New data for Pulmicort(reg) strengthens existing evidence for early intervention in asthma

Main Category: Respiratory / Asthma
Article Date: 24 Jan 2005 - 11:00 PDT


Lund, Sweden, January 24, 2004: New results from the START study1 are published today in the Annals of Allergy, Asthma and Immunology, revealing three-year safety outcome data for Pulmicort (budesonide). These data further reinforce previous findings that Pulmicort in low doses is well tolerated in long term treatment of asthma in both adults and children.

Patients enlisted in the START study - the largest ever controlled asthma trial involving more than 7,000 patients in 32 different countries - were aged from 5-66 years and randomised to receive either Pulmicort or placebo once daily in addition to their usual asthma therapy. Pulmicort was taken via Turbuhaler in a once daily dosing of 200 ug in children and 400 ug in adults. Adverse event related findings between the two treatment groups are as follows:

-- Fewer serious adverse events (SAE) related to asthma in the Pulmicort (30 per cent) versus placebo group (39 per cent)

-- Similar non-asthma related SAEs (Pulmicort n=378, placebo n=425)

-- Comparable incidence, severity and type of adverse events (AE) across all ages and both treatment groups (Pulmicort n=10,850, placebo n=10,670)

-- A similar number of AEs commonly associated with usage of inhaled corticosteroids were seen in those taking placebo

These important findings add further weight to previously revealed clinical benefits among patients in the Pulmicort group: reduced risk of first severe asthma related event by 44 per cent; improved asthma control indicated by 14.1 more symptom free days per year; 69 per cent reduction in days in hospital; 67 per cent reduction in emergency treatments; 36 per cent reduction in physician visits2,3.

Professor Silverman, co-author of the study commented, "The START study is an important study of the long-term tolerability of Pulmicort, demonstrating that as well as providing a well tolerated medication for the treatment of mild persistent asthma, early intervention with an ICS can actually prevent the transition to more severe asthma by reducing the number and severity of symptoms experienced."

Various short and long-term studies have shown initiating treatment with Pulmicort early in the asthma disease improves lung function, asthma control and airway inflammation to a higher extent than if treatment is delayed4-11. This ultimately decreases maintenance dose and overall drug load in the long-term4-11.

Included in the analysis of study results were the effects of Pulmicort in pregnant women. Pregnancy outcomes did not differ between the treatment categories.

Treatment guidelines such as GINA12 have advocated wider use of inhaled corticosteroids in mild persistent asthma for a number of years, but in practice many physicians choose to wait until the disease becomes more severe before initiating treatment with inhaled corticosteroids. START demonstrates powerful evidence to support the guidelines.

As with all inhaled corticosteroids systemic effects may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important therefore that the dose of inhaled steroid is titrated to the lowest dose at which effective control of asthma is maintained. It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

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Notes to editors

-- START - a 'real-life', long-term international study - is the first of its kind to investigate the outcomes of early intervention with Pulmicort in a large number of patients of all ages with newly diagnosed, mild persistent asthma

-- Inclusion criteria for the study involved patients who had suffered from mild persistent asthma for less than two years and who had not received regular corticosteroid treatment, Pulmicort or placebo once daily for three years in addition to their usual asthma therapy

-- Daily dosage for children younger than 11 years was 200 ug and for patients 11 years and older, dosage was 400ug

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E-mail: cecilia.svensson@astrazeneca.com

Virgo Health PR
Neil Flash/Rachel Chan
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rachel.chan@virgohealthpr.com

References

1 Sheffer AL, Silverman M, Woolcock AJ, Diaz PV, Lindberg B, Lindmark B. Long-term safety of once-daily budesonide in patients with early onset, mild persistent asthma: results of the inhaled Steroid Treatment As Regular Therapy in early asthma (START) study. Annals of Allergy, Asthma and Immunology 2005; 94:48-54.

2 Pauwels R, Pedersen P, Busse WW et al. Early intervention with budesonide in mild persistent asthma: a randomised double-blind trial. Lancet 2003;361:1071-1076.

3 Sullivan S, Buxton M, Andersson F, Lamm C J, Liljas B, Chen Y, Pauwels R, Weiss K. Cost-effectiveness analysis of early intervention with budesonide in mild persistent asthma. J Allergy Clin Immunol 2003;112(6)1229-1236.

4 Laitinen LA, Laitinen A, Haahtela T. Airway mucosal inflammation even in patients with newly diagnosed asthma. Am Rev Respir Dis 1993;147:697-704.

5 Haahtela T, Jarvinen M, Kava T, et al. Comparison of a beta 2-agonist, terbutaline, with an inhaled corticosteroid, budesonide, in newly detected asthma. New England Journal of Medicine 1991;325:388-392.

6 Haahtela T, Jarvinen M, Kava T, et al. Effects of reducing or discontinuing inhaled budesonide in patients with mild asthma. New England Journal of Medicine 1994;331:700-705.

7 Selroos O, Pietinalho A, Lofroos A-B, Riska H. Effect of early vs late intervention with inhaled corticosteroids in asthma. Chest 1995;108:1228-1234.

8 Selroos OB, Lofroos AB, Niemisto M, et al. Early introduction with inhaled steroids in asthma results in achievement of treatment goals. American Journal of Respiratory Critical Care Medicine 1999;159(3 Pt 2 Suppl):A627.

9 Selroos OB, Niemisto M, Lofroos A. A double blind, randomized, dose-response study with budesonide in asthma patients with short or long duration of symptoms. American Journal of respiratory Critical care medicine 1999;159(3 Pt Suppl):A627.

10 Agertoft L, Pedersen S. Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respiratory Medicine 1994;88:373-381.

11 Turpeinen M. Helsinki early intervention childhood asthma (HEICA) study: inhaled budesonide halved the number of asthma exacerbations compared with inhaled disodium cromoglycate during 18 months of treatment. European Respiratory Journal 2000;16(Suppl 31):311s.

12 National Institute for Health, National Heart Lung and Blood Institute. Global Initiative for Asthma (GINA). Publication number 02-3659, 2002. http://www.gina

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