Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
COPD, Retrospective, Observational, Triple Therapy, Cardiopulmonary, Mortality
Brief summary
Patients with chronic obstructive pulmonary disease (COPD) have elevated risk of mortality and cardiopulmonary events, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce mortality and cardiopulmonary event risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes associated with SITTs versus multiple inhaler triple therapies (MITTs). SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum's de-identified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality (ACM) and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020-June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference \>0.1) in baseline characteristics.
Interventions
DRUGBGF
Budesonide/glycopyrrolate/formoterol fumarate
DRUGMITT
Multiple-inhaler triple therapy
Sponsors
AstraZeneca
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1 initial prescription for BGF or MITT starting October 1, 2020 through to the latest available data update, AND * Age ≥40 years on date of first prescription for BGF or MITT episode, AND * Continuous medical and pharmacy health plan eligibility for ≥12-months (365 days) prior to first prescription for BGF or MITT AND * 2 medical claims with diagnoses for COPD at least 30 days apart occurring on or anytime in the patient's available 24-month history before the first BGF prescription or MITT episode, with one diagnosis occurring in the immediate 12-month period prior to or on initiation of BGF or MITT
Exclusion criteria
* Age \<40 at time of treatment initiation * Invalid or unknown gender * If death date occurs prior to or on study index date * \<12 months (365 days) of medical and pharmacy health plan eligibility/coverage prior treatment initiation * Presence of ≥1 prescription claim for any triple therapy during the patient's entire available baseline history (BGF, FF/UMEC/VI or MITT) * potential MITT use in baseline, MITT for baseline purposes will be defined as ≥1 days continuous days where all three MITT components (ICS, LABA, LAMA) are observed in combination (dual + monotherapy) or as three separate monotherapy components * History of any of the following conditions, procedures or events during the immediate baseline 12-month period: (a) ≥1 medical claim (i.e., office, ED or hospital) in any position with a diagnosis for alpha-1-antitrypsin deficiency, interstitial fibrosis, lung cancer, pulmonary embolism, sarcoidosis; (b) ≥1 medical claim for hospice services; (c) Any medical Bill Type Code (BILL\_TYPE\_CODE ) starting with 81 or 82; or Revenue codes (RVNU\_CD): 0651-0659; (d) ≥1 medical claim with a diagnosis code of encounter related to clinical trial participation (Z00.6) at any point during the study period (including both baseline and follow-up periods)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to and rate of all-cause mortality | During available follow-up; median 313 days | Time to and rate of all-cause mortality observed after initiation of BGF or MITT; all-cause mortality as defined by the available death information contained in the database. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to and rate of cardiopulmonary events | During available follow-up; median 313 days | Time to and rate of cardiopulmonary events observed during the follow-up period after initiation of BGF or MITT; cardiopulmonary events defined as a composite measure of severe (hospitalizations) COPD exacerbations and MACE-related events, and all-cause mortality |
Countries
United States
Outcome results
None listed