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• W2894873549 abstract "SESSION TITLE: Late Breaking Abstracts SESSION TYPE: Original Investigations PRESENTED ON: 10/08/2018 04:30 PM - 05:30 PM PURPOSE: ASCENT COPD (NCT01966107) was a Phase IV, double-blind, parallel-group study to evaluate the effects of the long-acting muscarinic antagonist, aclidinium bromide, on cardiovascular (CV) safety and exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) and CV risk factors. This post hoc analysis evaluated the effect of aclidinium on major adverse cardiovascular events (MACE) and COPD exacerbations in patients with different baseline CV risk factor levels. METHODS: Patients were randomized 1:1 to receive aclidinium 400 μg or placebo twice daily (BID) via a multidose dry powder inhaler for up to 36 months. Time to first adjudicated MACE (on-study analysis) and rate of moderate or severe COPD exacerbations during the first year (on-treatment analysis) were assessed. Data were compared in patients with any prior CV event vs patients with only ≥2 atherothrombotic risk factors, but no prior CV events. RESULTS: Of 3,630 patients randomized, 1,712 had a prior CV event and 1,865 had ≥2 atherothrombotic risk factors. Compared with patients with ≥2 atherothrombotic risk factors, patients with a prior event were older (68.0 years vs 66.4 years) and a greater proportion were: male (66.5% vs 51.7%); had ≥1 exacerbation in the last 12 months (63.9% vs 56.5%); and had greater COPD severity (55.8% vs 51.4% severe or very severe). Although the annualized rate of moderate or severe exacerbations was greater in patients with a prior CV event (aclidinium: 0.48; placebo: 0.63) vs patients with ≥2 atherothrombotic risk factors (aclidinium: 0.42; placebo: 0.52), aclidinium significantly reduced the rate of exacerbations vs placebo in both groups (rate ratio [95% confidence interval; CI]: 0.76 [0.63, 0.92], p=0.004 and 0.80 [0.66, 0.97], p=0.02 for patients with a prior event and ≥2 atherothrombotic risk factors, respectively). More patients with a prior CV event experienced MACE (aclidinium: 46/840 [5.5%]; placebo: 54/872 [6.2%]) vs patients with ≥2 atherothrombotic risk factors (aclidinium: 23/942 [2.4%]; placebo: 22/923 [2.4%]). The hazard ratio (95% CI) for MACE was 0.86 (0.58, 1.27) for patients with a prior CV event vs 0.99 (0.55, 1.78) for patients with ≥2 atherothrombotic risk factors, therefore, the upper bound of 95% CI did not exceed the non-inferiority margin of 1.8. There was no significant interaction between treatment and CV risk for exacerbations (p=0.67) or MACE (p=0.69). CONCLUSIONS: In patients with moderate to very severe COPD receiving aclidinium 400 μg or placebo BID, patients with higher CV risk (prior CV events) had slightly higher COPD exacerbation rates and were more likely to experience a MACE vs patients with lower CV risk (≥2 atherothrombotic risk factors). CLINICAL IMPLICATIONS: Aclidinium reduced the rate of exacerbations vs placebo regardless of CV risk, and was non-inferior to placebo in time to first MACE. DISCLOSURES: CEC Chair relationship with AstraZeneca Please note: $20001 - $100000 Added 06/01/2018 by Deepak Bhatt, source=Web Response, value=Grant/Research Support CEC Chair relationship with AstraZeneca Please note: $20001 - $100000 Added 06/01/2018 by Deepak Bhatt, source=Web Response, value=Grant/Research Support Removed 06/01/2018 by Deepak Bhatt, source=Web Response CEC Chair relationship with Forest Laboratories Please note: $20001 - $100000 Added 06/01/2018 by Deepak Bhatt, source=Web Response, value=Grant/Research Support Consultant relationship with AstraZeneca Please note: $5001 - $20000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Consulting fee Consultant relationship with Boehringer Ingelheim Please note: $1001 - $5000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Astra Zeneca Please note: $1001 - $5000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Honoraria Consultant Speaker/Speaker's Bureau relationship with Boehringer Ingelheim Please note: $1001 - $5000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Honoraria Consultant relationship with Boehringer Ingelheim Please note: $5001 - $20000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Grant/Research Support Consultant relationship with GSK Please note: $1001 - $5000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Consulting fee Consultant relationship with GSK Please note: >$100000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Grant/Research Support Speaker/Speaker's Bureau relationship with Grifols Please note: $1001 - $5000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Honoraria Investigator relationship with Grifols Please note: >$100000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Grant/Research Support Consultant relationship with Novartis Please note: $5001 - $20000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Novartis Please note: $20001 - $100000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Honoraria Investigator relationship with Novartis Please note: $20001 - $100000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Grant/Research Support Scientific Medical Advisor relationship with Sanofi Genzyme Please note: $5001 - $20000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Consulting fee Investigator relationship with Sanofi Genzyme Please note: $20001 - $100000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Grant/Research Support Consultant relationship with Kamada Please note: $5001 - $20000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Consulting fee Consultant relationship with Teva Please note: $1001 - $5000 Added 04/18/2018 by Kenneth Chapman, source=Web Response, value=Consulting fee Employee relationship with Astrazeneca Please note: >$100000 Added 06/01/2018 by Sami Daoud, source=Web Response, value=Salary Employee relationship with Astrazeneca Please note: >$100000 Added 06/01/2018 by Esther Garcia Gil, source=Web Response, value=Salary Employee relationship with Pearl Therapeutics, A member of the AstraZeneca Group Please note: >$100000 Added 06/01/2018 by Colin Reisner, source=Web Response, value=shares in AstraZeneca No relevant relationships by david schoenfeld, source=Web Response Advisory Committee Member relationship with AstraZeneca Please note: $5001 - $20000 Added 06/01/2018 by Benjamin Scirica, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Boerhinger-Ingelheim Please note: $5001 - $20000 Added 06/01/2018 by Benjamin Scirica, source=Web Response, value=Consulting fee Research relationship with Merck Please note: $20001 - $100000 Added 06/01/2018 by Benjamin Scirica, source=Web Response, value=Grant/Research Support Research relationship with AstraZeneca Please note: $20001 - $100000 Added 06/01/2018 by Benjamin Scirica, source=Web Response, value=Grant/Research Support Advisory Committee Member relationship with Eisai Please note: $5001 - $20000 Added 06/01/2018 by Benjamin Scirica, source=Web Response, value=Consulting fee research relationship with Eisai Please note: >$100000 Added 06/01/2018 by Benjamin Scirica, source=Web Response, value=Grant/Research Support Advisory Committee Member relationship with NovoNordisk Please note: $20001 - $100000 Added 06/01/2018 by Benjamin Scirica, source=Web Response, value=Consulting fee Scientific Medical Advisor relationship with GSK Please note: $5001 - $20000 Added 03/06/2018 by Robert Wise, source=Web Response, value=Consulting fee Advisory Committee Member relationship with AstraZeneca Please note: $5001 - $20000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Consulting fee Advisory Committee Member relationship with boehringer ingelheim Please note: $1001 - $5000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Pneuma Please note: $1001 - $5000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Consulting fee Advisory Committee Member relationship with spiration Please note: $1001 - $5000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Consulting fee DSMB relationship with pulmonx Please note: $1001 - $5000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Honoraria DSMB relationship with merck Please note: $1001 - $5000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Sunovion Please note: $1001 - $5000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Circassia Please note: $1001 - $5000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Consulting fee CEC relationship with Contrafect Please note: $1001 - $5000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Honoraria DSMB relationship with boehringer ingelheim Please note: $1001 - $5000 Added 05/12/2018 by Robert Wise, source=Web Response, value=Consulting fee Employee relationship with AstraZeneca Please note: $5001 - $20000 Added 06/01/2018 by Sofia Zetterstrand, source=Web Response, value=Salary" @default.
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• W2894873549 title "EFFECT OF ACLIDINIUM BROMIDE ON MAJOR ADVERSE CARDIOVASCULAR EVENTS AND EXACERBATIONS IN PATIENTS WITH COPD AND DIFFERENT CARDIOVASCULAR RISK FACTOR LEVELS" @default.
• W2894873549 doi "https://doi.org/10.1016/j.chest.2018.08.1011" @default.
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