Additional results from post-hoc analysis underline effectiveness of SPIRIVA^®

Summary: COPD (Chronic Obstructive Pulmonary Disease) is a chronic respiratory disease that progressively and permanently reduces the ability of adults to breathe well and maintain active lives. A history of COPD exacerbations is a predictor of progression and deterioration of a patient’s condition. One key treatment goal is to reduce the risk and occurrence of COPD exacerbations. Post-hoc analyses, presented at ATS 2014 confirm the effectiveness of SPIRIVA^®, the world’s leading COPD maintenance therapy, in reducing the risk and frequency of COPD exacerbations in a broad range of patients.^1,2Importantly, SPIRIVA^® was shown to have a potential stabilising effect on exacerbations after one year in COPD patients with low and high risk of exacerbations.^1,2

San Diego, USA, 19 May 2014  – Data analyses presented today at the Annual American Thoracic Society (ATS) International Conference 2014 reconfirm the efficacy of SPIRIVA^® (tiotropium) in reducing the risk of COPD exacerbations, a term used to describe a worsening or “flare up” of the disease.

“COPD can significantly limit daily life and it is critical to patients to effectively reduce the risk of COPD exacerbations,” commented Professor Dr. Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital, Marburg, Germany.  “These data confirm that tiotropium is effective not only in reducing the number of exacerbations and delaying time to first exacerbation but also a potential in stabilising the effect on exacerbations. This fulfils key goals of treatment, as outlined in global COPD expert guidelines, as well as supporting early treatment intervention with tiotropium.”

A post-hoc analysis of the UPLIFT^®ii trial presented at ATS 2014 showed that SPIRIVA^® significantly reduced the number of COPD exacerbations, as well as significantly prolonging the time to the occurrence of the first exacerbation in patients both at high and low risk of exacerbations compared to placebo.¹ Furthermore, based on this post-hoc analysis, one year of SPIRIVA^® treatment resulted in a favourable shift in the ratio for low risk / high risk for COPD exacerbations, suggesting SPIRIVA^® has a stabilising effect on exacerbations.¹

A post-hoc analysis from the POET-COPD^®iii trial revealed a similar favourable shift towards a lower risk of exacerbations after one year of SPIRIVA^® treatment.² In addition, data from this trial reconfirmed the higher efficacy of SPIRIVA^® compared with another COPD treatment, salmeterol, in reducing the number of COPD exacerbations, as well as prolonging the time to the occurrence of the first exacerbation in patients both at high and low risk of exacerbations.²

A recent survey revealed that US and European pulmonologists believe offering a reduction in exacerbations is one of the most important qualities for a COPD treatment.³ According to expert bodies such as GOLD (Global Initiative for Chronic Obstructive Lung Disease) and the World Health Organization (WHO) preventing disease progression and exacerbations are key goals for the treatment of COPD.⁴

SPIRIVA^® is a proven effective maintenance therapy for COPD patients with more than 200 clinical trials, including the milestone trials POET-COPD^®, UPLIFT^® and TIOSPIR^™, and approximately 38 million patient-years of real life experienceiv  to support the efficacy and safety profile. These latest analyses reinforce the importance of SPIRIVA^® as the world’s leading maintenance therapy for COPD.

ⁱ Low risk of exacerbations was defined as <1 exacerbation and no COPD-related hospitalisation(s) in the year preceding trial entry. High risk of exacerbations based on the GOLD 2013 definition of >2 exacerbations (courses of oral steroids/antibiotics) or >1 COPD-related hospitalisation(s) in the year preceding the trial
ⁱⁱ While SPIRIVA^® 18 μg via HandiHaler^® did not alter the rate of decline in lung function, a coprimary study endpoint in the UPLIFT^® trial, it sustained greater improvements in lung function vs. control (placebo)
ⁱⁱⁱ SPIRIVA^® 18 μg delivered via HandiHaler^®
iv Combined figures for HandiHaler^® and Respimat^®

Indication
Chronic Obstructive Pulmonary Disease (COPD)

Product
SPIRIVA^® (tiotropium bromide)

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