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Evidence-Based Medicine 2006;11:139; doi:10.1136/ebm.11.5.139
Copyright © 2006 by the BMJ Publishing Group Ltd.

Therapeutics

Addition of salmeterol to usual asthma pharmacotherapy may increase respiratory related deaths or life threatening experiences

Nelson HS, Weiss ST, Bleecker ER, et al. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 2006;129:15–26.[Abstract/Free Full Text]

Q In patients with asthma, is the addition of salmeterol to usual pharmacotherapy safe?

Clinical impact ratings GP/FP/Primary care *****{star}{star} Allergy & immunology ******{star} Respirology ******{star}

Key Words: asthma • glucocorticoids • adrenergic beta-agonists • albuterol • 46 • 210

The first 150 words of the full text of this article appear below.

METHODS

Formula Design: randomised placebo controlled trial (Salmeterol Multicenter Asthma Research Trial [SMART]).

Formula Allocation: {concealed}*.{dagger}

Formula Blinding: blinded (patients, healthcare providers, {data collectors}*, outcome assessors, and {data analysts}*).{dagger}

Formula Follow up period: 28 weeks.

Formula Setting: 6163 sites in the US.

Formula Patients: 26 355 patients >=12 years of age (mean age 39 y, 63% women) who were diagnosed with asthma and currently receiving prescription asthma medication. Exclusion criteria included previous use of inhaled long acting ß2 agonists and history of adverse reactions to sympathomimetic amine drugs.

Formula Intervention: salmeterol, 42 µg, twice daily (on arising and before bed) by metered dose inhaler (MDI) (n = 13 176) or placebo (n = 13 179) for 28 weeks. All patients continued use of current asthma medications.

Formula Outcomes: composite primary end point was respiratory related death or life threatening experience (ie, intubation and mechanical ventilation); secondary end points included all cause death, asthma related death, respiratory . . . [Full text of this article]

Randolph J Lipchik, MD

Medical College of Wisconsin,
Milwaukee, Wisconsin, USA


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