Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints: Mortality Study

Date of Approval
Application Number
16_155
Technical Summary

This nested case-control study aims to evaluate the risk of all-cause mortality in patients initiating aclidinium bromide and other study medications as compared to LABA and in patients initiating aclidinium bromide as compared to patients initiating other COPD medications. The study will also evaluate the effect of duration of use on the risk of death. The case-control is nested in a cohort of patients aged 40 years or under, with COPD initiating aclidinium bromide or other COPD medications in the CPRD in the UK between 2012 and 2016. All confirmed cases of death will be included in the nested case-control study. Density sampling will be used to select four controls for each case. Exposure to study medications will be ascertained by recorded prescriptions in the CPRD. Death and death date, and diagnosis for comorbidities of interest, will be defined based on information from the Office of National Statistics (ONS) Mortality dataset, the inpatient Hospital Episode Statistic (HES) dataset, and GP OnLine Dataset (GOLD). Statistical analysis will include: 1) descriptive statistics of the cohort, 2) descriptive statistics of cases and controls, and 3) conditional multiple logistic regression to estimate crude and adjusted risk ratios for mortality overall and stratified by subgroups of interest.

Health Outcomes to be Measured

All-cause mortality

Collaborators

Jordi Castellsague - Chief Investigator - RTI Health Solutions
Ana Frances Gonzalez - Collaborator - Astra Zeneca Inc - USA
Christine Bui - Collaborator - RTI Health Solutions
CRISTINA REBORDOSA GARCIA - Collaborator - RTI Health Solutions
Estel Plana Hortoneda - Collaborator - RTI Health Solutions
Esther Garcia-Gil - Collaborator - Astra Zeneca Inc - USA
Nuria Riera Guardia - Collaborator - RTI Health Solutions
Susana Perez-Gutthann - Collaborator - RTI Health Solutions

Linkages

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