Risk Assessment of Acute Myocardial Infarction and Stroke Associated with Long-Acting Muscarinic Antagonists, Alone or in Combination, versus Long-Acting beta2-Agonists

• Main Authors: Rebordosa C, Plana E, Rubino A, Aguado J, Martinez D, Lei A, Daoud S, Saigi-Morgui N, Perez-Gutthann S, Rivero-Ferrer E
• Format: Article in Journal/Newspaper
• Language: English
• Published: Dove Medical Press 2022
• Subjects: aclidinium; acute myocardial infarction; lama; stroke; united kingdom; Diseases of the respiratory system; RC705-779; Jaume; Lamas; Mace; Perez; Rivero; sami
• Online Access: https://doaj.org/article/e14880eff97247c8b800105549f270a8

Cristina Rebordosa,1 Estel Plana,2 Annalisa Rubino,3 Jaume Aguado,2 David Martinez,2 Alejhandra Lei,4 Sami Daoud,5 Nuria Saigi-Morgui,1 Susana Perez-Gutthann,1 Elena Rivero-Ferrer1 1Department of Epidemiology and Risk Management, RTI Health Solutions, Barcelona, Spain; 2Department of Biometrics, RTI Health Solutions, Barcelona, Spain; 3Epidemiology, Respiratory and Immunology, AstraZeneca, Cambridge, UK; 4Patient Safety Biopharma, AstraZeneca, Barcelona, Spain; 5BioPharmaceuticals Research and Development, Late-Stage Development Respiratory and Immunology, AstraZeneca, Gaithersburg, MD, USACorrespondence: Cristina Rebordosa, RTI Health Solutions, Department of Epidemiology and Risk Management, Av. Diagonal, 605, 9-1, Barcelona, 08028, Spain, Tel [phone], Fax [phone], Email [e-mail]: The long-acting muscarinic antagonist (LAMA) aclidinium was approved in Europe in 2012 to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). A post-authorization safety study was initiated to assess potential cardiovascular risks associated with LAMAs versus long-acting beta2-agonists.Purpose: To estimate incidence rates and adjusted incidence rate ratios (IRRs) for acute myocardial infarction (AMI), stroke, and major adverse cardiac events (MACE) in new users of aclidinium, aclidinium/formoterol, tiotropium, other LAMA, long-acting beta-agonists/inhaled corticosteroids (LABA/ICS), and LAMA/LABA compared with initiators of LABA.Patients and Methods: This population-based cohort study included patients with COPD aged ≥ 40 years initiating COPD medications in the UK Clinical Practice Research Datalink (CPRD) Aurum database from 2012 to 2019. Poisson regression models were used to estimate the IRR for AMI, stroke, and MACE in users of COPD medications versus LABA, adjusting for clinically relevant covariables.Results: The study included 11,121 new users of aclidinium, 4804 of aclidinium/formoterol, 56,198 of tiotropium, 23,856 of other LAMA, 17,450 of LAMA/LABA, ...