GlaxoSmithKline plc (GSK) today announced publication of results from the paediatric ‘LABA’ (long acting beta2-agonist) safety study, VESTRI (SAS115358) in the New England Journal of Medicine (NEJM). Headline results reported in March, demonstrated that the study had achieved its primary endpoint. The study compared Advair® Diskus®, a combination of the LABA, salmeterol and inhaled corticosteroid (ICS), fluticasone propionate (FP) to FP monotherapy, to assess the safety profiles of each medicine when used to treat children 4-11 years of age with asthma. This was assessed by the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations). These results are also being presented at the European Respiratory Society (ERS) International Congress in London, UK on 7th September, (Abstract number: OA4798).
The primary endpoint of the study showed the salmeterol/FP combination (FSC) twice-daily (100/50mcg, 250/50mcg) demonstrated non-inferiority compared to corresponding doses of FP twice-daily (100mcg, 250mcg), Hazard Ratio (HR) 1.285, (95% CI 0.726, 2.272) p=0.006 on the risk of serious asthma-related events. In the study a non-statistically significant reduction of 14% was observed in the risk of time-to-first asthma exacerbation for FSC compared to FP (HR 0.859; 95% CI 0.729, 1.012).
Kate Knobil, Chief Medical Officer - Pharmaceuticals at GSK said: “We are pleased that the study achieved its primary safety endpoint and has now been published in a key peer-reviewed journal as well as being presented at the forthcoming European Respiratory Society congress. These are important data, especially in an area where data are limited, such as in paediatric asthma. We understand how important it is for clinicians to have access to data that have been independently reviewed, to give them greater knowledge and understanding in this disease area.”