The US Food and Drug Administration posted a comprehensive review conducted by GlaxoSmithKline of its clinical and observational data that demonstrated better overall asthma control with the combination medicine Seretide/Advair (fluticasone propionate and salmeterol) than with a single medicine alone. The data also presents the well-established safety record for Seretide/Advair.

The data confirmed that Serevent (salmeterol) is effective and showed no increased risk of serious asthma-related outcomes when it was used appropriately with an inhaled corticosteroid (ICS). The risk increased when Serevent was used without an ICS, or use of an ICS could not be assured. However, current treatment guidelines recommend that both ICS and a LABA be used to treat patients with moderate to severe persistent asthma. Prescribing patterns reflect adherence to these guidelines; one survey shows salmeterol is prescribed with an ICS more than 98 per cent of the time.

Current US prescribing information advises patients to take Serevent in combination with another asthma controller medicine. To strengthen adherence to the guidelines, GSK has asked the FDA to revise the product label to direct that Serevent be used only with an inhaled corticosteroid for treating asthma. This advice is already listed in the EU label for Serevent.

The safety and efficacy data in children ages 4-11 were similar to those seen in adults and adolescents.

"These findings are consistent with current standard of care and medical guidelines for controlling asthma," said Katharine Knobil, GSK vice president for global clinical development of respiratory medicine. "Uncontrolled asthma is a significant health risk. Physicians have made great strides battling asthma through an increased understanding of the disease and optimal use of medicines to treat it. We believe the best way to continue this progress is by ensuring that doctors have access to a range of medicines to manage asthma."