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The long-acting beta-agonist controversy: A clinical dilemma

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The Food and Drug Administration approved new safety labeling on March 2, 2006 for medication containing salmeterol, a long-acting -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 ∼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.
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Keywords: ADVERSE REACTION; ASTHMA MORTALITY; DEATH; FATAL ASTHMA; FORMOTEROL; LONG-ACTING BETA AGONIST; PROBLEM-BASED LEARNING; SALMETEROL

Document Type: Review Article

Affiliations: 1: Allergy/Immunology Section, Department of Pulmonary, Allergy, and Critical Care Medicine, Cleveland Clinic Foundation, Cleveland, Ohio 2: Division of Allergy and Pulmonary Medicine, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis, Missouri

Publication date: 2007-03-01

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  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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