First head-to-head study comparing common treatments for patients with COPD

First head-to-head study comparing common treatments for patients with COPD shows quality of life and survival benefits for patients treated with Seretide

Issued — 28 December 2007, London, UK

The INSPIRE (Investigating New Standards for Prophylaxis In Reduction of Exacerbations) study, published today in The American Journal of Respiratory and Critical Care Medicine showed that while the two study medications; Seretide™ 50/500µgDiskus™ (salmeterol/fluticasone propionate) and tiotropium bromide 18µg Handihaler® had a similar impact on rate of exacerbations, patients treated with Seretide gained a significant improvement in health status and greater survival benefit than patients treated with tiotropium. INSPIRE is the first prospective study to report a statistically significant difference in the relative risk of all-cause mortality between two established treatments for COPD.1

The INSPIRE study is the first to investigate differences in exacerbation rates and related outcomes associated with two commonly used medicines in the treatment of COPD. The primary endpoint of the INSPIRE study was a comparative reduction in exacerbations, a sudden worsening of symptoms, which are debilitating and increase as the disease progresses. Interestingly, while the number of exacerbations reported between the two study groups was not significantly different, overall rates were 1.28 for Seretide and 1.32 for tiotropium bromide (p=0.656), the treatment for the acute exacerbation chosen by investigators whilst blinded was different. Exacerbations requiring antibiotics occurred more frequently in patients treated with Seretide while exacerbations requiring systemic steroids occurred more frequently in patients taking tiotropium, suggesting that the nature of the exacerbations was dissimilar and that COPD treatments affect individuals in different ways.

Further findings from INSPIRE showed that Seretide reduced the risk of COPD patients dying from any cause by 52% compared to patients on tiotropium bromide, a statistically significant finding (p=0.012). This reduction in the risk of dying was seen by week 13 of treatment and continued to grow throughout the study.1 In addition, patients on Seretide had significant improvements in quality of life from early in the study compared to patients on tiotropium bromide (2.07 unit improvement at 2 years, p=0.038), as measured by the St George’s Respiratory Questionnaire (SGRQ),a validated instrument used to assess the impact of airway disease on overall health, daily life, and perceived well-being2. These benefits lasted through the length of the 104 week study.

Commenting on the results, Professor Wisia Wedzicha, RoyalFreeHospital, London, said “The results seen in INSPIRE showing improvements in quality of life and survival are important for patients with COPD. There is no cure for COPD so we must manage the disease as effectively as possible to provide patients with the best outcomes.”

In terms of safety and tolerability there was an increase in reported pneumonias in the Seretide group (8%) compared to the tiotropium bromide group (4%). Candidiasis was also reported more often in the Seretide group (6%) than the tiotropium group (3%).

Patients in the tiotropium arm were 29% more likely to withdraw from the study with the probability of withdrawing prior to week 104 being 34.5% on Seretide and 41.7% on tiotropium bromide (p=0.005).

Withdrawals tend to be among patients who have worse health status and who deteriorate more rapidly. As more patients drop out of a study it can lead to a ‘health survivor’ effect with less severe patients in one treatment group being compared to more severe patients in the other treatment group.

INSPIRE was a European, 2-year multicentre, randomised, double-blind, double-dummy controlled trial that included over 1,300 patients, comparing the effects of Seretide and tiotropium bromide in patients with severe COPD.1

Professor Wedzicha concludes, “The study raises important questions regarding the nature of this progressive disease. Patients appeared to experience differences in the nature of their exacerbations, with different treatment being prescribed for each group, Seretide patients received more antibiotics during their exacerbations, and tiotropium patients more oral corticosteroid treatments and this resulted in different outcomes for patients. This study therefore could have important implications for the choice of medication used to manage patients with COPD”.

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