A new approach to asthma treatment approved by Health Canada



    ~ Symbicort(R) SMART(TM) can be used as immediate rescue - providing
    maintenance and reliever in one inhaler ~

    MISSISSAUGA, ON, March 6 /CNW/ - For the first time, Canadians with
asthma will be able to carry one inhaler that provides both maintenance
treatment and rapid symptom relief. AstraZeneca Canada today announced that
Symbicort(R) Maintenance And Reliever Therapy (Symbicort(R) SMART(TM)), a new
smart approach for asthma treatment, has received Health Canada approval.
    "Symbicort(R) SMART(TM) is a new approach to asthma management that
treats the underlying inflammation of the airways, one of the key causes of
asthma, with every inhalation - even when used as a rescue medication," said
Dr. Andrew McIvor, Professor of Medicine at McMaster University. "This simple
treatment approach has the potential to help patients control their asthma
more effectively and therefore reduce the incidence of asthma attacks."

    The Reality of Asthma Control

    Until now, there has been an unmet need for new approaches to asthma
management. Despite effective treatments, a recent survey showed that while
97 per cent of respondents believe their asthma is controlled, in reality,
more than half (53 per cent)(1) have not achieved control of their disease
according to Canadian Asthma Consensus Guidelines parameters.(2)
    People with asthma tend to over-rely on their reliever or short-acting
bronchodilators, increasing their use in response to a worsening of their
asthma symptoms.(3) However, since such treatments (e.g., salbutamol and
terbutaline) do not address the underlying inflammation of the airways, which
is a key cause of asthma, these treatments do not contribute to asthma symptom
control. Symbicort(R) SMART(TM) is a new management approach that helps
address this fundamental problem.

    Maintenance and Reliever in One Inhaler

    With Symbicort(R) SMART(TM), the treatment approach ensures that with
every inhalation, patients receive medication to treat their long-term disease
to improve control of their symptoms(4) and reduce exacerbations.(4) This is
possible with Symbicort(R) SMART(TM), since it combines two components:
budesonide, an inhaled corticosteroid (ICS) that provides an anti-inflammatory
effect in the airways, and formoterol, a bronchodilator that opens the airways
and is both rapid in effect and long-lasting.
    Recently updated international treatment guidelines, published by the
Global Initiative for Asthma (GINA), placed emphasis on the concept that the
goal of asthma treatment is to achieve and maintain clinical control.(5) The
guidelines support the need for a new management approach - Symbicort(R)
SMART(TM).(5)
    Symbicort(R) SMART(TM) has been tested in a large clinical trial program
involving more than 14,000 patients with mild to severe persistent asthma. The
results of the studies indicate that Symbicort(R) SMART(TM) improves overall
asthma symptom control. The data also shows a significant reduction in the
risk of patients developing potentially life-threatening asthma attacks,
compared to traditional treatment approaches.(6),(7),(8),(9),(10),(11) In
Canada, Symbicort(R) SMART(TM) is approved for use in adults and adolescents
(12 years and older).(4)

    About AstraZeneca

    AstraZeneca is a leading global pharmaceutical company with an extensive
product portfolio spanning six major therapeutic areas: gastrointestinal,
cardiovascular, infection, neuroscience, oncology, and respiratory.
AstraZeneca's Canadian headquarters and packaging facilities are located in
Mississauga, Ontario, and its state-of-the-art drug discovery centre is based
in Montréal, Québec. For more information, visit the company's Web site at
www.astrazeneca.ca.

    A B-roll will be available at 10:00 and 14:00 EST at the following
coordinates:

    Anik F2C/8B @ 111.1 West
    Vertical Polarization, D/L Freq. 4020 MHz.
    Audio subcarriers 6.8 left, 6.2 right

    Available at Toronto T.O.C.:
    PGAD 11:00 - 11:30 and 14:00 - 14:30 Eastern, Tuesday March 6th, 2007
    (SDI Router Position No. 42)

    NOTE TO EDITORS:

    Asthma is a chronic and variable disease that can change both daily and
seasonally. When not properly controlled, asthma symptoms can lead to
wheezing, tightness in the chest, difficulty breathing and cough.(12) More
than 2.4 million Canadians suffer from asthma(13) with symptoms that can be
mild, moderate or severe and may vary widely from person to person. Despite
effective treatment options, approximately 500 Canadians die each year from
asthma.(14)

    Symbicort(R) SMART(TM): Supported by International Treatment Guidelines

    Recently updated international treatment guidelines published by GINA
provide a change in emphasis to the recommended treatment approach for asthma,
and support the need for a new management approach in one inhaler -
Symbicort(R) SMART(TM). The guidelines state:

    
    -   Combination inhalers containing formoterol and budesonide may be used
        for both rescue and maintenance(5) - only Symbicort(R) SMART(TM) is
        approved for this indication;

    -   The use of the combination of a rapid and long-acting (beta)2-agonist
        (formoterol) and an inhaled glucocorticosteroid (budesonide) in a
        single inhaler both as a controller and reliever is effective in
        maintaining a high level of asthma control and reduces exacerbations
        requiring systemic glucocorticosteroids and hospitalization;(5)

    -   Both components of budesonide-formoterol given as-needed contribute
        to enhance protection from severe exacerbations in patients receiving
        combination therapy for maintenance and provide improvements in
        asthma control at relatively low doses of treatment.(5)

    The guidelines state that, since Symbicort(R) is the only ICS/LABA
(inhaled corticosteroid/long-acting (beta)2-agonist) combination medication
with data to demonstrate its efficacy for both maintenance and reliever
therapy, alternative approaches should be used for patients on other
controller therapies.

    References:

    -----------------------------
    (1) FitzGerald, et al. Asthma control in Canada remains suboptimal: The
        Reality of Asthma Control (TRAC) study. Can Respir J, 2006; 13
        (5):253-259.
    (2) Boulet LP, et al. Canadian asthma consensus report, 1999. CMAJ,
        Nov 30, 1999; 161(11 Suppl) S3.
    (3) Partridge MR, et al. Attitudes and actions of asthma patients on
        regular maintenance therapy: the INSPIRE study. BMC Pulmonary
        Medicine 2006; 6:13. http://www.biomedcentral.com/1471-2466/6/13.
        Retrieved on February 1, 2007.
    (4) AstraZeneca Canada Inc. Symbicort(R) Product Monograph: Part I:
        Health Professional Information, Dec. 19, 2006.
    (5) The Global Initiative for Asthma (GINA). GINA Report, Global Strategy
        for Asthma Management and Prevention. www.ginasthma.com. Retrieved on
        December 7, 2006.
    (6) Rabe K, Atienza T, Magyar P, Larsson P, Jorup C, Laloo U. Effect of
        budesonide in combination with formoterol for reliever therapy in
        asthma exacerbations: a randomized controlled, double-blind study.
        The Lancet August 26, 2006; Vol 368: 744-753.
    (7) Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S,
        Naya I, Price D. Budesonide/formoterol maintenance and reliever
        therapy: an effective asthma treatment option? Eur Respir J 2005;
        26(5): 819-828.
    (8) O'Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y,
        Ekstrvm T, Bateman E. Budesonide/Formoterol Combination Therapy as
        Both Maintenance and Reliever Medication in Asthma. Am J Respir Crit
        Care Med 2005; 171(2): 129-136.
    (9) Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S,
        Boulet LP, Naya IP, Hultquist C. Efficacy and safety of
        budesonide/formoterol single inhaler therapy versus a higher dose of
        budesonide in moderate to severe asthma. Curr Med Res Opin 2004;20
        (9): 1403-18.
    (10)Rabe K, Pizzichini E, Stdllberg B, Romero S, Balanzat A, Atienza T,
        Lier P, and Jorup C. Budesonide/formoterol in a Single Inhaler for
        Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized,
        Double-Blind Trial. Chest Feb 2006; 129: 246-256.
    (11)Kuna P, Peters MJ, Buhl R. Budesonide/formoterol as maintenance and
        reliever therapy reduces asthma exacerbations versus a higher
        maintenance dose of budesonide/formoterol or salmeterol/fluticasone.
        Abstract presented at the ERS Congress, 2006.
    (12)The Canadian Lung Association Web site. www.lung.ca. Retrieved on
        December 4, 2006.
    (13)Canadian Institute for Health Information. Respiratory Disease in
        Canada. http://www.cihi.ca/cihiweb/dispPage.jsp?cw_page=
        PG_84_E&cw_topic=84&cw_rel=AR_13_E. Retrieved
        on February 7, 2007.
    (14)Asthma Society of Canada Web site. www.asthma.ca. Retrieved on
        February 1, 2007.
    





For further information:

For further information: or for an interview with Dr. Andrew McIvor,
please contact: Sherry Zarins, AstraZeneca Canada Inc., Tel.: (905) 615-6845;
Daniela Ferri, Jennifer Goode, Edelman, Tel.: (416) 979-1120, ext. 272/230


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