during SMART trial: Particularly in those recruited in Phase 1 Particularly among African-Americans who were noted to have markers of more severe asthma and less likely to be using ICS Increase in adverse events in salmeterol group: Due to adverse effect of salmeterol? Due to inappropriate bronchodilator use? (affected patients were more severe at baseline and less likely to be using ICS) Long-Acting 2 -Agonists (LABAs)
FDA Safety Requirements for Long- Acting 2 -Agonists (LABAs) in Asthma The use of LABAs is contraindicated without the use of an asthma controller medication such as an inhaled corticosteroid. Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone. LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications. LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication. Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications. ~ February 2010
Conclusions: Black Box warning Do not use long-acting bronchodilators alone Always use with inhaled corticosteroids Newer Data: LABAs when used with inhaled corticosteroids are helpful. Multiple reviews/meta-analyses suggest that long-acting beta-agonists + inhaled corticosteroids reduce asthma hospitalizations compared to inhaled corticosteroids alone. Emphasize the weakness of the primary data in terms of statistical strength, simply because asthma-related deaths and intubations are so rare. Rodrigo GJ, Castro-Rodriguez JA. Safety of long-acting β agonists for the treatment of asthma: clearing the air. Thorax 2012;67:342-349 . Long-Acting 2 -Agonists (LABAs)
Patients Are Candidates for Maintenance Therapy if The “RULES OF TWO”™* Apply … They are using a quick-relief inhaler more than 2 times per week They awaken at night due to asthma more than 2 times per month They refill a quick-relief inhaler Rx more than 2 times per year *“RULES OF TWO”™ is a trademark of the Baylor Health Care System.
Out of Control! Rules of Two TM If your patient can answer “YES” to ANY of these questions, his/her asthma is probably not under good control. These rules define persistent asthma.
Asthma Severity Intermittent Mild Persistent Moderate Persistent Severe Persistent
Classification of Asthma Severity Persistent Intermittent Mild Moderate Severe Components of Severity Impairment Normal FEV 1 /FVC 8-19 yr 85% 20-39 yr 80% 40-59 yr 75% 60-80 yr 70% Risk Recommended Step for Initiating Treatment Symptoms Nighttime Awakenings SABA use for sx control Interference with normal activity Lung Function Exacerbations (consider frequency and severity)
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- Summer '15