Effect of aclidinium bromide therapy on quality of life and symptoms of patients with chronic obstructive pulmonary disease: pooled analysis results of the Greek and Austrian ON-AIR real-world observational studies.

内容摘要

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory condition characterized by persistent airflow limitation and debilitating symptoms that impair patients&#x2019; quality of life (QoL) and daily functioning. Aclidinium bromide is a long-acting muscarinic antagonist approved as a maintenance bronchodilator to relieve symptoms in adults with COPD. While randomized controlled trials have established the efficacy of aclidinium, real-world data are essential for understanding its effectiveness in routine clinical practice. This pooled analysis of data from two prospective observational studies conducted in Austria and Greece aimed to supplement real-world evidence on the effects of aclidinium bromide on QoL, symptoms, and activity impairment of patients with COPD. METHODS: Eligible participants were &#x2265;40 years old and newly initiated on aclidinium bromide as monotherapy or add-on therapy, according to the approved product&#x2019;s label. Patient-reported COPD assessment test (CAT), severity of night-time and early-morning symptoms, and interference of COPD with patients&#x2019; daily activities were assessed at enrollment and the 12-week follow-up visit. RESULTS: One thousand one hundred twenty-seven patients (median age: 65.0 years, 65.8% male; 29.7% newly diagnosed) were enrolled between May 31st, 2013 and January 29th, 2016. Aclidinium bromide was initiated as monotherapy in 40.2% of patients. The median (interquartile range [IQR]) baseline CAT score decreased from 17.0 (11.0&#x2013;23.0) to 11.0 (7.0&#x2013;17.0) points (p&#x2009;<&#x2009;0.001) after 12 weeks of treatment, with 82.7% of patients achieving a &#x2018;minimal clinically important difference&#x2019; (MCID, i.e., &#x2265;&#x2009;2-point decrease). The severity of night-time and early-morning symptoms significantly decreased over the 12-week follow-up period (p&#x2009;<&#x2009;0.001 for both), while 51.9% of patients with &#x2018;at least moderate impact&#x2019; of COPD on their daily activities at enrollment shifted to &#x2018;small or no impact&#x2019; at the follow-up visit. Treatment with aclidinium was more likely to provide a clinically meaningful improvement in patients&#x2019; symptoms in patients who were treatment-na&#xef;ve [adjusted odds ratio (OR): 2.14, 95% confidence interval (CI): 1.42&#x2013;3.22; p&#x2009;<&#x2009;0.001] and in those who were more symptomatic at baseline (OR: 1.13, 95% CI: 1.10&#x2013;1.16; p&#x2009;<&#x2009;0.001). CONCLUSIONS: This analysis of real-world data describes detailed aclidinium treatment benefit on COPD patients&#x2019; QoL, symptom severity and daily activity impairment. TRIAL REGISTRATION: The Austrian ON-AIR trial was registered in a national Austrian NIS register with trial registration number NIS004104. The Greek ONAIR trial was registered on the SFEE&#x2019;s (Hellenic Association of Pharmaceutical Companies) &#x201c;dilon&#x201d; registry, with trial registration number MeGR/14/BreCOPD/001.