Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Case-series
Study drug and medical condition

Name of medicine

XEPLION
TREVICTA
Population studied

Short description of the study population

Patients treated with paliperidone palmitate (PP) between January 1, 2013, and December 31, 2019.

Age groups

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)

Estimated number of subjects

400
Study design details

Main study objective

The main objective was to describe PP-related adverse drug reactions (ADRs) leading to death or life-threatening events, specifying their main clinical and pharmacological characteristics.

Outcomes

Compare paliperidone palmitate mortality rate from the rates for oral risperidone and parenteral risperidone.

Data analysis plan

This observational study was a retrospective review of FPVD cases in patients treated with PP between January 1, 2013, and December 31, 2019. To approximate the number of patients exposed to PP or risperidone (oral and parenteral forms), we used data from the annual Medic’AM spreadsheet, which catalogs all drug reimbursements by the French health insurance system, and the World Health Organization’s Defined Daily Doses (DDDs). The DDD is the average daily maintenance dose of a drug used for its main indication in adults. Mortality was calculated as the ratio of the number of deaths reported in the FPVD to the number of patients treated with PP or risperidone, over the study period.Continuous data was summarized with means and standard deviations, or medians. Categorical data was summarized with tallies and percentages, and they were compared using Fisher’s exact tests (two-sided, α =