The safety of the use of a combined drug for asthma management is supported by a meta-analysis of a significant amount of clinical trial data.
A group of international researchers, including McMaster University's Paul O'Byrne, conducted the analysis to better understand the safety, as measured by serious asthma events, of long-acting beta2-agonists, or LABAs, when administered with an inhaled glucocorticoid.
The results were published in The New England Journal of Medicine (NEJM).
"There have been some safety concerns around LABAs when they are administered alone in the management of asthma, which raised questions about its impact when taken with an inhaled glucocorticoid," said O'Byrne, a respirologist, a professor of medicine at McMaster University's Michael G. DeGroote School of Medicine and a clinician scientist at the Firestone Institute for Respiratory Health at St. Joseph's Healthcare Hamilton.
"This meta-analysis provides support for both the safety and efficacy of using this combined drug treatment for patients with asthma."
The data was collected from four multi-centred trials mandated by the U.S. Food and Drug Administration (FDA). The studies were conducted by AstraZeneca, GlaxoSmithKline, Merck and Novartis. The study sample included more than 36,000 adolescent and adult patients with persistent asthma.
The analysis of the study sample shows that the co-administration of a LABA with an inhaled glucocorticoid resulted in significantly fewer asthma attacks, but did not lead to a higher risk of serious asthma-related events than treatment with an inhaled glucocorticoid alone.
The researchers note the meta-analysis data supports the recent FDA decision to remove the boxed safety warning on LABA/inhaled glucocorticoid combination therapy for asthma treatment.
The meta-analysis was sponsored by AstraZeneca, GlaxoSmithKline, Merck and Novartis.
Access the NEJM paper here.
Read the Brighter World profile on Paul O'Byrne here.