GSK's Advair Diskus safety study in children published in NEJM

GlaxoSmithKline plc (GSK) has published results in the New England Journal of Medicine (NEJM) from a long-term safety study assessing the use of its medication Advair Diskus in children.

The study, named VESTRI, compared Advair Diskus, a combination of the long-acting beta2-agonist (LABA) salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate (FP), against FP monotherapy. The trial aimed to assess the safety profiles of each treatment when used for children aged 4 to 11 years with asthma.

Headline results from the study demonstrated that the salmeterol/FP combination achieved its primary endpoint, showing non-inferiority compared to FP alone in terms of the risk of serious asthma-related events. These events included deaths, intubations, or hospitalisations. While the study observed a non-statistically significant reduction in the risk of asthma exacerbation with the combination therapy, the primary safety outcome met its predefined non-inferiority margin.

GSK stated that the study achieved its primary safety endpoint and the publication in a peer-reviewed journal provides important data, particularly in the area of paediatric asthma where data are limited. The company noted that access to independently reviewed data is crucial for clinicians to enhance their knowledge and understanding of the disease.

The VESTRI trial was one of two LABA safety studies conducted by GSK as a post-marketing requirement from the US Food and Drug Administration (FDA). GSK was the sole manufacturer to conduct a study in the 4-11 year age group, as it is the only manufacturer with an asthma indication for this age range in the US. Results from a similar study in adolescents and adults, AUSTRI, were also published in NEJM in March 2016.