Pulmicort In Childhood Mild, Persistent Asthma - Shown To Be Effective, Safe And Cost-effective

Main Category: Respiratory / Asthma
Also Included In: Pediatrics / Children's Health
Article Date: 09 May 2006 - 0:00 PDT

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New data published in the May supplement to the journal, Pediatric Allergy and Immunology,1,2,3 show that Pulmicort is effective, safe and well-tolerated, and cost-effective in the early treatment of mild, persistent childhood asthma.

In the past decade several studies have demonstrated that airway inflammation, bronchial hyperresponsiveness, airway remodelling and variability in airflow obstruction, which can be most effectively treated with inhaled corticosteroids, are observed not only in severe patients but also in those with mild, persistent asthma.4,5,6 Additionally, several studies reported an often unexpected high morbidity and impairment in patients with mild, persistent asthma.7,8

The results presented today were obtained in children who participated in the Steroid Treatment As Regular Therapy in early asthma (START) study. START was the first worldwide, randomised, controlled, prospective study to investigate early intervention with inhaled glucocorticosteroids (budesonide / Pulmicort Turbuhaler) in newly diagnosed asthmatics. START evaluated early intervention using inhaled Pulmicort once-daily for treatment of newly diagnosed asthma, regardless of their usual asthma therapy.

The traditional approach has been to start treatment in patients with mild disease using reliever bronchodilator only. For some years now, however, interest has been growing in the benefits that may be realised by the use of inhaled corticosteroids as soon as asthma has been diagnosed.

Individually the published papers from the trial sought to answer one of the following three key questions:

-- Does early pharmacologic intervention with inhaled corticosteroids really result in clinically relevant benefits in children with a recent onset mild disease? 1

-- Is early pharmacologic intervention with inhaled corticosteroids safe enough to be justified as a recommended treatment strategy approach in children? 2

-- Is early pharmacologic intervention cost-effective? 3

1,981 children aged between five to ten years were involved in the START study, which was conducted over a three-year study period in 32 countries.

Efficacy results

Addition of 200 μg once-daily budesonide Turbuhaler to usual care in asthmatic children aged <11 years was associated with a significant increase in the time to first severe asthma-related event (SARE) and significantly reduced risk of SARE over three years. The hazard ratio relative to usual care (placebo) was 0.60 (95% confidence interval: 0.40-0.90; p=0.012), with a relative risk reduction of 40%. Children receiving budesonide Turbuhaler also needed significantly less intervention with other inhaled corticosteroids (12.3% vs. 22.5% over three yrs; p<0.01), with trends towards decreased usage of oral/systemic corticosteroids and inhaled short-acting b2-agonists. In conclusion, early intervention adding once-daily budesonide Turbuhaler to usual care in children with mild, persistent asthma of recent onset reduces the long-term risk and frequency of SAREs compared with usual care alone.1

Safety results

Of the study population (1004 on budesonide and 977 on usual care), 81% in the budesonide group and 82% in the usual care group experienced a total of 6414 events (3209 budesonide plus usual care and 3205 placebo plus usual care). The most commonly reported events included respiratory infection, pharyngitis, rhinitis, viral infection and bronchitis, and there were no clinically relevant differences in incidence between treatments. The authors concluded that the addition of once-daily inhaled budesonide 200 µg via Turbuhaler to usual care is safe and well-tolerated in children with newly diagnosed asthma.2

Cost effectiveness results

The addition of once-daily budesonide therapy to usual asthma care was associated with 16 additional symptom-free days (SFDs) per child over the three-year period (p<0.001), with a substantial reduction (50%) in the mean number of days spent in hospital, and with reduced frequency of emergency room visits and missed school and caregiver work days. From the healthcare payer's perspective (direct costs), the increase in mean direct cost over three years with budesonide was $169, which translated into an incremental cost of early intervention with budesonide in children of $10.50 (95% CI $1.20-33.30) per SFD gained. From the societal perspective, there was a cost reduction over three years of $192 with budesonide relative to usual care. In conclusion, early intervention with once-daily budesonide added to usual asthma care in children with mild persistent asthma is cost-saving from a societal perspective and is acceptably cost-effective when viewed from a healthcare payer perspective.3

The prevalence of asthma is increasing, as has the cost of living with the illness. Cost-effectiveness is an increasingly important consideration in modern disease management. With the limited healthcare resources available today, health providers cannot afford the introduction of new treatment strategies that are not cost-effective.

Professor Soren Pedersen, Kolding Hospital, Denmark,comments 'What I think clinicians will find particularly interesting in these new data are their ability to build the fullest picture with regard to the early use of Pulmicort in a real world setting in children with newly diagnosed mild asthma. It closes the circle in terms of the uncertainties that have existed with regards to whether an early intervention strategy in asthma can improve outcomes and shows that first-line treatment with Pulmicort is not only effective, safe and well-tolerated, but also justified in terms of health provider cost and in improvement to patients' well being.'

Pulmicort

Pulmicort (budesonide) is an inhaled corticosteroid indicated for maintenance treatment of asthma in children and adults. In some countries Pulmicort is also indicated for maintenance treatment of COPD.

Budesonide has pronounced and long lasting anti-inflammatory effects in the airways, and has a rapid systemic elimination, which results in a high therapeutic ratio. Administration via Turbuhaler, which delivers a high fraction of budesonide fine particles into the lungs, and less drug at unwanted sites, further enhances the therapeutic ratio.

Core documentation of the benefits and possible side effects of inhaled steroids has been gained through studies with Pulmicort. Once daily administration, early intervention and long-term use in children have thoroughly been documented with Pulmicort. Long-term safety studies using clinically relevant doses show no influence on final height of children, nor on bone mineral density or fracture risks in adult asthma and COPD patients.

The START Study

START was the first worldwide, randomised, controlled, prospective study to investigate early intervention with inhaled glucocorticosteroids (budesonide / Pulmicort Turbuhaler) in newly diagnosed asthmatics. START evaluated whether early intervention using inhaled Pulmicort once daily was an optimal treatment for newly diagnosed asthma, regardless of their usual asthma therapy.

Full efficacy results for START have already been published in Pauwels et al., Lancet 2003; 361: 1071-76

AstraZeneca

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 $23.95 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 FTSE4Good Index.

References

1. Chen Y-Z, Busse WW, Pedersen S, et al. Early intervention of recent onset mild persistent asthma in children aged under 11yrs: the Steroid Treatment As Regular Therapy in early asthma (START) trial. Pediatr Allergy Immunol 2006: 17 (Suppl. 17): 7-13
2. Silverman M, Sheffer AL, Diaz PV, et al. Safety and tolerability of inhaled budesonide in children in the Steroid Treatment As Regular Therapy in early asthma (START) trial. Pediatr Allergy Immunol 2006: 17 (Suppl. 17): 14-20
3. Weiss K, Buxton M, Andersson FL, et al. Cost-effectiveness of early intervention with once-daily budesonide in children with mild persistent asthma: results from the START study. Pediatr Allergy Immunol 2006: 17 (Suppl. 17): 21-27
4. National Asthma Education and Prevention Program (NAEPP). Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD: National Heart, Lung, and Blood Institute, National Institutes of Health, 1997
5. National Asthma Education Prevention Program (NAEPP). Expert panel report: guidelines for the diagnosis and management of asthma-update on selected topics. J Allergy Clin Immunol 2002: 110: S141-219
6. Laitinen LA, Laitinen A, Haahtela T. Airway mucosal inflammation even in patients with newly diagnosed asthma. Am Rev Respir Dis 1993: 147: 697-704
7. Robertson CF, Rubinfeld AR, Bowes G. Pediatric asthma deaths in Victoria: the mild are at risk. Pediatr Pulmonol 1992: 13:95-100
8. Suissa S, Ernst P, Benayoun S, et al. Low-dose inhaled corticosteroids and the prevention of death from asthma. N Engl J Med 2000: 344: 332-6

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