SMART
Trial question
What is the effect of salmeterol plus usual pharmacotherapy in patients with asthma?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
63.0% female
37.0% male
N = 26355
26355 patients (16671 female, 9684 male).
Inclusion criteria: patients > 12 years of age with asthma.
Key exclusion criteria: pregnancy, high-risk significant systemic disease, history of adverse reaction to sympathomimetic amine drug, or current use of β-blockers.
Interventions
N=13176 salmeterol (42 mcg twice a day via metered-dose inhaler plus usual pharmacotherapy).
N=13179 placebo (placebo metered-dose inhaler twice a day plus usual pharmacotherapy).
Primary outcome
Respiratory-related deaths or life-threatening experiences
0.38%
0.27%
0.4 %
0.3 %
0.2 %
0.1 %
0.0 %
Salmeterol
Placebo
No significant
difference ↔
No significant difference in respiratory-related deaths or life-threatening experiences (0.38% vs. 0.27%; RR 1.4, 95% CI 0.91 to 2.14).
Secondary outcomes
Borderline significant increase in respiratory-related deaths (0.18% vs. 0.08%; RR 2.16, 95% CI 1.06 to 4.41).
Borderline significant increase in asthma-related deaths (0.1% vs. 0.02%; RR 4.37, 95% CI 1.25 to 15.34).
Borderline significant increase in asthma-related death or life-threatening experiences (0.28% vs. 0.17%; RR 1.71, 95% CI 1.01 to 2.89).
Safety outcomes
No significant difference in serious adverse events.
Significant difference in survival rate in relation to time to the first serious adverse event causing discontinuation (95.61% vs. 96.18%).
Conclusion
In patients > 12 years of age with asthma, salmeterol was not superior to placebo with respect to a respiratory-related deaths or life-threatening experiences.
Reference
Nelson HS, Weiss ST, Bleecker ER et al. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006 Jan;129(1):15-26.
Open reference URL