Baseline Holter monitoring was performed in all patients entering the 2-week single-blind placebo run-in period, whether or not they were randomized to treatment. 31. 27. The authors thank all the investigators, study coordinators, and site personnel who participated in these trials. In this analysis we sought to describe the cumulative frequency of tachyarrhythmias in a cohort of COPD patients with no overt or stable cardiac disease, and to determine the effect of LABA treatment on these arrhythmias and heart rate. Each Holter record was interpreted in a blinded fashion by cardiologists at a central electrocardiogram laboratory (SpaceLabs Medical Data, Issaquah, WA). 2. A complete description of the patient disposition in these trials has been previously reported14. Inhaled beta-agonists are among the first treatment options for the management of COPD. Multifocal atrial tachycardia, atrial fibrillation, and ventricular arrhythmias are common co-morbidities among patients with COPD [ 2 ]. The 95% confidence intervals (CIs) and statistical tests were performed based on exact distribution methods1. This website uses cookies. Chronic obstructive pulmonary disease (COPD) is a significant and increasing cause of death in the United States20,21. The fact that the majority of the arrhythmias were atrial fibrillation and flutter is consistent with the fact that this is the most common sustained arrhythmia encountered in clinical practice, 35 Sra J Patients taking beta-blockers were also excluded. There was no tendency for the frequency of these more serious arrhythmias to increase over the 12 weeks of LABA treatment (Table 5). Holter monitoring was performed using a Burdick 6732 digital 3-channel Holter monitor at baseline (the first 24-hour period at the start of the 2-week single-blind placebo run-in), after the first dose at Week 0, and at Weeks 6 and 12. This could have contributed to an underestimation of arrhythmia occurrence with longer duration of LABA treatment. Abbreviations: bpm = beats per minute, CI = confidence interval, COPD = chronic obstructive pulmonary disease, FEV1 = forced expiratory volume in 1 second, FVC = forced vital capacity, ITT = intent-to-treat, LABA = long-acting beta2-agonist, MedDRA = Medical Dictionary for Regulatory Activities. Atrial tachycardia was present in a large proportion of these patients, but the cumulative frequency of more serious arrhythmias was low. Dr. Grogan is currently at Foldrx Pharmaceuticals Inc. Cambridge, MA. Effect of nebulized arformoterol on airway function in COPD: results from two randomized trials. Efficacy of salmeterol xinafoate in the treatment of COPD. This review summarises the current knowledge on the different aspects of COPD exacerbations. Copyright © 2021 Elsevier B.V. or its licensors or contributors. The proportion of patients with each type of arrhythmia (both the total number of arrhythmias at each assessment time and the proportion of patients with new, treatment-emergent arrhythmias [i.e., arrhythmias occurring on-treatment and not present at baseline]) was summarized by treatment group. Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. 13. Address reprint requests to: Amy Wilson, PhD, Sepracor Inc., 84 Waterford Drive, Marlborough, MA 01752. In stable COPD patients enrolled in our study, new cutoff levels for predicting arrhythmic fatality were proposed for the QTc parameter (395 ms with a sensitivity of 92% and a specificity of 83%) and the QTd parameter (58 ms with a sensitivity of 100% and a specificity of 92%). 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