Representing a major revision, the rules say you should take into account both underlying disease and responsiveness to treatment.
Since 1993, the Global Initiative for Asthma (GINA) has issued periodic treatment guidelines, with yearly updates to incorporate new research findings. The most recent Global Strategy for Asthma Management and Prevention, which was released last November, represents a major revision that embodies a fundamental change in approach: While earlier versions recommended treatment on the basis of asthma severity—intermittent and mild, moderate, and severe persistent—the latest revision emphasizes degree of control.
The shift grows out of a recognition that severity may change over time. A more clinically relevant stratification also takes into account both underlying disease and responsiveness to treatment.
“Is the patient sleeping through the night? Has he had to use his rescue inhaler every day? Is he able to carry out the activities of daily life? Based on the patient’s responses, the clinician will step up treatment, leave it unchanged, or step it down. This approach is more consistent with how primary-care clinicians actually practice,” comments Jeffrey M. Drazen, MD, professor of medicine at Harvard Medical School in Boston, editor-in-chief of The New England Journal of Medicine, and a member of the GINA science committee that wrote the guidelines.
A new approach
This focus on severity, according to the guidelines’ authors, is emphasized throughout the new document and reflects pharmacologic advances that have made essentially normal lives a reasonable expectation for the vast majority of patients coping with asthma.
The guidelines define full control as:
• Daytime symptoms no more than twice a week
• No limitations of daily activities, including exercise
• No nocturnal symptoms or awakenings
• Reliever treatment needed no more than twice a week
• Normal or near-normal lung-function tests
• No exacerbations
Within this model, management is presented as a dynamic process in which assessment guides treatment, and control is monitored in a continuous cycle. The guidelines stress that increased use of reliever (rescue) medications (especially on a daily basis) is a warning of deteriorating control.
As earlier, assessment of lung function by spirometry and peak expiratory flow is a keystone of diagnosis and monitoring. New prominence, however, is given to variability in these parameters, determined by a history that may rely to some extent on home measurement. “A number in the lab is not as sensitive as change over time,” Dr. Drazen observes.
The degree to which measures of lung function fluctuate in the course of a day, from month to month, or from season to season, is now regarded as an important index of disease severity. Fluctuations also play an important role in clinical decisions and in determining the need for further investigation, such as airway-responsiveness testing.
An active partnership
The 2006 revision gives new prominence to developing a patient/clinician partnership, treating it as a major component of management. Of course, reducing exposure to risk factors and step-based treatment remain important. The aim of the partnership is a program of “guided self-management” through which patients can control their own condition under professional supervision.
The guidelines emphasize education to prepare patients with asthma for their more active role: This includes information on various medications and training in their use as well as strategies for preventing symptoms and attacks. Patients participate in the development of a written action plan and help execute it by monitoring their own lung function and symptoms, adjusting medication when necessary, and seeking appropriate medical assistance.
The guidelines recognize that asthma management is chiefly the province of primary-care clinicians. “But referral is indicated if the patient has to be on two controller medications and asthma is still not in excellent control,” Dr. Drazen says.
Within the step schema (see algorithm), the guidelines set forth preferred and other drug options.
A fast-acting beta2-agonist bronchodilator is the as-needed reliever medication of choice, recommended as monotherapy at step 1 and as part of the regimen for all the other steps.
An inhaled glucocorticosteroid is the first-line controller medication when one is needed. Leukotriene receptor antagonists and synthesis inhibitors provide an alternative controller monotherapy, particularly for individuals who do not want to use inhaled glucocorticosteroids or cannot tolerate them. These immune modulators are also recommended as an add-on that may make it possible to achieve fuller control with an inhaled glucocorticosteroid or to reduce the dose.
The greater prominence of leukotriene modifiers represents a change from earlier guidelines, reflecting the weight of data showing that they effectively reduce symptoms, airway inflammation, and exacerbations and improve lung function, albeit less so than inhaled glucocorticosteroids.
At the same time, the new guidelines reduce the role of two other drug classes: long-acting beta2 agonists and cromones (sodium cromoglycate and nedocromil sodium). They em-phasize that the former are not to be prescribed except with a glucocorticosteroid, because of reports of exacerbations and increased mortality in some patients. (The FDA and Health Canada have issued advisories to the same effect.) Long-acting beta2 agonists remain the add-on medication of choice when an inhaled glucocorticosteroid alone fails to achieve control. The guidelines note that inhalers delivering this combination have been shown to be as effective as separate applications and may improve compliance.
Cromones are no longer recommended as an alternative to low-dose inhaled glucocorticosteroids. Moreover, the use of cromones in adults is limited. These agents can be an alternative to rapid-acting beta2-agonist bronchodilators to relieve or prevent exercise-induced asthma.
The notion of “difficult-to-treat” asthma is formally discussed for the first time in the 2006 guidelines. Under this heading fall patients whose symptoms are not adequately controlled even with two or more controller medications. Since many treatment-resistant individuals are partly, but not entirely, nonresponsive to glucocorticosteroids, these drugs usually continue to be a mainstay of treatment.
In addition, the guidelines emphasize the importance of confirming the diagnosis; considering comorbidities, such as chronic sinusitis, gastroesophageal reflux, and obesity/sleep apnea; investigating medication compliance; and rigorously counseling cessation for patients who still smoke.
The Global Initiative for Asthma’s 2006 Global Strategy for Asthma Management and Prevention is available online at: www.ginasthma.org/Guidelineitem.asp??l1=2&l2=1&intId=60 (Accessed April 13, 2007).