Patel, Viral

Background/Objectives: Fixed-dose triple therapy is recommended for patients with chronic obstructive pulmonary disease (COPD) at high risk of exacerbations; however, direct comparative effectiveness data between available triple therapy regimens remain limited. We compared real-world clinical outcomes among adults with COPD receiving fluticasone furoate/vilanterol/umeclidinium (FF/VI/UMEC) or budesonide/glycopyrrolate/formoterol (BUD/GLY/FOR). Methods: We conducted a retrospective propensity score-matched cohort study using the TriNetX Research Network. Adults with a spirometrically confirmed diagnosis of COPD who received fluticasone furoate/vilanterol/umeclidinium (FF/VI/UMEC) or budesonide/glycopyrrolate/formoterol (BUD/GLY/FOR) between July 2020 and August 2024 were included in the analysis. A 365-day landmark period was applied to establish maintenance therapy, with outcome follow-up beginning 1 year after treatment initiation. Patients were followed for outcomes through August 2025, the date of database analysis. After 1:1 propensity score matching, treatment groups were compared for COPD exacerbations, acute respiratory failure (ARF), hospitalization, and all-cause mortality using RR and Cox proportional hazards analyses. Results: In matched cohorts, FF/VI/UMEC was associated with a significantly higher risk of COPD exacerbations (5.6% vs. 3.9%; RR 1.44; 95% CI 1.30–1.59; p < 0.001) and ARF (2.5% vs. 1.9%; RR 1.28; 95% CI 1.11–1.46; p < 0.001) compared with BUD/GLY/FOR. Time-to-event analyses demonstrated lower event-free probability for exacerbations (HR 1.35; (95% CI 1.21–1.50) and ARF (HR 1.15; (95% CI 1.00–1.32))). All-cause mortality was numerically higher in the FF/VI/UMEC cohort (5.2% vs. 4.7%; RR 1.09; 95% CI 1.00–1.19; p = 0.050); however, time-to-event analysis did not demonstrate a statistically significant difference. Hospitalization rates were similar between groups. Conclusions: In this large propensity score-matched real-world cohort study, patients receiving BUD/GLY/FOR experienced lower rates of COPD exacerbations and acute respiratory failure than those receiving FF/VI/UMEC. Because of the retrospective observational nature of the analysis, these findings should be considered hypothesis-generating and require confirmation in prospective comparative effectiveness studies.

Abstract Introduction: Chronic obstructive pulmonary disease (COPD) represents a significant global health challenge, particularly in its moderate to severe cases, where effective management is crucial to improving patient outcomes. The integration of inhaled corticosteroids with long-acting β2-adrenoceptor agonists and long-acting muscarinic antagonists in fixed-dose combinations has emerged as a cornerstone of therapy. This study evaluates the efficacy of two triple therapy regimens — Glycopyrrolate, Budesonide, and Formoterol Fumarate (GLY/BUD/FOR) and Fluticasone Furoate, Vilanterol, and Umeclidinium (FF/VI/UMEC) —in adults aged 45 and older with diagnosed COPD with FEV1/FVC &lt; 70% to assess the impact of these regimens on the preventing COPD exacerbations and acute hypoxemic respiratory failure. Methods: A retrospective cohort analysis was conducted using the TriNetX database. Patients with moderate to severe COPD and FEV1/FVC &lt; 70% were identified based on ICD codes, and two cohorts were formed based on the prescribed inhaler therapy: GLY/BUD/FOR and FF/VI/UMEC. Patients with comorbid asthma, heart failure, or pneumonia were excluded. A 1:1 propensity-score matching (PSM) analysis was performed to balance covariates such as age, gender, smoking status, and baseline lung function to minimize confounding and bias. Post-matching, both had 16,052 patients. Ultimately, 23,331 patients (FF/VI/UMEC: 11,234, GLY/BUD/FOR: 12,097) with a mean age of 67.4 ± 10.1 years and 55.3% males were included. Results: Among groups, 10.4% of patients on FF/VI/UMEC experienced COPD exacerbations compared to 6.7% on GLY/BUD/FOR (Risk Ratio: 1.55, 95% CI: 1.42-1.69, p &lt; 0.001). Kaplan-Meier analysis showed a lower survival probability in the FF/VI/UMEC group (77.7% vs. 83.9%, p &lt; 0.001). For acute respiratory failure, 3.5% of patients on FF/VI/UMEC experienced this outcome compared to 2.8% on GLY/BUD/FOR (Risk Ratio: 1.28, 95% CI: 1.12-1.45, p = 0.003). Conclusion: Our study suggests that FF/VI/UMEC demonstrated an increased risk of COPD exacerbations and acute hypoxic respiratory failure compared to the group receiving GLY/BUD/FOR. This indicates that GLY/BUD/FOR may provide enhanced protective benefits in patients with moderate to severe COPD, improving disease management and minimizing healthcare resource utilization. Further studies are warranted to explore the long-term benefits and potential mechanisms underlying the observed differences.

Abstract Introduction: Obesity's increasing prevalence significantly impacts Intensive Care Unit (ICU) patient outcomes, especially for those requiring prolonged mechanical ventilation. This study investigates the effect of Body Mass Index (BMI) on mortality and complications—such as acute respiratory distress syndrome (ARDS), pulmonary embolism (PE), and deep vein thrombosis (DVT)—in ICU patients intubated for over 96 hours. Methods: We conducted a retrospective cohort study using the TriNetX database to identify patient populations with relevant ICD codes. Patients who had received anticoagulation and had been on mechanical ventilation for more than 96 hours were included. Cohort 1 consisted of patients with a BMI of 30-44.9 kg/m² (n = 70,379), and Cohort 2 included patients with a BMI of 18.5-29.9 kg/m² (n = 111,054). Both cohorts were matched using propensity score matching (PSM), resulting in balanced groups of 47,233 patients. The mean age was 64.3 ± 15.1 years in Cohort 1 and 64.5 ± 16.5 years in Cohort 2, with a male predominance of 57.9% in both cohorts after matching. Outcomes (mortality, PE, DVT, and ARDS) were identified using ICD-10 codes and analyzed on Days 14, 30, and 90. Results: Higher BMI was associated with increased all-cause mortality across all measured time points. By Day 14, mortality was 23.0% in Cohort 1 versus 19.2% in Cohort 2 (RiskRatio [RR]: 1.196; 95% CI: 1.166-1.226). By Day 90, mortality reached 37.6% in Cohort 1 compared to 32.6% in Cohort 2 (RR: 1.151; 95% CI: 1.132-1.171). Additionally, the risk of developing ARDS was higher in Cohort 1, with statistically significant risk ratios observed on Day 14 (RR: 1.117; 95% CI: 1.020-1.222) and Day 30 (RR: 1.094; 95%CI: 1.010-1.186). PE risk in Cohort 1 significantly increased by Day 30 (RR: 1.119; 95% CI: 1.008-1.243), while DVT risk was also elevated in Cohort 1 at both Day 14 (RR:1.140; 95% CI: 1.037-1.253) and Day 30 (RR: 1.129; 95% CI: 1.040-1.224). Conclusion: Higher BMI in mechanically ventilated ICU patients intubated for more than 96 hours is associated with increased mortality and a higher incidence of complications, including ARDS, PE, and DVT. This study contributes to our understanding of BMI's impact on ICU outcomes, highlighting critical areas for improved clinical management in this population and the need for targeted interventions in obese ICU patients, such as optimized respiratory support and monitoring for thromboemboliccomplications.