Patient-reported outcomes and considerations in the management of COPD: focus on aclidinium

Abstract

Chronic obstructive pulmonary disease (COPD) is a complex heterogeneous disease, in which several factors combine to give the final clinical expression. Both early and more recent studies have shown that forced expiratory volume in one second (FEV1), despite being an extremely important parameter to predict the progression of the disease, is a poor surrogate marker for symptoms perception. Accordingly, patient-reported outcomes (PROs) have gained popularity as a measure of the impact of treatment from the patients’ perspective, since they represent the individuals’ perception of their health status, beyond any physiological limitations. Several such PROs, therefore, are currently included in multidimensional COPD evaluation. This multidimensional approach helps identify different patient types and individualize, up to a certain point, pharmacological treatment. In this multidimensional approach it is important to highlight the importance of long-acting bronchodilators in COPD treatment strategies. Long-acting bronchodilators are cost-effective and have been shown to achieve the greatest functional and clinical improvements in COPD. As a result, long-acting bronchodilators are now the main pharmacological treatment for COPD at all stages of the disease. Until recently, tiotropium was the leading bronchodilator for the treatment of COPD. The clinical development of this medication, unprecedented in inhaled therapy, involved tens of thousands of patients and yielded consistent outcomes in terms of lung function, symptoms, quality of life, exacerbations, and prognosis. However, new long-acting bronchodilators have recently been developed or are currently under development. In this review, we evaluate the effects of aclidinium bromide, a novel long-acting bronchodilator, on PROs in COPD. Aclidinium is a novel long-acting muscarinic antagonist with a good safety profile for the treatment of COPD, and has proven efficacy in both objective functional measurements and PROs. Comparison studies with tiotropium have shown it to have similar lung function improvement and a similar impact on PROs, including quality of life or symptom perception.

Bronchodilator efficacy of 18 µg once-daily tiotropium inhalation via Discair^® versus HandiHaler^® in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial

“…FEV 1 obtained during forced spirometry is the main parameter used to evaluate progression and extent of airflow obstruction, and to select optimal treatment strategies for COPD patients 1,2,38. Thus, we used maximum change in FEV 1 -related bronchodilator efficacy as the basis of a non-inferiority hypothesis in this study.…”

“…However, FEV 1 and other indices may be poor surrogate markers for symptoms 38. Accordingly, some studies have suggested use of multidimensional evaluation of COPD by inclusion of patient reported outcomes (PROs) 38,42,43. The emphasis on use of FEV 1 , other markers of lung function, and other clinical variables (eg, chronic symptoms and exacerbations) may be valuable because of their potential modulatory effects.…”

New opportunities of dual bronchodilation therapy for patients with chronic obstructive pulmonary disease

“…Низкая абсорбция и быстрый гидролиз препарата объясняют его низкую системную биодоступность и дают ос-нование предполагать, что частота развития внелегочных побочных действий аклидиния будет ниже, чем у других ДДАХ [23]. Это подтвердилось и в клинических исследованиях, которые продемонстрировали, что такие типичные для антихолинергических препаратов осложнения терапии, как сухость во рту и кардиоваскулярные эффекты, возникают при лечении аклидинием крайне редко, не чаще чем в группе плацебо [24,25].…”

“…Влияние на симптомы ХОБЛ На сегодняшний день убедительно доказано, что оценка эффективности терапии ХОБЛ должна быть основана не только на объективных параметрах (таких как ОФВ 1 , легочные объемы и др. ), но и на субъективном восприятии пациентами эффективности проводимого лечения [23].…”

Serum Metabolite Biomarkers Discriminate Healthy Smokers from COPD Smokers

“…COPD is characterized by progressive restriction to expiratory airflow [ 4 ]. The forced expiratory volume in 1 second (FEV1) both defines and characterizes the severity of the disease, and is a well-known predictor of mortality [ 5 ].…”