INGELHEIM AM RHEIN, Germany - Monday, September 3rd 2012 [ME NewsWire]
(BUSINESS WIRE)-- For medical media outside the USA and UK
Coinciding with the annual European Respiratory Society Congress, ERS 2012, SPIRIVA® (tiotropium), the first once-daily long-acting inhaled anticholinergic maintenance treatment for patients with Chronic Obstructive Pulmonary Disease (COPD) will mark its 10th anniversary since launch.* With over 25 million patient years of experience†, once-daily SPIRIVA® is the most prescribed COPD maintenance treatment worldwide.1,2 This unique position is rooted in the wealth of clinical trial data available to prove tiotropium’s clinical efficacy in reducing breathlessness (dyspnoea) and the risk of exacerbations as well as improving patients’ quality of life.3,4,5,6 Over the years, more than 175 clinical trials with tiotropium in COPD have been conducted investigating a broad range of patients in studies of up to four years.7
“What is important to note is that from the first COPD patients to receive SPIRIVA® over ten years ago, to the thousands who are currently prescribed it every day, SPIRIVA® has made a significant and lasting contribution to our scientific understanding and management of COPD,” said Professor Antonio Anzueto, Professor of Medicine Pulmonary/Critical Care Medicine, University of Texas Health Science Center at San Antonio, Texas, USA. “This has been chronicled through evidence from large scale clinical trials, notably UPLIFT®‡ and POET-COPD®§, which prove the efficacy of SPIRIVA® in reducing the risk of exacerbations, improving lung function, reducing shortness of breath and increasing patient quality of life.”
SPIRIVA® reduces the risk of exacerbations and improves lung function in low risk patients as defined by the new GOLD** COPD Patient Group criteria 8
Data presented at ERS 2012 provide further evidence from one of the pivotal long-term SPIRIVA® trials, UPLIFT®‡9, demonstrating a reduced risk of exacerbations with SPIRIVA® in low risk COPD patients (GOLD Patient Groups A and B). This adds to the body of evidence that SPIRIVA® reduces the risk of exacerbations in all GOLD Patient Groups.3,9
In the analysis of the UPLIFT® trial presented at ERS 2012, the study investigators showed that in low risk COPD patients:8
- The hazard ratio (tiotropium vs. control) for time to first exacerbation was significantly improved; 0.76 (95% CI, 0.68; 0.86; P<0 .0001=".0001" 0.40="0.40" 0.43="0.43" 0.48="0.48" 0.61="0.61" 0.66="0.66" 0.72="0.72" 0.81="0.81" annual="annual" as="as" ci="ci" em="em" exacerbation="exacerbation" mean="mean" nbsp="nbsp" rate="rate" rates="rates" ratio="ratio" vs.="vs." were="were" with="with">P
In its recent report “Global Strategy for Diagnosis, Management, and Prevention of COPD", GOLD extensively revised their COPD severity classification to focus on the evaluation of exacerbation risk as well as analysis of COPD symptoms. This new evaluation now not only includes spirometry tests but also a combination of a patient’s severity of symptoms and a history of exacerbations. The new Global Initiative for Chronic Obstructive Lung Disease (GOLD) report recommends long-acting anticholinergics for every patient requiring maintenance therapy (first choice for Patient Groups B-D and second option for Patient Group A). 10 This recommendation was based on data for the long acting anticholinergic tiotropium.
Professor Dr. Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital, Marburg, Germany said, “With a new emphasis in the updated GOLD report on managing exacerbations, SPIRIVA® meets the criteria for all GOLD Patient Group COPD patients requiring maintenance therapy, including a positive effect on risk reduction of exacerbations. Reduction of exacerbations is key to improvement in COPD patient status as they have a major impact on patients’ quality of life and often lead to hospitalisation.”
“The data from the ERS Congress add further weight to COPD patient benefits as a result of tiotropium treatment, particularly the positive impact on exacerbations, quality of life and improved lung function,” said Dr. Marc Miravitlles, Chest Physician and Senior Researcher, Department of Pneumology, Hospital Clinic, Barcelona, Spain. “COPD remains a debilitating, progressive and under-recognised lung disease and it is important that the most widely prescribed COPD treatment is central to future prospects for advancing treatment for the millions of patients with this condition.”
Ends
* First introduced to the market via HandiHaler® in 2002
† Combined figures for HandiHaler® and Respimat®
‡ While SPIRIVA® 18 μg via HandiHaler® did not alter the rate of decline in lung function, a coprimary study endpoint in the UPLIFT® study, it sustained greater improvements in lung function vs. placebo
§ SPIRIVA® 18 μg delivered via HandiHaler®
** GOLD –Global Initiative for Chronic Obstructive Lung Disease
†† St George’s Respiratory Questionnaire is a recognised indicator of health-related quality of life, measuring impairment on a scale of 0 to 100. Minimal Clinically Important Difference in SGRQ is defined as 4 units
‡‡ Increased exacerbation risk is typically defined by a FEV1 of <50 0-1="0-1" a="a" and="and" by="by" c="c" class="Apple-converted-space" exacerbation="exacerbation" exacerbations="exacerbations" fev1="fev1" in="in" low="low" nbsp="nbsp" or="or" pred="pred" previous="previous" risk="risk" span="span" the="the" year="year">
(GOLD A+B).
§§ In the UPLIFT® trial, Spiriva® did not alter the rate of decline in lung function in the overall clinical trial population, which was the primary end point (Spiriva® delivered via HandiHaler®)
References
1 Boehringer Ingelheim. Data on file.
2 IMS Health, IMS MIDAS(™), Q2 2012.
3 Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011;364(12):1093-1103.
4 Casaburi R, Kukafka D, Cooper CB, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest2005;127:809-817.
5 Anzueto A, Tashkin D, Menjoge S, Kesten S. One-year analysis of longitudinal changes in spirometry in patients with COPD receiving tiotropium. Pulm Pharmacol Ther2005;18:75-81.
6 Celli B, ZuWallack R, Wang S, Kesten S. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003;124:1743-1748.
7 COPD tiotropium clinical trials http://clinicaltrials.gov/ct2/results?term=COPD+tiotropium&recr=&rslt=&type=&cond=&intr=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=(last accessed July 2012).
8 Halpin D, Decramer M, Celli B et al. Effectiveness of tiotropium in low-risk patients according to new GOLD severity grading. ERS 2012 Poster P2190 Thematic Poster Session 249: Translational respiratory medicine in asthma and COPD. 12:50 – 14:40 Monday 3 September 2012, Vienna, Austria.https://www.ersnetsecure.org/public/prg_congres.abstract?ww_i_presentation=57889. Accessed August 2012.
9 Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543-1554.
10 Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2011.http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989. (Accessed: August 2012).
11 World Health Organization. Global Alliance Against Chronic Respiratory Diseases. http://www.who.int/mediacentre/factsheets/fs315/en/index.html. (Accessed 10 December 2010).
12 World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3:120-131.
13 Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 year’s treatment with tiotropium. Eur Respir J 2002;19:209-216.
14 Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002;1:217-224.
15 O'Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J 2004;23(6):832-48.
16 Decramer M, Celli B, Kesten S, et al. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomized controlled trial. Lancet 2009;374:1171-78.
17 Troosters T, Celli B, Lystig T, et al. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT® trial. Eur Respir J 2010;36:65-73.
Please click on the link below for ‘Notes to Editors’:
Contacts
Boehringer Ingelheim GmbH
Sebastian Wachtarz
Corporate Communications
Respiratory and Established Products
Phone: + 49 6132 77 3519
E-mail: press@boehringer-ingelheim.com
No comments:
Post a Comment