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Background: Chronic obstructive pulmonary disease (COPD) is one of the most important reasons for hospitalizationworldwide with high 30-day readmission rates. Although the prognostic significance of early readmission is not fully understood,they are often associated with poor outcomes including high mortality rates of 4%–19% at 30 and 365 days, respectively.Similarly, in acute exacerbations of COPD (AECOPD) cases receiving emergency department care, current status on lungfunction and cardiovascular comorbidities are considered as best predictors for both 30- and 90-day COPD readmission rates.Dual bronchodilator strategy with long-acting muscarinic antagonist (LAMA)/long-acting beta-agonists (LABA) is thereforerecommended by GOLD (2019) in the postdischarge phase following an acute exacerbation.Aim: To further assess the clinical impact of dual bronchodilators including glycopyrronium and arformoterol as home nebulizationin the post-discharge phase of AECOPD, the current postapproval, observational study was conducted.Materials and Methods: An observational, concurrent, and non-inferiority study with glycopyrronium and arformoterol homenebulizing solutions on patients with moderate and severe COPD was conducted at two centers in India. An estimated samplesize of 40 patients involving moderate and severe COPD cases was factored for per-protocol analyses with P < 0.05 consideredas statistically significant. A concurrent study analysis for the follow-up visit was conducted as per the principles of InternationalConference of Harmonization for Good clinical practice and Declaration of Helsinki while ensuring confidentiality during accessof patient support registration sheets.Results: Per protocol analyses for consecutive 46 cases from two centers receiving Nebulized glycopyrronium (25 mcg) andarformoterol (15 mcg), as separate formulations are given as admixed solution with follow-up visit for at least 4 weeks wascarried out. Baseline demographics for the overall group showed exacerbation history (46, 100%), hospitalization for AECOPD(21, 45.6%); ED visit (25, 54.3%), forced expiratory volume in one second (FEV1) 1.2 ± 0.6 L/min; FEV1/FVC64.8% ± 10.6;reversibility 8.4% ± 11.8; CAT 34.6 ± 2.3; and vibrating mesh nebulizer (46, 100%). The mean predose FEV1 (∆) at the end of 4weeks for overall, moderate and severe COPD cases were observed as of 9.6±3.1%, 11.8% ± 3.1, and 8.4% ± 1.6, respectively(P < 0.0001). Similarly, the mean CAT(∆) score at the end of 4 weeks was observed as of 18.1 ± 0.69, 20.6 ± 0.69, and 18.26 ±0.6 for overall, moderate and severe COPD cases, respectively (P < 0.0001). The intergroup differences for rescue medicationuse for a lone case with severe COPD (1, 2.04%) complied with the suggested non-inferiority margin between the groups.There were no other treatment-emergent adverse events or serious adverse events that warranted treatment modification orwithdrawals in both groups.
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Background: Inhalation therapy involving nebulization remains important modality of therapy for severe or high-risk obstructive airwaydiseases including bronchial asthma. The likely incremental factors for the translational impact of this delivery strategy includes fine particledose (FPD), fine particle fraction (FPF), mass median aerodynamic diameter (MMAD), and respirable fraction (RF) of the pharmaceuticalaerosols playing a key role in site-specific delivery to the lungs. The new generation active vibrating mesh nebulizers (VMNs) offer aconvenient, portable strategy in above clinical cases without compromising the delivery efficiency for improved therapeutic outcomes.Aim: This in vitro study was conducted to validate the improved efficiency and aerodynamic effect of glycopyrronium solutionnebulization with novel patented active and passive VMN devices.Materials and Methods: A in vitro lung deposition study was conducted using drug samples of glycopyrronium bromide(25 mcg/2 ml and 1 ml) using new generation cascade impactor at a flow rate of 15 L/min at Glenmark R&D Center, Sinnar, India.Results: Three samples of glycopyrronium nebulizing solution were analyzed using next generation impactor at a flow rate of15 L/min for aerodynamic aerosol parameters (FPF and RF) and total/active substance delivered (FPD and delivered dose) whenloaded with active (NEBZMART*, 2 ml) and passive (E-flow*, 1 ml) VMN. The results demonstrated comparable aerodynamicaerosol, particle size, and total delivered dose as FPF (64.9% vs. 72.8%), FPD (16.4 vs. 14.2 mcg), MMAD (3.9 vs. 3.2), andGSD (1.8 vs. 1.62) for active and passive VMN, respectively. The nebulization time was observed as 3–5 min for both thedevices demonstrating higher efficiency for active VMN.Conclusion: The results showed comparable aerodynamic aerosol, particle size, and total delivered dose or RF forglycopyrronium nebulizing solution delivered by the VMNs.
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Objective: To compare the effect of tiotropium bromide and glycopyrronium bromide in the treatment of chronic obstructive pulmonary disease. Methods: This was an open labeled Randomized controlled trial study. Patients diagnosed with COPD according to the Global Initiative for chronic Obstructive Lung Disease (GOLD) strategy were included in the study. The patients were divided in two groups and each group had 100 patients. Group A- COPD patients on Tiotropium bromide + Salmeterol/Fluticasone; Group B – COPD patient on Glycopyrronium bromide + Salmeterol/Fluticasone. Tiotropium bromide: 18 mcg OD, Glycopyrronium bromide: 50 mcg OD along with Salmeterol 50 mcg/Fluticasone 100mcg was given. Results: The mean age of patients of Group A and Group B was 56.28±7.78 and 57.64±8.06 years respectively. Baseline variables were comparable between the groups. There was significant (p<0.05) difference in PFT parameters between the groups at 12 and 24 weeks except for FEV1/FVC. The mean change was higher in Group B compared to Group A from 0 week to 24 weeks. There was clinical improvement among all the patients in both the groups. Conclusion: Once-daily GLY demonstrated similar effects to TIO when combined with SAL/FP in patients with moderate and severe COPD.
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<p><b>INTRODUCTION</b>In light of the growing evidence base for better clinical results with the use of the dual bronchodilator indacaterol/glycopyrronium (IND/GLY) over inhaled corticosteroid-containing salmeterol/fluticasone combination (SFC), this study aimed to evaluate the cost-effectiveness of IND/GLY over SFC in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) who are at low risk of exacerbations, in the Singapore healthcare setting.</p><p><b>METHODS</b>A previously published patient-level simulation model was adapted for use in Singapore by applying local unit costs. The model was populated with clinical data from the LANTERN and ECLIPSE studies. Both costs and health outcomes were predicted for the lifetime horizon from a payer's perspective and were discounted at 3% per annum. Costs were expressed in 2015 USD exchange rates. Uncertainty was assessed through probabilistic sensitivity analysis.</p><p><b>RESULTS</b>Compared to SFC, use of IND/GLY increased mean life expectancy by 0.316 years and mean quality-adjusted life years (QALYs) by 0.246 years, and decreased mean total treatment costs (drug costs and management of associated events) by USD 1,474 over the entire lifetime horizon. IND/GLY was considered to be 100% cost-effective at a threshold of 1 × gross domestic product per capita. The cost-effectiveness acceptability curve showed that IND/GLY was 100% cost-effective at a willingness-to-pay threshold of USD 0 (additional cost) when compared to SFC.</p><p><b>CONCLUSION</b>IND/GLY was estimated to be highly cost-effective compared to SFC in patients with moderate-to-severe COPD who are not at high risk of exacerbations in the Singapore healthcare setting.</p>
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Neste artigo de atualização discutiremos, à luz dos mais recentes e relevantes trabalhos, a terapia dupla com broncodilatadores de longa ação para os pacientes com Doença Pulmonar Obstrutiva Crônica (DPOC) no período estável, destacando sua proteção quanto a exacerbações, dispneia, qualidade de vida, utilizando como orientador de sua oportunidade de uso a recomendação mais recente do Iniciativa Global para Doenças Pulmonares (GOLD) da sigla em língua inglesa.
In this update article we will discuss the light of the most recent and relevant studies on dual therapy with long acting bronchodilators for patients with chronic obstructive pulmonary disease (COPD) in the stable period, highlighting their protection against exacerbations, dyspnea, quality of life, Using the most recent recommendation of the Global Initiative for Lung Disease (GOLD) as the guideline of their opportunity to use the English acronym.