Established Safety Profile of SPIRIVA(R) reinforced by analysis from 30 Rigorously Controlled Clinical Trials



    New data from landmark UPLIFT(R) Trial Further Supports Spiriva's Safety

    BURLINGTON, ON, Sept. 23 /CNW/ - Boehringer Ingelheim and Pfizer have
performed a new analysis of 30 rigorously controlled clinical trials
confirming the long term safety profile of Spiriva(R) (tiotropium). The new
and expanded safety data contradicts the conclusions about tiotropium in an
article by Singh et al. published in the September 24 issue of the Journal of
the American Medical Association.(1) Both companies considered it important to
communicate these data prior to publication to ensure doctors have the most
comprehensive, up-to-date safety information on tiotropium in order to make
the best treatment decisions for their patients.
    Because COPD patients (Chronic Obstructive Pulmonary Disease) have in
general a higher cardiovascular risk than the average population(2),
cardiovascular safety in a COPD medication is of critical importance.
Therefore Boehringer Ingelheim has put special emphasis on the broad
investigation of Spiriva(R) including its cardiovascular safety.
    The latest analysis of 30 placebo-controlled double-blind, randomized
trials with data from 19,545 COPD patients (tiotropium 10,846; placebo 8,699),
conducted by Boehringer Ingelheim demonstrated that there is no increased risk
of death (all-cause) or death due to cardiovascular events in patients treated
with (*)Spiriva(R) specifically:

    
    -  All-cause mortality (relative risk ratio for all cause
       mortality= 0.88, CI=95% 0.77, 0.999)(xx)
    -  Mortality due to cardiac events (relative risk ratio for mortality due
       to cardiac events= 0.77, CI= 95% 0.55, 1.03) and
       vascular events (relative risk ratio for mortality due to vascular
       events= 0.44, CI= 95% 0.19, 1.02)(xx).
    -  Risk of stroke (relative risk ratio for stroke = 1.03,
       CI= 95% = 0.79,1.35)(xx) and
    -  Risk for myocardial infarction (relative risk ratio for myocardial
       infarction 0.78, CI= 95% 0.59, 1.02)(xx) associated with
       tiotropium.(3)
    

    "We strongly disagree with the conclusion reached by Singh et al. We have
disclosed to regulatory authorities worldwide this important information which
is part of a very robust analysis of all our double-blind, placebo-controlled,
parallel group trials with a duration of at least four weeks. Our analysis,
which includes data from the four-year UPLIFT trial, supports the safety
profile of Spiriva," commented Dr. Andreas Barner, Vice Chairman of the Board
of Managing Directors at Boehringer Ingelheim, responsible for Research,
Development and Medicine. "Patients and physicians can be confident that
Spiriva is a safe and effective medication. In clinical trials and since its
introduction, we have collected extensive safety data adding up to an exposure
of more than 10 million patient years."
    Peer-reviewed meta-analyses of aggregate published data like Singh et
al(1) have their appropriate place in scientific research. However, these
analyses have well-recognised limitations, such as combining study summaries
rather than analyzing individual patient data, or not correcting for patients
who dropped out of trials early.
    Most of the evidence in the analysis by Dr. Singh and colleagues is
contributed by a single study, the Lung Health Study(4), involving a different
anticholinergic medication, (ipratropium). In this study most of the
cardiovascular deaths occurred among patients who were not using their
medication. Other limitations include the inability to adjust for treatment
duration, accounting for patients who discontinue the trial early, apparent
double-counting of trials, and combining placebo and active comparator drugs
in the control group.
    The integrated safety data communicated today includes data from the
UPLIFT(R) trial, a study that includes mortality as a pre-specified endpoint.
UPLIFT(R) (Understanding Potential Long-term Impacts on Function with
Tiotropium), one of the largest COPD trials ever undertaken, involved 5,993
COPD patients from 37 countries around the globe over a four-year treatment
period. Patient safety during the trial was closely followed by an independent
Data Safety Monitoring Board.
    The complete results of the UPLIFT(R) trial will be presented on October
5th during the European Respiratory Society 2008 Annual Congress in Berlin.
    "What's important is for Canadian physicians and patients to realize that
the research strongly supports Spiriva as a safe and important medication for
the management of this serious respiratory disease," said Dr. Brad Pamenter,
Director of Medical Affairs at Boehringer Ingelheim Canada. "Many Canadians
with COPD rely on this important and safe medication."
    A 2007 report commissioned by The Canadian Lung Association shows that
1.5 million Canadians have been diagnosed with COPD, Canada's fourth leading
cause of death. Another 1.6 million Canadians may have COPD but haven't yet
been diagnosed which means up to 3 million Canadians may have COPD. Doctors
project that COPD will be the third leading cause of death around the world
(and in Canada) by the year 2020.

    About Spiriva(R) (tiotropium)

    Spiriva(R), a long-acting inhaled anticholinergic medication, is the
first inhaled treatment to provide significant and sustained improvements in
lung function with once-daily dosing. Spiriva(R) is indicated for the long
term, once daily, maintenance treatment of bronchospasm associated with
chronic obstructive pulmonary disease (COPD), including chronic bronchitis and
emphysema It is the most prescribed medication for the treatment of COPD in
the world.(5)
    Spiriva(R) works through targeting of a dominant reversible mechanism of
COPD - cholinergic bronchoconstriction. Spiriva(R) helps COPD patients breathe
easier by opening narrowed airways and helping to keep them open for 24 hours.
    The Spiriva(R) clinical trials programme has recruited over 20,000
patients.(6) Spiriva(R) has demonstrated significant and sustained
bronchodilation (opening of the airways)(6),(7) and reduction in
hyperinflation (air trapping).(8),(9) Spiriva(R) also demonstrated superior
and sustained improvements in lung function (FEV1) over ipratropium bromide
(ATROVENT(R)) Inhalation Aerosol, a current first-line therapy for COPD, which
were maintained over one year(6) and has also performed better than salmeterol
in trough response over the 24 weeks of the study.(10) In addition, in
placebo-controlled studies, patients treated with Spiriva(R) had less
activity-induced breathlessness and improved exercise endurance. They required
fewer doses of rescue medications, had fewer exacerbations and fewer
exacerbations leading to hospitalizations(9). In clinical trials, the most
common adverse reaction reported with Spiriva(R) was dry mouth, which was
usually mild and often resolved during treatment.(6),(9)
    Long-acting bronchodilators, including Spiriva(R), are a preferred
maintenance therapy for COPD from stage II onwards according to the Global
Initiative for Chronic Obstructive Lung Disease (GOLD) treatment
guidelines.(11)
    About Boehringer Ingelheim

    The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 135 affiliates in 47 countries and 39,800 employees. Since it
was founded in 1885, the family-owned company has been committed to
researching, developing, manufacturing and marketing novel products of high
therapeutic value for human and veterinary medicine.
    In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while
spending one fifth of net sales in its largest business segment Prescription
Medicines on research and development.
    For more information please visit www.boehringer-ingelheim.com

    References

    
    -------------------------
    (*)  Data currently under review by Health Canada.
    (xx) Relative Risk Ratio (less than) 1= lower risk with
         tiotropium; Relative Risk Ratio (greater than) 1= higher
         risk with tiotropium; Data currently under review by Health Canada

    (1)  Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of
         major adverse cardiovascular events in patients with chronic
         obstructive pulmonary disease. A systematic review and meta-
         analysis. JAMA. 2008;300:1439-1450.
    (2)  Huiart L, Ernst P, Suissa S. Cardiovascular morbidity and mortality
         in COPD. Chest.2005;128:2640-2646.
    (3)  Boehringer Ingelheim, Data on file.
    (4)  Lanes S, Golisch W, Mikl J. Ipratropium and Lung Health Study. Am J
         Respir Crit Care Med. 2003:167:801.
    (5)  IMS Health, IMS MIDAS(tm), 2Q2005
    (6)  Boehringer Ingelheim. Data on file.
    (7)  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.
    (8)  Celli B, ZuWallack R, Wang S, et al. Improvement in resting
         inspiratory capacity and hyperinflation with tiotropium in COPD
         patients with increased static lung volumes. Chest 2003; 124:
         1743-1748.
    (9)  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
    (11) Pocket Guide to COPD diagnosis, management, and prevention - A guide
         for healthcare professionals. Global Initiative for Chronic
         Obstructive Lung Disease. Available at: http://www.goldcopd.com
    





For further information:

For further information: Boehringer Ingelheim Canada Limited: Derek
O'Toole, Director, Market Access and Communications, Phone: (905) 631-4757,
derek.otoole@boehringer-ingelheim.com


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