SMART
Salmeterol Multicenter Asthma Research Trial
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 26,355 patients with asthma, salmeterol added to usual care increased respiratory-related and asthma-related mortality compared with placebo plus usual care.
N
26 355
Schéma
Multicentre RCT, USA
Critère
Respiratory- and asthma-related death/life-threatening event
Pertinence
1
RésultatRespiratory deaths 24 vs 11 (RR 2.16); asthma deaths 13 vs 3. Excess concentrated in African-Americans and ICS-naïve patients.
Nelson HS, et al. Chest. 2006;129(1):15-26. 10.1378/chest.129.1.15
Discussion et critique
Triggered the FDA LABA black-box warning and the modern rule that LABAs must be combined with ICS in asthma.