Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable condition of the lungs. Patients with COPD experience various symptoms including shortness of breath, coughing and wheezing.
There are a wide range of drugs that are available for the treatment of COPD in the UK. To help prevent “flare-ups” in symptoms (called exacerbations) patients are usually given inhaler treatments which contain a combination of two types of drug (termed “dual therapy”) taken together as part of a single inhaler and used daily to prevent symptoms over an extended period of time (termed “long-acting”). There are a range of long-acting single inhaler dual therapies available in the UK, including Umeclidinium/Vilanterol (UMEC/VI) and Indacaterol/ Glycopyrronium bromide (IND/GLY).
Treatments aim to reduce exacerbations in patients with COPD, as these accelerate disease progression and damage patients’ quality of life and health status. This study aims to see whether there are any differences in patient outcomes when starting patients with COPD on dual therapy with UMEC/VI versus IND/GLY. This will include comparing how frequently patients receiving these drugs experience exacerbations, as well as the need for other healthcare services and the associated costs to the National Health Service. The study will also assess the requirement for these patients to have additional support in the form of triple therapy (combinations of three different drugs given in the most severe of cases).
Aim: To compare real-world effectiveness of Umeclidinium/Vilanterol (UMEC/VI) versus Indacaterol/ Glycopyrronium bromide (IND/GLY) on acute exacerbations of COPD (AECOPD) and health care resource utilisation (HCRU) and direct medical costs, among a General Practice (GP) chronic obstructive pulmonary disease (COPD) cohort in England.
Objectives: To compare i) rate of moderate-to-severe AECOPD (also moderate and severe separately); ii) time to first on treatment AECOPD (moderate-to-severe, moderate, severe) and iii) all-cause and COPD-related HCRU/ direct medical costs, among COPD patients newly initiating dual therapy with single inhaler UMEC/VI versus IND/GLY. Uptake of triple therapy will also be described (proportion of patients receiving single- or multiple-inhaler triple therapy [(SITT or MITT]) and time until triple therapy initiation).
Primary exposures: Single inhaler UMEC/VI or IND/GLY initiation.
Primary outcomes: Rate of moderate-to-severe AECOPDs
Methods: A new-user, active comparator, retrospective cohort study using inverse probability of treatment weighting (IPTW) to adjust for measured confounders to assess the non-inferiority of UMEC/VI versus IND/GLY using linked CPRD Aurum and Hospital Episode Statistics (HES) data. In the event that non-inferiority is demonstrated, superiority will then be examined. The first/earliest date of dual therapy (UMEC/VI or IND/GLY) initiation between January 2015 and September 2019 will determine the index date. No minimum follow-up is required for inclusion into the study.
Data analysis: A propensity score (PS) method will be implemented to minimise potential confounding and evaluate average effects in the population. Logistic regression will generate the PS, which will be applied via IPTW. Rate of AECOPDs (events per person-year) will be compared using IPTW-weighted rate ratios (RRs) from negative binomial regression. HCRU and costs (derived via application of unit costs/tariffs) will be compared using IPTW-weighted RRs from negative binomial regression and relative rates from generalised linear models, respectively. Time-to-triple therapy will be assessed using Kaplan-Meier survival analysis and Cox proportional hazards models.
Rate of AECOPD (moderate-to-severe, moderate, severe); time to first AECOPD (moderate-to-severe, moderate, severe); HCRU (all-cause and COPD-related); Direct medical costs (all-cause and COPD-related); proportion of patients receiving triple therapy; Time-to-triple therapy
Gema Requena - Chief Investigator - GlaxoSmithKline Services Unlimited (UK)
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GlaxoSmithKline Services Unlimited (UK)
Catherine Castillo - Collaborator - Adelphi Real World
Eunmi Ha - Collaborator - Adelphi Real World
Jie Yeap - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real World
HES Accident and Emergency;HES Admitted Patient Care;Patient Level Index of Multiple Deprivation