The Pharmaceutical Journal
Vol 270 No 7242 p429
29 March 2003

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The Lancet (www.thelancet.com)

Steroids show benefits in mild asthma

A large international trial has found that low-dose inhaled corticosteroids (ICS) improve outcome in children and adults with mild asthma (Lancet 2003;361:1071).

The three-year study involved over 7,000 patients aged from five to 66 years recruited from 32 different countries. They all had recent asthma onset and had not received steroid treatment previously. Patients were assigned to either inhaled budesonide (400µg for an adult or 200µg for those under 11 years) or placebo, in addition to their usual asthma medication.

Budesonide reduced the risk of a first severe asthma-related event (admission to hospital, emergency treatment or death) by 44 per cent. After three years, 117 patients in the budesonide group had had at least one such event compared with 198 in the placebo group. Patients treated with budesonide were also 40 per cent less likely than those given placebo to need systemic corticosteroids and had more symptom-free days.

Although budesonide was seen to improve long-term lung function and was well tolerated, the drug had a negative impact on growth in children under 11 years of age (three-year growth was reduced by 1.34cm). However, lead author Professor Romain Pauwels from Ghent University Hospital, Belgium, says the benefits of once-daily, low dose budesonide outweigh the small growth effect in children.

The authors say that the effectiveness of early intervention had not been established in mild persistent disease of recent onset since previous large studies had included patients with moderate, as well as mild, asthma and had included those with more established disease.

Recent guidelines from the British Thoracic Society and the Scottish Intercollegiate Guidelines Network do not include ICS in Step 1 for mild intermittent asthma (PJ, 1 February, p141 and 8 February, p182). However, they do state that the threshold for introduction of inhaled steroids has never been firmly established. Although there is strong evidence that patients requiring short-acting b-agonists two or three times a day should be treated with inhaled steroids, the BTS/SIGN guidance adds that patients with lower inhaler requirements may also benefit.

Commenting on the study, consultant respiratory pharmacist Anna Murphy, Glenfield Hospital, Leicester, said that early introduction of ICS did, fundamentally, make sense because these agents treated the underlying symptoms of asthma. However, there was always a risk of adverse effects with ICS.

She noted that the trial recruited patients with relatively frequent symptoms ("at least once a week but not as often as daily"). Although these patients were classed as mild asthmatics, Ms Murphy believes that they might nonetheless have been candidates for the introduction of inhaled steroids to control their symptoms.

In her experience in primary care, many patients are stepped up to an ICS if they used their b₂-agonist more than once each day. "This trial is useful to encourage this early use of ICS and to support the use of low doses to treat mild asthma," Ms Murphy said.