SMC Adopts Positive Opinion For Symbicort® Maintenance And Reliever Therapy (Symbicort SMART®)

Main Category: Respiratory / Asthma
Also Included In: Allergy
Article Date: 12 Jun 2007 - 1:00 PDT

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AstraZeneca's Symbicort® (budesonide/formoterol) Maintenance And Reliever Therapy (Symbicort SMART®) has today been accepted for use in Scotland by the Scottish Medicines Consortium (SMC).

Thousands of adult asthma patients aged 18 years of age and over will now have access to the medicine, following its approval for NHS prescription in Scotland. Symbicort SMART, launched in the UK earlier this month, is the first treatment approach to allow patients uncontrolled on inhaled corticosteroids (ICS) to receive both maintenance and reliever therapy in a single inhaler.

It is estimated that as many as 5.2 million people in the UK suffer from asthma - 390,000 in Scotland alone - making it one of the most common chronic diseases. With as many as 1,400 annual deaths from asthma in the UK2, 90% are preventable, and an estimated 75% of hospital admissions are avoidable.2 Poorly controlled asthma places a substantial economic burden on the NHS, with the annual cost of treating asthma estimated at £889 million.2

The SMC, which advises the NHS boards on the use of newly licensed medicines in Scotland, has advised that Symbicort SMART be accepted for use within NHS Scotland for the regular treatment of adult asthma, where the use of a combination (inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA)) is appropriate. Symbicort is taken as regular maintenance treatment and as needed for relief of symptoms. Patients suitable for the Symbicort SMART treatment approach would no longer require a separate short-acting bronchodilator (SABA) for the treatment of asthma symptoms. Patients should be advised to always have their Symbicort available for rescue use.

Aberdeen based General Practitioner, Dr Iain Small, comments "The Symbicort SMART approach is easy to use, and offers patients the convenience of achieving control of their asthma symptoms using a single inhaler. Whilst benefiting patients, it can also benefit the NHS - a reduction in both symptoms and the number of attacks patients experience has the potential to reduce emergency admissions and unscheduled hospital visits."

The SMC recommendation is based on clinical trial evidence submitted by AstraZeneca. Five double blind randomised controlled trials were conducted which support the use of Symbicort for maintenance and reliever therapy. Three of these studies included combination (ICS and LABA) maintenance treatment as comparative.4,5,6 Symbicort SMART significantly increased the time to the first severe exacerbation and the rate of exacerbations was reduced by 45% 4,5 compared with fixed dose Symbicort plus a separate short acting reliever inhaler. Compared with Seretide (salmeterol/fluticasone) at a higher maintenance steroid dose plus separate reliever, Symbicort SMART significantly prolonged the time to the first severe exacerbation and reduced the rate of hospitalisation/emergency room treatment.6

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

· Full details of the SMC recommendation can be found on the SMC website http://www.scottishmedicines.org.uk.

The full wording is:

Budesonide/formoterol turbohaler (Symbicort® SMART®) is accepted for use within NHS Scotland, in adults, for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2- agonist) is appropriate; Symbicort is taken as regular maintenance treatment and as needed in response to symptoms.

In patients using inhaled budesonide/formoterol as preventer therapy, use of the same inhaler for reliever therapy is associated with a longer time to first severe exacerbation than use of comparator reliever regimens.

In addition, some patients may be able to reduce the dose of preventer therapy.

-- Many asthma patients require maintenance treatment with an inhaled corticosteroid, which suppresses the underlying airway inflammation, and a bronchodilator, which relaxes the smooth muscle of the airways.

-- With Symbicort SMART, patients receive a maintenance dose of Symbicort to establish asthma control, and take additional inhalations 'as needed' of Symbicort if symptoms occur, to provide both rapid symptom relief and increased asthma control.

-- As with other combination asthma therapies, Symbicort SMART is not licensed for prophylactic use e.g. before exercise.1

1) Symbicort Summary of Product Characteristics
2) Asthma UK, http://www.asthma.org.uk/news_media/media_resources/for_1.html
3) Asthma UK - Scotland, http://www.asthma.org.uk/scotland/index.html
4) Rabe K, Atienza T, Magyar P, Larsson P, Jorup C, Lalloo UG. Reduction in asthma exacerbations with budesonide in combination with formoterol for reliever therapy: a randomised, controlled, double-blind study. Lancet 2006;368: 744-53.
5) O'Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y, Ekström T, Bateman E. Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma. American Journal of Respiratory and Critical Care Medicine 2005; 171(2): 129-136.
6) 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.
7) Rabe K, Pizzichini E, Ställberg B, Romero S, Balanzat AM, Atienza T, Lier PA, 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.
8) Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, Boulet L-P, Naya IP, Hultquist C. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Current Medical Research

http://www.astrazeneca.com

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