SESSION TITLE: New treatments for COPD
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Monday, October 28, 2013 at 01:45 PM - 03:15 PM
PURPOSE: Aclidinium is a long-acting muscarinic antagonist indicated for long-term maintenance treatment of COPD-associated bronchospasm. Pooled analysis of 3 trials (ACCORD I and II, 12 weeks, and ATTAIN, 24 weeks) in moderate to severe COPD patients investigated the effects of aclidinium in various subgroups.
METHODS: Data from 3 randomized double-blind trials of aclidinium 200 µg (n=643), 400 µg (ACL400, n=636), and placebo (PBO, n=640) BID were pooled to evaluate morning predose (trough) and peak FEV1 in the intent-to-treat (ITT) population (all randomized patients who had ≥1 dose of treatment and had ≥1 postbaseline assessment). Trough FEV1 was also assessed in subgroups of patients defined by sex (male vs female), age (<60 vs ≥60-70 vs ≥70 years), smoking status (current vs former), COPD severity (mild/moderate vs severe/very severe), concomitant ICS (use vs nonuse), and bronchodilator reversibility (reversible [reversibility ≥12% and change from prebronchodilator FEV1 ≥200 mL from short-acting β-agonist treatment] vs nonreversible). Results from patients treated with the approved dose (ACL400) and PBO up to the pooled 12-week endpoint are reported.
RESULTS: At Week 1, patients on ACL400 showed clinically and statistically significant improvements from baseline in adjusted mean trough FEV1 vs PBO (110mL, p<0.0001), which were maintained to Week 12 (100mL, p<0.0001). Similarly consistent improvements from baseline over PBO were seen for peak FEV1 with ACL400 at Week 1 (196mL, p<0.0001) through Week 12 (172mL, p<0.0001). ACL400 resulted in statistically significant improvements from baseline to Week 12 in trough FEV1 over PBO in all subgroups (all p<0.0001), similar to that seen in the ITT population. Although both patients with and without bronchodilator reversibility showed significant improvements over PBO in trough FEV1 at Week 12, a significant difference in magnitude of improvement was observed between these 2 patient populations (132mL and 82mL, respectively; p<0.05).
CONCLUSIONS: These data show that ACL400 produces clinically and statistically significant improvements in lung function from Week 1 through Week 12. These improvements were seen regardless of sex, age, smoking status, COPD severity, concomitant ICS, or bronchodilator reversibility status. A larger improvement in lung function was seen with ACL400 in patients with bronchodilator reversibility than without.
CLINICAL IMPLICATIONS: Aclidinium 400 µg BID is effective for maintenance treatment in a wide range of patients with moderate to severe COPD.
DISCLOSURE: Anthony D'Urzo: Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Sepracor, Schering Plough, Altana, Methapharma, AstraZeneca, ONO pharma, Merck Canada, Forest Laboratories, Novartis Canada/USA, Boehringer Ingelheim (Canada) Ltd, Pfizer Canada, SkyePharma, and KOS Pharmaceuticals Paul Jones: Consultant fee, speaker bureau, advisory committee, etc.: Consultancy fees charged through my University Gary Ferguson: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim, GlaxoSmithKline, Novartis, AstraZeneca, Forest, Sunovian and Pearl, Grant monies (from industry related sources): Boehringer-Ingelheim, Forest, GlaxoSmithKline, Novartis and Pearl Ludmyla Rekeda: Employee: Forest Research Institute Esther Garcia Gil: Employee: Almirall S.A. Cynthia Caracta: Employee: Forest Research Institute
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