Sandeep Dhanda, Jan Slade, Vicki Osborne, Lesley Wise, Saad Shakir<\/p>\n\n\n\n
The OBSERVA specialist cohort event monitoring (SCEM) study, conducted in secondary care in the UK, formed part of an EU risk management plan to monitor the use and short-term safety of asenapine, licensed for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. 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 \u22657% at end of study vs. index).<\/p>\n\n\n\n
To describe the utilisation and safety of asenapine prescribed in secondary care in the UK.<\/p>\n\n\n\n
An observational cohort study identified patients via a network of psychiatrists in collaboration with the Mental Health Research Network from November 2012-September 2016. Patient characteristics, drug utilisation and outcome data were collected via questionnaires completed by specialists sent at baseline and after 12 weeks of observation. Summary descriptive statistics were calculated.<\/p>\n\n\n\n
The final cohort consisted of 125 patients; the median age was 44 years [IQR 35-52]; 63 (50.4%) were male. Asenapine was most frequently prescribed for bipolar disorder (n=81, 64.8%); 15 of these patients (18.5%) had bipolar I disorder reported. There were also a number of off-label indications e.g., schizophrenia (n=18, 14.4%). Asenapine was largely prescribed in accordance with the product label; 56 patients (44.8%) were started on 5mg bd and at 12 weeks 34 patients (27.2%) were taking 10mg bd.<\/p>\n\n\n\n
The incidence of targeted events was as follows; oral hypoaesthesia n=9 (7.2%), oropharyngeal swelling n=0 (0.0%), sedation n=13 (10.4%), somnolence n=11 (8.8%), acute allergic reactions n=0 (0.0%), weight gain n=1 (0.8%).<\/p>\n\n\n\n
No deaths or pregnancies were reported in the OBSERVA study.<\/p>\n\n\n\n
Asenapine was largely prescribed in accordance with prescribing recommendations; the majority of patients were taking asenapine for bipolar disorder at the recommended dose. Event counts were small and no new safety signals were identified. This study provides valuable real-word data to support the post marketing risk-benefit profile of asenapine, however as a result of the small cohort size, any conclusions from this study should be put into context with results from other research evidence.<\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false},"categories":[45],"tags":[],"class_list":["post-4811","abstract","type-abstract","status-publish","hentry","category-isop-18th-annual-meeting-geneva-november-2018"],"acf":[],"yoast_head":"\n