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Related Experiment Videos

Long-acting beta2-agonists in asthma: not so SMART?

Graeme P Currie1, Daniel K C Lee, Brian J Lipworth

  • 1Department of Respiratory Medicine, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK. graeme.currie@nhs.net

Drug Safety
|July 29, 2006
PubMed
Summary

The SMART study found that adding long-acting beta2-agonists (LABAs) to inhaled corticosteroids increased asthma-related deaths. This highlights risks of regular LABA use in persistent asthma patients.

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Area of Science:

  • Pulmonology
  • Pharmacology
  • Clinical Trials

Background:

  • Asthma is a chronic respiratory disease characterized by airway inflammation and hyper-responsiveness.
  • Inhaled corticosteroids (ICS) are foundational for managing inadequately controlled asthma.
  • Many patients remain symptomatic despite ICS, necessitating add-on therapies.

Purpose of the Study:

  • To evaluate the efficacy and safety of add-on salmeterol therapy in patients with persistent asthma.
  • To assess the impact of long-acting beta2-adrenoceptor agonists (LABAs) as a second-line treatment.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial (SMART study) was designed to enroll 60,000 asthma patients.
  • Participants received either add-on salmeterol or placebo alongside their existing inhaled corticosteroid therapy.

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  • The study was designed for a 28-week duration but was halted prematurely.

    • Main Results:

    • Preliminary data indicated an increased risk of mortality associated with the regular use of salmeterol.
    • A concerning incidence of respiratory-related deaths, asthma-related deaths, and life-threatening events was observed, particularly in African American participants.
    • The study's premature termination was prompted by these safety concerns.

    Conclusions:

    • Regular use of long-acting beta2-agonists (LABAs) in persistent asthma may carry a small but significant risk of asthma-related deaths.
    • The findings led to FDA safety communications and revised labeling for LABA-containing inhalers.
    • This review highlights potential drawbacks of LABA use in managing persistent asthma.