Inhaled Corticosteroids Protect Against Cardio-Ischaemic Events in COPD

Main Category: COPD
Article Date: 25 Sep 2005 - 14:00 PDT

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For the first time, the inhaled corticosteroid (ICS) budesonide - a common treatment for Chronic Obstructive Pulmonary Disease (COPD) - has been shown to reduce cardio-ischemic events in patients with mild to moderate COPD, according to a post-hoc analysis of the EUROSCOP study, presented at the European Respiratory Society (ERS) Congress in Copenhagen today.1

The post-hoc analysis found that, during the EUROSCOP study, of the 49 patients who experienced cardio-ischaemic events, 37% of patients belonged to the budesonide group, whereas 63% of patients belonged to the placebo group (p < 0.05). The number of events showed similar differences, 22 events in 593 patients in the budesonide group compared with 38 events in 582 patients in the placebo group. These encouraging results were retrieved from the pivotal EUROSCOP study from 1999, which was a three year placebo controlled trial in 1,175 patients with mild to moderate COPD.

Professor Claes-G�ran L�fdahl, from the Department of Respiratory Medicine and Allergology at Lund University, who conducted the post-hoc analysis, comments: "This study indicates that COPD is much more than just a respiratory disease, and treating the condition is not just about improving airflow, but should also focus on improving cardiovascular outcomes. The study shows that, potentially, cardiovascular events in COPD patients could be significantly reduced if an inhaled corticosteroid is prescribed. Furthermore, COPD is a very under-diagnosed condition, and it may well be that many people are dying as a result of cardiovascular events caused by undiagnosed COPD, rather than other, more widely recognised conditions."

COPD is a chronic disease which is expected to be the third leading cause of death by 2020.2 The condition affects 600 million people worldwide3 and most cases develop after repeatedly breathing in noxious agents or fumes that irritate and damage the airways and lung tissue. In the western world cigarette smoke is the major contributing factor, but indoor air pollution, e.g. from cooking in poorly ventilated areas and intense occupational exposure to dust, gases or fumes and also genetic factors may contribute to development of the disease.4, 5

Current guidelines for COPD recommend the use of an ICS, such as budesonide, alongside a long-acting bronchodilator to prevent exacerbations in COPD. Exacerbations are an acute worsening of symptoms, often triggered by a respiratory infection, requiring medical intervention and often hospitalisation and have been shown to cause more deaths than myocardial infarctions.6 Studies indicate that approximately 22% of patients can be expected to die within a year of being admitted to hospital as a result of their exacerbations7 and many patients never fully recover to their previous state of health.8 Clinical studies with an ICS, especially when combined with a long-acting B2 agonist (LABA) in COPD have shown to reduce the frequency and severity of exacerbations9,10 and in retrospective studies, an ICS alone and in combination with LABA have also been shown to reduce the number of hospitalisations and mortality rate.10,11

Dr L�fdahl concludes: "Treatments which have been shown to offer cardiovascular benefits, in addition to exacerbation prevention and symptom relief, should be considered for COPD patients."

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 over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

Study specifics:

The EUROSCOP study was a three year placebo controlled study of budesonide 800 mcg daily in 1175 patients with mild to moderate COPD originally conducted in 1999. The incidence of (first-time) cardio-ischemic adverse events, defined as Angina pectoris (n=32), Myocardial infarction (n=23), Coronary artery disorder (n=4) and Myocardial ischaemia (n=1), was compared in budesonide vs placebo treated patients. Overall, among the 1175 patients evaluated for safety 49 patients (4.2%) had 60 cardio-ischemic events distributed as above. 18/593 (3.0%) occurred in the budesonide group vs 31/582 (5.3%) in placebo treated patients (p<0.05). Lung function and pack-years were similar in patients with cardio-ischemic events compared with others.

Further information on COPD:

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, anxiety and confusion. For patients with severe COPD, exacerbations tend to be associated with cardiac symptoms as well as respiratory symptoms. Exacerbations often require medical intervention, and may lead to hospitalisation or death.

References
1. L�fdahl CG, Postma D, Pride N et al. Does inhaled budesonide protect against cardio-ischemic events in mild-moderate COPD - a post-hoc evaluation of the EUROSCOP study. Abstract presented at the European Respiratory Society Conference, Copenhagen, 2005. Abstract Number: 255621
2. Calverley PMA and Walker P. Chronic Obstructive Pulmonary Disease. Lancet 2003. 362:1053-1061
3. WHO: The World Health Report 1998. Life in the 21st Century. A vision for all. World Health Organisation. Geneva 1998
4. Pauwels RA, Rabe KF. Burden and clinical features of chronic obstructive pulmonary disease (COPD). Lancet 2004. 364:613-620
5. 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
6. Fabbri L, Beghe B, Caramori G, Papi A, Saetta M. Similarities and discrepancies between exacerbations of asthma and chronic obstructive pulmonary disease. Thorax 1998;53(9):803-8
7. Almagro P, Calbo E, de Echag�en AO, Barreiro B, Quintana S, Heredia JL, Garau J. Mortality After Hospitalization for COPD. Chest 2002; 121 (5): 1441-48
8. Kessler R, Lofdahl C-G, Tornling G, St�hl E. An evaluation of exacerbations in COPD. Poster presented at the European Respiratory Society Conference, Glasgow 2004
9. Sin DD, Man SFP. Inhaled corticosteroids in the long-term management of patients with chronic obstructive pulmonary disease. Drugs & Aging 2003; 20(12):867-80
10. Selroos O. The place of inhaled corticosteroids in chronic obstructive pulmonary disease. Current Medical Research and Opinion 2004; 20(10):1579-93
11. Soriano JB, Kiri VA, Pride NB, Vestbo J. Inhaled corticosteroids with/without long-acting beta-agonists reduce the risk of rehospitalisation and death in COPD patients. American Journal of Respiratory Medicine 2003;2(1):67-74

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