia n=0 (0.0%), oropharyngeal swelling n=1 (0.8%), sedation/somnolence n=5 (4.1%), acute allergic reactions n=0 (0.0%).

For the 12-month cohort, incidence of targeted events was; oral hypoaesthesia n=0 (0.0%), oropharyngeal swelling n=1 (1.8%), sedation/somnolence n=6 (10.7%), acute allergic reactions n=0 (0.0%), weight gain n=10 (17.9%).

In addition to the targeted outcomes other events of interest included four deaths, one of which was a completed suicide, and a case of foetal spina bifida diagnosed in a pregnant patient taking multiple psychiatric medications.

Conclusions

Asenapine was largely prescribed in accordance with prescribing recommendations. Event counts were small and no new safety signals were identified. This study design allowed for the timely collection of drug utilisation and safety data directly from prescribing GPs. However, as a result of the small cohort size, any conclusions from this study should be put into context with results from other post-marketing studies.