Long-Acting Beta agonists and their relation to increased Asthma Morbidity and Mortality. The FDA Meta-Analysis

Abstract

When long-acting beta-agonists (LABA) were initially introduced overseas, salmeterol was compared head to head with albuterol in a randomized, double blind study over 16 weeks (1) in addition to usual asthma care. There was a 3fold greater probability of death with the use of salmeterol (12/16,787) compared to albuterol (2/8,393). This outcome comparison did not reach statistical significance and the results did not address the issue of the use of inhaled steroids as background treatment with LABA. In the U.S. the FDA requested GlaxoSmithKline obtain more data related to its product salmeterol, sold as Serevent or Advair and this resulted in the SMART study.