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ICS-LABA Safety Studies in Asthma: An Update

Camargo CA.

Respiratory Drug Delivery 2014. Volume 1, 2014: 49-60.

Abstract:

Since 1997, asthma guidelines have recommended that clinicians avoid long-acting beta-agonist (LABA) monotherapy for both efficacy and safety reasons; when LABAs are used in the long-term management of asthma, they should always be used in combination with an inhaled corticosteroid (ICS). Indeed, the vast majority of United States (US) asthma patients use LABA only in conjunction with ICS. Nevertheless, lingering concerns that LABA therapy might increase risk of fatal asthma led the US Food and Drug Administration (FDA) in 2011 to mandate five post-market safety trials. Together, the trials will randomly allocate >50,000 patients with moderate persistent asthma to six months of treatment with ICS-LABA versus ICS only; results are expected in 2017. Although the safety signal has revolved around fatal asthma, the FDA expanded the primary end point of the mandated trials to a composite end point (asthma-related death, intubation, and hospitalization) that will be dominated by hospitalizations. Large observational studies offer an alternative approach to this research question but they also are challenging due to the rarity of asthma mortality. Indeed, while the search for answers continues, sales of ICS-LABA combination inhalers remain high and asthma mortality continues to decline.