Journal Top Ten, Columns-Drugs & Supplements, November 2005

ARTICLE: 'Misleading data analyses in salmeterol (SMART) study'

JOURNAL: The Lancet. 2005; 366:1261-1262

BACKGROUND: In 1996, due to reports of paradoxical bronchospasm associated with the use of GlaxoSmithKline's salmeterol, and previous epidemics of asthma-related deaths in patients taking other long-acting b agonists, the company initiated a trial comparing salmeterol (Serevent, known as Advair when combined with the steroid fluticasone) to placebo. The results have never been published. The authors only know the results of this study because the drug came before the FDA's Pulmonary-Allergy Drugs Advisory Committee on July 13.