a comparative effectiveness study of mortality outcomes and related cardiopulmonary events among a cohort of chronic obstructive pulmonary disease (copd) patients who initiate breztri and multiple inhaler triple therapy (mitt) in the united states (us)

Conditions: Pulmonary Disease, Chronic Obstructive

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.


Eligibility criteria:
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)

Keywords: copd retrospective observational triple therapy cardiopulmonary mortality