GlaxoSmithKline Plc (ADR) (NYSE:GSK) has revealed that the results from thelong acting beta2-agonist (LABA) safety study of AdvairDiskus, AUSTRI (SAS115359), will be published in the New England Journal of Medicine (NEJM). The results were initially reported in October by GSK.
Simultaneously, the results of the said study are presented at the annual meeting of the American Academy of Asthma, Allergy, and Immunology (AAAAI) Congress in California.
Safety Study Design and Results
The safety study was designed to compare AdvairDiskus, a combination of salmeterol, inhaled corticosteroid (ICS), and LABA, fluticasone propionate (FP), to FP monotherapy. It was made to evaluate the safety of each drug when used to asthmatic patients. Accordingly, AdvairDiskus’ safety profile is comparable to FP. Simply speaking— the combination of LABA, salmeterol, and fluticasone in one inhaler does not have adverse effects.
The risk of complications resulting from severe asthma attacks was 21% lower in the fluticasone-salmeterol group than in the fluticasone group, with exacerbations occurring in 10% of the glucocorticosteroid group and 8% of the combination group. Patients, who were primarily located in the US, Australia, Germany, Bulgaria, Denmark, Italy, Canada, and Slovenia, had undergone the testing for 26 weeks.
The Food and Drug Administration mandated GSK’s AUSTRI as a post-marketing requirement. It is the first to report results among numerous large-scale safety studies.
Three other manufacturers of drugs containing LABA are performing similar studies to assess whether LABA can heighten the risk of an event in the composite endpoint of asthma-related cases.
Moreover, GSK is also working on a second LABA safety study known as the VESTRI. AUSTRI was made for asthma on adolescent and adult patients while VESTRI is designed for asthma on children ages four to 11 years old. Results for VESTRI are expected by the end of the first quarter.
In 2012, the Department of Justice filed a number of criminal and civil allegations against GSK on grounds of the unlawful promotion of several drugs that have not yet been medically approved. To settle the charges, GSK had to pay $3 billion. The drug maker argues that there have not been any corporate promotional strategies for the use of Advair.