Characterising the safety profile of lurasidone in clinical practice: A drug utilisation and safety study using a United Kingdom primary care database.

Date of Approval
Application Number
16_004
Technical Summary

The overall study aim is to characterise the safety profile of lurasidone in UK primary care in comparison to other second generation antipsychotics (SGAs) through a descriptive drug utilisation study (DUS) and a comparative longitudinal post-authorisation safety study (PASS). The DUS will assess initiation of prescribing of lurasidone versus SGAs, and characterise patients with respect to demographics, comorbidities, comedications, and off-label prescribing. The PASS will assess incidence rates and rate ratios for safety outcomes in patients who are prescribed lurasidone versus other SGAs. Safety outcomes will include: mortality, extrapyramidal symptoms, angioedema, neuroleptic malignant syndrome, suicidality, cardiac disease, cerebrovascular accident, increased serum creatinine, renal impairment/failure, metabolic effects (hyperglycaemia, weight gain, dyslipidemia), rhabdomyolysis, agranulocytosis, and seizure. Subgroup analyses will be conducted in both components in the following sub-populations: patients with renal and hepatic impairment, the elderly, patients with cardiac impairment, those co-prescribed strong CYP3A inhibitors/inducers, and children/adolescents. Exploratory analyses will be conducted on exposure to SGAs in pregnant women. The safety of lurasidone with other antipsychotics will be also be assessed. Asthenia, as a safety outcome in the elderly as well as dose in the elderly will be studied.

Collaborators

Andrew Maguire - Chief Investigator - OXON Epidemiology - Spain
Shreya Davé - Corresponding Applicant - Takeda Pharmaceuticals Company Ltd
Michelle Johnson - Collaborator - Roche
Shuk-Li Collings - Collaborator - Pfizer Ltd - UK

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Townsend Score