From Sepracor Inc. (JPH, DRG, RAB, AW, HC), Marlborough, Massachusetts; Beth Israel Deaconess Medical Center (PJZ), Harvard Medical School, Boston, Massachusetts; University of Pennsylvania School of Medicine (JM) and eResearch Technology, Inc. (JM), Philadelphia, Pennsylvania. Ferguson GT, Funck-Brentano C, Fischer T, Darken P, Reisner C. Cardiovascular safety of salmeterol in COPD. Two patients died from cardiovascular adverse events (abdominal aortic aneurysm [arformoterol 15 μg BID]; and type A aortic dissection [arformoterol 50 μg QD]). 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 ]. We found negative significant correlation between O2 tension and the occurrence of fatal arrhythmias; the same as between O2 tension and QTd value (P values were <0.0005 in both), with QTd as the dependent variable, and age, pulmonary pressure, duration, Mg, Na, K, Hb PH, CO2 and O2 tensions as the independent variables in all subjects, it was shown that only PaO2 was the predictor of QTd with a P value of 0.02. 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. The primary cause of COPD is tobacco smoke (including second­hand or passive exposure). 21 However, neither the … Comorbid cardiovascular conditions associated with tobacco smoking and/or aging occur frequently in patients with COPD. Women, having proportionately smaller lungs and airways than men, are more likely to develop symptoms of COPD. Arrhythmic adverse events occurred in 4.4% of patients in the placebo group and in 3.1%-5.5% of patients in the LABA groups. Multifocal atrial tachycardia, atrial fibrillation, and ventricular arrhythmias are common co-morbidities among patients with COPD [ 2 ]. We do not believe that the retrospective assignment of arrhythmia categories was biased as the assignment was performed independently, and without knowledge of treatment, by 2 physicians who utilized the Holter interpretation of the cardiologist and the total number of beats in the arrhythmia run. Fax: 508-357-7864; e-mail: [email protected]. The availability of arrhythmia prevalence data derived from ambulatory heart rate monitoring in a large cohort of healthy elderly patients is surprisingly sparse, although several smaller studies have been published11,13,17. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. 20. All treatment groups (LABA and placebo) had consistent small decreases from baseline in mean 24-hour and maximum hourly heart rate. This conclusion is supported by both the absence of a dose response with arformoterol and the lack of a statistically significant difference among the treatment groups. Nebulized arformoterol in patients with COPD: a 12-week, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled trial. For immediate assistance, contact Customer Service: While no statistically significant differences were observed (p > 0.71), the proportion of patients with episodes of atrial tachycardia not present at baseline was slightly higher in the LABA groups than in the placebo group (by ∼2%-5%). Patterns of comorbidities in newly diagnosed COPD and asthma in primary care. 24. 13. 1 This can lead to blood clots and stroke. 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). 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%). National Heart Lung and Blood Institute. Our results rule out the electropathy hypothesis and underline autonomic neuropathy as the most possible mechanism of arrhythmias in hypoxaemic, non-respiratory failure, and COPD patients. Severe exacerbations are related to a significantly worse survival outcome. Proportions were based on the number of patients with data at each assessment time. Published by Wolters Kluwer Health, Inc. Dr. Hanrahan is currently at Pulmatrix, Lexington, MA. Data is temporarily unavailable. 800-638-3030 (within USA), 301-223-2300 (international). Cigarette smoking is usually cited as the most common risk factor for COPD. 3–6 CVD comorbidity is not limited to … They were double-blind, double-dummy, placebo- and active-controlled, parallel-group, 12-week multiple-dose clinical trials. Few studies have had an adequate number of patients and sufficient duration of monitoring to characterize the occurrence of transient and infrequent arrhythmias such as atrial fibrillation and ventricular tachycardia. 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. Other risk factors may include: 1. indoor air pollution (such as solid fuel used for cooking and heating) 2. outdoor air pollution 3. occupational dusts and chemicals (such as vapours, irritants, and fumes) 4. frequent lower respiratory infections during childhood.Many cases of COPD are preventable. It is important to note that patients with COPD who participated in the current trials may have been less prone to arrhythmia than COPD patients in general, with similar arrhythmia risk as "healthy"; elderly individuals. 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. It occurs when the atria, the two upper chambers of the heart, beat very fast in a disorganized way. Heeringa J, van der Kuip DA, Hofman A, Kors JA, van HG, Stricker BH, Stijnen T, Lip GY, Witteman JC. 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. Get new journal Tables of Contents sent right to your email inbox, November 2008 - Volume 87 - Issue 6 - p 319-328. 1-2 It occurs when the atria, the two upper chambers of the heart, beat very fast in a disorganized way. Patients with MAT frequently have significant comorbidities, especially chronic obstructive pulmonary disease (COPD) and respiratory failure, and are often treated in ICUs. Mannino DM, Homa DM, Akinbami LJ, Ford ES, Redd SC. The item(s) has been successfully added to ", This article has been saved into your User Account, in the Favorites area, under the new folder. There is a positive significant correlation between pulmonary pressure and QTc where the P value was 0.041 and pulmonary pressure with QTd where the P value was 0.028. Hanrahan, Grogan, Baumgartner, Wilson, and Mr. Cheng were full-time employees of Sepracor Inc. when the study was conducted. 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). This implies that selection factors may have excluded patients with serious arrhythmias at baseline from qualifying for the trial and receiving study drug (Table 3). Cardiac arrhythmias in a healthy elderly population: detection by 24-hour ambulatory electrocardiography. The authors thank all the investigators, study coordinators, and site personnel who participated in these trials. Baseline heart rate was similar across groups (81.1-82.8 beats per minute [bpm]). Chronic obstructive pulmonary disease (COPD) is a complex respiratory disorder characterised by chronic airflow limitation and an increased inflammatory response of the lung . Huiart L, Ernst P, Suissa S. Cardiovascular morbidity and mortality in COPD. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing. Kleiger RE, Senior RM. 27. Occurrence of frequent complex arrhythmias detected by ambulatory monitoring: findings in an apparently healthy asymptomatic elderly population. 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. A total of 1178 (81%) patients completed the studies (ranging from 77% to 85% across the treatment groups). Lippincott Journals Subscribers, use your username or email along with your password to log in. 4 The estimated prevalence of ischemic heart disease (IHD) in COPD patients varies between 20% and 60%, whereas the prevalence of heart failure (HF) lies between 10% and 30% and cardiac arrhythmias between 15% and 30% in most studies and systematic reviews. The observation that more patients who discontinued participation before being randomized had arrhythmias than those who were given study drug may support this interpretation. The results are consistent with other studies in which the prevalence of arrhythmias following LABA treatment was determined by 24-hour ambulatory monitoring4,10. Arrhythmias are common in most people who have undergone heart surgery or a coronary stent procedure or are genetically carrying a structural defect in the heart. Atrial fibrillation (AF) is one of the most common arrhythmias and causes substantial morbidity and mortality. 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. Whether these results imply that arrhythmia risk is related more to underlying comorbidities than to airway function compromise is not known. Campbell SC, Criner GJ, Levine BE, Simon SJ, Smith JS, Orevillo CJ, Ziehmer BA. Production and hosting by Elsevier B.V. Egyptian Journal of Chest Diseases and Tuberculosis, https://doi.org/10.1016/j.ejcdt.2013.05.005. Peer review under responsibility of The Egyptian Society of Chest Diseases and Tuberculosis. 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. 15. Consequently, a high mortality rate (ie, up to 45%) is associated with this arrhythmia, although it is not a direct consequence of the rhythm abnormality. Those patients who had baseline Holter recordings, but did not later receive study medication are referred to as nonrandomized patients. Your message has been successfully sent to your colleague. Some error has occurred while processing your request. 1,2 The condition is frequently complicated by other diseases, which further exacerbate COPD and increase the associated mortality. Copyright © 2013 The Egyptian Society of Chest Diseases and Tuberculosis. Ventricular tachycardia occurs when the ventricles start pounding away at up to 200 bpm—a disruption that can cause dizziness and breathlessness. Nevertheless, use of inhaled short-acting beta2-agonists may have affected the occurrence of arrhythmias observed in all groups, especially the placebo group. 6. Management of COPD. While increases in the number of patients with atrial fibrillation/flutter were observed with increasing doses of arformoterol, only a small proportion of patients was affected in each treatment group (0.3%-1.4%). This website uses cookies. 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. One of the most common, albuterol, is a beta2-agonist that is short-acting and used as a "quick fix" for shortness of breath. Support for this study provided by Sepracor Inc., Marlborough, MA. LABA administration did not increase mean heart rate. Available at. Please enable scripts and reload this page. Please try after some time. 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. 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. Glasser SP, Clark PI, Applebaum HJ. The occupational burden of chronic obstructive pulmonary disease. Baseline Clinical Characteristics and Medical Histories*, Proportion of Patients With Holter Arrhythmia Events at Baseline*, Cumulative Proportion of COPD Patients With Treatment-Emergent (Not Present at Baseline) Holter Arrhythmia Events Over 12 Weeks of Treatment, Proportion of Patients at Weeks 0 (Post-First Dose), 6, and 12 With Treatment-Emergent (Not Present at Baseline) Holter Arrhythmia Events, Cumulative Proportion of COPD Patients With Holter Arrhythmia Events Present Over 12 Weeks of Treatment, Proportion of Patients at Weeks 0 (Post-First Dose), 6, and 12 With Holter Arrhythmia Events Present at Each Visit Including Baseline, Patients With Treatment-Emergent Cardiovascular Adverse Events. 3. The 2 trials were identically designed Phase III multicenter randomized trials. 1, 2 Globally, COPD is projected to rise from the sixth leading cause of death in 1990 to the third most common cause of death in 2020. Fleg JL, Kennedy HL. There were 5226 Holter recordings in 1429 treated patients. Chronic obstructive pulmonary disease (COPD) is a progressive condition that makes it hard to breathe. 7. 30. World Medical Association Declaration of Helsinki. This observation suggests either that COPD patients are less affected by atrial fibrillation than other elderly individuals, or, more likely, selection factors caused COPD patients with atrial fibrillation to be excluded from the current trial. … The Authors. The highest proportion of withdrawals occurred in the placebo (21.8%) and arformoterol 25 μg BID groups (23.3%). For information on cookies and how you can disable them visit our Privacy and Cookie Policy. 7. 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. AFib can cause blood to pool in the atria, which can lead to blood clots, stroke, and heart failure. 9. By continuing to use this website you are giving consent to cookies being used. And if air leaks into the space between a lung and your chest wall, that lung can collapse like a deflated balloon. Eisner MD, Balmes J, Katz PP, Trupin L, Yelin EH, Blanc PD. This pattern was also evident in patients who had atrial tachycardia present at baseline (Tables 6 and 7). Primary symptom of COPD randomized trials, eisner MD, Balmes J, Katz PP, PD. Laba therapy and nonrandomized patients of chronic obstructive pulmonary disease as the common. And maximum hourly heart rate was similar to placebo in mean 24-hour and maximum hourly heart rate was similar the. 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