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Observational assessment of safety in seroquel (OASIS): a specialist cohort event monitoring (SCEM) study in England
- Source :
- Therapeutic Advances in Psychopharmacology, Vol 10 (2020), Therapeutic Advances in Psychopharmacology
- Publication Year :
- 2020
- Publisher :
- SAGE Publishing, 2020.
-
Abstract
- Background: This study was designed to monitor the short-term (up to 12 weeks) use and safety of quetiapine (Seroquel) extended release (XL) and quetiapine immediate release (IR) prescribed to patients with a clinical diagnosis of schizophrenia, and/or manic episodes associated with bipolar disorder by psychiatrists under normal conditions of use. Methods: A Specialist Cohort Event Monitoring (SCEM) study was conducted in England February 2010–April 2013. This observational cohort study recruited patients prescribed quetiapine XL within the secondary care setting by psychiatrists. A reference cohort of quetiapine IR users was also recruited. Baseline and 12 week observational data were collected from psychiatrists who abstracted information from medical records onto bespoke questionnaires. Data were collected on demographics, indication, past medical history, prescribing information and events of interest. Summary descriptive statistics were calculated. Results: The final cohort consisted of 869 eligible patients; 646 XL users and 223 IR users. The majority of XL and IR users were female (56.2% and 55.6%, respectively), with a median age of 40 (interquartile range [IQR]: 29, 49) and 39 (IQR: 28, 50) years, respectively. The most frequent indication for treatment was Manic episodes associated with Bipolar Affective disorder (53.4% XL and 49.8% IR). Median index dose was 200 mg/day (IQR: 100, 300) for XL users and 50 mg/day (IQR: 50, 100) for IR users, while median final maintenance dose was 400mg/day (IQR: 250, 600) and 300 mg/day (IQR: 100, 400), respectively. The most frequently reported event of interest in both cohorts was sedation ( n = 151, 23.9% XL cohort and n = 49, 23.0% IR cohort). Conclusion: Utilisation of quetiapine XL appeared to be in line with prescribing guidelines in terms of dose, and commonly reported events of interest were in concordance with the known safety profile. Overall, this SCEM study provided important information on the safety and utilisation of quetiapine XL in the secondary care setting in England.
- Subjects :
- safety
Event monitoring
medicine.medical_specialty
lcsh:RC435-571
Observational assessment
03 medical and health sciences
0302 clinical medicine
lcsh:Psychiatry
medicine
Immediate release
Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Original Research
seroquel
business.industry
lcsh:RM1-950
quetiapine
030227 psychiatry
lcsh:Therapeutics. Pharmacology
observational cohort
Emergency medicine
Cohort
Quetiapine
Psychology (miscellaneous)
Extended release
business
030217 neurology & neurosurgery
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 20451261
- Volume :
- 10
- Database :
- OpenAIRE
- Journal :
- Therapeutic Advances in Psychopharmacology
- Accession number :
- edsair.doi.dedup.....a84806bbfad51fdab468ca6417615c53