Umeclidinium/vilanterol (UMEC/VI) and umeclidinium (UMEC) are two treatments - called long-acting bronchodilators (LABD) launched in the UK during 2014. These are approved for chronic obstructive pulmonary disease (COPD). This study will describe the characteristics of patients who started taking UMEC/VI or UMEC and other LABDs between July 2014 and June 2016. To ensure there are enough patients in the study, information from two very similar GP databases (CPRD and THIN) will be combined.
Key questions include:
• How many new users of each treatment group (1) UMEC/VI, 2) UMEC and 3) other LABDs) have a diagnosis of COPD, asthma, or neither and whether there are any differences between these treatment groups?
• How often do new users of UMEC/VI and UMEC experience important health events, including heart attacks, strokes, pneumonia, exacerbations of COPD, or death?
• How many users of the UMEC/VI or UMEC, continue with this treatment after their first prescription, how many stop, switch to a different treatment, or start taking an additional COPD treatment?
The results will provide valuable information about whether UMEC/VI and UMEC are being prescribed as recommended, and help in planning any future risk-benefit studies for these treatments.
Umeclidinium/vilanterol (UMEC/VI) and umeclidinium (UMEC) launched in the UK during 2014, along with other long-acting bronchodilator (LABD) medications, are indicated for the treatment of Chronic Obstructive Pulmonary Disease (COPD). This study will describe the patient populations newly prescribed 1) UMEC/VI, 2) UMEC, and 3) other specified LABDs, and determine the frequency of possible off-label use i.e. prescribing in patients without a COPD diagnosis. New users of other LABD comprise a natural comparator group for any future study of the safety and effectiveness of UMEC /VI and UMEC. It is therefore of interest to assess the extent of any baseline differences between new users of UMEC /VI and UMEC, and new users of similar treatments. Incidence of major cardiovascular and cerebrovascular events, pneumonia, COPD exacerbations, and death will be estimated in new users of UMEC/VI and UMEC only. Treatment patterns in the first 12 months following initiation will also be described for UMEC/VI and UMEC. The results will inform feasibility assessment and planning potential future risk-benefit studies.
To ensure adequate numbers of new users of the recently launched UMEC/VI and UMEC, the study will use data from two primary care electronic medical record (EMR) databases: CPRD GOLD; and the THIN database.
Daniel Dedman - Chief Investigator - CPRD
Daniel Dedman - Corresponding Applicant - CPRD
Gema Requena - Collaborator - GlaxoSmithKline Services Unlimited (UK)
Jeanne Pimenta - Collaborator - BioMarin Pharmaceutical Inc.
Rachael Williams - Collaborator - CPRD
Rebecca Ghosh - Collaborator - CPRD
Sonia Coton - Collaborator - CPRD
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Townsend Score;Practice Level Index of Multiple Deprivation