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Symbicort(R) Turbuhaler(R) SMART Improves Asthma Symptom Control And Reduces Risk Of Severe Exacerbations, Regardless Of Maintenance Dose

Main Category: Respiratory / Asthma

Article Date: 15 Sep 2009

European Respiratory Society Congress 2009, Vienna, Austria, 15 September 2009: Symbicort® (budesonide/formoterol) Turbuhaler® Maintenance and Reliever Therapy (Symbicort SMART®) provides effective symptom control and reduces the risk of severe exacerbations in symptomatic asthma patients on inhaled corticosteroids (ICS) or combination therapy of ICS and long-acting beta agonists (LABAs) over six months according to today's results from EUROSMART, a large pan-European study of more than 8,000 patients.1

Professor Michel Aubier of Hôpital Bichat, Paris, France, a study investigator said: "EUROSMART shows that budesonide/formoterol maintenance and reliever therapy is highly effective for improving patient outcomes, by controlling symptoms and reducing the risk of asthma attacks. In simple terms, it helps patients to get on with their everyday lives and know that they are also benefitting from a reduced risk of future exacerbations."

The study examined the efficacy and safety of a lower and the highest recommended maintenance doses. Patients in the study took either one or two inhalations of Symbicort Turbuhaler 160/4.5µg twice daily as maintenance therapy, with additional reliever inhalations as needed. The primary endpoint was measured as time to first severe exacerbation and was prolonged with two inhalations of Symbicort 160/4.5µg twice daily as maintenance therapy (hazard ratio 0.82; p=0.03) compared to those patients on one inhalation.

In addition, secondary endpoints included severe exacerbation rate and asthma daily control, as measured by the Asthma Control Questionnaire 5 item version (ACQ-5). ACQ scores improved from 1.85 to 1.09 for patients in the higher maintenance dose inhalation group and from 1.85 to 1.18 for patients in the lower maintenance inhalation group. In addition, the number of uncontrolled patients (ACQ>1.5) was significantly reduced from 60% to 27% in the patients taking two maintenance inhalations twice daily and from 60% to 30% in patients taking one maintenance inhalation twice daily.1

Further results from the EUROSMART study showed that some more severe asthma patients treated in the higher inhalation group may be offered improved efficacy compared to the lower maintenance dose. Lung function as a measure of asthma severity was found to be a significant predictor of improved response to the highest recommended maintenance dose of Symbicort Turbuhaler therapy.2 Patients taking two 160/4.5µg maintenance inhalations twice-daily plus reliever inhalations as needed who had a baseline peak expiratory flow (PEF) of less than 80% predicted normal (PN) reduced their risk of exacerbation by 31% (p=0.02) compared to those taking one 160/4.5µg maintenance inhalation twice-daily plus reliever inhalations as needed.2 In patients with a PEF of above 80% PN, there was a non-significant reduction in the risk of exacerbation by 14% (p=0.2).2

Professor Michel Aubier continued: "Whereas most patients are well-controlled on a maintenance dose of one 160/4.5µg inhalation twice-daily, there are certain patients with more severe asthma who require additional treatment. These patients can benefit from the higher maintenance dose of two 160/4.5µg inhalations twice-daily, and a simple lung function test that can be conducted in a primary care setting can help identify these patients."

EUROSMART also highlighted that patients lacking in asthma control may have lung function values within the normal range, indicating that measures of asthma control in addition to lung function are useful in managing asthma in the clinical setting.3

Additional retrospective analyses derived from five pivotal Symbicort SMART studies were also presented in three abstracts during the ERS Congress. As set out by the GINA guidelines, the goal of asthma management is to achieve daily control and minimise future risk including prevention of exacerbations. Overall Asthma Control (OAC) is the composite of both of these aspects and was demonstrated by the analysis, which showed that Symbicort SMART provided similar or better daily asthma control, as measured by ACQ-5, but with a reduced risk of exacerbations, compared to other common treatment regimens.4

Symbicort SMART was compared to: higher dose ICS, same dose ICS/LABA (long-acting beta agonist) and higher dose ICS/LABA plus SABA (short-acting beta agonist) to assess the percentage of patients with GINA-based controlled asthma and the probability of a change in control status over time.5

The percentage of patients whose asthma was controlled/partly controlled was at least similar with Symbicort SMART compared with higher dose ICS (wk 52: 56% vs 45%), same-dose ICS/LABA (wk 52: 56% vs 53%) and higher dose ICS/LABA plus SABA (wk 25: 54% vs 54%), and also improved over time. The study also showed that across all treatment groups the current level of asthma control in any week predicts stability in the next. Patients who were partly controlled or uncontrolled in any week had significantly lower risk of having an exacerbation the following week when treated with Symbicort SMART compared to all comparators.5

Professor O'Byrne, McMaster University, Hamilton, Canada, an investigator in the analysis, said: "The ability of budesonide/formoterol maintenance and reliever therapy to effectively control asthma daily, as well as reduce the risk of exacerbations compared to other treatment regimens, is extremely important. The incidence of asthma in Europe has doubled to almost 30 million in the past decade and it is still a significant cause of morbidity and mortality.6 It is important that we look at optimising an individual's treatment regime to be able to give them the day-to-day control they need."

Further results from the study confirmed that the similarity between GINA and GOAL definitions of asthma control, with both GINA controlled and partly controlled and GOAL totally and well controlled asthma being similar to ACQ-5<1.0.7

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com

ACQ

The Asthma Control Questionnaire enables a physician to measure both the adequacy of daily asthma control and change in asthma control, comprising seven questions to assess five symptoms of asthma, FEV1% predicted normal and daily rescue bronchodilator use. A score of 0 indicates that asthma is totally controlled, and a score of 6, that it is severely uncontrolled.

About EUROSMART

The open label real-life EUROSMART study followed 8,424 uncontrolled asthma patients (baseline 48 years, 62% female, FEV1 85% PN, inhaled corticosteroid (ICS) dose 1041 µg/day BDP equivalents) for six months, who were treated with budesonide/formoterol maintenance and reliever therapy, largely in a standard primary care setting. Patients were randomised to receive either two 160/4.5µg inhalations twice-daily plus prn or one 160/4.5µg inhalation twice-daily. The primary endpoint was time to first severe exacerbation, and secondary endpoints included severe exacerbation rate and ACQ-5.

Symbicort Turbuhaler SMART

Symbicort Turbuhaler SMART therapy is a patient focussed management approach for improving asthma control and reducing future risk of exacerbations, in line with the practical realities for both the patient and the prescribing physicians.

Symbicort Turbuhaler SMART therapy is the first treatment approach to provide patients with both asthma maintenance and reliever therapy together in one inhaler.

This treatment approach is given an Evidence A rating in the most recent Global Initiative for Asthma's (GINA) guidance: Global Strategy for Asthma Management and Prevention8

Patients prescribed Symbicort Turbuhaler SMART therapy take a maintenance dose of budesonide/formoterol everyday in line with normal practice to establish asthma control and take additional inhalations 'as needed' of budesonide/formoterol if symptoms occur, giving patients a unique opportunity to improve overall asthma control and prevent exacerbations.

Symbicort Turbuhaler SMART therapy successfully completed the European Union Mutual Recognition procedure (MRP) in October 2006 and it is currently approved in over 90 countries worldwide (outside US).

References

1. Aubier M et al. Budesonide/formoterol maintenance and reliever therapy at two different maintenance doses. Abstract presented during the European Respiratory Society Annual Congress, Vienna, Austria, 12-16 September 2009

2. Haughney J et al. Patient characteristics to determine an appropriate maintenance dose of budesonide/formoterol maintenance and reliever therapy. Abstract presented during the European Respiratory Society Annual Congress, Vienna, Austria, 12-16 September 2009

3. Buhl et al: Patients with persistent asthma may have poor disease control despite normal lung function: baseline data from a pan-European real-life study Abstract presented during the European Respiratory Society Annual Congress, Vienna, Austria, 12-16 September 2009

4. Bateman et al: Asthma Control Questionnaire (ACQ-5) predicts future risk of exacerbations. Abstract presented during the European Respiratory Society Annual Congress, Vienna, Austria, 12-16 September 2009 5. Bateman E D et al. Stability of overall asthma control achieved with budesonide/formoterol maintenance and reliever therapy. Abstract presented during the European Respiratory Society Annual Congress, Vienna, Austria, 12-16 September 2009

6. The Global Burden of Asthma Report 2004, Global Initiative for Asthma (GINA). Available from: http://www.ginasthma.org

7. O'Byrne et al. Measuring asthma control: a comparison of three classification systems. Abstract presented during the European Respiratory Society Annual Congress, Vienna, Austria, 12-16 September 2009

8. Global Initiative for Asthma. Global strategy for asthma management and prevention 2007. Available from http://www.ginasthma.org Accessed September 8th, 2008.

Source
Astrazeneca

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Symbicort(R) Turbuhaler(R) SMART Improves Asthma Symptom Control And Reduces Risk Of Severe Exacerbations, Regardless Of Maintenance Dose

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