control was achieved and maintained, to minimize exposure to LABA1. ⢠Recent results from a 26-week double-blind randomized controlled trial of 11,729.
P871
Serious Asthma Outcomes and Asthma Exacerbations With Maintenance on Inhaled Corticosteroid (Mometasone Furoate)/Long-Acting Beta Agonist (Formoterol) Combination Compared With Step Down to Mometasone Monotherapy •• Historical safety concerns with use of long-acting beta agonists (LABAs) in asthma led to a regulatory directive by the United States Food and Drug Administration (FDA) to include a black box warning about serious asthma outcomes, including death, for all LABA-containing products1 •• This black box warning also advised prescribers to step down from inhaled corticosteroid (ICS)/LABA combination therapy to ICS monotherapy once asthma control was achieved and maintained, to minimize exposure to LABA1 •• Recent results from a 26-week double-blind randomized controlled trial of 11,729 asthmatics ≥12 years of age demonstrated that the combination of mometasone furoate and formoterol (MF/F) compared with mometasone (MF) alone did not pose a significantly greater risk of serious asthma outcomes (SAOs) and also reduced the risk of asthma exacerbation (AEX)2 –– SAOs included hospitalizations, intubations, and deaths adjudicated as asthma related –– AEX included hospitalizations ≥24-hour stay, emergency visits 64
258 (6.1) 3326 (78.6) 647 (15.3)
270 (6.4) 3319 (78.7) 627 (14.9)
Females — no. (%)
2750 (65.0)
2822 (66.9)
Race subgroup of interest — no. (%) Black Non-black
Incoming Treatment → Received Treatment
303 (7.2) 3927 (92.8)
258 (6.1) 3958 (93.9)
Time to First Serious Asthma Outcome – Asthma-Related: Hospitalization, Intubation, and Death
