The Pharmaceutical Journal
Vol 270 No 7235 p180
8 February 2003

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The Lancet (www.thelancet.com)

Consider combined salmeterol/fluticasone in COPD

Combination inhaled therapy with salmeterol and fluticasone should be considered for some patients with chronic obstructive pulmonary disease (COPD), according to data published this week.

A 12-month study of the combination, in 1,465 patients, found that it produced an improvement in health status and a higher rise in lung function compared with either drug alone. "Although the absolute changes in lung function induced by combination treatment were modest, they did happen rapidly," say the researchers. Combination treatment also reduced breathlessness and the use of relief medication compared with placebo or the individual agents. Combined treatment reduced the total exacerbation rate by 25 per cent (P=0.0001) and exacerbations requiring oral steroids by 39 per cent (P=0.0001) compared with placebo.

Although these reductions were not statistically significant when compared with monotherapy, the authors note a trend in favour of the combination group that became more pronounced with increasing severity of disease. They cite earlier research indicating that long acting b₂-agonists may enhance the anti-inflammatory effect of corticosteroids and that corticosteroids may help upregulate b-receptors.

The study (Lancet 2003;361:449) is from the TRISTAN (trial of inhaled steroids and long acting b₂-agonists) study group. Patients received either salmeterol 50µg twice daily, fluticasone 500µg twice daily, a combination of both or placebo.

A spokeswoman for Allen & Hanburys told The Journal that European marketing authorisations for Seretide (combined salmeterol and fluticasone) as a treatment for COPD are expected to be granted within the next few months.