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Warnings & Precautions
WARNING:
Data from a large placebo-controlled US study that compared the safety of
salmeterol (SEREVENT ® Inhalation Aerosol) or placebo added to usual asthma therapy showed a small but significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,174 patients treated for 28 weeks) versus those on placebo (4 of 13,179).
Subgroup analyses suggest the risk may be greater in African American patients compared to Caucasians (see WARNINGS). WARNINGS Text Continues Below
DATA FROM A LARGE PLACEBO-CONTROLLED SAFETY STUDY THAT WAS STOPPED EARLY SUGGEST THAT SALMETEROL, A COMPONENT OF ADVAIR DISKUS, MAY BE ASSOCIATED WITH RARE SERIOUS ASTHMA EPISODES OR ASTHMA-RELATED DEATHS. The Salmeterol Multi-center Asthma Research Trial (SMART) enrolled long-acting beta2-agonist-naive patients with asthma to assess the safety of salmeterol (SEREVENT Inhalation Aerosol) 42 mcg twice daily over 28 weeks compared to placebo, when added to usual asthma therapy. The primary endpoint was the combined number of respiratory-related deaths or respiratory-related life-threatening experiences (intubation and mechanical ventilation). Other endpoints included combined asthma-related deaths or life-threatening experiences and asthma-related deaths. A planned interim analysis was conducted when approximately half of the intended number of patients had been enrolled (N = 26,353). The analysis showed no significant difference for the primary endpoint for the total population. However, a higher number of asthma-related deaths or life-threatening experiences (36 vs. 23) and a higher number of asthma-related deaths (13 vs. 4) occurred in the patients treated with SEREVENT Inhalation Aerosol. Post hoc subgroup analyses revealed no significant increase in respiratory-or asthma-related episodes, including deaths, in Caucasian patients. In African Americans, the study showed a small, though statistically significantly greater, number of primary events (20 vs. 7), asthma-related deaths or life-threatening experiences (19 vs. 4), and asthma-related deaths (8 vs. 1) in patients taking SEREVENT Inhalation Aerosol compared to those taking placebo. Even though SMART did not reach predetermined stopping criteria for the total population, the study was stopped due to the findings in African American patients and difficulties in enrollment. The data from the SMART study are not adequate to determine whether concurrent use of inhaled corticosteroids, such as fluticasone propionate, a component of ADVAIR DISKUS, provides protection from this risk. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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