Severe Asthma Research - April 2016
Christina E Ciaccio, MD, MSc
Assistant Professor of Pediatrics
University of Chicago Medicine
Comer Children’s Hospital
Chicago, Illinois, United States
Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone.
The safety of both short acting beta agonists (SABAs) and long acting beta agonists (LABAs) has been debated over the years. In response to a 2006 study, examining the safety of LABA without addressing concurrent use of inhaled corticosteroids, the FDA placed a black box warning on all medications containing a LABA. In this study, investigators aimed to determine if the risk of serious asthma related events are higher when salmeterol is used concomitantly with fluticasone compared to fluticasone alone. This multicenter trial enrolled asthmatics ages 12 and up between 2011 and 2015 for 26 weeks. Just under 12,000 patients were randomized at 694 centers. In all, 67 patients had 74 serious asthma-related events (36 events in 34 patients in the fluticasone-salmeterol group vs. 38 events in 33 patients in the fluticasone group). There were no asthma-related deaths in either group. The hazard ratio was 1.03 showing fluticasone-salmeterol was noninferior to fluticasone (p=0.003). The risk of a severe asthma exacerbation was lower in the fluticasone-salmeterol group (hazard ratio, 0.79). The authors of this study, therefore, concluded that asthmatics who receive salmeterol in combination with fluticasone did not have a significantly higher risk of serious asthma-related events than those who received fluticasone alone. Although long suspected, this important study strongly supports the continuation of current severe asthma practices.
Stempel DA, Raphiou IH, Kral KM, Yeakey AM, Emmett AH et al. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. The New England Journal of Medicine 2016; published online ahead of print, March 6. (doi:10.1056/NEJMoa1511049)