rescue medication use

RESCUE MEDICATION USE

Secondary endpoint: Daily rescue albuterol use reduced by nearly one-third compared with placebo over 24 weeks (all study treatments administered BID)1-4

Rescue medication use over 24 weeks
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  • BEVESPI AEROSPHERE is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
  • In Trial 1, mean change from baseline in daily rescue albuterol use was -0.8 puffs/day (baseline 3.2 puffs/day) over 24 weeks with BEVESPI AEROSPHERE (n=525), compared with an increase of 0.3 puffs/day with placebo (n=218) (P<0.0001)1-3†
  • Statistically significant reduction in average daily rescue medication use vs placebo was also demonstrated in Trial 21,3‡
  • Adverse reactions with BEVESPI AEROSPHERE with a ≥2% incidence and more common than placebo were urinary tract infection and cough1

*P value is based on treatment comparison of absolute mean change from baseline for BEVESPI AEROSPHERE vs placebo.2,3

†In Trial 1, mean change from baseline in daily rescue albuterol use over 24 weeks was -0.5 puffs/day (baseline 3.4 puffs/day) with glycopyrrolate 18 mcg (n=449), -0.8 puffs/day (baseline 3.4 puffs/day) with formoterol fumarate 9.6 mcg (n=446), and 0.3 puffs/day (baseline 3.4 puffs/day) with placebo (n=218) (P<0.0001 for all active treatments vs placebo).2,3

‡Trial 2 demonstrated a 31% reduction from baseline in rescue albuterol use vs placebo (P<0.0001). P value is based on treatment comparison of absolute mean change from baseline for BEVESPI AEROSPHERE vs placebo.3,4 In Trial 2, mean change from baseline in daily rescue albuterol use was -1.0 puffs/day over 24 weeks with BEVESPI AEROSPHERE (baseline 3.2 puffs/day, n=510), -0.4 puffs/day with glycopyrrolate 18 mcg (baseline 3.6 puffs/day, n=438), -0.7 puffs/day with formoterol fumarate 9.6 mcg (baseline 3.5 puffs/day, n=437), and 0.0 puffs/day with placebo (baseline 3.9 puffs/day, n=223)(P<0.01 for all active treatments vs placebo).3,4

References: 1. BEVESPI AEROSPHERE [Package Insert]. Wilmington, DE: AstraZeneca; 2016. 2. Data on File, 3236300, AZPLP. 3. Martinez FJ et al. Chest. 2017;151(2):340-357. 4. Data on File, 3236400, AZPLP.