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The Burden of Asthma and Improving Patient Outcomes
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Asthma is a significant national burden owing to patient morbidity and mortality, rising healthcare costs, and employee absenteeism. The National Asthma Education and Prevention Program (NAEPP) guidelines were created to improve the diagnosis and treatment of asthma, and stress 4 central components for the management of asthma: (1) measures of assessment and monitoring (obtained by patient history and patient reports; physical examinations and objective tests to confirm, diagnose, and assess severity of asthma initially, and to monitor asthma control subsequently); (2) education for a partnership in asthma care; (3) a focus on control of environmental factors and comorbid conditions that affect asthma; and (4) evidence-based decision making about pharmacologic therapy. The NAEPP guidelines recommend step-up and step-down programs for pharmacologic therapy. There are several barriers to effective asthma control. Treatment adherence in patients with asthma is suboptimal. Moreover, clinicians may not completely adhere to treatment guidelines. Finally, insurance companies may indirectly contribute to poor guideline adherence by failing to adequately recognize the time required to educate patients on asthma and develop a partnership for success, as requested by the guidelines. Successful asthma management requires effort by all parties involved, with the ultimate goal of improved outcomes, including reduced medical complications and costs.
(Am J Manag Care. 2011;17:S75-S81)
Prevalence and Epidemiology of Asthma
In an era of scientific research and breakthroughs, asthma still exacts a significant national burden owing to patient morbidity and mortality, rising healthcare costs, and employee absenteeism. This burden is due to both the sheer number of people with asthma and a small subset of patients with refractory or difficult to control asthma who require much urgent care and hospitalization for asthma. The American Lung Association estimates that approximately 38.4 million Americans, or 12.8% of the population, have been diagnosed with asthma at some point in their lifetime.1 Currently, asthma affects an estimated 23.3 million Americans (7.8% of the population), including 6.9 million children.1 Asthma affects all races, sexes, and ages, in all regions (Figure 1).1
All patients with asthma benefit from medical care. In 2006, asthma was responsible for 10.6 million physician office visits, 1.2 million hospital outpatient department visits, and 1.7 million emergency department visits.1 Estimated medical costs for asthma in 2010 were $5.5 billion for hospital care, $5.9 billion for prescription care, and $4.2 billion for physicians’ services, totaling $15.6 billion in direct medical expenses.1
As the number of clinicians involved in direct or indirect management of asthma continues to grow, it becomes increasingly important for physicians to be aware of the guidelines for asthma management and use them appropriately.
Asthma Treatment Guidelines
To improve diagnosis and treatment of asthma, the National Heart, Lung, and Blood Institute established the National Asthma Education and Prevention Program (NAEPP) guidelines in 1991.2 As our knowledge about asthma advanced, these guidelines were updated twice,3,4 and the latest version was published in 2007.5 The current version stresses 4 central components for the management of asthma: (1) measures of assessment and monitoring (obtained by patient history and patient reports; physical examinations and objective tests to confirm, diagnose, and assess severity of asthma initially, and to monitor asthma control subsequently); (2) education for a partnership in asthma care; (3) a focus on control of environmental factors and comorbid conditions that affect asthma; and (4) evidence-based decision making about pharmacologic therapy.
The preferred method to utilize pharmacologic agents in asthma that is recommended by the NAEPP is a step-up and step-down program (Figure 2).5 Although the program emphasizes the pharmacologic options that are available for each level of asthma severity, it is recognized that pharmacologic therapy is only 1 of the 4 central components of asthma management, and that each component is important to longterm asthma control.
Assessment and Monitoring
Assessment and monitoring tools are used longitudinally in the management of asthma. They are utilized initially to determine patients’ asthma severity at the time of initial diagnosis and then subsequent control of asthma and responsiveness to treatment.5 Severity is best determined if the patient has not begun long-term treatment; otherwise, it can be inferred from the least amount of treatment required to maintain control. Asthma severity and asthma control are determined clinically through assessment of impairment (ie, symptom severity and functional limitations), lung function, and future risk of exacerbations or decline in lung function. Attention is also paid to medication side effects. For assessment of asthma control, patient-centric questionnaires such as the Asthma Control Test,6 the Childhood Asthma Control Test,7 the Asthma Control Questionnaire,8 and the Asthma Therapy Assessment Questionnaire control index9 can be used by patients to guide themselves and clinicians.
Assessment should evaluate both impairment and risk. Determining impairment is often straightforward. Determining risk of future exacerbations or loss of lung function is more difficult. A medical history may help to infer the patient’s risk. For example, patients without a good asthma action plan, or those with a history of recent exacerbations requiring emergency department visits, hospitalization, or intensive care unit admission, generally are at greater risk of future exacerbations.10-12 Evaluation of lung function through spirometry is commonly used as part of the assessment of risk of future adverse events. Development of biomarkers, however, would be beneficial and may enable better risk assessment.
Selecting the proper treatment program (including appropriate and directed environmental modification, recognition and management of comorbid conditions, and careful choice of pharmacotherapy) is essential to improve asthma control.13 Assessment and monitoring of treatment should include focus on the environment the patient inhabits (). Monitoring asthma control in the manner outlined above is important, as it can determine if the patient was prescribed appropriate therapy and if he or she is adhering to the treatment regimen. Evaluation of response to pharmacotherapy is also important, as some patients do not respond well to prescribed therapy. An asthma specialist may be needed to determine whether poor response is due to poor adherence to treatment, comorbid conditions, or other factors.
Patient Education
Asthma self-management education is important to achieve asthma control and improve outcomes, as most asthma treatment is self-administered. Patients must be familiar, at some level, with the pathophysiology of asthma, and with how (and when) to correctly use different asthma medications. Asthma self-management education should be provided by trained healthcare professionals and be considered an integral part of effective asthma care for policies and reimbursement.5 This education should also be repeated and reinforced often. In addition to in-office education, written materials should be given to the patient, and, at the very least, patients should receive a written action plan that includes: (1) daily management recommendations and (2) how to recognize and handle worsening asthma.5 Patient education should also include a detailed understanding of how asthma symptoms are influenced by treatment adherence and the environment. Clinicians can encourage treatment adherence by recommending a regimen that achieves asthma control, is simple to follow, and addresses the preferences that may be important to the patient and caregiver.
Control of Environmental Factors and Comorbid Conditions
As shown in the ,5 numerous environmental factors can contribute to asthma severity. Asthma is associated with an allergic response. As such, patients need to be adequately evaluated and specifically educated on reducing exposure to identified and relevant allergens. During a medical examination, clinicians need to evaluate the potential role of allergens, particularly indoor inhalant allergens and indoor sources of irritants, including environmental tobacco smoke. A medical history, together with allergy skin tests or in vitro testing for specific immunoglobulin E (IgE), will determine relevant allergens to avoid.
Clinicians should also look for chronic comorbid conditions such as gastroesophageal reflux disease, obesity, obstructive sleep apnea, rhinitis/sinusitis, and chronic stress or depression, which may influence the efficacy of asthma therapy. Consideration should also be given to allergic bronchopulmonary aspergillosis.
The central goal of optimal asthma care is to control asthma with the least amount of medication necessary. Therefore, medical care and education must focus on the avoidance of environmental triggers and the recognition and management of comorbidities and complications.
Pharmacologic Therapy
Asthma medications are classified into 2 broad groups, long-term controller medications and quick-relief medications. Long-term controllers are typically taken on a daily basis to maintain control of persistent asthma. Long-term controller medication classes include inhaled corticosteroids (ICSs), long-acting beta2-agonists (LABAs), leukotriene modifiers, sustained-release theophyllines, cromolyn sodium and nedocromil, and anti-IgE agents (taken every 2-4 weeks).5
Of these classes, ICSs are the most potent and effective anti-inflammatory medications currently available in the US market. They block late-phase reactions to allergens, reduce airway hyperresponsiveness, and inhibit inflammatory cell migration and activation. Clinical studies have shown that ICSs have numerous benefits in patients with asthma, including reduction in severity of symptoms, improvement in asthma control and quality of life, improvement in peak expiratory flow and spirometry, diminished airway hyperresponsiveness, prevention of exacerbations, and reduction in systemic corticosteroid requirements, emergency department care, hospitalizations, and deaths (due to asthma).5
LABAs are often used in combination with ICSs or other antiinflammatory agents for control of symptoms, especially nighttime symptoms. LABAs act as bronchodilators. They are not recommended as monotherapy, but are often used in combination with an ICS for step 3 or 4 in the step-up treatment regimen recommended by the NAEPP (Figure 2).5 Current ICS/LABA combinations include fluticasone and salmeterol,14 budesonide and formoterol,15 and mometasone and formoterol.16
Leukotriene modifiers, which decrease the production or action of leukotrienes (substances that are potent bronchoconstrictors), may be considered as an alternative to low-dose ICSs in patients greater than 12 years old with mild persistent asthma. Leukotriene modifiers may also be used as adjuvant therapy to ICS therapy, but the combination of ICS plus a LABA is preferred.5 Two leukotriene receptor blockers (montelukast and zafirlukast) and 1 leukotriene synthesis inhibitor, a 5-lipoxygenase inhibitor (zileuton), are available.
Sustained-release theophyllines are primarily used as an adjuvant therapy to ICSs for prevention of nighttime symptoms and may have mild anti-inflammatory effects.5
Cromolyn sodium and nedocromil are alternative agents for mild asthma, but not the preferred medications. They are often used in children as long-term controllers. They can also be used to combat exercise- or allergen-induced asthma symptoms. These medications stabilize mast cells and interfere with chloride channel function.5
The immunomodulator, omalizumab, is a monoclonal antibody (anti-IgE) used as add-on therapy for severe, persistent asthma (ie, step 5 or 6). It has been shown to reduce exacerbations and improve symptoms. Omalizumab inhibits the binding of IgE to the high-affinity receptors on basophils and mast cells, thus decreasing the release of mediators in response to allergen exposure. It is administered as a subcutaneous injection.5 A recent review of 8 placebo-controlled clinical trials which assessed the safety and efficacy of an ICS plus omalizumab found that the combination reduced the number of exacerbations by almost 50%.17
Quick-relief medications are ideally taken on a short-term basis to deliver fast-acting relief of bronchoconstriction and reverse acute airflow obstruction. Quick-relief medications consist of short-acting beta2-agonists (SABAs), anticholinergics, and oral or systemic corticosteroids.
SABAs are the therapy of choice for relief of acute asthma symptoms and prevention of exercise-induced bronchospasm. 5 Common SABAs, such as albuterol, levalbuterol, and pirbuterol, are bronchodilators that relax smooth muscle.
The anticholinergic agent, ipratropium bromide, provides additive benefit to SABAs in moderate-to-severe asthma exacerbations. It works by inhibiting muscarinic cholinergic receptors and reducing intrinsic vagal tone of the airway.5
Oral systemic corticosteroids are used as adjuncts to SABAs for moderate and severe exacerbations, to speed recovery and prevent recurrence of exacerbations.5
The overarching goal of improved asthma care is to decrease the morbidity and mortality associated with asthma. The NAEPP incorporates this philosophy, with a strong focus on asthma control and a recommended stepwise program of treatment based on the patient’s preference and asthma severity (Figure 2).5
Treatment Compliance
Asthma, like most chronic conditions, requires long-term adherence to treatment. Unfortunately, treatment adherence in patients with asthma is suboptimal. There are numerous reasons for noncompliance. Poor adherence to asthma treatment is not limited to patients forgetting to take their medicine. Patients may forget to take their rescue inhalant when playing outside with their children. They may not be able to remove the carpeting in their house, or avoid outdoor work during high pollen season. It has been speculated that over half of patients with asthma are not compliant with therapy.18 Barriers to adherence are numerous, and include sex, ethnicity, socioeconomic status, and age.19 In addition, psychological factors such as depression and fear of the medical community can result in poor treatment adherence. Clinicians, however, can often recognize patients at risk for not adhering to treatment and make appropriate adjustments.20
Clinicians may also not completely adhere to treatment guidelines. A report by Ohar et al noted that some clinicians are reluctant to use aspects of current guidelines for a variety of reasons.21 Some clinicians may be skeptical of newer guidelines, while others are reluctant to abandon practice traditions they feel have worked in the past. Furthermore, many patients with asthma are treated by primary care doctors who may not have the time, funding, or equipment necessary to comply fully with guidelines. The guidelines are not prescriptive, but do provide an evidence base for best practice recommendations.
Finally, insurance companies may indirectly contribute to poor guideline adherence by failing to adequately recognize the time required to educate patients on asthma and develop a partnership for success, as requested by the guidelines.
Conclusions
Asthma is a complex disease with multiple triggers of exacerbations, and it requires a comprehensive approach to maintain good control. The guidelines developed by the NAEPP provide an excellent starting point to manage patients with asthma. The guidelines are focused on controlling asthma using the minimal amount of medication. Instead of focusing solely on the pharmacologic aspects of asthma control, the guidelines place emphasis on patient education, environmental control, management, recognition and management of comorbidities,1 and frequent and adequate assessment of asthma control. Asthma management requires constant dialogue between patients and clinicians. Proper knowledge and adherence by all parties involved in the care of asthma can help minimize medical complications and costs.
Author Affiliation: Massachusetts General Hospital, Boston, MA.
Funding Source: Financial support for this work was provided by Merck & Co, Inc.
Author Disclosure: Dr. Long reports providing expert testimony for GlaxoSmithKline.
Authorship Information: Concept and design; analysis and interpretation of data; drafting of the manuscript; and critical revision of the manuscript for important intellectual content.
Address correspondence to: Aidan A. Long, MD, Massachusetts General Hospital, Cox 201, 55 Fruit St, Boston, MA 02114. E-mail: aalong@partners.org.
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