Major exclusion criteria were the use of non-protocol-specified beta-agonists; life-threatening/unstable respiratory status within 30 days before screening; asthma or any chronic respiratory disease other than COPD; lung resection of more than 1 full lobe; and/or continuous supplemental oxygen (unless the patient resided at elevation ≥4000 feet). Mahler DA, Donohue JF, Barbee RA, Goldman MD, Gross NJ, Wisniewski ME, Yancey SW, Zakes BA, Rickard KA, Anderson WH. 28. 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 For information on cookies and how you can disable them visit our Privacy and Cookie Policy. COPD patients are more likely to be diagnosed with CVD than the general population (odds ratio of 2.46). Production and hosting by Elsevier B.V. Egyptian Journal of Chest Diseases and Tuberculosis, https://doi.org/10.1016/j.ejcdt.2013.05.005. Thus, one should not infer that these results apply to COPD patients with unstable or more severe cardiac conditions, especially those with pre-existing arrhythmias and hypoxemia5,30. A total of 1829 patients met eligibility at the screening visit and received single-blind placebo; 364 patients were not randomized, 329 of whom had a baseline Holter assessment (nonrandomized patients). 800-638-3030 (within USA), 301-223-2300 (international) Chronic obstructive pulmonary disease (COPD) is a progressive condition that makes it hard to breathe. Dr. Hanrahan is currently at Pulmatrix, Lexington, MA. One of the most common, albuterol, is a beta2-agonist that is short-acting and used as a "quick fix" for shortness of breath. Overall, the proportion of LABA-treated patients with treatment-emergent (i.e., not present at baseline) nonsustained ventricular tachycardia was similar to placebo (p = 0.86), and atrial fibrillation/flutter and >10 beat ventricular tachycardia were rarely observed in all groups (Table 4). 10. Articles in PubMed by John P. Hanrahan, MD, MPH, Articles in Google Scholar by John P. Hanrahan, MD, MPH, Other articles in this journal by John P. Hanrahan, MD, MPH. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Chronic obstructive pulmonary disease (COPD) is one of the most important comorbidities of CVD, which causes serious consequences in patients with ischemic heart disease, stroke, arrhythmia, and heart failure. Fleg JL, Kennedy HL. Chronic obstructive pulmonary disease. Copyright © 2013 The Egyptian Society of Chest Diseases and Tuberculosis. One larger study of approximately 1300 asymptomatic elderly patients reported cumulative arrhythmia proportions (ventricular tachycardia, 7.3%; supraventricular tachycardia, 48.8%) that were generally similar to those reported for the COPD patients in the current study22. Cigarette smoking is a common risk factor for COPD. The 2 trials were identically designed Phase III multicenter randomized trials. This could have contributed to an underestimation of arrhythmia occurrence with longer duration of LABA treatment. The 95% confidence intervals (CIs) and statistical tests were performed based on exact distribution methods1. Yet these drugs, especially nonselective beta-agonists, directly increase the rate and vigor of cardiac contractions. Indeed, COPD imposes a heavy economic burden on individual families and societies. The institutional review boards at each study site approved each protocol, and written informed consent was obtained from all participants. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Rescue albuterol use during the 24-hour Holter monitoring period was similar across the treatment groups at baseline (40.3%-44.8%). Another limitation to be considered in the interpretation of these trial results is that all patients, including those in the placebo group, were allowed the use of albuterol and ipratropium as rescue medications for acute symptom relief. Inhaled bronchodilators are an essential element of the pharmacologic management of COPD. Sin DD, Man SF. The medical histories revealed that the 293 patients randomized to the placebo group had fewer overall cardiac disorders and coronary artery disorders than the 1163 patients randomized to the LABA groups (Table 1). Patients treated with placebo used more rescue drugs during the 24-hour Holter period than those treated with LABAs, although overall beta-agonist exposure was likely greater in patients in the active treatment groups. Finally, the initial Holter interpretations did not a priori place arrhythmias into the categories described in this report. A high proportion of patients had runs of atrial tachycardia at baseline, while few had more serious arrhythmias such as afibrillation/flutter, nonsustained ventricular tachycardia, and >10 beat ventricular tachycardia. Hanrahan, Grogan, Baumgartner, Wilson, and Mr. Cheng were full-time employees of Sepracor Inc. when the study was conducted. Ferguson GT, Funck-Brentano C, Fischer T, Darken P, Reisner C. Cardiovascular safety of salmeterol in COPD. These medications were available to all patients, including those in the placebo group, as needed during the entire study period. Sin DD, Anthonisen NR, Soriano JB, Agusti AG. An estimated 1.2 million people are living with diagnosed COPD – considerably more than the 835,000 estimated by the Department of Health in 2011. The most common arrhythmic events in the LABA treatment groups were tachycardia (0.3%-1.7% vs. 1.4% in the placebo group), ventricular extrasystoles (0.3%-1.7% vs 1.4% in the placebo group), and ventricular tachycardia (0.3%-1.0% vs. 1.4% in the placebo group) (Table 8). Cardiac disorders of any type (as categorized by the MedDRA system organ class term), apart from hypertension, were present in 19% of ITT patients and 22% of patients who did not receive study drug; a history of cardiac arrhythmias (as categorized by the MedDRA high level group term) was present in 5% of the 1456 ITT patients and 8% of the 373 patients who were not treated. People with COPD are at increased risk of developing heart disease, lung cancer and a variety of other con… The percentage of patients with cardiovascular adverse events was 11.2%. We assessed the proportion of patients with each of 4 arrhythmias: atrial tachycardia, atrial fibrillation/flutter, and "nonsustained"; (4-10 beats) and "sustained"; (>10 beats) ventricular tachycardia. Comparisons between all intent-to-treat (ITT) patients and nonrandomized patients at baseline were performed using the Fisher exact test. 14. It occurs when the atria, the two upper chambers of the heart, beat very fast in a disorganized way. The only cardiac exclusions were patients with clinically significant abnormal electrocardiograms at screening, or clinically significant cardiac disorders that in the opinion of the investigator would have interfered with the patient's ability to complete the study. Chronic obstructive pulmonary disease as a risk factor for cardiovascular morbidity and mortality. The rates of serious cardiovascular events (0.7%-1.4%) were similar in the LABA and placebo groups, but the proportion of patients who discontinued due to cardiovascular adverse events was slightly higher in those with LABA treatment (3.8%) compared to those with placebo (1.7%; p = 0.101). Cardiac safety of formoterol 12 microg twice daily in patients with chronic obstructive pulmonary disease. In this assessment, "sustained"; ventricular tachycardia was based on a minimum number of consecutive ventricular beats, not the presence of runs within a specific duration of time. Inhaled beta2-adrenergic agonists have been reported to increase heart rate and contribute to the occurrence of arrhythmias, as suggested in a 2004 meta-analysis25. Stewart AG, Waterhouse JC, Howard P. The QTc interval, autonomic neuropathy and mortality in hypoxaemic COPD. Mortality in COPD: role of comorbidities. The observation that more patients who discontinued participation before being randomized had arrhythmias than those who were given study drug may support this interpretation. Effect of nebulized arformoterol on airway function in COPD: results from two randomized trials. Patients taking beta-blockers were also excluded. A complete description of the methodology has been reported previously2,14. The Authors. Eligible patients were entered into a 2-week single-blind placebo run-in period. Peer review under responsibility of The Egyptian Society of Chest Diseases and Tuberculosis. Registered users can save articles, searches, and manage email alerts. It is unclear whether these comorbidities are due to the disease itself27,28, its associated risk factors8,26,31, or its treatment24. Mannino DM, Homa DM, Akinbami LJ, Ford ES, Redd SC. Data is temporarily unavailable. Cardiac arrhythmias in a healthy elderly population: detection by 24-hour ambulatory electrocardiography. At baseline, there was a low frequency of occurrence of atrial fibrillation/flutter (0.1%), nonsustained ventricular tachycardia (3.1%), and >10 beat ventricular tachycardia (0.3%). Atrial fibrillation (AF) is one of the most common arrhythmias and causes substantial morbidity and mortality. The commonest arrhythmia was ventricular premature beats (VPB) – 88.8%, followed by supraventricular premature beats (SPB) – 56.5%. 3–6 CVD comorbidity is not limited to … 29. COPD is associated with many comorbidities [ 2 , 3 ] ( figure 1 ) and can be one of multiple chronic or acute diseases and medical conditions present within one person [ 4 ]. Registered users can save articles, searches, and manage email alerts. There was no tendency for the frequency of these more serious arrhythmias to increase over the 12 weeks of LABA treatment (Table 5). The implication of this is not known, but the increase is unlikely to be clinically significant, as atrial tachycardia is generally considered to be a benign arrhythmia and the magnitude of increase was small. During treatment, more patients in the placebo group used rescue albuterol (post-first dose, 35.8%; Week 6, 30.4%; Week 12, 28.0%) than patients in the active treatment groups throughout the monitoring period (range post-first dose, 20.5%-25.3%; range Week 6, 18.4%-20.3%; range Week 12, 17.1%-25.7%). And if air leaks into the space between a lung and your chest wall, that lung can collapse like a deflated balloon. 17. MacNee W, Calverley PM. A 68-year-old female sits at her kitchen table, conscious, alert and oriented times four, in no apparent distress, but says, “I feel like I can’t catch my breath.” You note she’s on home oxygen via nasal cannula. Most patients were male (59%), white (95%), had an average age of approximately 63 years, and had moderate to severe COPD (mean forced expiratory volume in 1 s [FEV1], 1.2 L; mean predicted FEV1, ∼41%). 5. AFib can cause blood to pool in the atria, which can lead to blood clots, stroke, and heart failure. In addition, the observation that nonsustained ventricular tachycardia occurred predominantly in different patients at each of the 3 Holter assessment times supports the position that treatment did not influence their occurrence. The occupational burden of chronic obstructive pulmonary disease. Several limitations of these trials should be considered in the interpretation of these results. Recent estimates are that more than 12 million adults are currently diagnosed with COPD, and that the actual prevalence may be more than double that number23. While COPD is a mainly chronic disease, a substantial number of patients suffer from exacerbations. More serious arrhythmias were infrequent and did not increase with inhaled LABA therapy. Most of the time, these Arrhythmias can be non-threatening, but there are instances where they can cause a few fatal conditions. Atrial tachycardia was present in a large proportion of these patients, but the cumulative frequency of more serious arrhythmias was low. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. The purpose of this investigation was to 1) describe the background occurrence frequency of 4 arrhythmias (atrial tachycardia, atrial fibrillation/flutter, "nonsustained"; ventricular tachycardia, and "sustained"; ventricular tachycardia) in these trials; and 2) assess whether LABA treatment resulted in any change in heart rate or in the occurrence of these arrhythmias. Comorbid cardiovascular conditions associated with tobacco smoking and/or aging occur frequently in patients with COPD. 9. Unexpectedly, that study also reported a similar proportion of patients with comorbidities as those in the current COPD cohort. In fact, the 3 more serious arrhythmia categories (afibrillation/flutter, nonsustained ventricular tachycardia, and >10 beat ventricular tachycardia) did occur in a significantly greater proportion of patients who did not receive study drug when compared to those who did. Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States. When asked specifically, she says her dyspnea gets worse with exertion, but she feels “almost normal” when sitting down. Ventricular tachycardia occurs when the ventricles start pounding away at up to 200 bpm—a disruption that can cause dizziness and breathlessness. 11. 25 COPD patients were subjected for Standard 12-lead ECG for arrhythmia detection and the measurement of QT intervals, chest X-ray, two dimensional echocardiography and myocardial nuclear imaging to exclude IHD. Baseline was calculated from the 24-hour Holter records obtained at the start of the placebo run-in period 2 weeks before study drug administration. Address reprint requests to: Amy Wilson, PhD, Sepracor Inc., 84 Waterford Drive, Marlborough, MA 01752. This website uses cookies. In this analysis, 24-hour Holter monitoring data were pooled from 2 identically designed Phase III trials. The proportion of patients with treatment-emergent atrial tachycardia ranged from 27% to 32% and was non-significantly higher, by ∼2%-5% (p = 0.70), in the LABA groups compared with the placebo group. Engstrom G, Wollmer P, Hedblad B, Juul-Moller S, Valind S, Janzon L. Occurrence and prognostic significance of ventricular arrhythmia is related to pulmonary function: a study from "men born in 1914,"; Malmo, Sweden. These are the five most common symptoms of COPD: • Coughing. Chronic coughing at least three months out of the year for two consecutive years is a primary symptom of COPD. Copyright © 2021 Elsevier B.V. or its licensors or contributors. Efficacy of salmeterol xinafoate in the treatment of COPD. Baumgartner RA, Hanania NA, Calhoun WJ, Sahn SA, Sciarappa K, Hanrahan JP. Although asymptomatic in its early stages, COPD is characterized by a gradual and progressive loss of lung function, and is an independent risk factor for ventricular arrhythmia9 and cardiovascular morbidity and mortality16,28,29. The results were similar in those who did not receive study drug. Manolio TA, Furberg CD, Rautaharju PM, Siscovick D, Newman AB, Borhani NO, Gardin JM, Tabatznik B. Cardiac arrhythmias on 24-h ambulatory electrocardiography in older women and men: the Cardiovascular Health Study. Patients were given guidance on their use throughout the trial and were instructed to withhold them for 6 hours before clinic visits. There were 5226 Holter recordings in 1429 treated patients. Beta-adrenergic stimulation may increase heart rate and the potential for cardiac arrhythmias. Dr. Grogan is currently at Foldrx Pharmaceuticals Inc. Cambridge, MA. With respect to more serious arrhythmias, the proportion of patients with nonsustained ventricular tachycardia was small, with no evidence of a dose response for arformoterol. All patients had moderate to severe COPD, and those with stable cardiac or other comorbidities were not excluded from the study cohort. Each Holter record was interpreted in a blinded fashion by cardiologists at a central electrocardiogram laboratory (SpaceLabs Medical Data, Issaquah, WA). The effect of inhaled long-acting beta2-agonists (LABAs) on these outcomes was evaluated in patients with chronic obstructive pulmonary disease (COPD) in 2 double-blind randomized clinical trials. Measure of disability in patients with cardiovascular adverse events ( 9 % overall ) were the common!, and manage email alerts increased risk of atrial tachycardia present at baseline medications improve objective of! 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