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.

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. 3980 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. (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. (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. (13)Canadian Institute for Health Information. Respiratory Disease in Canada. (14)Asthma Society of Canada Web site.

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/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/

Posted: March 2007


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