Risk of Life-Threatening Asthma Seen With Salmeterol

August 19, 2003

Medscape Staff Report

Aug. 19, 2003 — New safety information and warnings have been added to the labeling for drug products that contain salmeterol, a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease (COPD), according to a U.S. Food and Drug Administration (FDA) Talk Paper released last week. The new labeling includes a boxed warning about a small, but significant, increased risk of life-threatening asthma episodes or asthma-related deaths observed in patients taking salmeterol in a recently completed large U.S. safety study.

In January, GlaxoSmithKline halted a trial of salmeterol, the Salmeterol Multi-center Asthma Research Trial (SMART), which compared the effects of salmeterol (Serevent Inhalation Aerosol, 42 µg twice daily) with placebo in patients with asthma for a period of 28 weeks. The preliminary results of an interim analysis showed an increased risk of life-threatening adverse events in those treated with the drug compared with placebo.

The trial showed a higher number of asthma-related deaths (13 vs. 4), and a higher number of asthma-related deaths or life-threatening experiences (36 vs. 23) in the salmeterol group compared with placebo. The SMART study was not prospectively designed to analyze differences in outcome based on demographic characteristics; however post-hoc subgroup analyses based on race and ethnicity were conducted. These analyses showed no increase in respiratory- or asthma-related events among white patients; but among African-American patients there was a statistically significant increase in primary events (respiratory-related death of life-threatening experience) in the salmeterol group (20 vs. 7). In addition, the occurrence of asthma-related death (8 vs. 1) and asthma-related death or life-threatening experience (19 vs. 4) was statistically significantly greater in African-American patients treated with salmeterol compared with placebo.

According to the FDA, "the benefits of treatment with salmeterol in patients with asthma and COPD continue to outweigh the potential risks when used according to the instructions contained in the product labeling."

Reviewed by Gary D. Vogin, MD

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