Funding for this newsletter series was provided by
Pulmonary Practice Pearls for Primary Care Physicians
9-part eNewsletter series
Vol 1, Issue 6
Primary care physicians routinely see patients with chronic respiratory diseases, such as asthma and chronic obstructive pulmonary disease (COPD). Although treatment guidelines are available, we still need practical information that translates guidelines and other evidence so that we can better diagnose and manage these diseases. Each issue in the Pulmonary Practice Pearls for Primary Care Physicians eNewsletter series focuses on a key topic in the management of COPD or asthma within the context of current national guidelines and clinical practice. Topics are brought to life through the presentation of hypothetical clinical cases, and an emphasis is placed on applying key learnings to clinical practice. Practice tools and links to additional information are featured in each issue.

Series author
Barbara P. Yawn, MD, MSc, FAAFP
Director of Research
Olmsted Medical Center
Rochester, Minnesota

Dr. Yawn disclosed that she serves on advisory boards for Boehringer Ingelheim and Novartis and has received grant support from Novartis, Boehringer Ingelheim, Merck, and AstraZeneca LP.

Laurie Orloski, PharmD, of Pharmite in Douglassville, Pennsylvania, and Anny Wu, PharmD, of Scientific Connexions in Newtown, Pennsylvania, provided medical writing support for this article through funding from AstraZeneca LP.




Highlights From the Updated 2011 GOLD Guidelines and Application to COPD Management

Chronic obstructive pulmonary disease is among the leading causes of death in the United States (ranked third when combined with other chronic lower respiratory diseases based on 2008 data) and carries a significant burden for patients, their families, and the health care system.1,2 COPD itself is projected to be the fourth leading cause of death globally by 2030.3

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) was formed in 1998 to increase awareness of COPD and bring attention to both prevention and management of the disease,4 producing guidelines and several updates, with the most recent update in 2011.4 Previous versions of the GOLD guidelines relied almost entirely on assessments of patients' pulmonary function to guide care. However, pulmonary function is not always associated with symptoms or risk for future exacerbations. The 2011 modifications to the COPD guidelines better address issues that are important to patients with COPD—improving symptoms and the impact of symptoms on their daily lives.

This e-newsletter provides an overview of the major revisions included in the updated 2011 GOLD guidelines and practical information for managing COPD using the updated guidelines.

Case

Marilyn is a 52-year-old black woman who has a 5-year history of recurrent bronchitis episodes. Beginning 6 months ago she stopped smoking, and 3 months ago had a diagnostic spirometry performed due to continuing cough and sputum production. With a forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of 0.58 and FEV1 % predicted of 68% as adjusted for her age, height, and race, Marilyn was diagnosed with COPD.

Note: This is a hypothetical case description for teaching purposes.

Summary of Revisions in the 2011 GOLD Guidelines

The 2011 modifications to the GOLD guidelines have increased the utility of the guidelines in the primary care setting in several ways, including the incorporation of simple and reliable tools for assessing COPD symptoms and functional status that can be used in routine clinical practice.5 The 2011 GOLD guidelines also represent a new approach to COPD management that is easy to use in any clinical setting and matches assessment to treatment objectives.4,5 Previously, management recommendations were based solely on spirometric category; however, the updated guidelines recommend a strategy that also considers the impact of the disease (based on symptom burden and activity limitation) and future risk of adverse outcomes (primarily based on history of previous exacerbations).5

A number of specific noteworthy revisions are included in the 2011 GOLD guidelines. First, clarification of the definition of COPD is provided, eliminating the reference to airflow limitation "that is not fully reversible"6 and adding mention of exacerbations and comorbidities.4 The definition reads as follows:

"COPD, a common preventable and treatable disease, is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients."4

Additionally, spirometry is now required for the diagnosis of COPD—not just to support a diagnosis of COPD, as had been its role in previous guidelines.4 According to the 2011 GOLD guidelines, the diagnosis of COPD is made based on symptoms of dyspnea, chronic cough or sputum production, and/or a history of exposure to COPD risk factors, as well as the presence of a postbronchodilator FEV1/FVC ratio <0.70.4

Moreover, the previous staging system that used FEV1 alone to assess COPD severity has been abandoned.4 Instead, the 2011 GOLD guidelines use letter categories to evaluate a combination of COPD severity and control (Figure).4 The category includes information about pulmonary function, history of exacerbations, and severity of symptoms (most importantly dyspnea).4 The updated guidelines also revised the definition of a COPD exacerbation to include stronger language regarding changes in medication, as follows4,6:

"An exacerbation of COPD is an acute event characterized by a worsening of the patient’s respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication."4

Finally, the 2011 GOLD guidelines include an expanded section on comorbidities of COPD, focusing on cardiovascular disease, osteoporosis, depression and anxiety, lung cancer, infections, and diabetes and metabolic syndrome.5


Using the New GOLD Model for Evaluating COPD Symptoms and Risk

Case (continued)

Within the past year, Marilyn has had 3 episodes that would have been considered exacerbations if she had been diagnosed with COPD at the time: 2 episodes of bronchitis and 1 episode of pneumonia (x-ray confirmed). On the Modified Medical Research Council (mMRC) assessment of dyspnea severity, she reported shortness of breath when walking long distances on level ground and when walking up even small hills or a few steps of stairs (Table 1). She is classified as having an mMRC grade of 1.

Note: This is a hypothetical case description for teaching purposes.


Marilyn's case highlights the importance of not only assessing a patient's spirometry values but also asking the patient about her symptoms and ability to function. Under the previous 2010 GOLD guidelines, Marilyn would have been classified as having moderate COPD; however, according to the updated 2011 guidelines, she has COPD Category C. Using the updated guidelines—revised to include consideration of a patient's symptoms and future risk of exacerbations, not just spirometry (Figure)—it is necessary to obtain additional information about a patient’s current symptoms and risk for future exacerbations.4 Compared with other baseline characteristics, such as pulmonary function, patient-reported outcomes, laboratory values, and mMRC dyspnea assessment, a history of previous exacerbations is the best predictor of having future exacerbations.7

Classification of the severity of airflow limitation into grades is based on postbronchodilator FEV1 values (Table 2).4 Current guidelines also recommend using the mMRC questionnaire or the COPD Assessment Test (CAT) for evaluating symptoms (Table 1).4 The mMRC dyspnea assessment is considered a simple measure for assessing disability due to breathlessness.8 Additionally, dyspnea severity has been shown to more closely correlate with survival than FEV1-based disease severity classification.9 The CAT is a short and simple patient-completed questionnaire that has exhibited sensitivity to changes in overall health status.4,10,11


Using the New GOLD Model for Treating COPD

The goals of COPD treatment are 2-fold: (1) to reduce burden or impairment, including relieving symptoms, improving exercise tolerance, and improving health status, and (2) to reduce risk, including preventing disease progression, preventing and treating exacerbations, and reducing mortality.4

In the 2011 GOLD guidelines, pharmacologic management of COPD is now based on disease impact and future risk of disease progression, not solely on spirometric category.4 The updated 2011 GOLD guidelines not only capture Marilyn's history of exacerbations, but also recommend additional treatment beyond what would have been recommended under the previous 2010 guidelines. Based on the 2010 guidelines, in which Marilyn would have been diagnosed with moderate COPD (defined as FEV1/FVC <0.70 and FEV1 ≥50% but <80% predicted), the recommended pharmacologic treatment would have been a long-acting bronchodilator and a rescue inhaler.6 Based on the updated 2011 guidelines, Marilyn has COPD Category C (few symptoms but a high risk of exacerbations),4 which suggests that she needs therapy for the prevention of exacerbations. Accordingly, the recommended first-choice treatment for Marilyn is the combination of an inhaled corticosteroid and a long-acting β2-adrenergic agonist or a long-acting anticholinergic (Table 3).4 As a second-choice treatment option for COPD Category C, the combination of 2 long-acting bronchodilators (a β2-adrenergic agonist and an anticholinergic) may be considered.4 Alternative options for COPD Category C, which may be used in combination with first- or second-choice regimens, include a phosphodiesterase-4 inhibitor (for patients with chronic bronchitis) and theophylline.4

Several nonpharmacologic treatments are of utmost importance for the routine management of COPD. Based on the 2011 guidelines, pulmonary rehabilitation is a recommended intervention for patients with COPD Categories B to D (Table 3).4 Pulmonary rehabilitation programs, which can include exercise training, smoking cessation, nutrition counseling, and patient education, have the ability to improve exercise capacity and health-related quality of life, among other benefits.4 An effective pulmonary rehabilitation program is a minimum of 6 weeks, but longer programs are even more effective.4 Patients unable to participate in a formal program are advised to exercise at home, such as walking 20 minutes daily.4 Patients must continue to exercise at home after completing a comprehensive rehabilitation program; otherwise, the gains achieved in exercise endurance and psychological functioning will not be maintained, and patients will quickly revert to previous levels of fitness.12

Smoking cessation is the most effective way to slow COPD progression.4 Although Marilyn is not a current smoker, she should be educated on the critical importance of continuing to abstain from cigarettes and followed accordingly. As with all patients with COPD, efforts should be made to ensure that Marilyn is, and continues to be, up-to-date on her influenza and pneumococcal vaccinations based on local guidelines.4,13 In the United States, annual influenza vaccination is recommended for everyone aged ≥6 months.13 Pneumococcal polysaccharide vaccination is recommended for all adults aged ≥65 years without a history of the vaccination or adults aged <65 years with certain conditions, such as chronic lung disease, chronic cardiovascular disease, and diabetes.13

Although not specifically recommended for people with COPD, pertussis immunizations are recommended for all adolescents and adults in the form of a Tdap booster, which is active against tetanus and diphtheria, as well as pertussis.14 Protecting patients with COPD from the rigors of 6 weeks of whooping cough seems reasonable in this period of widespread pertussis epidemics.

Conclusions

COPD is associated with substantial morbidity and mortality, with no foreseeable reversal of trends based on future projections. The important revisions presented within the 2011 GOLD guidelines move care from simply looking at a pulmonary function value to assessing the outcomes that are important to patients—dyspnea, cough, functional limitations, and rates of exacerbations. For patients with COPD Category C, the focus of the presented case study, additional modifications from a therapeutic standpoint include the recommended use of a therapy to prevent future exacerbations and pulmonary rehabilitation. The 2011 GOLD updates were made with the practicing clinician in mind—try them, I think you will find them to be practical and useful.

References

  1. National Institutes of Health. National Heart, Lung, and Blood Institute. Morbidity & Mortality: 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases. http://www.nhlbi.nih.gov/resources/docs/2012_ChartBook.pdf. Published February 2012. Accessed June 11, 2012.
  2. American Lung Association. Trends in COPD (Chronic Bronchitis and Emphysema): Morbidity and Mortality. American Lung Association Web site. http://www.lung.org/finding-cures/our-research/trend-reports/copd-trend-report.pdf. Published August 2011. Accessed June 11, 2012.
  3. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3(11):e442.
  4. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. GOLD Web site. http://www.goldcopd.org/uploads/users/files/
    GOLD_Report_2011_Feb21.pdf
    . Revised 2011. Accessed June 11, 2012.
  5. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Summary Handout. GOLD Web site. http://www.goldcopd.org/
    uploads/users/files/GOLD2011_Summary.pdf
    . Revised 2011. Accessed September 11, 2012.
  6. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. GOLD Web site. http://www.goldcopd.org/uploads
    /users/files/GOLDReport_April112011.pdf
    . Updated 2010. Accessed July 10, 2012.
  7. Hurst JR, Vestbo J, Anzueto A, et al; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010;363(12):1128–1138.
  8. Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999;54(7):581–586.
  9. Nishimura K, Izumi T, Tsukino M, Oga T. Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest. 2002;121(5):1434–1440.
  10. Jones PW, Harding G, Wiklund I, et al. Tests of the responsiveness of the COPD assessment test following acute exacerbation and pulmonary rehabilitation. Chest. 2012;142(1):134-140.
  11. Jones PW, Harding G, Berry P, et al. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009;34(3):648–654.
  12. Ries AL, Bauldoff GS, Carlin BW, et al. Pulmonary rehabilitation: joint ACCP/AACVPR evidence-based clinical practice guidelines. Chest. 2007;131(5 suppl):4S–42S.
  13. Centers for Disease Control and Prevention. Recommended adult immunization schedule–United States, 2012. MMWR Morb Mortal Wkly Rep. 2012;61(4):1–7.
  14. Centers for Disease Control and Prevention. Pertussis: Summary of Vaccine Recommendations for Health Care Professionals. CDC Web site. http://www.cdc.gov/vaccines/vpd-vac/pertussis/recs-summary.htm. Published January 2011. Accessed September 18, 2012.

Figure. Model of Symptom/Risk of Evaluation of COPD



Patient Category

Characteristics

Spirometric
Classification
Exacerbations per year mMRC

CAT

A

Low risk, less symptoms

GOLD 1-2 ≤1 0-1

<10

B Low risk, more symptoms GOLD 1-2 ≤1 ≥2 ≥10
C HIgh risk, less symptoms GOLD 3-4 ≥2 0-1 <10
D High risk, more symptoms GOLD 3-4 ≥2 ≥2 ≥10

CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; GOLD, the Global Initiative for Chronic Obstructive Lung Disease; mMRC, Modified British Medical Research Council scale.

Source: Reprinted with permission from the Global Strategy for Diagnosis, Management, and Prevention of COPD, www.goldcopd.org.
4










aCan include pharmacologic treatment.
b
Medications in each box are not necessarily in order of preference.
cMedications in this column can be used alone or in combination with other options in the First and Second columns.

A = low risk, less symptoms; B = low risk, more symptoms; C = high risk, less symptoms; D = high risk, more symptoms.

ICS, inhaled corticosteroid; LABA, long-acting β2-adrenergic agonist; LAMA, long-acting muscarinic antagonist; PDE-4, phosphodiesterase-4; prn, “pro re nata” (as needed); SABA, short-acting β2-adrenergic agonist; SAMA, short-acting muscarinic antagonist.

Source: Adapted by the author from the Global Strategy for Diagnosis, Management, and Prevention of COPD, 2011, available at www.goldcopd.org.4