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(Chest. 2000;117:29S-32S.)
© 2000 American College of Chest Physicians

The Reality of Drug Use in COPD*

The European Perspective

Michael Rudolf, MD

* From the Ealing Hospital, London, UK.

Correspondence to: Michael Rudolf, MD, Department of Respiratory Medicine, Ealing Hospital, Uxbridge Rd, Southall, Middlesex UB1 3HW, UK


   Abstract
TOP
 Abstract
Introduction
 Analysis of Prescribing Data
 Medications in COPD Trials
 Specific Studies in Primary...
 Conclusion
 References
 
COPD guidelines provide advice about the appropriate use of various medications in treating patients with this condition. Comparisons of drug therapy as recommended by these guidelines with what is actually prescribed by both primary care physicians and specialist pulmonologists in a number of European countries can be examined in a variety of ways. Nonadherence to guidelines and differences between countries are caused by a number of factors, including varying degrees of misdiagnosis and different national attitudes to various classes of drugs.

Key Words: COPD • drug treatment • management guidelines


   Introduction
TOP
 Abstract
 Introduction
Analysis of Prescribing Data
 Medications in COPD Trials
 Specific Studies in Primary...
 Conclusion
 References
 
Guidelines for the management of COPD are intended both to provide a benchmark for current best practice and also to facilitate the development of rational cost-effective care. However, it cannot be assumed that guidance about drug therapy is necessarily reflected in day-to-day clinical practice. This article will examine what is actually happening within and between different European countries and compare the use of various classes of drugs with what is currently recommended in COPD guidelines issued by the European Respiratory Society (ERS)1 and by the British Thoracic Society (BTS)2 (Table 1) .


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  		Table 1.. Current Recommendations for COPD Drug Therapy

 
Information about actual drug therapy can be obtained in a number of different ways: analysis of overall primary care prescribing data using computerized records, looking at the medication taken by large numbers of patients recruited by respiratory physicians into national and international clinical trials for COPD, and designing specific studies to investigate the accuracy of diagnosis of COPD and its treatment.


   Analysis of Prescribing Data
TOP
 Abstract
 Introduction
 Analysis of Prescribing Data
Medications in COPD Trials
 Specific Studies in Primary...
 Conclusion
 References
 
Intercontinental Medical Statistics data relate the numbers of prescriptions for various drug classes to the diagnoses of the patients for whom the treatments are prescribed. In the United Kingdom, for example, data on diagnoses and drugs prescribed are collected from 500 doctors from a panel of practices who all use computer systems that provide continuous information matching prescriptions to diagnoses. These practices are recruited to be nationally representative in terms of geography, range of doctor years since qualification, etc, and they allow calculations to be made about the total amounts of diagnosis-related prescribing in the United Kingdom. It is thus possible to examine the total number of prescriptions written for patients with COPD and see how many (or what percentage) are for each major drug type.

Similar information can be collected from a number of different countries, and international comparisons made between prescribing habits. Table 2 shows the percentages of different drug classes prescribed for COPD in seven European countries in 1997, and also the total numbers of prescriptions. Although this sort of data has enormous limitations and must be interpreted with great caution, there do nevertheless appear to be substantial discrepancies not only between actual prescribing and what guidelines recommend, but also between what is happening in different countries.


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  		Table 2.. Percentage of Each Drug Class by Country (1997)

 
Inhaled corticosteroids, which account for more than one fifth of all COPD prescribing in the United Kingdom and one quarter of all COPD prescriptions in the Netherlands, only total one tenth of all prescriptions in Germany and Austria. Although there may indeed be different national attitudes about the role of inhaled corticosteroids in COPD, this is partly explained by the fact that, at least in the United Kingdom, substantial numbers of COPD patients are misdiagnosed as having asthma (see below), for which the use of inhaled corticosteroids can be regarded as far more appropriate.

Preparations for "coughs and colds" (which include expectorants, antitussives, and mucolytics), which specifically are not recommended in either ERS or BTS guidelines, account for approximately one third of all COPD prescriptions in France and Germany, whereas they are hardly used at all in the United Kingdom where prescriptions for such compounds are not reimbursed by the National Health Service. Although both sets of guidelines effectively recommend theophylline only as third-line bronchodilators, prescriptions for xanthines outnumber those for anticholinergics in four countries, and in three countries (Italy, Germany, and Austria) they are the single most prescribed bronchodilator preparation.

In the United Kingdom in 1997, of a total of 36.68 million prescriptions for asthma and COPD, 29.12 million (79%) were for asthma and 7.56 million (21%) were for COPD, giving an asthma-to-COPD prescribing ratio of 79:21. The asthma-to-COPD prescribing ratios for Germany, Italy, the Netherlands, Belgium, Austria, and France were 53:47, 52:48, 64:36, 49:51, 58:42, and 71:29, respectively. Inasmuch as it is unlikely that there are enormous differences in the prevalence of asthma and COPD in these countries, the ranges of these ratios most likely reflect the degree to which COPD is misdiagnosed as asthma in some countries; the extent to which this is a problem particularly in the United Kingdom (and the financial consequences of this) will be explored later.

However, because the accuracy of the diagnosis of COPD is clearly a major limiting factor in the interpretation of prescribing data, it is important to examine COPD therapy in groups of patients in which the diagnosis is far more likely to be correct.


   Medications in COPD Trials
TOP
 Abstract
 Introduction
 Analysis of Prescribing Data
 Medications in COPD Trials
Specific Studies in Primary...
 Conclusion
 References
 
Patients recruited by respiratory physicians into national and international COPD trials have to satisfy stringent diagnostic criteria. Accordingly, analysis of concurrent medication on entry into such trials should provide valuable information on treatment with specific drugs in groups of patients in which the accuracy of the diagnosis of COPD is far more secure.

Table 3 shows the percentages of patients being treated with specific classes of drugs in five large European studies: the French CFC-free fenoterol/ipratropium (Berodual) study (Boehringer Ingelheim, data on file), the German dry powder fenoterol/ipratropium (Berodual) study (Boehringer Ingelheim, data on file), the UK CFC-free ipratropium study,3 the European salmeterol study,4 and the European inhaled corticosteroid (ISOLDE) study.5


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  		Table 3.. Medications on Entry Into COPD Trials

 
Although the age ranges and the degree of severity of COPD (in terms of impaired spirometry) were broadly comparable in all these studies, there were again large variations in the use of different therapies. In some cases (for example, the use of anticholinergics), this was caused by different entry or concurrent medication criteria, but the higher than average use of xanthines in the salmeterol study, and lower than average use of inhaled ß2-agonists in the French Berodual study, clearly reflects the fact that respiratory physicians make their own decisions about how to treat patients and do not necessarily follow advice in guidelines, with which they may well disagree.

Nowhere is this more apparent than in the use of inhaled corticosteroids. All five of these trials were conducted at a time when there was a great deal of uncertainty about the role of inhaled corticosteroids in COPD and when guidelines were very cautious about recommending these drugs. Nevertheless, significant percentages of patients were receiving inhaled corticosteroids.

This use of inhaled corticosteroids in patients with moderate-to-severe disease by specialist respiratory physicians who were presumably making informed decisions about the management of correctly diagnosed patients may well have been appropriate, especially in light of recently published studies showing much more evidence for the use of these drugs.6 7 8 This needs to be differentiated from the much more uncritical widespread use of inhaled corticosteroids in patients who may not even have been correctly diagnosed, for which the extent of the problem can only be ascertained by studies specifically designed to investigate this.


   Specific Studies in Primary Care
TOP
 Abstract
 Introduction
 Analysis of Prescribing Data
 Medications in COPD Trials
 Specific Studies in Primary...
Conclusion
 References
 
ERS guidelines quote evidence suggesting significant underdiagnosis of COPD in the general population, with only about 25% of cases being diagnosed.9 10 11 In a study designed to investigate the possibility that older adults with chronic airflow limitation (caused by either asthma or COPD) frequently do not receive any appropriate treatment, spirometry, respiratory symptoms, and medication use were studied in a random sample of adults > 45 years of age living in Manchester, United Kingdom. Spirometric evidence of chronic airways obstruction was found in 26% of 247 representative subjects, and of these, only 55% had received a diagnosis of asthma or chronic bronchitis and only 37% were using any inhaled medication (bronchodilators or corticosteroids).12

The extent to which COPD is misdiagnosed as asthma, and the economic implications of this in terms of inappropriate prescribing of inhaled corticosteroids, has been examined in another study conducted in nine UK general practices.13 Subjects were identified who satisfied the following six criteria: (1) were > 40 years of age, (2) were prescribed an inhaled ß2-agonist within a defined 6-month period, (3) had a history of cigarette smoking, (4) had peak expiratory flows persistently < 70% predicted, (5) had chronic sputum production, and (6) had a history of recurrent chest infections. These six criteria were specifically chosen to identify patients who probably did have COPD rather than asthma.

Of 434 patients who fulfilled these criteria, the diagnosis was recorded as asthma in 227 (52%) and as COPD (including chronic bronchitis and/or emphysema) in 193 (45%); 14 (3%) had either another or no diagnosis. Analysis of prescribing data showed that inhaled corticosteroids had been used in 81% of the patients diagnosed with asthma and in 72% of those diagnosed as having COPD. If these nine practices are typical of the United Kingdom as a whole, the financial consequences of prescribing inhaled corticosteroids to 70 to 80% of patients with COPD can be calculated. Assuming that adherence to BTS guidelines should have led to only 10 to 15% of patients receiving this medication, the British National Health Service could potentially have saved up to £42 million annually ($67 million, euro 63 million).


   Conclusion
TOP
 Abstract
 Introduction
 Analysis of Prescribing Data
 Medications in COPD Trials
 Specific Studies in Primary...
 Conclusion
References
 
COPD remains both under- and misdiagnosed, and there are large differences between different European approaches to drug therapy. Recommendations in COPD guidelines are often not followed.


   Footnotes
 
Abbreviations: BTS = British Thoracic Society; ERS = European Respiratory Society


   References
TOP
 Abstract
 Introduction
 Analysis of Prescribing Data
 Medications in COPD Trials
 Specific Studies in Primary...
 Conclusion
 References
 

  1. Siafakas, NM, Vermeire, P, Pride, NB, et al (1995) Optimal assessment and management of chronic obstructive pulmonary disease (COPD): The European Respiratory Society Task Force. Eur Respir J 8,1398-1420[CrossRef][ISI][Medline]
  2. BTS guidelines for the management of chronic obstructive pulmonary disease: the COPD Guidelines Group of the Standards of Care Committee of the BTS. Thorax 1997; 52(suppl 5):S1–S28
  3. Wedzicha, JA, Towse, LJ, Jirou-Najou, JP (1997) Therapeutic equivalence of ipratropium bromide MDIs formulated with HFA or CFC propellant in long-term treatment of COPD [abstract]. Eur Respir J 10(suppl 25),427S
  4. Boyd, G, Morice, AH, Pounsford, JC, et al (1997) An evaluation of salmeterol in the treatment of chronic obstructive pulmonary disease. Eur Respir J 10,815-821[Abstract]
  5. . for the ISOLDE Study groupBurge, PS, Calverley, PMA (1994) Inhaled steroids in obstructive lung disease in Europe, the ISOLDE trial: protocol and progress [abstract]. Am J Respir Crit Care Med 149,A21
  6. Paggiaro, PL, Dahle, R, Bakran, I, et al (1998) Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease: International COPD Study Group. Lancet 351,773-780[CrossRef][ISI][Medline]
  7. van Grunsven, PM, van Schayck, CP, Derenne, JP, et al (1999) Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis. Thorax 54,7-14[Abstract/Free Full Text]
  8. Jarad, NA, Wezicha, JA, Burge, PS, et al (1999) An observational study of inhaled corticosteroid withdrawal in stable chronic obstructive pulmonary disease. Respir Med 93,161-166[CrossRef][ISI][Medline]
  9. Lundback, B, Nystrom, L, Rosenhall, L, et al (1991) Obstructive lung disease in northern Sweden: respiratory symptoms assessed in a postal survey. Eur Respir J 4,257-266[Abstract]
  10. Viege, G, Paoletti, P, Carrozzi, L, et al (1991) Prevalence rates of respiratory symptoms in Italian general population samples exposed to different levels of air pollution. Environ Health Perspect 94,95-99[ISI][Medline]
  11. Manfreda, J, Mas, Y, Litven, W (1989) Morbidity and mortality from chronic obstructive pulmonary disease. Am Rev Respir Dis 140(suppl),S19-S26
  12. Renwick, DS, Connolly, MJ (1996) Prevalence and treatment of chronic airways obstruction in adults over the age of 45. Thorax 51,164-168[Abstract/Free Full Text]
  13. Peperell, K, Rudolf, M, Pearson, M, et al (1997) General practitioner prescribing habits in asthma/COPD. Asthma Gen Pract 5,29-30



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This Article
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