Abstract
BackgroundRevefenacin 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.MethodsIn 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.ResultsOver 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.ConclusionsSignificant 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 registrationNCT02518139; Registered 5 August 2015.
Highlights
Revefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD)
Patients were ineligible for participation if they had been hospitalized for COPD or pneumonia within 8 weeks of screening or had used systemic corticosteroids or antibiotics within 6 weeks of screening
Over the year-long study, there were more withdrawals from the revefenacin treatment arms (39–43%) than from the tiotropium arm (26%), which led to wider confidence intervals (CIs) and more variable data at the 9and 12-month time points for all treatment arms (Table 2)
Summary
Revefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD). Treatment guidelines produced by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommend inhalation therapy with long-acting muscarinic antagonist (LAMA) or long-acting β-agonist (LABA) bronchodilators as first-line therapy to address COPD symptoms and prevent exacerbations [1]. Beyond the differences in frequency and method of administration, revefenacin is a different molecular class than glycopyrrolate bromide—it is a tertiary amine, not a quaternary ammonium compound It is a different molecular class from all the inhaled muscarinic antagonists (glycopyrrolate bromide, tiotropium bromide [tiotropium], umeclidinium bromide, aclidinium and ipratropium bromide) available to date. Revefenacin was designed to produce sustained local bronchodilation with minimal systemic drug exposure [4, 5], and as a result appears to have lower potential for systemic anti-muscarinic side effects than quaternary ammonium compounds [6]
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