Chronic Obstructive Pulmonary Disease Exacerbations and Pneumonia Hospitalizations Among New Users of Combination Maintenance Inhalers

Abstract

ImportanceClinical guidelines on chronic obstructive pulmonary disease (COPD) recommend inhalers containing long-acting muscarinic antagonists (LAMAs) and long-acting β-agonists (LABAs) over inhalers containing inhaled corticosteroids (ICSs) and LABAs. However, data from randomized clinical trials comparing these combination inhalers (LAMA-LABAs vs ICS-LABAs) have been conflicting and raised concerns of generalizability.ObjectiveTo assess whether LAMA-LABA therapy is associated with reduced COPD exacerbations and pneumonia hospitalizations compared with ICS-LABA therapy in routine clinical practice.Design, Setting, and ParticipantsThis was a 1:1 propensity score–matched cohort study using Optum’s Clinformatics Data Mart, a large commercial insurance–claims database. Patients must have had a diagnosis of COPD and filled a new prescription for a combination LAMA-LABA or ICS-LABA inhaler between January 1, 2014, and December 31, 2019. Patients younger than 40 years were excluded, as were those with a prior diagnosis of asthma. The current analysis was performed from February 2021 to March 2023.ExposuresCombination LAMA-LABA inhalers (aclidinium-formoterol, glycopyrronium-formoterol, glycopyrronium-indacaterol, tiotropium-olodaterol, or umeclidinium-vilanterol) and combination ICS-LABA inhalers (budesonide-formoterol, fluticasone-salmeterol, fluticasone-vilanterol, or mometasone-formoterol).Main OutcomeThe primary effectiveness outcome was first moderate or severe COPD exacerbation, and the primary safety outcome was first pneumonia hospitalization. Propensity score matching was used to control for confounding between the 2 groups. Logistic regression analysis was used to estimate propensity scores. Hazard ratios (HRs) and 95% CIs were estimated using Cox proportional hazards models stratified on matched pairs.ResultsAmong 137 833 patients (mean [SD] age, 70.2 [9.9] years; 69 530 [50.4%] female) (107 004 new ICS-LABA users and 30 829 new LAMA-LABA users), 30 216 matched pairs were identified for the primary analysis. Compared with ICS-LABA use, LAMA-LABA use was associated with an 8% reduction in the rate of first moderate or severe COPD exacerbation (HR, 0.92; 95% CI, 0.89-0.96) and a 20% reduction in the rate of first pneumonia hospitalization (HR, 0.80; 95% CI, 0.75-0.86). These findings were robust across a range of prespecified subgroup and sensitivity analyses.ConclusionIn this cohort study, LAMA-LABA therapy was associated with improved clinical outcomes compared with ICS-LABA therapy, suggesting that LAMA-LABA therapy should be preferred for patients with COPD.

Effects of the valsartan recall on heart failure patients: A nationwide analysis

“…We conducted a cohort study using retrospective data from Optum's de‐identified Clinformatics® Datamart Database, commonly used for observational analyses 21–23 . Clinformatics includes national claims from commercial and Medicare Advantage plans from a single payer representing over 60 million unique persons.…”

“…We conducted a cohort study using retrospective data from Optum's de-identified Clinformatics ® Datamart Database, commonly used for observational analyses. [21][22][23] Clinformatics includes national claims from commercial and Medicare Advantage plans from a single payer representing over 60 million unique persons. The data includes information on demographic characteristics, enrollment status, inpatient and outpatient medical diagnoses (coded using ICD-10-CM and CPT-4) and prescriptions dispensed (National Drug Code number, quantity, and days' supply).…”

Introducing the Guide to Statistics and Methods

“…JAMA Internal Medicine publishes a wide range of articles, from those using weighting in surveys to produce nationally representative estimates, to methods such as regression discontinuity to address causal inference, to consideration of many forms of bias (including anchoring bias), and to the use of propensity score methods to balance potential confounding factors between exposed and unexposed groups . Understanding the statistical methods and concepts used in our publications will help clinicians interpret the literature, stay current, and make evidence-based informed decisions.…”