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Patients taking long-acting beta2
agonists should also be taking inhaled steroids, and should be monitored closely for therapeutic response in the early months of treatment.
Prescribers were previously reminded1 to follow the British Thoracic Society (BTS) guidelines for the treatment of asthma2. The final results from the Salmeterol Multi-Centre Asthma Research Trial (SMART), conducted in the United States, showed that patients who did not use inhaled corticosteroids with salmeterol had a higher incidence of asthma-related adverse events than patients who did use inhaled corticosteroids with salmeterol, particularly African-American patients.
The main findings of the SMART study for the primary endpoint of combined respiratory-related death or life threatening experience are summarised in the table below. It is not possible to rule out similar concerns for formoterol.
Main findings from the SMART study
| Patient group | Number of primary endpoint events /number of patients | Relative Risk (95% confidence intervals) |
|
|---|---|---|---|
| salmeterol | placebo | ||
| All patients | 50/13,176 | 36/13,179 | 1.40 (0.91, 2.14) |
| Patients using inhaled steroids | 23/6,127 | 19/6,138 | 1.21 (0.66, 2.23) |
| Patients not using inhaled steroids | 27/7,049 | 17/7,041 | 1.60 (0.87, 2.93) |
| African-American patients | 20/2,366 | 5/2,319 | 4.10 (1.54, 10.90) |
Prescribers are reminded that:
• patients given salmeterol or formoterol should always be prescribed an inhaled corticosteroid
• patients with acutely deteriorating asthma should not be initiated on salmeterol or formoterol
• patients should be monitored closely during the first 3 months of treatment.
It is not clear if underlying genetic variations are responsible for the differences observed between African-American and Caucasian patients, in this study and whether these results are relevant to the UK population.
1. Current Problems in Pharmacovigilance Volume 30 (pages 1-10) September 2003
2. BTS/SIGN, Management of Asthma. A national clinical guideline. Thorax 2003; 54 (suppl 1 ): 1-94 (updated Nov 2005)
Questions and answers: safety of Long-Acting Beta-Adrenoceptor agonists (formoterol and salmeterol) in the treatment of asthma. 
