title: The long-acting beta-agonist controversy: a clinical dilemma.
abstract: The Food and Drug Administration approved new safety labeling on March 2, 2006 for medication containing salmeterol, a long-acting beta-agonist (LABA), because of data suggesting an increased risk of fatal or potentially fatal asthma episodes. The "black box" warning, public health advisory, and label change for salmeterol, salmeterol-fluticasone combination, and formoterol has heightened public and physician concern over the risk-to-benefit ratio and the medicolegal implications of prescribing these agents for patients with asthma. A problem-based learning (PBL) case was presented to several breakout groups at the Eastern Allergy Conference, May 6, 2006, in Naples, FL, focusing on the LABA controversy in the context of an actual patient. The consensus of opinion during the interactive group sessions among approximately 100 allergists was that (1) the patient had poorly controlled asthma on inhaled corticosteroid (ICS) monotherapy and that warranted a change of therapy; (2) each physician must choose which option presents the best benefit-to-risk ratio after a thorough and open discussion with the patient; (3) of the several choices for step-up therapy when a patient is not well controlled on an ICS alone, the best choice based on current evidence is combined ICS plus LABA. After the PBL case discussion, a didactic lecture was presented describing the evidence pertaining to the LABA controversy, which is detailed in this article.
authors.affiliation: Allergy/Immunology Section, Department of Pulmonary, Allergy, and Critical Care Medicine, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. langd@ccf.org
authors.forename: David M
authors.initials: DM
authors.lastname: Lang
authors.forename: Ray S
authors.initials: RS
authors.lastname: Davis
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000318:Adrenergic beta-Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D000420:Albuterol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000401:mortality; D002908:Chronic Disease; D004334:Drug Administration Schedule; D004348:Drug Labeling; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D018794:Problem-Based Learning; D018570:Risk Assessment; D000068299:Salmeterol Xinafoate; D012720:Severity of Illness Index; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D000068299:Salmeterol Xinafoate; D000420:Albuterol