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COPD: Managing the Daily Burden of Disease

Introduction

Thomas Petty, MD MASTER FCCP, Co-Chair of the National Lung Health Education Program and Professor of Medicine at the University of Colorado Health Science Center in Denver, CO began the symposiums with a brief overview of Chronic Obstructive Pulmonary Disease (COPD). “When I encounter a patient with cough, wheeze, dyspnea, sputum, smoker or not, who comes to my office with air flow obstruction, I don’t know whether I’m dealing with asthma, COPD or both,” said Dr. Petty, adding, “at the onset, you might not be able to tell until you treat the patient and sometimes it is both.” Unlike asthma, however, COPD is neither highly reversible nor familial. It is, however, very progressive. Dr. Petty advised clinicians to obtain a copy of the book “Frontline Advice for COPD Patients” to help clinicians and patients properly manage this condition (see left). One reason Dr. Petty recommended this book was because neither clinicians nor patients fully understand the severity of this disease. It is estimated that 16 million people are being treated for COPD while another 16 million go undiagnosed. “The public does understand emphysema because they see 1 million people carrying oxygen with them into grocery stores and sporting events,” stated Dr. Petty, adding, “that doesn’t relate, entirely, to COPD but there’s a certain measure of COPD involved.”

Education of COPD was further stressed by Douglas Mapel, MD, FCCP, Medical Director of the Lovelace Clinic Foundation in Albuquerque, NM. Dr. Mapel stated that the lack of COPD education can be reflected in the increased death rate due to COPD (168% increase since 1968) while other common medical conditions have decreased. Lack of education may also explain why COPD is the only major medical problem, besides AIDS, that has a lower life expectancy in the past 30 years (Figure 1), stated Idelle Weisman, MD, FCCP, Director of the Human Performance Laboratory in the Department of Clinical Investigations at the William Beaumont Army Medical Center in El Paso, TX.

“Among the leading top 10 causes of death in the United States, COPD is the only one that is projected to continue to increase for the next 20 years,”
stated Dr. Mapel. Part of the problem is that these patients are not being diagnosed and treated properly. For example, one survey found that less than half of COPD patients have had a pulmonary function test (Chest. 2000;117: 346S-353S). In another study, pulmonary function tests were requested less than 25% of the time, even though the patients complained of respiratory problems (Chest. 2001; 119:1691-1695).

The increasing prevalence of COPD is also reflected in its costs. Dr. Weisman said, “COPD costs the U.S. economy $30.4 billion a year.” Direct costs related to the hospital are approximately $9 billion and COPD patients account for 2% of hospitalizations (726,000 hospitalizations in 2000).

Dr. Weisman stated there were approximately 119,000 deaths in the year 2000 attributed to COPD and women exceeded men by approximately 600 to 700 deaths (MMWR Surveillance Summaries 2002; 51:1-16).

Multisystemic Consequences of COPD

COPD is not simply a pulmonary disorder but is a catalyst for a host of other medical problems. The multisystemic consequences of COPD were summarized by Claudia Cote, MD, FCCP of the Pulmonary and Critical Care Division at Bay Pines VA Medical Center in Bay Pines, FL. Although COPD is a respiratory illness, “it has very important multisystemic consequences such as malnutrition and wasting, peripheral muscle dysfunction, cardiovascular impairment, hypoxemia, hypercapnia, hyperinflation, depression and significant symptoms such as dyspnea,” says Dr. Cote. With regard to blood gas abnormalities, hypoxemia can be observed in moderate COPD while hypercapnia occurs in severe COPD. Both hypoxemia and hypercapnia, however, are very important predictors of survival and both are correctable. “Oxygen therapy will correct the hypoxemia,” stated Dr. Cote, adding, “we can also correct hypercapnia” (Ann Intern Med .1980;93:391-398; Chest. 1999;116:521-534; New Engl J Med. 1996;333:317).

COPD patients also have cardiac dysfunctions. Among the problems, they have right ventricular systolic dysfunction that can be seen during physiological stress (Am Rev Respir Dis. 1984; 130:722-729), reduced venous return from IVC due to a flattened diaphragm (Circulation. 1966;33:8-16), exercised induced pulmonary hypertension, and hampered diastolic filling of the atrium due to hyperinflation (Ann Rev Respir Dis .1988;138:350-354).

Peripheral muscles are also affected by COPD and the 6-minute walking test is an excellent predictor of mortality (Eur Respir J. 1996;9:431-435; Chest. 1997;111:550-558; Am J Respir Crit Care Med. 2003: A38). Another predictor of survival is body mass index. Approximately, 50-60% of severe COPD patients show signs of malnutrition and 20-35% have muscle wasting (Am J Respir Crit Care Med. 1996;152:S77-S121; Am J Respir Crit Care Med.1998; 157:1791-1797).

The multisystemic consequences of COPD have led Dr. Cote and others to propose a new classification of disease severity called BODE (Body Mass Index Obstruction Dyspnea and Exercise Capacity). “We look at several variables such as lung function symptoms, exercise capacity as measured by the six- minute walking distance and their body mass index,” said Dr. Cote, adding, “BODE had a coefficient of .49 to predict mortality and very highly statistically significant P value.” It was a better predictor of survival than the gold standard, the FEV1.

 

Treatment Options for COPD

Along with the books by Dr. Petty, there are also several guidelines available to aid clinicians on educating and treating COPD patients. Denis E. O’Donnell, MD, FCCP of the Pulmonary Division, at Queen’s University in Kingston, Ontario, Canada, discussed these guidelines beginning with the Canadian Thoracic Society Guidelines that Dr. O’Donnell helped develop. “We used a very practical, pragmatic definition of COPD,” said Dr. O’Donnell, adding, “we stressed partial reversibility and this is a deviation from previous guidelines which talk about irreversibility, which has lead to a great deal of therapeutic nihilism.” Similarly, the GOLD Committee set its goals for COPD management to include:

• Prevent disease progression
• Relieve symptoms
• Improve exercise tolerance
• Prevent and treat complications
• Prevent and treat exacerbations
• Reduce mortality

In the ideal management of COPD, the stepwise approach would begin with education/self-management followed by short acting bronchodilators, then long- acting bronchodilators, then rehabilitation, then inhaled steroids, then oxygen. In the real world, however, Dr. O’Donnell stated that education/self-management and rehabilitation are not properly utilized, adding to the cost and severity of this disease. Dr. O’Donnell also stated that in the real world, clinicians prescribe inhaled steroids too often and too quickly and they should be used only in more severe cases of COPD with frequent exacerbations.

Education/Self-Management
Smoking cessation is the pivotal intervention in COPD patients. Other self- management programs are also helpful. A study by Dr. Bourbeau’s group showed that patients educated about early recognition and prompt treatment of exacerbations had higher quality of life scores and lower hospital visits (i.e., 40% fewer hospital visits due to exacerbations and 59% fewer unscheduled visits) (Arch Intern Med. 2003; 10:585-591).

Bronchodilators
Short-acting bronchodilators, such as salbutamol and ipratropium consistently improve both pulmonary function (FEV1) and exercise testing as measured by the 6- and 12-minute walk distance tests. Unfortunately they have not been shown to improve the patient’s quality of life.

One option thought to improve treatment is combining two short-acting agents. To illustrate, Bruce K. Rubin, MD, FCCP, Professor and Vice Chair of Pediatrics at the Wake Forest University Scholl of Medicine, Winston-Salem, NC, categorized bronchodilators into anti-cholinergic (ipratropium) or beta-adrenergic (salbutamol). Combining these two systems (i.e., combivent) does produce superior bronchodilation to either agent alone.

Since COPD is a chronic disease, long- acting bronchodilators may be a better option for treating COPD, especially as maintenance therapy. One such long- acting bronchodilator is the muscarinic receptor antagonist, tiotropium, which is a once- daily inhaled bronchodilator. Like ipratropium bromide, tiotropium bromide is a quaternary ammonium derivative that binds to muscarinic receptors. Although tiotropium binds with high affinity to muscarinic receptors of M1-, M2- and M3-subtypes, it dissociates very slowly from M1- and M3-receptors and more rapidly from M2-receptors, thereby giving it a unique kinetic selectivity. Clinical trials with tiotropium have demonstrated superior efficacy to ipratropium and for improving FEV1 for up to one year (Eur Respir J. 2002;19:209-216.) (Figure 2). Furthermore, as an assessment of dyspnea, TDI focal scores were significantly better in patients taking tiotropium compared to ipratropium, stated Dr. Rubin. The multitude of improvements seen with tiotropium and other bronchodilators was also discussed by Donald Mahler, MD FCCP, Professor of Medicine at Dartmouth Medical School, Lebanon, NH, who stated, “the relief of dyspnea with bronchodilators appears to be related to two mechanisms, an increase in ventilatory capacity which we typically measure by flow rates and/or a decrease in hyperinflation which we don’t routinely measure but maybe we should as we gain more information about this mechanism of action of broncho-dilators,” adding, “for those of us who see patients in practice, we need to ask questions about dyspnea and physical activities.”

Dr. Mahler stated that the impact of COPD exacerbations is also an important outcome measure. In two 6-month trials comparing placebo, salmeterol and tiotropium, patients treated with tiotropium had significantly fewer COPD exacerbations (and exacerbation days) per patient-year compared to those treated with placebo. There was no difference between salmeterol and placebo.(Thorax 2003;58:399).

Dr. O’Donnell added to this discussion stating that tiotropium can improve exercise performance in COPD patients (AJRCCM.2002;165:A265), result in sustained bronchodilation (DFEV1 “trough” ~0.15 L, post-dose ~0.26 L), improve quality of life (SGRQ ~4 units), reduce frequency of exacerbations (~20%) and hospitalizations (~49%), and improve chronic activity-related dyspnea (TDI ~ 1 unit) (Eur Respir J.. 2002; 19:217-224; Eur Respir J. 2002;19:209-216; Chest. 2002;122:47-55; Thorax. 2003;58:399-404). Dr. O’Donnell stated that the Canadian Thoracic Society guidelines include long-acting bronchodilators as an important component of COPD treatment (Figure 3).

Steroids
As the severity of the COPD progresses, patients may require inhaled steroids. Dr. O’Donnell stated, “regular use of high dose inhaled steroids alone should only be considered in patients with severe exacerbations because, if you look at the ISOLDE Study and more recent meta-analysis of all the available data, those that benefit are those with more severe disease and more frequent exacerbations.” Overall, the benefits of inhaled steroids in terms of pulmonary function improvement is limited (Lancet 1999; 353:1819-1823; N Engl J Med. 1999; 340:1948-1953; BMJ. 2000;320:1297-1303; N Engl J Med. 2000;343:1902-1909; Am J Med. 2002;113:59-65.) and to date, the only evidence of a significant effect with inhaled corticosteroids is in reducing the rate of exacerbation (Am J Med .2002;113:59-65).

 

Concluding Remarks

The chairman of the evening symposia, Dr. Bartolome R. Celli, MD, FCCP, Chief of Pulmonary and Critical Care Medicine at St. Elizabeth’s Medical Center in Boston ,MA, advocated for more aggressive patient/doctor education of COPD. Currently, there is a myth that COPD is progressive and there is no effective treatment. The reality is that COPD patients do respond to treatment and they can get better. Dr. Celli proposed that we should think of COPD and COPD treatment in the same manner in which we think of hypertension. “The reason why anti-hypertensive agents are a mainstay therapy for those of us who have high blood pressure is that we do not want to have angina, MI, stroke and congestive heart failure,” said Dr. Celli, adding, “the model that I believe we ought to explore and make very popular is to simplify the spirometry, make it a working number that is not too complex to use and then look at other outcomes of more importance to the patient.” In other words, dyspnea should be discussed by patients and doctors in the same way that they discuss angina. Dr. Celli further proposed that exacerbations should be considered like an unstable angina or a myocardial infarction, and ventilatory failure requiring mechanical ventilation, the equivalent to cardiogenic shock. One way to educate people on this disease is to make exacerbations and dyspnea part of their daily vocabulary and an outcome that is more important than the actual change in lung function.

Dr. Celli also stated that treatment for COPD is not as pessimistic as it is perceived by stating “if the changes in FEV1 or dyspnea scores that have been shown in these symposia were presented as antihypertensive agents affecting hypertension, these drugs would be considered highly effective.” For example, Dr. Celli cited an article in the New England Journal of Medicine showing antihypertensive therapy to decrease blood pressure by 9% (N Engl J Med. 2003; 348:583). In cardiology, this was considered a great breakthrough since the medication also decreased myocardial infarction, CHF, and strokes of 13%. In pulmonary medicine however, bronchodilators that show improvements in the range of 16-18% (Figure 2) or more are often viewed as ‘slight improvements’. Among the reasons cited by Dr. Celli for this negative perception is that these studies tend to be smaller trials (i.e, n~900) and he strongly suggested that larger ‘mega-trials’ be completed.

Dr. Celli concluded by saying, “COPD is not a non-treatable disease and patients will improve if diagnosed and treated appropriately,” adding, “those of you who are here tonight I hope will go back and charge on, preach spirometry and treat your patients well because they do get better!”



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