THE NHLBI GUIDELINES: WHERE DO WE STAND AND WHAT IS THE NEW DIRECTION FROM THE NAEPP?

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1 THE NHLBI GUIDELINES: WHERE DO WE STAND AND WHAT IS THE NEW DIRECTION FROM THE NAEPP? Peter S. Creticos, MD ABSTRACT In 1991 and 1997, the National Heart, Lung, and Blood Institute s National Asthma Education and Prevention Program (NAEPP) issued guidelines for the diagnosis and management of asthma. Results of the Asthma in America study, a nationwide survey conducted in 1998, demonstrate that despite the availability of these guidelines and widespread education about them, asthma care in the United States is suboptimal. This is particularly worrisome in view of the availability of effective therapies that can control asthma in the majority of patients. In efforts to address the shortcomings in asthma care in the United States and to ensure that the guidelines reflect the most recent research, the NAEPP updated the guidelines in This paper reviews the 1997 NAEPP guidelines, describes 1998 data on the state of care of asthma in the United States, and discusses the 2002 updated guidelines, intended to improve asthma management. (Advanced Studies in Medicine. 2002;2(14): ) In 1991 and 1997, the National Heart, Lung, and Blood Institute s (NHLBI s) National Asthma Education and Prevention Program (NAEPP) issued guidelines for the diagnosis and management of asthma. 1,2 The guidelines were developed to assist clinicians in understanding the rapidly growing field of knowledge about asthma and implementing the best asthma-management methods in their clinical practices. However, results of a nationwide survey conducted in 1998 demonstrate that, the availability of the guidelines and widespread education about them notwithstanding, asthma care in the United States is suboptimal. 3 In efforts to address the shortcomings in asthma care in the United States and to ensure that the guidelines take into account the most recent research, the NAEPP updated the guidelines in Although the 2002 update retains most of the elements of the 1997 guidelines, key modifications have been made in the areas of medication use, asthma monitoring, and asthma prevention. Complete versions of both the 1997 guidelines and the 2002 update are available online. 2,4 THE ASTHMA IN AMERICA STUDY: THE STATUS OF ASTHMA MANAGEMENT VIS-Á-VIS NAEPP GUIDELINES The 1997 NAEPP guidelines establish several goals of asthma care and outline practical means of achieving these goals. The goals of asthma care include: Address correspondence to: Peter S. Creticos, MD, Johns Hopkins Asthma and Allergy Center, 5501 Hopkins Bayview Circle, Room 2B.57, Baltimore, MD Prevention of both chronic and troublesome symptoms; Maintenance of (nearly) normal pulmonary function; Advanced Studies in Medicine 499

2 Provision of optimal pharmacotherapy with minimal or no adverse effects; Maintenance of normal activity levels; Prevention of recurrent exacerbations and minimization of the need for emergency-department visits or hospitalizations; and Fulfillment of patients and families expectations of asthma care. 2 In 1998, the Asthma in America survey was conducted to examine the state of asthma care in the United States relative to these NAEPP goals. 3 The survey differed from past survey research in asthma in its comprehensiveness: data were obtained by screening a nationally representative sample of more than US households and reflected the views of both healthcare providers (512 physicians, 101 nurses, 113 pharmacists) and patients with asthma (n = 2509, including 721 parents of children with asthma) as well as a comparison group of nonasthmatic individuals from the general adult population (n = 1000). [Nancy Sander, President, Allergy and Asthma Network/Mothers of Asthmatics, and Dr Scott Weiss, asthma expert and epidemiologist, Brigham and Women s Hospital, Harvard Medical School, and Harvard School of Public Health, served as advisors to the project.] The Asthma in America survey posed several questions designed to address the issue of whether the NAEPP goals of maintenance of near-normal lung function and the prevention of symptoms are being met. Results of the survey show that use of inhalers for quick relief, a practice that reflects poor control of asthma, is pervasive across the spectrum of asthma severity. At least once-daily use of inhalers for quick relief was reported by 25% of patients with mild intermittent asthma; 1 in 3 patients with mild persistent asthma; more than one half of patients with moderate persistent asthma; and three quarters of patients with severe persistent asthma (Figure 1). 3 That these patients asthma was poorly controlled is also reflected in the additional finding that 38% of patients met National Institutes of Health criteria for moderate persistent asthma or severe persistent asthma. [The criteria for moderate persistent asthma include daily symptoms with concomitant use of short-acting bronchodilators and exacerbations that affect activity and occur at least twice weekly, whereas the criteria for severe persistent asthma include continual symptoms, limited physical activity, and frequent exacerbations.] The finding that asthma prevented many patients from engaging in normal daily activities is consistent with these asthma-severity data and demonstrates that another NAEPP goal of asthma care maintenance of normal activity levels is generally not being met. One quarter of adults reported missing work, and one half of children reported missing school because of asthma during the year before the Asthma in America survey. Significant proportions of patients also reported functional impairment in other areas ranging from sports/recreation to lifestyle and sleep (Figure 2). 3 Twenty-four percent of adults indicated that their choice of job or career was influenced by asthma. Similar to these findings showing the substantial impact of asthma on patients daily activities, the data on patients use of healthcare services as a result of asthma also suggest that asthma is debilitating for many patients, and that the NAEPP goals of preventing recurrent exacerbations and minimizing need for emergency visits are not being met. The proportions of patients who reported using healthcare services for asthma during the year before the survey Figure 1. Percentage of Patients Reporting Use of an Inhaler at Least Once Daily for Quick Relief in the Asthma in America Survey Data from the Asthma in America Survey Vol. 2, No. 14 September 2002

3 were 41% for urgent-care visits, 23% for emergency-department visits, 29% for unscheduled office visits, and 9% for hospitalizations UPDATE OF THE NAEPP GUIDELINES Figure 2. Percentage of Patients Reporting Activity Restriction in the Asthma in America Survey These highlights of data from the Asthma in America survey establish that, as of 1998, the NAEPP goals of asthma management were unfulfilled for many patients. In 2002, the NAEPP modified the 1997 guidelines in an attempt to improve this state of affairs and to accommodate new data on optimal means of managing asthma. 4 The NAEPP based their revision on a systematic evaluation and grading of the medical literature as reviewed by the Agency for Healthcare Research and Quality Evidence Practice Center. The 2002 revision updates the recommendations in the areas of medication use, asthma monitoring, and asthma prevention. MEDICATION USE The pathophysiologic importance of both inflammation and smooth muscle dysfunction (with resultant bronchial hyperreactivity) in asthma is well established. That importance is reflected in the NAEPP working definition of asthma:...asthma is...defined as a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role...in susceptible individuals, this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness, and cough, particularly at night and in the early morning. These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment. The inflammation also causes an associated increase in the existing bronchial hyperresponsiveness to a variety of stimuli. 2 Airway inflammation, the first pathophysiologic component of asthma, is characterized by activation and accumulation of inflammatory cells and edema and causes damage to the airway epithelium and thickening of the airway basement membrane (Figure 3). 5 Smooth muscle dysfunction, the second pathophysiologic component of asthma, can lead to bronchoconstriction, bronchial hyperreactivity, and smooth muscle hypertrophy and hyperplasia. Data from the Asthma in America Survey. 3 Figure 3.The Pathophysiologic Components of Asthma Advanced Studies in Medicine 501

4 The 1997 NAEPP guidelines noted the importance of addressing both of these pathophysiologic components with respect to the pharmacotherapy of asthma and indicated that, particularly in patients with severe persistent asthma, pharmacotherapeutic interventions need to address both inflammation and bronchial obstruction to be most effective. 2 Based on new data, the 2002 revision strengthened this recommendation and indicated that combination therapy incorporating the use of an inhaled corticosteroid, to address airway inflammation, and a long-acting inhaled beta-2 agonist, to combat the smooth muscle dysfunction, provides the optimal therapeutic approach and is therefore recognized as the preferred treatment regimen for patients with moderate persistent asthma. 4 The NAEPP...recommendations for moderate persistent asthma have been revised: The preferred treatment for adults and children over 5 years of age is the addition of long-acting inhaled beta-2 agonists to low-to-medium doses of inhaled corticosteroids. 4 The 2002 revision indicated that there is no evidence that adding an antibiotic to standard care regimens for asthma improves outcomes and reinforced the 1997 view that antibiotics are not recommended for the treatment of acute asthma exacerbations except as needed for comorbid conditions (eg, pneumonia, bacterial sinusitis). Besides reinforcing the importance of combination anti-inflammatory/bronchodilator therapy in patients with persistent asthma, the 2002 revision addressed use of inhaled corticosteroids in children. 4 The NAEPP revision strongly endorsed the use of inhaled corticosteroids over other pharmacotherapies, including cromolyn, nedocromil, theophylline, and leukotriene modifiers, in children on the basis of strong evidence from well-controlled clinical trials. This recommendation constitutes a significant change from the 1997 guidelines, which listed several pharmacotherapies as options for initial therapy in children. In this context, the 2002 guidelines recommend inhaled corticosteroids as the preferred treatment for all levels of persistent asthma and do not distinguish among the alternative therapies. Furthermore, adding to the 1997 recommended indications for use of longterm controller therapy in children, the NAEPP recommended that initiation of long-term controller therapy with inhaled corticosteroids be considered in infants and young children with more than 3 episodes of wheezing that lasted more than 1 day and that affected sleep in the past year. Finally, the NAEPP addressed concerns about possible systemic effects of inhaled corticosteroids in children. They concluded that at recommended doses, inhaled corticosteroids do not clinically significantly affect outcomes such as vertical growth, bone mineral density, or the hypothalamic-pituitary-adrenal axis in children. This conclusion was based on strong evidence accumulated from clinical trials in which children treated with inhaled corticosteroids were observed for up to 6 years. ASTHMA MONITORING The 1997 NAEPP guidelines recommended use of a written action plan to aid in managing asthma and monitoring outcomes. 2 Although the NAEPP concluded in the 2002 revision that data are insufficient to establish the benefits of a written action plan versus medical management alone, they did not change their 1997 recommendation that a written action plan be used, particularly for those with moderate or severe persistent asthma and patients with a history of severe exacerbations. 4 ASTHMA PREVENTION In addition to the possible benefit of written action plans, another question that remains unresolved is whether inhaled corticosteroids or other asthma pharmacotherapies can prevent progression of asthma as reflected in changes in lung function or severity of symptoms. In the 2002 revision, the NAEPP panel concluded that evidence is insufficient to draw conclusions about the possible benefits of initiating treatment early in the course of disease regarding the progression of asthma. 4 However, insight into this issue should be gained from various long-term studies of airway remodeling that are currently under way. CONCLUSION The 1998 data from the Asthma in America survey reveal several areas in which asthma care in the United States is suboptimal. This state of affairs is particularly worrisome in the context of the availability of effective therapies that can control asthma in the overwhelming majority of patients. The 2002 revision to the NAEPP guidelines critically addresses several of the recognized shortfalls in asthma care. However, it is essential that these recommendations be translated into day-to-day clinical practice. The 2002 revision emphasizes the 502 Vol. 2, No. 14 September 2002

5 importance of dual-controller therapy with both antiinflammatory and bronchodilating properties for persistent asthma and reinforces the favorable risk-benefit ratio of inhaled corticosteroids in children. REFERENCES 1. National Asthma Education and Prevention Program. Guidelines for the Diagnosis and Management of Asthma. Bethesda, Md: US Department of Health and Human Services, National Institutes of Health; NIH publication National Asthma Education and Prevention Program. Guidelines for the Diagnosis and Management of Asthma. Bethesda, Md: US Department of Health and Human Services, National Institutes of Health; NIH publication Available at: guidelines/asthma. Accessed August 15, Asthma in America survey. Available at: Accessed July 18, National Asthma Education and Prevention Program. Guidelines for the Diagnosis and Management of Asthma Update on Selected Topics Bethesda, Md: US Department of Health and Human Services, National Institutes of Health; NIH publication Available at: asthma. Accessed August 15, Creticos PS. Best-practice strategies for management of asthma: monitoring and prevention of asthma exacerbations. Adv Stud Med. 2002;2: Advanced Studies in Medicine 503