The U.S. Food and Drug Administration (FDA) yesterday announced that an interim analysis of a large safety study of the approved asthma drug salmeterol xinafoate (Serevent Inhalation Aerosol) suggests that the drug may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths, particularly in some patients.
At the same time, the drug’s manufacturer, GlaxoSmithKline, notified investigators that it is stopping this study, mostly due to difficulties in enrollment and the likelihood the study would not give a clear result, even if fully enrolled. The interim analysis did not show a statistically significant result for the primary endpoint a combination of respiratory-related deaths or intubations (or ventilatory failure). There was a trend, however, toward increases in asthma deaths and serious asthma episodes when all patients in the study were considered, though again this did not reach statistical significance.
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