New study calls for change in the management of COPD to focus on prevention of "lung attacks" to address patients' fears

Main Category: COPD
Article Date: 01 Oct 2005 - 0:00 PDT

email to a friend   printer friendly   opinions  

An international study of COPD patients, published today in the European Respiratory Journal, shows that, above all else, COPD patients want to avoid being housebound or hospitalised due to attacks of acute worsening, known as exacerbations or "lung attacks".1 Dr John Haughney, lead study author, GP and lecturer at the University of Aberdeen comments: "I strongly believe that reducing the frequency and severity of exacerbations, and treating them aggressively and effectively, are even more important than long term symptom management, and should be the main focus of treatment. This will help patients to remain active and avoid being housebound and hospitalised".

Previously, the popular belief was that patients primarily wanted fewer of their usual respiratory symptoms such as breathlessness and cough, however, this study has shown that the impact of worsenings on everyday activities is more important to patients.

COPD is a devastating lung disease that gradually destroys the lungs, robs a person of their ability to breathe and can ultimately lead to their death. Exacerbations - an acute worsening of symptoms, often triggered by a respiratory infection, requiring medical intervention and often hospitalisation - are extremely distressing for patients and their families. 91% of patients report that exacerbations impact on everyday activities and cause 50% of patients to stop all activities.2,3

The study was the first to use discrete choice modelling methods in COPD patients, a method which identifies their individual preferences by inviting them to prioritise attributes associated with COPD exacerbations. The authors conclude that the paramount concerns for patients with COPD worsenings are the level of impact on daily activities and the level of medical care they require. These are more important than concerns over the number of future attacks and severity of breathlessness.

Dr John Haughney continues: "Exacerbations have a huge impact on patients' quality of life and on their daily activities - we have to remember that many patients can end up being housebound or bedridden as a result of their condition worsening. This study shows that although patients quite understandably want to see an improvement in their general symptoms, avoiding the fear and inconvenience of hospital admission is more important to them."

COPD is estimated to affect 600 million people worldwide, making it one of the world's biggest chronic diseases, and it is expected to be the third leading cause of death by 2020.4,5,6 Between 22-40% COPD patients die within one year of an admission for their worsenings,7,8 which have been shown to cause more deaths than myocardial infarctions.3,9 It is well documented that exacerbations have a significant impact on the quality of life of both patients and their families - patients who have more frequent exacerbations have a worse quality of life1, which in turn means they are more likely to experience frequent exacerbations, hospitalisations2 and even death.11

The internationally recognised GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines for the management of COPD were updated in 2004 and recommend the treatment and prevention of exacerbations as key treatment goal in COPD.12 Particularly in patients visiting their GP with a worsening of their COPD, their treatment should be assessed to ensure that further exacerbations of COPD can be prevented.

Several treatments have been shown to reduce the frequency of exacerbations. However, budesonide/formoterol (Symbicort(R)) combination inhaler is the only treatment that has been shown to reduce the frequency of exacerbations requiring medical intervention compared to a long-acting bronchodilator (LABA) alone as an initial maintenance treatment in COPD. Since quality of life is impaired because of COPD exacerbations, an effective preventive treatment should result in a better health-related quality of life (HRQL). Symbicort is the only combination product in COPD that has been shown to produce a clinically important improvement in HRQL (according to St George's Respiratory Questionnaire) when compared to placebo.13 Furthermore, studies have shown that with Symbicort only about two COPD patients need to be treated over one year to avoid one exacerbation requiring medical intervention, compared to a LABA alone. For, e.g. medical treatments meant for prevention of myocardial infarction cardiovascular disease, the NNT (Number Needed to Treat) values are typically considerably higher14, often over ten, and NNTs over 100 have frequently been observed for medical preventive treatments of severe outcomes in other disease areas.15

Discrete choice modelling:

The study was the first of its kind in COPD, using discrete choice modelling to describe, quantify, and prioritise attributes associated with COPD exacerbations from the patients' perspective. The attributes of exacerbations considered most important were (ranked in order of importance): impact on everyday life and medical care, followed by number of attacks, breathlessness, speed of recovery, cough and phlegm/spit, and social impact, and sleep disturbance and impact on mood.

Study specifics:

The study was an international, cross-sectional study of patients' values regarding the characteristics and burden of COPD exacerbations in 125 patients in France, Germany, Spain, Sweden, and the UK. Men and women aged _50 years with a diagnosis of COPD based on GOLD criteria (GOLD 2003) presenting with forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) of <70%, and who had experienced 2 or more exacerbations (defined as the worsening of respiratory symptoms so as to require medical intervention [oral corticosteroids and/or antibiotics and/or hospitalization]) during the previous year and at least 1 exacerbation within the past 6 months were eligible for study inclusion.

Further information on COPD:

In addition to their everyday symptoms, patients with COPD suffer from periods of worsenings, so called exacerbations. In general, patients with severe COPD experience exacerbations more frequently than those with mild disease. An exacerbation is a deterioration in a patient's clinical status, with acute worsening of respiratory symptoms, such as coughing, wheezing, sputum production and shortness of breath and impaired lung function. Exacerbations are also accompanied by increase in non-respiratory symptoms such as e.g. fatigue, malaise, insomnia, depression, anxiety and confusion. For patients with severe COPD, exacerbations tend to be associated with cardiac symptoms in addition to respiratory symptoms. Exacerbations often require medical intervention, and may lead to hospitalisation or death.

Studies have shown that exacerbations account for 25% of all emergency admissions in some countries.16 Between 22-40% COPD patients die within one year of an admission for their exacerbations. 17,18,19

Most cases of COPD develop after repeatedly breathing in noxious agents and fumes that irritate and damage the lungs and airways. 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 possibly genetic factors may contribute to development of the disease.20,21

1. Haughney J, Partridge MR, Vogelmeier C, Larsson T, Kessler R, Stohl E, Brice R, Lofdahl CG. Exacerbations of COPD: quantifying the patient's perspective using discrete choice modeling. European Respiratory Journal 2005;26 (4).

2. Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 1998;157(5):1418-22.

3. Vogelmeier C, Partridge M, Stahl E. Burden of exacerbations in COPD: The patient's perspective. American Journal of Respiratory and Critical Care Medicine 2004;169(7 Suppl):A769

4. Murray CJ, Lopez AD. Alternative projection of mortality by cause 1990-2020: Global Burden of Disease Study. Lancet 1997; 349:1498-504.

5. Murray CJ, Lopez AD. Mortality by cause for eight regions of the world: Global Burden of Disease Study. Lancet 1997; 349:1269-76.

6. Murray CJ, Lopez AD. Global mortality, disability and the contribution of risk factors: Global Burden of Disease Study. Lancet 1997; 349:1436-42.

7. Almagro P, Calbo E, de Echagoen AO, Barreiro B, Quintana S, Heredia JL, Garau J. Mortality After Hospitalization for COPD. Chest 2002; 121 (5): 1441-48.

8. Wouters EF. Economic analysis of the Confronting COPD survey: an overview of results. Respir Med. 2003 Mar; 97 Suppl C:S3-14.

9. Connors Jr AF, Dawson NV, Thomas C, Harrell Jr FE, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes Following Acute Exacerbation of Severe Chronic Obstructive Pulmonary Disease. The SUPPORT Investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). American Journal of Respiratory Critical Care Medicine 1996; 154:959-67.

10. Traver GA. Measures of symptoms and life quality to predict emergent use of institutional health care resources in chronic obstructive airways disease. Heart Lung. 1988 Nov;17(6 Pt 1):689-97.

11. Fan VS, Curtis JR, Tu SP, McDonell MB, Fihn SD. Using Quality of Life to Predict Hospitalization and Mortality in Patients With Obstructive Lung Diseases. Chest 2002 122: 429-436.

12. 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.
http://www.goldcopd.dk/index_uk.htm, updated 2004

13. Halpin D et al. Number needed to treat (NNT) with budesonide/formoterol to avoid one COPD exacerbation with cost analysis of treatment. Presented at the European Respiratory Society Conference, Glasgow, 2004

14. Lonn E at all. Effects of ramipril on left ventricular mass and function in cardiovascular patients with controlled blood pressure and with preserved left ventricular ejection fraction: a substudy of the Heart Outcomes Prevention Evaluation (HOPE) Trial. J Am Coll Cardiol. 2004 Jun 16; 43 (12): 2200-6

15. Centre for Evidence-Based Medicine
http://www.cebm.utoronto.ca/glossary/nnts.htm#table

16. Anderson HR, Esmail A, Hollowell J et al. Epidemiologically based needs assessment: lower respiratory disease. London: Department of Health, 1994

17. Almagro P, Calbo E, de Echagoen AO, Barreiro B, Quintana S, Heredia JL, Garau J. Mortality After Hospitalization for COPD. Chest 2002; 121 (5): 1441-48.

18. Connors Jr AF, Dawson NV, Thomas C, Harrell Jr FE, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes Following Acute Exacerbation of Severe Chronic Obstructive Pulmonary Disease. The SUPPORT Investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). American Journal of Respiratory Critical Care Medicine 1996; 154:959-67.

19. Wouters EF. Economic analysis of the Confronting COPD survey: an overview of results. Respir Med. 2003 Mar; 97 Suppl C:S3-14.

20. Pauwels RA, Rabe KF. Burden and clinical features of chronic obstructive pulmonary disease (COPD). Lancet 2004. 364:613-620

21. 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

http://www.astrazeneca.com

• Additional
• References
• Citations