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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LURASIDONE
• Anatomical Therapeutic Chemical (ATC) code:
  (N05AE05) lurasidone

  lurasidone
• Medical condition to be studied:
  Schizophrenia

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  6611

Study design details

• Main study objective:
  The overall aim of this research was to characterise the safety profile of lurasidone compared with other second-generation antipsychotics in clinical practice.
• Setting:
  Primary care database
• Data analysis plan:
  Drug Utilisation Study: Descriptive statistics, including means (SDs) and medians (10th–90th percentiles) for continuous variables, and frequencies and percentages for categorical variables, were used to examine the following characteristics among new users of lurasidone compared with new users of all other second-generation antipsychotics combined: demographics, comorbidities and concomitant medications, treatment initiation patterns, dose adjustments, duration of therapy, prevalence of schizophrenia diagnoses, and prevalence of other relevant psychiatric indications in the absence of a schizophrenia diagnosis. The number of patients censored during follow-up, by calendar year, and the duration of follow-up, by year of treatment initiation, were also reported.; ; Post-Authorisation Safety Study (PASS): Exposure propensity scores were used to frequency-match new users of lurasidone with new users of comparator second-generation antipsychotics. Patients were additionally matched on age and sex.