Two Main Treatments For COPD Go Head To Head On Exacerbations, Quality Of Life And Survival

Main Category: Respiratory / Asthma
Article Date: 07 Jan 2008 - 1:00 PDT

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A new study published in The American Journal of Respiratory and Critical Care Medicine shows that patients treated with Seretide 500 Accuhaler (salmeterol 50µg/fluticasone propionate 500µg) experience a similar rate of exacerbations to patients treated with tiotropium Handihaler 18µg, but gain statistically significant improvements in health status and greater survival benefit.

The INSPIRE (Investigating New Standards for Prophylaxis In Reduction of Exacerbations) study is the first prospective study to report a difference in the risk of all-cause mortality between two established treatments for COPD,1 with Seretide showing a statistically significant reduction in all-cause mortality compared to tiotropium over 2 years (p=0.012).1

INSPIRE is a European, 2-year multicentre, randomised, double-blind, double-dummy controlled trial of over 1,300 patients with severe COPD.1 The primary endpoint of the trial was the rate of exacerbations requiring use of healthcare resources. Interestingly, 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).1

Importantly, the INSPIRE study also showed that Seretide reduced the relative risk of COPD patients dying from any cause by 52% (p=0.012) compared to patients on tiotropium.1 38 patients died in the tiotropium arm compared to only 21 in the Seretide arm (p=0.032).1 In addition, patients on Seretide had significant improvements in quality of life from early in the study that were sustained throughout, compared to patients on tiotropium (2.07 unit improvement at 2 years, p=0.038),1 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-being.2

Commenting on the results, Professor Wisia Wedzicha, Royal Free Hospital, 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 group (4%) (p=0.008). Candidiasis was also reported more often in the Seretide group (6%) than the tiotropium bromide group (3%). However no significant differences were seen between the treatments in other adverse events such as bruising and fractures. There was a 29% increased risk of withdrawal from the tiotropium arm compared with the Seretide arm over the 2 years (p=0.005).

An interesting finding from the INSPIRE study is that significantly more patients in the tiotropium arm needed oral steroids to treat their exacerbations whereas significantly more patients on Seretide required more antibiotics. This raises questions about the nature of exacerbations in 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 treatments 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".

The study was sponsored by GlaxoSmithKline (GSK) and overseen by a steering committee consisting of external experts and representatives from GSK.

Seretide and Accuhaler are registered trademarks of the GlaxoSmithKline group of Companies.

Handihaler is a registered trademark of the Boehringer Ingelheim/Pfizer group of Companies.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the equality of human life by enabling people to do more, feel better and live longer.

http://www.gsk.com

References

1. Wedzicha, JA et al 2008. The prevention of COPD exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. AJRCCM Articles in Press. Published on October 4, 2007

2. Jones PW, Quirk FH, Baveystock CM. The St. George's Respiratory Questionnaire. Resp Med 1991;85(suppl):25-31.

Notes

Seretide 500 Accuhaler was approved in the European Union in 2003 for the symptomatic treatment of severe COPD; i.e. for patients with a FEV1 <50% of predicted normal, a history of repeated exacerbations and significant symptoms despite regular bronchodilator therapy. The licence was extended in 2007 to include those patients with FEV¬I <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.1

References

1. Seretide Summary of Product Characteristics (July 5th 2007)

GlaxoSmithKline