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Treatment of Only 2 COPD Patients with Symbicort(reg) Needed to Avoid 1 Exacerbation Per Year Requiring Medical Intervention

New data analysis reveals that only two patients need to be treated with Symbicort as compared to the long-acting bronchodilator formoterol alone, to avoid one exacerbation requiring medical intervention in one year.1 The analysis, presented for the first time at ATS, is based on data from two clinical trials with patients having moderate to severe chronic obstructive pulmonary disease (COPD).2,3 This numbers needed to treat (NNT) analysis suggests a potential for improvements in quality of life and cost savings with the use of Symbicort in the treatment of COPD.

Dr David Halpin, Consultant Physician and Senior Lecturer in Respiratory Medicine, Royal Devon & Exeter Hospital, UK and author of the study commented: "We know that patients worry about having exacerbations. They are the respiratory equivalent of heart attacks.

They are distressing for patients, they lead to a significant reduction in quality of life and contribute to the decline in lung function, ultimately leading to death. The NNT values provided by this analysis are good news for doctors and patients.

In many disease areas we need to treat many more patients before a benefit is seen. For example, for in cardiovascular disease we are more familiar with NNT values of over ten and often over 100. A NNT value of two to prevent an exacerbation is very encouraging."

Lower exacerbation frequency consistently correlates with better health-related quality of life and Symbicort has previously been shown to reduce the frequency of COPD exacerbations and improve quality of life.2,3 In addition, the cost of a severe exacerbation has been estimated to be almost $3,0001. In light of the economic, physical and psychological burden, preventing exacerbations is an important treatment goal in COPD.4

Data for COPD patients participating in two randomised clinical trials comprising more than 1800 patients were analysed.2,3 The NNT to avoid one exacerbation requiring medical intervention in one year was calculated and medication costs were recorded.

The analysis shows that treating 24 and 21 patients in the two studies, with Symbicort instead of a long-acting bronchodilator (formoterol) alone, avoids 10 exacerbations requiring medical intervention in one year.1 The NNT values for avoiding one exacerbation using Symbicort instead of a long-acting bronchodilator alone in the two studies were 2.4 and 2.1 respectively.

The mean total Swedish unit cost of medication per patient per year was estimated to be $1126 for Symbicort and $874 for formoterol.1 Thus, treating COPD patients with Symbicort was very effective as measured by the numbers needed to treat (NNT=2.1 and 2.4).1

Dr Anders Ekblom, Vice President & Head of the Respiratory & Inflammation Therapy Area, AstraZeneca explained: "AstraZeneca is encouraging clinicians to offer a positive outlook towards the management of COPD, helping patients to make the most of living with their condition." He continued: "With effective treatments, clinicians can help these patients reduce the exacerbations that can have a large impact on their lives, and improve patients' quality of life. Even for those patients who have severe COPD, clinicians should aim to achieve the best quality of life possible for them through such treatments."

Additional data also presented at ATS has revealed that exacerbations associated with COPD exert a huge physical and psychological impact on patient's lives5 and avoiding these times of 'crisis' is what matters most to patients and even more so than improving symptoms.6

There are 600 million COPD sufferers worldwide; making COPD one of the world's most common chronic diseases.4 Most cases of COPD develop after repeatedly breathing in fumes and other things that irritate and damage the lung and airways. Cigarette smoking is the most common irritant that causes COPD.7 By 2020, COPD is estimated to become the third leading cause of death.8

Notes to Editors

Further information is provided on:

-- COPD and Exacerbations: Background Information

-- COPD and Exacerbations: Key Facts and Figures

Definition of an Exacerbation

"The exacerbation of respiratory symptoms requiring medical intervention [oral steroids and/or antibiotics and/or or hospitalisation]."

In addition to their everyday symptoms, patients with more severe COPD suffer acute exacerbations (of symptoms). An exacerbation is a deterioration in a patient's clinical status, with worsening of respiratory symptoms, such as coughing, wheezing, sputum production and shortness of breath. Exacerbations may also be accompanied by non-specific complaints such as malaise, insomnia, fatigue, depression, and confusion. For patients with severe COPD, exacerbations tend to be associated with cardiac symptoms as well as respiratory symptoms.

Health-Related Quality of Life (HRQL): Refers to the overall enjoyment of life and an individual's sense of well-being and ability to perform various tasks.

Health Status: Refers to the level of health of the patient as subjectively assessed by the individual or by more objective measures.

Numbers Needed to Treat (NNT)

The number needed to treat (NNT) provides an estimate of the number of patients who need to be treated to attain an additional favourable outcome, or to prevent an additional adverse outcome, and is the reciprocal of the absolute risk reduction. The closer the NNT is to 1.0 - meaning that every patient who is treated achieves a benefit - the more effective the treatment.

Unit Cost of Medication

Swedish unit cost of medication was calculated for the sole reason that the analysis itself was carried out in Sweden.

www.astrazenecapressoffice.com About Symbicort(reg) (budesonide/formoterol)

-- Budesonide is an inhaled corticosteroid (ICS) and formoterol a rapid- and long-acting beta-agonist (LABA)

-- Symbicort is indicated for the treatment of asthma and severe COPD.

-- Symbicort is a valuable addition to the range of medications for COPD as it is the first ICS/ LABA combination medicine that has been shown in studies to reduce the risk of exacerbations requiring medical intervention more than long-acting bronchodilators alone.2,3 Symbicort also provides a rapid and sustained improvement in symptoms and lung function, and an improvement in health-related quality of life that the patient clearly can recognise.

About AstraZeneca

AstraZeneca is a major international health care business engaged in the research, development manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceuticals in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4 Good Index.

For more information, please visit http://www.astrazenecapressoffice.com

Press Contacts:
AstraZeneca Virgo HEALTH PR
Anette Orheim Louisa Hull/Jennie Conway
Phone: +46 46 33 60 00 Phone: +44 (0) 20 8822 6707
E-mail: anette.orheim@astrazeneca.com louisa.hull@virgohealthpr.com
jennie.conway@virgohealthpr.com

References

1. Halpin, D. Treatment costs and number needed to treat (NNT) with budesonide/formoterol to avoid one exacerbation of COPD. Abstract presented at ATS, 2004.
2. Calverley, P. Eur Respir J 2003; 22: 912-919
3. Szafranski, W. Eur Respir J 2003;21:74-81
4. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy For the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease NHLBI/WHO Workshop Report, 2002. http://www.goldcopd.com

5. Volgelmeier, C. Burden of exacerbations in COPD: The patient's perspective. Abstract presented at ATS, 2004.

6. Haughney, J. Conjoint analysis of patient perceptions of COPD exacerbations. Abstract presented at ATS, 2004.

7. National Heart, Blood and Lung Institute. Diseases and conditions index. What causes COPD? Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_Causes.html

8. Murray CJ, Lopez AD. Alternative projection of mortality by cause 1990-2020: global burden of disease study. Lancet 1997; 349:1498-1504.





Tratamentul de numai 2 Pacienþii cu BPOC Symbicort (REG) necesare pentru a evita 1 de agravare pe an cere intervenþie medicalã - Treatment of Only 2 COPD Patients with Symbicort(reg) Needed to Avoid 1 Exacerbation Per Year Requiring Medical Intervention - articole medicale engleza - startsanatate