Salmeterol safety alert: use with an inhaled steroid. (Consistent with Guidelines).

Add an asthma controller--preferably an inhaled corticosteroid--to the treatment regimen of patients using salmeterol as monotherapy, salmeterol manufacturer GlaxoSmithKline said in a recent letter to prescribers.

This recommendation was made in response to the interim analysis of a safety study suggesting that salmeterol may be associated with an increased risk of asthma-related deaths or life-threatening asthma episodes.

"This is consistent with both national guidelines for optimal asthma treatment and with the trend we've seen in our interim analysis of the study data," Dr. Kathy Rickard, GSK vice-president of respiratory, clinical development, and medical affairs said in a statement. The "Dear Health Care Professional" letter also emphasized that patients taking salmeterol should not abruptly stop taking the drug without first seeing their physician, a recommendation that also was among those made by the Food and Drug Administration.

Based on the available data, the drug's benefits "for the asthma population continue to outweigh the risk, and the serious adverse events reported in the trial were rare," the FDA said in a statement.

Salmeterol, a long-acting [[beta].sub.2]-agonist marketed as Serevent Inhalation Aerosol, is approved to treat asthma in patients 12 years and older. A powder formulation is available as Serevent Diskus, which is approved for patients 4 years and older. It is also available in combination with the powder formulation of the steroid fluticasone as Advair Diskus, approved in patients 12 and older.

In January the manufacturer and the FDA announced an interim analysis of the Serevent Multicenter Asthma Research Trial (SMART), a 28-week safety study comparing 42 [micro]g of salmeterol twice a day through a metered-dose inhaler with placebo. The analysis of nearly 29,000 subjects aged 12 and over found no significant differences between the two groups in the combined number of respiratory-related deaths and respiratory-related life-threatening experiences (intubations and mechanical ventilation), the primary end points. There was a higher, but insignificant number of asthma-related life-threatening experiences and asthma-related deaths in salmeterol-treated patients. However, because the rate of primary events in the study was low, these ...