By Christian Duffin
UK researchers have urged GPs to consider switching asthma patients from long-acting beta-agonist inhalers to oral leukotriene-receptor antagonist treatment, after their study showed they were preferred by patients.
The study – involving primary care patients with mild to moderate asthma – found oral LTRAs were as effective as LABA inhalers either as first-line therapy or in combination with inhaled steriods, and had improved adherence rates compared with those on LABA-steriod combinations.
The trial, published in the New England Journal of Medicine, randomly assigned patients on an LTRA to two years of daily open-label therapy, under the care of their GP at 53 practices, in one of two trials.
The first compared either montelukast or zafirlukast in 148 patients, with an inhaled steroid – either beclomethasone, budesonide or fluticasone – as first-line controller therapy in 158 patients.
The second trial compared 170 patients on an LTRA with 182 patients on a long-acting beta-agonist – either salmeterol or formoterol – together with an inhaled corticosteroid as an add-on therapy.
The researchers collected data on history of exacerbations, lung function, and quality of life at two, six, 12, 18 and 24 months using the Mini Asthma Quality of Life Questionnaire and other tools.
Mean scores increased by 0.8 to 1.0 point over two years in both trials. At two months, differences in the scores between the two treatment groups met the researchers’ definition of equivalence.
At two years, mean scores approached equivalence, with an adjusted mean difference between treatment groups of –0.11 in the first-line controller therapy trial and of –0.11 in the add-on therapy trial.
Exacerbations did not differ significantly between the two groups overall, and the median rate of adherence, based on the number of prescriptions issued, was significantly higher in patients on LTRA therapy in the add-on therapy trial (see box).
LTRAs are more expensive than steroid inhalers and are currently only recommended as third or fourth step treatments in asthma management in guidance by the British Thoracic Society and the Scottish Intercollegiate Guidelines Network.
But montelukast and zafirlukast will soon be off patent and will become much cheaper, prompting the researchers to urge GPs to consider the switch, which they argued could translate to reduced costs and unscheduled admissions through better adherence.
Lead researcher Professor David Price, a sessional GP in Norfolk and professor of primary care respiratory medicine at the University of Aberdeen, said the new findings show that GPs can now offer LTRAs as an alternative to steroid inhalers and to preventer inhalers when used in addition to steroid inhalers.
‘We hope these findings will increase the options. We found that adherence to treatment was vastly improved – and patients did not have to worry about using appropriate inhaler technique.’
Dr Stanley Musgrave, a GP and research associate at the University of East Anglia who also worked on the study, said: ‘LTRAs are easy to use and can help patients control their asthma effectively and improve their quality of life.’
Mean Mini AQLQ scores at two months – adjusted mean difference of –0.02 in the first-line controller therapy trial and of –0.10 in the add-on therapy trial.
Mean Mini AQLQ scores at two years – adjusted mean difference of –0.11 in the first-line controller therapy trial and of –0.11 in the add-on therapy trial.
Exacerbation rate ratio – 1.27 in first-line controller therapy trial and 1.02 in add-on therapy trial, neither difference statistically significant
Median rate of adherence – 74% in LTRA treated patients compared with 46% in patients on inhaled steroids in add-on therapy trial.
N Engl J Med 2011;364:1695-707