Clinical effectiveness study compares asthma control treatments in routine care setting
By Jane Lewis
Asthma control in symptomatic patients can be improved with the introduction of a once-daily combination treatment of fluticasone furoate and vilanterol, without increasing the risk of serious adverse events, reports a clinical effectiveness study published in The Lancet.
The authors of the Salford Lung Study claim it is ‘the largest, randomised, comparative effectiveness study performed in a population intended to represent that seen in everyday clinical practice.’ They explained that this is distinct from efficacy randomised controlled trials, which are usually done in ‘highly selected and closely monitored patient populations,’ with ‘limited relevance to everyday clinical practice.’
Commenting on the findings, respiratory physician, Conjoint Professor Peter Gibson, CoDirector of the Centre for Asthma and Respiratory Diseases at the University of Newcastle, and author of an editorial published with the paper, told Medicine Today the study is important because it codifies an effective approach to asthma in primary care.
‘The spectrum of responses in this trial ring true with asthma management in primary care, and for this reason they need to be heeded,’ he said.
The industry-funded, open-label, randomised, controlled, two-arm effectiveness trial was conducted at 74 general practice clinics in the UK and enrolled 4725 adult patients with GP-diagnosed symptomatic asthma who were taking maintenance inhaler therapy. The patients were randomly assigned to initiate treatment with a once-daily inhaled combination of either 100mcg or 200mcg fluticasone furoate with 25mcg vilanterol using a fixed-dose device (FF/VI group), or optimised usual care by their GP, and followed up for 12 months.
At 24 weeks, 71% of the FF/VI group were ‘responders’ (defined as improvement from baseline of 3 or more points or a total score of 20 or greater on the asthma control test [ACT]), compared with 56% of the usual-care group (odds ratio, 2.0). The adjusted mean ACT score increased by 4.4 points from baseline in the FF/VI group compared with 2.8 points in the usual care group, a result that was consistent for the duration of the study. There was no difference between the groups in serious adverse events. During the study, 18% of the FF/VI group elected to change back to usual therapy.
‘These data tell you what is likely to happen when you treat your next asthma patient,’ commented Professor Gibson. ‘Only a little over half will achieve asthma control, but you can increase this to 71% with FF/VI. Not everyone will want to stay on the treatment, and some will want to swap back to their usual inhaler. Most people will remain free of severe asthma exacerbations over one year with either approach.’
In his accompanying editorial, Professor Gibson highlighted the limitations of evidence-based practice, pointing out that ‘only a minority of patients in your clinic’ would ever meet the eligibility criteria for double-blind, randomised, placebo-controlled trials.
‘The evidence-based practice mantra sounds great, but it is only a part of the whole picture that enables GPs to provide good asthma care,’ he told Medicine Today. ‘The big limitation is that the data that underpin it may not be generalisable to many patients in your clinic. To balance this out, we need practice-based evidence.’
Lancet 2017; http://dx.doi.org/10.1016/S0140-6736(17)32397-8.
Lancet 2017; http://dx.doi.org/10.1016/S0140-6736(17)32398-X.
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