In 2006, it was decided to add warnings similar to those made by the FDA to product labelling of LABA compounds in Germany, too. In Germany, the national drug regulatory authority (“BfArM”) published in August 2003 a statement presenting results of the SMART trial and pointing out the need for a guideline-adherent treatment. In 2005, information for health care providers were sent out by the FDA stating that LABA should be prescribed to asthma patients only if other medicines, including low-or-medium dose ICS, do not control asthma and a ‘Black box’ warning on LABA was imposed by the FDA. After presentation of SMART results to the public, an intensive and somewhat controversial discussion occurred between the stakeholders. In 2003, “Dear doctor” letters were sent out by GlaxoSmithKline and detailed results of the SMART trial were added to the respective SPCs of LABA-containing products. Regarding these results as well as previously and recently published guidelines, LABA should be prescribed only to patients receiving ICS. In contrast, if ICS was present at baseline no significant differences between patients receiving salmeterol or placebo were found. Furthermore, a significantly increased risk for “combined respiratory-related death or life-threatening experience” (RR = 5.6, 95% CI: 1.2-25.3) and “combined asthma-related deaths or life-threatening experience” (RR = 10.5, 95% CI: 1.3-81.6) was found for African Americans who had no prescription of an inhaled corticosteroid (ICS) at baseline. In an interim analysis, a non-significant increase in combined respiratory-related deaths or life-threatening events was found in patients receiving salmeterol but for African Americans, this increase was statistically significant. In 2003, this trial was prematurely terminated by GlaxoSmithKline due to recruitment problems and safety issues. The Salmeterol Multicentre Asthma Research Trial (SMART) was a large randomized controlled trial in asthma patients evaluating the safety of salmeterol (i.e., a long-acting beta-2-agonist ) compared to placebo in addition to usual asthma care.
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