Two large randomised trials published to coincide with the launch of The Lancet Respiratory Medicine provide compelling new evidence that using two types of common asthma medications combined in one inhaler for both preventive and rescue treatment (Single inhaler Maintenance and Reliever Therapy; SMART) is more effective at reducing attacks than guideline-based treatment in adults whose asthma is not well controlled, and is safe and well tolerated.
These findings challenge national and international medical guidelines, particularly in the USA, where this approach has yet to be approved.
Despite effective drug treatment options, most adults with asthma fail to achieve good control of symptoms. In these patients, medical guidelines recommend prescribing a corticosteroid (ICS) plus rapid-onset long-acting β2 agonist (LABA) combination inhaler to achieve control along with a second short-acting β2 agonist (SABA) inhaler for rescue use, to treat symptoms. In contrast, SMART uses just a single ICS/LABA inhaler for both preventive and relief treatment.
The first study of 1714 adults with moderate persistent asthma from 14 European countries found that those treated with the SMART beclometasone/formoterol combination had a significantly reduced risk of severe asthma attacks and hospitalisation or urgent medical care compared to current best practice.
The authors say, “We believe that the additional cost of inhaled corticosteroid and rapid-onset, long-acting β2 agonist combination (29 Eurocents per patient per day) is justifiable because of the significant reduction in severe exacerbations, and specifically hospital admissions, known to have a huge effect on health-care costs in asthma.”
Previous studies have reported that higher doses of corticosteroids do not improve symptoms for all patients and can have substantial side effects, while LABAs have come under scrutiny for their risk of worsening asthma symptoms that could result in hospitalisation.
By contrast, the first non-pharmaceutical industry sponsored study of its kind involving 303 adults (16–65 years) at increased risk of flare-ups and high use of reliever medication, reported that the SMART budesonide/formoterol regimen reduced the risk of severe asthma exacerbations without increasing the risk of beta-agonist overuse or increasing long-term corticosteroid exposure.