scholarly journals Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
James F. Donohue ◽  
Edward Kerwin ◽  
Sanjay Sethi ◽  
Brett Haumann ◽  
Srikanth Pendyala ◽  
...  

Abstract Background Revefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD). Although shorter duration studies have documented the efficacy of revefenacin in COPD, longer-term efficacy has not been described. In a recent 52-week safety trial, revefenacin was well tolerated and had a favorable benefit-risk profile. Here we report exploratory efficacy and health outcomes in patients receiving revefenacin 175 μg or 88 μg daily during the 52-week trial. Methods In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 175 μg or 88 μg in a double-blind manner, or open-label active control tiotropium. Results Over the 52-week treatment period, both doses of revefenacin, as well as tiotropium, elicited significant (all p < 0.0003) improvements from baseline in trough forced expiratory volume in 1 s (FEV1). The trough FEV1 profile (least squares mean change from baseline) for revefenacin 175 μg ranged from 52.3–124.3 mL and the trough FEV1 profile for tiotropium ranged from 79.7–112.8 mL. In subgroup comparisons, the effect of revefenacin on trough FEV1 was comparable in patients taking concomitant long-acting β-agonists, with or without inhaled corticosteroids, with patients who were not taking these medications. There were statistically significant (p < 0.05) improvements in all measured health status outcomes (evaluated using St. George’s Respiratory Questionnaire, COPD Assessment Test, Clinical COPD Questionnaire and Baseline and Transition Dyspnea Index) from 3 months onward, in all treatment arms. Conclusions Significant sustained improvements from baseline in trough FEV1 and respiratory health outcomes were demonstrated for 175-μg revefenacin over 52 weeks, further supporting its use as a once-daily bronchodilator for the nebulized treatment of patients with COPD. Trial registration NCT02518139; Registered 5 August 2015.

2021 ◽  
Vol 31 (1) ◽  
pp. 75-87
Author(s):  
I. V. Leshchenko ◽  
A. S. Meshcheryakova

Chronic obstructive pulmonary disease (COPD) is the leading cause of death in the structure of respiratory diseases. The problem of rational pharmacotherapy of COPD have attracted attention of the medical scientific society for many years. The understanding of the pathogenesis of the disease has deepened and approaches to the therapy have changed. Some COPD patients need regular fixed-combination therapy: long-acting bronchodilators (LABD) and inhaled corticosteroids (ICS) in order to prevent exacerbations and reduce the severity of symptoms of the disease. Blood eosinophils count is one of criteria for choosing regular therapy. The appearance of fixed triple combinations of ICS/LABD increased the effectiveness of COPD therapy, and a new delivery device for fixed combination of budesonide/formoterol makes it possible to use ICS successfully in the most severe patients.


2021 ◽  
Author(s):  
Yoko Azuma ◽  
Atsushi Sano ◽  
Takashi Sakai ◽  
Satoshi Koezuka ◽  
Hajime Otsuka ◽  
...  

Abstract Background: Chronic obstructive pulmonary disease (COPD) is an important risk factor for postoperative complications and mortality. The utility of several perioperative bronchodilators in patients with COPD requiring surgery for lung cancer has been reported, but the most suitable agent and its specific effect on postoperative long-term prognosis remain unclear. To determine the effects of perioperative combination therapy, using a long-acting muscarinic antagonist (LAMA) and a long-acting β2 agonist (LABA), on preoperative lung function, postoperative morbidity and mortality, and long-term outcome in COPD patients.Methods: Between January 2005 and October 2019, 130 consecutive patients with newly diagnosed COPD underwent surgery for lung cancer. We conducted a retrospective review of their medical records. Patients were divided into 3 groups according to perioperative management: LAMA/LABA (n=64), LAMA (n=23) and rehabilitation only (no bronchodilator) (n=43). Results: Patients who received preoperative LAMA/LABA therapy showed significant improvement in lung function before surgery (p<0.001 for both forced expiratory volume in 1 second (FEV1) and percentage of predicted forced expiratory volume in 1 second (FEV1 %pred). Compared with patients who received preoperative LAMA therapy, patients with LAMA/LABA therapy had significantly improved lung function (ΔFEV1, 223.1 mL vs 130.0 mL, ΔFEV1 %pred, 10.8% vs 6.8%; both p<0.05). There was a trend toward a lower incidence of postoperative complications in the LAMA/LABA group compared with the LAMA and rehabilitation-only groups. In patients with moderate to severe air flow limitation (n=61), those who received LAMA/LABA therapy had significantly longer overall survival and disease-free survival compared with patients in the other groups. Perioperative LAMA/LABA therapy was also associated with lower recurrence rates. Conclusions: Patients who receive perioperative LAMA/LABA for moderate to severe COPD have improved prognosis and better pulmonary function with surgery for lung cancer. We believe this treatment combination is optimal for patients with lung cancer and COPD.


2008 ◽  
Vol 15 (8) ◽  
pp. 437-443 ◽  
Author(s):  
Anderson Chuck ◽  
Philip Jacobs ◽  
Irvin Mayers ◽  
Darcy Marciniuk

BACKGROUND: There is evidence that combination therapy (CT) in the form of long-acting beta2-agonists (LABAs) and inhaled corticosteroids can improve lung function for patients with chronic obstructive pulmonary disease (COPD).OBJECTIVE: To determine the cost-effectiveness of using CT in none, all or a selected group of COPD patients.METHODS: A Markov model was designed to compare four treatment strategies: no use of CT regardless of COPD severity (patients receive LABA only); use of CT in patients with stage 3 disease only (forced expiratory volume in 1 s [FEV1] less than 35% of predicted); use of CT in patients with stages 2 and 3 disease only (FEV1less than 50% of predicted); and use of CT in all patients regardless of severity of COPD. Estimates of mortality, exacerbation and disease progression rates, quality-adjusted life years (QALYs) and costs were derived from the literature. Three-year and lifetime time horizons were used. The analysis was conducted from a health systems perspective.RESULTS: CT was associated with a cost of $39,000 per QALY if given to patients with stage 3 disease, $47,500 per QALY if given to patients with stages 2 and 3 disease, and $450,333 per QALY if given to all COPD patients. Results were robust to various assumptions tested in a Monte Carlo simulation.CONCLUSION: Providing CT for COPD patients in stage 2 or 3 disease is cost-effective. The message to family physicians and specialists is that as FEV1worsens and reaches 50% of predicted values, CT is recommended.


2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Balazs Antus

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of mortality and morbidity worldwide. In addition to generating high healthcare costs, COPD imposes a significant burden in terms of disability and impaired quality of life. Unlike many leading causes of death and disability, COPD is projected to increase in many regions of the world as the frequency of smoking is rising and the population is aging. The pharmacological treatment of COPD includes bronchodilators to relax smooth muscle, such as β2-agonists (salbutamol, terbutaline, and fenoterol, short-acting β2-agonists as well as salmeterol, formoterol, and indacaterol, and long-acting β2-agonists) and anticholinergics, such as ipratropium, oxitropium (short-acting anticholinergic), and tiotropium (long-acting anticholinergic). Although airway inflammation in COPD poorly responds to steroids, several inhaled corticosteroids (fluticasone, budesonide, and beclomethasone) are in use in combination with long-acting β2-agonists. Other medications include theophylline (both a bronchodilator and a phosphodiesterase inhibitor) and the phosphodiesterase-4 antagonists, such as roflumilast. Finally, a number of novel long-acting anticholinergics and β2-agonists with once- or twice-daily profiles are in development and clinical testing.


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