Aclidinium bromide 375micrograms/dose dry powder inhaler

BACKGROUND AND AIM: Long-acting bronchodilators are the mainstay of pharmacological treatment for patients with chronic obstructive pulmonary disease (COPD). The aim of this review is to provide an overview of the clinical studies evaluating the safety and efficacy of inhaled aclidinium bromide, a novel long-acting anticholinergic bronchodilator, for the treatment of COPD. METHOD: This systematic review explored the efficacy and safety of aclidinium bromide in comparison with placebo and other long-acting bronchodilators for treatment of moderate to severe COPD. Randomised controlled trials were identified through systematic searches of different databases of published trials. RESULTS: Ten trials (3.922 participants) were included. Aclidinium bromide appears to be a safe and well-tolerated long-acting anti-cholinergic bronchodilator with a relatively fast onset of action. Compared with other long-acting bronchodilators, including tiotropium bromide, aclidinium bromide leads to at least similar clinically important improvements in level of FEV(1), health status, use of rescue medication, and day-time dyspnea scores in patients suffering from moderate to severe COPD. With twice-daily dosing, aclidinium bromide may have clinically important effect on night-time symptom scores in COPD patients, but further studies are needed in order to permit valid conclusions with regard to this point. The effect of aclidinium bromide on exercise tolerance, as assessed by exercise endurance time, and dynamic hyperinflation in patients with moderate to severe COPD seems to be at least comparable to other long-acting bronchodilators, incl. tiotropium bromide and indacaterol. Aclidinium bromide might reduce the rate of exacerbations in COPD patients, but conclusions must await further long-term controlled trials. CONCLUSION: Aclidinium bromide has effects on relevant COPD outcome measures, including level of FEV(1), similar to other long-acting bronchodilators, and therefore seems to have the potential for a significant role in the future management of moderate to severe COPD.

Abstract licence: CC BY 4.0

PURPOSE: Aclidinium bromide is a long-acting muscarinic antagonistic used in maintenance treatment of chronic obstructive pulmonary disease (COPD). A model-based health economic study evaluated the cost-effectiveness of aclidinium 400 μg bid as an alternative to tiotropium 18 μg od for this indication in the US. PATIENTS AND METHODS: PATIENT CHARACTERISTICS IN THIS MODEL REFLECT THOSE IN THE ACLIDINIUM CLINICAL STUDIES: age >40 years, stable moderate-to-severe COPD, current or ex-smokers (>10 pack-years), post-salbutamol forced expiratory volume in 1 second (FEV1) ≥30% and <80% of predicted normal value, and FEV1/forced vital capacity <70%. The model consists of five main health states indicating severity of COPD and the level of utility, resource use, and costs. Treatment efficacy over 5 years was modeled using FEV1% predicted; a network meta-analysis comparing aclidinium and tiotropium was used to estimate disease progression during the first 24 weeks, and results from the UPLIFT trial were used for time points after 24 weeks. Quality of life was assessed using utility scores in US patients from the UPLIFT trial. Cost-effectiveness was assessed as the incremental cost per quality-adjusted life year (QALY) gained. RESULTS: Over 5 years, QALYs were 3.50 for aclidinium versus 3.49 for tiotropium; life years accumulated were 4.52 for both. In this economic model, aclidinium versus tiotropium showed marginally fewer exacerbations (3.364 versus 3.390, respectively) and mean total health care costs (US$126,274 versus US$128,591, respectively). In all scenario analyses performed (discount factors of 0% and 6% for benefits and costs; time horizon of 1 year; mapping St George's Respiratory Questionnaire to European Quality of Life-5 Dimensions; excluding pharmacy costs, COPD-related cost only; cost of exacerbations; including ACCORD II trial in the network meta-analysis), aclidinium was associated with lower costs and marginally greater QALYs versus tiotropium. CONCLUSION: Aclidinium is potentially cost-effective compared with tiotropium for maintenance treatment of moderate-to-severe COPD.

Abstract licence: CC BY-NC 3.0