Article date: January 2008
MHRA has reviewed the use of long-acting β2 agonists (LABA) in the treatment of asthma after concerns raised by the Salmeterol Multicenter Asthma Research Trial (SMART).
This double-blind randomised placebo-controlled trial recorded more respiratory-related deaths, asthma-related deaths, and combined asthma-related deaths or lifet-hreatening experiences in the salmeterol group than in the placebo group.
MHRA has reviewed: the pharmacology of the 2 currently available LABA—salmeterol (Serevent) and formoterol (Atimos Modulite▼, Foradil, Oxis), and the combination products Seretide and Symbicort; the current position of research into the β2 adrenoreceptor genotype; the epidemiology of asthma in relation to the introduction of LABA; and an overall assessment of the benefits and risks of LABA in the treatment of asthma.
The conclusions from the review include:
- epidemiological data show that since the introduction of LABA, there has been a decrease in asthma-related hospitalisations in adolescents and a decrease in asthma-related mortality in all ages
- data from randomised controlled clinical trials do not suggest a similar safety concern to that shown in postmarketing studies, probably because of moreconsistent use of concomitant inhaled corticosteroids in randomised controlled settings - the data supports the use of LABA in conjunction with inhaled corticosteroids in the treatment of moderate to severe asthma consistent with the guideline on the management of asthma from the British Thoracic Society and Scottish Intercollegiate Guidelines Network
- to aid compliance with the concomitant use of inhaled corticosteroids and LABA, a combination inhaler should be used when appropriate
Further epidemiological studies are under way to assess the relation between adverse outcomes and use of LABA, the results of which are expected before the end of 2008. MHRA is also reviewing of the role of LABA in the treatment of asthma in children younger than age 12 years.
LABA in asthma management is available on our website.
Guidelines on management of asthma by the British Thoracic Society
The Scottish Intercollegiate Guidelines Network (SIGN)
Article citation: Drug Safety Update Jan 2008; Vol 1, Issue 6: 9