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) as were mean annual exacerbation rates with 0.43 (95% CI, 0.40; 0.48) vs. 0.61 (0.56; 0.66), rate ratio 0.72 (0.63; 0.81; P<0.0001)
- The St George’s Respiratory Questionnaire (SGRQ)†† total score after four years was significantly improved by tiotropium vs. placebo: −3.63 (95% CI, −5.14; −2.12;P<0.0001)
- The respective increase for trough FEV1 was 110 mL for tiotropium (95% CI, 84; 136; P<0.0001)
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% pred and/or
≥2 exacerbations in the previous year (GOLD C+D) and low risk by a
FEV1 ≥50% pred and 0-1 exacerbation in the previous 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
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