Search Results (6)

Background/Objectives: Due to limited current evidence, this post-marketing database surveillance study aimed to investigate the occurrence of hospitalization due to community-acquired pneumonia (CAP) among patients with chronic obstructive pulmonary disease in Japan who received single-inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol; FF/UMEC/VI) or multiple-inhaler triple therapy (MITT). Methods: This retrospective cohort study used health insurance claims data from the Medical Data Vision Co., Ltd. database (November 2017–April 2023) to identify overall and incident users of FF/UMEC/VI or MITT. Index date was the start of FF/UMEC/VI or MITT. Hazard ratios (HRs) for CAP hospitalization were assessed using inverse probability of treatment weighting based on propensity scores (PS). Incidence rates and time to occurrence of CAP hospitalization were also assessed. Adjustments were made to the PS model to address missing body mass index data. Results: In total, 8790 and 10,881 patients were included in the overall FF/UMEC/VI and MITT cohorts, and 3939 and 4017 patients were included in the incident FF/UMEC/VI and MITT cohorts, respectively. HR for CAP hospitalization among incident users ranged from 1.05 to 1.15 across all PS adjustments. Similar incidence rates of CAP hospitalization were reported among both cohorts and across all PS adjustments. The cumulative adjusted incidence rates of first CAP hospitalization at 360 days post-index among incident users was 0.060 and 0.054 in the FF/UMEC/VI and MITT cohorts, respectively. Conclusions: There was no difference in the risk of CAP between patients treated with FF/UMEC/VI and MITT. This safety information may help healthcare providers select appropriate treatments. Full article

Background/objectives: This study aimed to investigate the impact of single-inhaler triple therapy on selecting treatment for lung cancer and the perioperative period in lung cancer patients with chronic obstructive pulmonary disease (COPD) and a forced expiratory volume in 1 s (FEV₁) <1.5 L. Methods: All patients had baseline FEV₁ < 1.5 L. The therapeutic drug for COPD, fluticasone furoate/umeclidinium/vilanterol, was initiated 2 weeks preoperatively and continued until 3 months postoperatively. Radical surgery was actively recommended for patients with an FEV₁ ≥ 1.5 L after COPD treatment; otherwise, palliative surgery and postoperative complication risks were discussed. Results: Among 675 lung cancer patients, 214 (31.7%) had COPD, 41 of whom with FEV₁ < 1.5 L were enrolled. After triple-inhaler therapy, FEV₁ improved to ≥1.5 L in 63.4% of patients. Significant differences in the Brinkman index (840 vs. 1120, p = 0.0058) and radical resection (88.5% vs. 40.0%, p = 0.0030) were observed between patients with FEV₁ ≥ 1.5 L and <1.5 L post-treatment. Pneumonia and home oxygen therapy occurred in two cases (4.9%) and one case (2.4%), respectively, all of which were patients with FEV₁ < 1.5 L post-treatment. Among patients undergoing anatomical lung resection, triple-inhaler therapy significantly improved not only post-inhalation FEV₁ (1.26 vs. 1.55 L, p < 0.0001), but also FEV₁ at 3 months postoperatively compared to the value before inhalation (1.31 vs. 1.26 L, p = 0.042). Conclusions: Preoperative triple therapy in lung cancer patients with untreated COPD and FEV₁ < 1.5 L improved respiratory function and increased the feasibility of performing radical resection surgery. Furthermore, it was considered safe and effective, indicating the potential to maintain preoperative respiratory function without increasing perioperative complications. Full article

Background: Japanese guidelines recommend the addition of a long-acting muscarinic antagonist for patients with asthma uncontrolled on inhaled corticosteroid/long-acting β₂-agonist (ICS/LABA) therapy, the effectiveness of which is evaluated here. Methods: Retrospective, observational, single-arm cohort study in patients with asthma initiating fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) following ICS/LABA, using independently analyzed data from Japanese claims databases: JMDC and Medical Data Vision (MDV). The index date was that of the first FF/UMEC/VI prescription. Outcomes were assessed during a 12-month follow-up versus a 12-month pre-index period (baseline) and included asthma exacerbations, oral corticosteroid (OCS) use, and short-acting β₂-agonist (SABA) use. P-values associated with rate ratios (RRs) were estimated using Conditional Poisson regression. Results: Overall, 3229 patients in the JMDC database and 1135 in the MDV database were included. Following FF/UMEC/VI initiation, the total annualized moderate–severe asthma exacerbation rate in the JMDC database reduced from 0.50 to 0.40 per-person-per-year (PPPY) (RR [95% confidence interval]: 0.78 [0.73, 0.84]; p < 0.001), with similar reductions in the MDV database: 0.53 to 0.42 PPPY (0.79 [0.70, 0.89]; p < 0.001). In both databases, there was a 20% reduction (JMDC: 0.80 [0.73, 0.88]; p < 0.001; MDV: 0.80 [0.68, 0.94]; p = 0.005) in patients with ≥1 OCS prescription after FF/UMEC/VI initiation. The proportion of patients with ≥1 SABA canister prescription dropped by 31% 0.69 [0.57, 0.84]; p < 0.001) in the JMDC database and 23% (0.77 [0.66, 0.90]; p < 0.001) in the MDV database. Conclusions: This suggests FF/UMEC/VI is effective in improving asthma exacerbations and reducing OCS and SABA use in Japanese patients previously using ICS/LABA in real-world clinical practice. Full article

Background/Objectives: Effective airway delivery of a fixed-dose combination of triple-aerosolized inhaled corticosteroid (ICS)/long-acting beta agonist (LABA)/long-acting muscarinic antagonist (LAMA) is likely to positively affect therapeutic responses predicted in patients with asthma and chronic obstructive pulmonary disease. This study aimed to conduct in vitro fluticasone furoate, vilanterol trifenatate, and umeclidinium bromide depositions in a Next Generation Impactor. The aerodynamic properties of these inhaled medications influence the spatial distribution and drug abundance, particularly in the smaller airways, to reverse or alleviate disease pathology. Methods: The Next Generation Impactor was used to demonstrate the aerodynamic particle size distributions of fluticasone furoate, vilanterol trifenatate, and umeclidinium bromide delivered from a dry powder inhaler at different flow rates across all stages of the impactors. This in vitro study analyzed the distribution pattern of individual drug components to simulate mono-component deposition and co-deposition in the official model in the United States Pharmacopeia. An Andersen cascade impactor together with scanning electron microscope–energy-dispersive X-ray was employed to observe the drug deposition on each stage of the impactor. Results: We found that the distribution pattern of each component at the same cascade level was comparable, and the aerosol particles of the three drugs reached the in vitro representation of the lower airway compartment. The specified flow rates generated the desired fine particle fraction, fine particle dose, and mass median aerodynamic diameter. Our results also demonstrated visualized deposition patterns of the delivered drugs from different stages of the cascade impactor that may predict deposition as it occurs in vivo. Conclusions: Spatial distribution and abundance of ICS/LABA/LAMA in the same cascade levels were closely comparable, and the aerosol particles were able to reach the small aerosol-sized cascades at the lower levels to some extent. Full article

Background: Triple fixed-dose combination (FDC) therapy is recommended in severe chronic obstructive pulmonary disease (COPD) patients experiencing frequent exacerbations and/or symptoms not controlled by dual FDCs. Since no randomized controlled trials (RCTs) have directly compared the different inhaled corticosteroid/long-acting β₂-adrenoceptor agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) FDCs, we performed a meta-analysis to compare the impact of the current available ICS/LABA/LAMA FDCs in COPD. Methods: A meta-analysis was performed by connecting beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide or glycopyrrolate (BDP/FOR/GLY), budesonide (BUD)/GLY/FOR, and fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) FDCs via ICS/LABA or LABA/LAMA FDCs arms. The safety and efficacy profiles were investigated, and the Implemented Bidimensional Surface under the cumulative ranking curve analysis (IBiS) was carried out. Protocol registration: CRD42022301189. Results: Data from 21,809 COPD patients were extracted from the ETHOS, IMPACT, KRONOS, and TRILOGY studies. No significant (p > 0.05) differences were detected across the triple FDCs with respect to the risk of exacerbation, trough forced expiratory volume in the first second (FEV₁), transition dyspnea index (TDI), St. George’s Respiratory Questionnaire (SGRQ), risk of serious adverse events (SAEs), cardiovascular (CV) SAEs, pneumonia, and all-cause mortality. According to IBiS score, BDP/FOR/GLY 200/12/25 µg twice daily (BID) was the FDC reporting the best combined efficacy/safety profile (area 41.41%), although FF/UMEC/VI 100/62.5/25 µg once daily (QD) showed the greatest efficacy profile (50.54%). The protection against mortality related to the dose of ICS. Conclusions: All triple FDCs are effective and safe in COPD regardless of the regimen of administration (twice daily vs. once daily), with no relevant difference in the risk of CV SAEs and pneumonia. Full article

Background: Evidence suggests that triple therapy for patients with chronic obstructive pulmonary disease (COPD) is being used in a broader range of patients than recommended by guidelines, which may have health and cost implications. Objective: To explore the relationship between national health technology assessment (HTA) agency appraisals and market penetration of two fixed-dose combination (FDC) triple therapies. Study design: HTAs from Q3 2017 to Q1 2020 from 10 countries were evaluated. Intervention: Glycopyrronium bromide/formoterol fumarate/beclomethasone (Trimbow^®) and umeclidinium/vilanterol/fluticasone furoate (Trelegy™ Ellipta^®). Main outcome measure: HTA restrictions and prescribing rates (days of therapy). Results: Seven countries (70%) imposed restrictions on use including prescription only for patients stable on free-combination triple therapy or not controlled on dual therapy, requirement of a specialist prescription or therapeutic plan, prescription only for patients with severe COPD, and use as second-line therapy or later. In general, countries that have imposed restrictions on the use of FDC triple therapies have seen a lower than average uptake. Conclusion: Payer guidance on prescribing FDC triple therapy may potentially support more appropriate prescribing in line with clinical guidelines. It is important for payers to consider which restrictions would ensure the most efficient use of scarce resources. Full article