Landmark TIOSPIR™ Trial Further Reinforces Safety and Efficacy Profile of Spiriva® Respimat® in the Treatment of COPD

  Landmark TIOSPIR™ Trial Further Reinforces Safety and Efficacy Profile of
                 Spiriva® Respimat® in the Treatment of COPD

  PR Newswire

  BRACKNELL, England, September 8, 2013

BRACKNELL, England, September 8, 2013 /PRNewswire/ --

One of largest chronic obstructive pulmonary disease (COPD) trials conducted
to-date confirms comparable safety and efficacy profile of Spiriva ^® 
Respimat ^®  5 mcg and Spiriva ^®  HandiHaler ^®  18 mcg

  *Spiriva ^®  Respimat ^®  5mcg has a comparable mortality  profile and
    exacerbation efficacy similar to those of Spiriva ^®  HandiHaler ^®  18
    mcg [1]
  *The TIOSPIR™ trial population was representative of typical, real-world
    COPD patients, including patients with the full range of COPD severities,
    comprehensive use of concomitant COPD medications, and patients with
    stable cardiac disorders [1]

TIOSPIR™ ( Tio tropium S afety and P erformance i n R espimat), with over
17,000 COPD patients included, was one of the largest international COPD
trials ever conducted, confirmed the comparable mortality and exacerbation
efficacy profile of Spiriva ^® Respimat ^® 5 mcg and Spiriva ^® HandiHaler ^®
18 mcg. [1]

The results showed no difference between Spiriva ^® Respimat ^® 5 mcg and
Spiriva ^® HandiHaler ^® 18 mcg in:

  *risk of death [1]
  *risk of first exacerbation [1]
  *on-treatment all-cause mortality [1]
  *incidents of cardiovascular adverse events [1]

In particular, in patients with a history of cardiac arrhythmia, there was no
difference in mortality between Spiriva ^® Respimat ^® 5 mcg and Spiriva ^®
HandiHaler ^® 18 mcg. [1]

The results from the three year trial were published in the New England
Journal of Medicine on 8 September 2013. TIOSPIR™ was designed to provide
evidence of the relative safety and efficacy profile of Spiriva ^® Respimat ^®
5 mcg compared with Spiriva ^® HandiHaler ^® 18 mcg. [1] TIOSPIR™ was
specifically designed to be of an adequate size and duration, to enable
analysis of all-cause mortality and risk of first COPD exacerbation in a large
COPD patient population, with broad inclusion criteria, that closely reflects
the real-world COPD patient population. [1]

Commenting on the results, Dr Richard Russell, Consultant Chest Physician,
Wexham Park Hospital said "The results of this trial have been hugely
anticipated and hopefully will draw a line under the debate on the safety and
efficacy profile of Respimat. ^®

"The results provide clear evidence that Spiriva ^® Respimat ^® has an equally
good mortality profile in COPD patients to Spiriva ^® HandiHaler ^® ,
including those with a history of cardiac disease."



Exacerbations

The TIOSPIR™ trial demonstrated comparable results for risk of first COPD
exacerbation between Spiriva ^® Respimat ^® 5 mcg and Spiriva ^® HandiHaler ^®
18 mcg. 1 In particular, the median time to the first COPD exacerbation was
more than two years for both Spiriva ^® Respimat ^® 5mcg (756 days) and
Spiriva ^® HandiHaler ^® 18 mcg (719 days). [1]

COPD exacerbations have a significant impact on patients' lives and reducing
their frequency and severity are principal goals of COPD treatment. [2]
TIOSPIR™ builds upon the established efficacy profile of Spiriva ^® as
demonstrated in several trials, including the large-scale, POET-COPD ^[®]*
study that was specifically powered to investigate COPD exacerbations. [3]

  *Spiriva ^® HandiHaler ^® 18 mcg demonstrated a 28% reduction in the
    relative risk of a COPD exacerbation leading to hospitalisation (2.1% ARR;
    HR=0.72; 95% CI, 0.61 to 0.85; p<0.001) compared with the long-acting
    beta [2] -agonist salmeterol, as observed in the POET-COPD ^®* trial [4]
  *In a separate trial Spiriva ^® Respimat ^® 5mcg demonstrated a 27%
    reduction in the relative risk of hospital admission due to exacerbation
    (1.8% ARR; HR=0.73; 95% CI, 0.59 -0.90; p<0.005) compared with control.
    [5]

Safety as measured by survival rates

The three year TIOSPIR™ trial also showed an comparable impact on survival -
as measured by all-cause mortality for tiotropium (Spiriva ^® Respimat ^® 5
mcg vs. HandiHaler ^® 18 mcg). [1] This adds to evidence from UPLIFT ^[®]** ,
a four-year trial [6] in which Spiriva ^® HandiHaler ^® (18 mcg) demonstrated
there was a 16% reduction in the relative risk of on-treatment mortality (the
incidence rate of death was 4.79 per 100 patient years in the control group
compared with 4.10 per 100 patient years in the tiotropium group HR
(tiotropium/control) =0.84, 95% CI =0.73, 0.97)). [7]

Dr Brian Wong, Head of UK Medical and Scientific Affairs at Boehringer
Ingelheim said "We are delighted with the results of this landmark TIOSPIR™
trial, which has met its primary endpoint. The study was designed to answer a
specific question and we now have robust clinical evidence that Spiriva ^®
Respimat ^® has similar safety and exacerbation efficacy compared with Spiriva
^® HandiHaler ^® . We hope that these results reassure healthcare
professionals that they can provide a choice of device to their COPD
patients."

--------------------------------------------------

* The POET-COPD ^® (The P revention O f E xacerbations with T iotropium in
COPD) trial was a 1-year, randomised, double-blind, double-dummy,
parallel-group trial with a primary endpoint of time to first exacerbation,
comparing once-daily Spiriva( HandiHaler( 18 mcg with twice-daily salmeterol
50 mcg

** UPLIFT ^® ( U nderstanding P otential L ong-Term I mpacts on F unction with
T iotropium) While Spiriva ^® HandiHaler ^® 18 mcg did not alter the rate of
decline in lung function, a co-primary study endpoint in the UPLIFT ^® study,
it sustained greater improvements in lung function vs. control

Notes to Editors

About Spiriva ^®  HandiHaler ^®  and Spiriva ^®  Respimat ^®

Spiriva ^® HandiHaler ^® is a breath-actuated, single-dose dry powder inhaler.
[7]

Spiriva ^® Respimat ^® is a soft mist inhaler (SMI); an innovative delivery
device which uses mechanical energy (a spring) to generate a long-lasting,
slow-moving mist for inhalation. [8];[9]

About Tiotropium

Tiotropium (Spiriva ^® ) is a long-acting muscarinic antagonist (LAMA) with a
mode of action that works by opening narrowed airways by targeting a dominant
reversible mechanism - cholinergic bronchoconstriction helping to keep them
open for 24 hours with once-daily dosing. [7];[9]

Tiotropium is licensed for the maintenance treatment of chronic obstructive
pulmonary disease (COPD) symptoms and has comprehensive clinical trial data,
demonstrating extensive experience since its introduction 11 years ago and
over 34 million patient years of real life experience to support its efficacy
and safety profile. [10]

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical
companies. Headquartered in Ingelheim, Germany, it operates globally with 140
affiliates and more than 46,000 employees. Since it was founded in 1885, the
family-owned company has been committed to researching, developing,
manufacturing and marketing novel medications of high therapeutic value for
human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act
socially responsible. Involvement in social projects, caring for employees and
their families, and providing equal opportunities for all employees form the
foundation of the global operations. Mutual cooperation and respect, as well
as environmental protection and sustainability are intrinsic factors in all of
Boehringer Ingelheim's endeavours.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro.
R&D expenditure in the business area Prescription Medicines corresponds to
22.5% of its net sales.

For more information please visit http://www.boehringer-ingelheim.com

Date of Preparation - September 2013

UK/SPI- 131521

                                  References

  (1)  Wise RA, Cotton D, Dahl R et al. Tiotropium Respimat Inhaler and
the Risk of Death in COPD: The TIOSPIR Trial. NEJM 2013; 369(10).

  (2)  National Clinical Guideline Centre. (2010) Chronic obstructive
pulmonary disease: management of chronic obstructive pulmonary disease in
adults in primary and secondary care. London: National Clinical Guideline
Centre. Available from: http://guidance.nice.org.uk/CG101/Guidance/pdf/English
. 2010.

  (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)  Vogelmeier C, Hederer B, Glaab T et al. Tiotropium versus
Salmeterol for the Prevention of Exacerbations of COPD. New Engl J Med:
Supplemental Appendix 2011; 364(12).

  (5)  Bateman ED, Tashkin D, Siafakas N et al. A one-year trial of
tiotropium Respimat plus usual therapy in COPD patients. Respir Med 2010; 104
(10):1460-1472. Respir Med 2010; 104(10):1460-1472.

  (6)  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(15):1543-1554.

  (7)  Boehringer Ingelheim. Spiriva 18 microgram inhalation powder, hard
capsule. Summary of Product Characteristics. (The Electronic Medicines
Compendium) http://www.medicines.org.uk/emc/medicine/10039/SPC/ . Last
accessed: September 2013.

  (8)  Hochrainer D, Hölz H, Kreher C et al. Comparison of the aerosol
velocity and spray duration of Respimat ^® Soft Mist™ inhaler and pressurized
metered dose inhalers. J Aerosol Med 2005; 18(3):273-282.

  (9)  Boehringer Ingelheim. Spiriva Respimat 2.5 micrograms solution for
inhalation. Summary of Product Characteristics. (The Electronic Medicines
Compendium) http://www.medicines.org.uk/emc/medicine/20134/SPC/ . Last
accessed: September 2013.

  (10)  Boehringer Ingelheim. Data on File: SPI13-02(b). 2013.

For further information, please contact: Nick Johnson Communications Manager
Boehringer Ingelheim Limited Tel: +44(0)1344-746792
nick.johnson@boehringer-ingelheim.com Hayley Jayawardene Account
DirectorPorter Novelli Tel: +44(0)20-7853-2227 / +44(0)7720-277117
hayley.jayawardene@porternovelli.co.uk
 
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