Glaxo Smithkline (GSK) has presented the results of the EXCEL (EXacerbation Control Evaluated in a 6 month Long) study, a head to head trial comparing Seretide (salmeterol/fluticasone propionate) with the formoterol/budesonide combination in the treatment of asthma exacerbations at the 14th annual European Respiratory Society (ERS) Congress in Glasgow last week.
Conducted in over 1,000 patients, the study shows that whilst there was no significant difference between the two treatments in the primary endpoint of all exacerbations over the six-month period, post hoc analysis showed that there was a 30 per cent lower annualised rate of moderate/severe exacerbations on Seretide compared with formoterol/budesonide (p=0.059). This was most apparent in the last two months of the trial, where the rate of oderate/severe exacerbations was 57 per cent lower for patients treated with Seretide than with formoterol/budesonide and this difference was statistically significant (p=0.006). This post hoc analysis was conducted when in the primary endpoint, it was observed that the rate of all exacerbations decreased with time, release from GSK said.
Commenting on the findings, study author Professor Ronald Dahl said: "The results of EXCEL show that it was possible to reduce exacerbations if patients take regular sustained combination treatment. This is in sharp contrast to the current situation; where patients often take variable amounts of their anti-inflammatory treatment and rely on taking rescue treatment to react to their breakthrough symptoms."
The primary endpoint, the rate of all exacerbations over six months (which included mild, moderate and severe) was 2.69 for Seretide and 2.79 for formoterol/budesonide combination and was not significantly different. Lung function and symptom control improved to a similar degree in both groups.
The release adds, it was clear from the data that there was a definite improvement in PEF, symptoms, rescue medication use and exacerbations over time with both treatments. As there was a numerical difference between the two treatments in the number of patients with moderate/severe exacerbations for the duration of the study (67 for Seretide and 80 for formoterol/budesonide combination), a further investigation was warranted, particularly as moderate/severe exacerbations have a significant impact on the patient and healthcare providers. As well as this, data from recent studies have shown that the rate of exacerbations decline with regular sustained combination treatment and the results of the EXCEL post hoc analysis add to the growing body of evidence supporting the rationale for sustained regular treatment with Seretide.
"Much is claimed about adjustable dosing, but this means that patients chase their symptoms by deciding their level of treatment based on their symptoms, increasing or decreasing their dose as symptoms fluctuate. Every time this happens the patient is not only symptomatic but they are also reminded that they suffer from asthma," said Professor Chuchalin, co-author of the EXCEL study.
"These results have shown that regular sustained treatment is a highly effective treatment strategy for patients and is an effective way of gaining asthma control (as derived from GINA and NIH guidelines)," he added.
Poorly treated asthma presents a significant burden to the patient and the healthcare system. In particular, exacerbations can increase the cost of caring for asthma sufferers nearly six fold, according to one European study. A recent health economics analysis showed that the cost per patient is 37 per cent more for poorly treated patients than well treated patients, in terms of direct costs such as drugs and hospitalisations, and 25 per cent more in terms of indirect costs such as sick leave and early retirement.
Meantime, GSK has filed a regulatory application in Europe to extend the therapeutic indications for Seretide to include Initial Maintenance Therapy (IMT). An IMT indication would allow Seretide to be used as a first-line preventer treatment for patients with persistent asthma that are not adequately controlled with "as needed" short-acting beta2-agonist treatment alone. Seretide is the first inhaled long acting beta2-agonist/corticosteroid combination therapy to file for Initial Maintenance Therapy.