| Chronic
Obstructive Pulmonary Disease
Epidemiological studies suggest that the true prevalence
of COPD in the UK may be several times higher than recorded
and that up to 9% of the population over age 45 may
be affected3. NICE guidance recommends performing spirometry
in all current or ex-smokers over 35 who have a chronic
cough, exertional breathlessness, regular sputum production,
frequent winter ‘bronchitis’ or wheeze4.
The Medical Research Council (MRC) dyspnoea scale should
be used to grade breathlessness. Patients with COPD
experience a variety of symptoms reflecting the multi-dimensional
nature of the condition. The NICE guideline groups these
into eight broad problem areas, each of which may require
drug therapy: smoking, breathlessness, exacerbations,
respiratory failure, cor pulmonale, weight loss, chronic
productive cough, and anxiety and depression.
Smoking: Smoking cessation is the most
important component of COPD prevention and management.
It is the only intervention shown to slow the decline
of forced expiratory volume in 1 second (FEV1). Advice
and encouragement should be offered at every opportunity.
NICE Public Health Intervention Guideline 1 recommends
referral to an intensive support service for all smokers.
Prescriptions for nicotine replacement therapy (NRT),
buproprion or varenicline are recommended, with appropriate
support, for those smokers unwilling or unable to accept
referral5.
Breathlessness:
Short-acting bronchodilators (e.g. salbutamol or ipratropium)
as needed are recommended for initial empirical therapy
for breathlessness and exercise limitation. A Cochrane
review found small benefits with respect to quality
of life and lung function for ipratropium bromide over
short-acting ß2 agonists and recommended conducting
‘n of 1’ trials to determine the treatment
that gives best relief of symptoms6. NICE guidance recommends
using a variety of measures, such as improvement in
symptoms, activities of daily living, exercise capacity,
and rapidity of symptom relief, to assess the effectiveness
of therapy. Ineffective treatments should be discontinued
after 1-2 months. Options for patients who remain symptomatic
are combining a short-acting anticholinergic with a
short-acting ß2 agonist, or adding a long-acting
ß2 agonist (LABA). Theophylline should only be
used after trying short-acting and long-acting bronchodilators
or in patients unable to use inhalers.
Exacerbations:
Long-acting bronchodilators should be prescribed to
patients who have two or more exacerbations per year.
There is little evidence to suggest clinically significant
differences between long-acting anticholinergics and
LABAs. Choice of drug should take account of patient
response to a trial, side effects, patient preference
and cost. Inhaled corticosteroids should be added to
long-acting bronchodilators for patients with an FEV1<=50%
predicted who experience two or more exacerbations requiring
treatment with either oral steroids or antibiotics in
a 12 month period. The aim is to reduce exacerbation
frequency. Recent trials do not support wider use of
inhaled steroid therapy. A large trial over 3 years,
comparing salmeterol plus fluticasone to salmeterol
alone, fluticasone alone or placebo, among people with
an FEV1<60% of predicted, failed to demonstrate a
significant difference in mortality rates7. Salmeterol
alone and combination therapy both resulted in a lower
annual rate of hospital admission for severe exacerbations
than placebo. Combination therapy showed some advantages
over individual drugs in the rates of moderate to severe
exacerbations and exacerbations requiring treatment
with oral steroids, but there was a significantly higher
incidence of pneumonia in the groups treated with either
combination therapy or fluticasone alone (NNH = 14 and
17, respectively). A recent case-controlled study of
175,906 patients also found an increased risk of hospital
admission for pneumonia among elderly patients with
COPD prescribed inhaled corticosteroids8. Early use
of prednisolone (30mg for 7-14 days) should be considered
for treatment of any exacerbation causing a significant
increase in breathlessness which interferes with daily
activities. Antibiotics may be of benefit when there
is an increase in sputum purulence. Where appropriate,
patients at risk of having an exacerbation of COPD should
be given a course of antibiotic and corticosteroid tablets
to keep at home for use as part of a self-management
plan that includes adjustment of bronchodilator therapy
and advice to contact a healthcare professional if symptoms
do not improve.
Oxygen:
Although long term oxygen therapy (LTOT) has been shown
to improve survival in people with hypoxaemia, inappropriate
oxygen therapy can cause respiratory failure. Patients
with an FEV1 < 30% predicted, or with cyanosis, polycythaemia,
peripheral oedema, raised jugular venous pressure or
oxygen saturations = 92% when breathing air, should
be referred for specialist assessment for LTOT. Short
burst oxygen therapy, which can be ordered without specialist
assessment, should only be considered for periods of
severe breathlessness not relieved by other treatments.
Therapy should only continue when there is a documented
improvement in breathlessness.
Pulmonary
Rehabilitation: Pulmonary rehabilitation has
been shown to lead to statistically significant and
clinically meaningful improvements in health related
quality of life, functional exercise capacity and maximum
exercise capacity. A programme of pulmonary rehabilitation,
incorporating a programme of physical training, disease
education, nutritional, psychological and behavioural
intervention, should be offered to all patients who
consider themselves to be functionally disabled by COPD.
Asthma
Asthma UK estimates that there are 5.2 million people
with asthma in the UK, 1.1. million of whom are children.
Although overall mortality rates are low and have been
declining for over 20 years, the rate of decline appears
to be slowing9. There is some evidence of gaps between
current practice and British Thoracic Society / Scottish
Intercollegiate Guideline Network (BTS/SIGN) guidelines.
A recent study looking at community prescribing for
children with asthma in the UK between 2000 and 2006
found evidence of important variations from recommended
practice, including a significant number of prescriptions
for bronchodilator syrups10. BTS/SIGN guidelines do not
recommend oral ß2 agonists for children; a pressurised
metered dose inhaler (pMDI) plus a spacer, with a facemask
if needed, is recommended for children 0-5 years. The
proportion of inhaled steroids prescribed as combination
products rose to 25% over the same period. The authors
point out that this is not consistent with guideline
recommendations, asserting that steroid inhalers alone
should be the mainstay for the vast majority of asthmatics
who require controller medication.
A
meta-analysis concluded that LABAs increase both severe
asthma exacerbations and asthma-related deaths, and
that concomitant inhaled steroids do not adequately
protect against adverse effects11. BTS/SIGN guidelines
have been updated recently12, partly in response to a
trial demonstrating lower exacerbation rates with a
budesonide/formoterol device used for both maintenance
and relief of symptoms. Subjects randomised to use of
a budesonide/formoterol combination inhaler for both
maintenance and relief of symptoms were exposed to lower
overall doses of LABA13. The guidelines point out that
doubling the dose of inhaled steroid at the time of
an exacerbation has not been shown to be effective and
note that it is not clear that adjusting the dose of
a budesonide/formoterol combination inhaler according
to symptoms is superior to conventional treatment. The
two approaches have not been directly compared. The
Commission on Human Medicines is carrying out a full
review of LABAs. Current advice is that benefits outweigh
risks when prescribed appropriately. The following cautions
are recommended: only use LABAs when standard doses
of inhaled steroids have failed to control asthma adequately;
always prescribe an inhaled steroid; do not initiate
in patients with rapidly deteriorating asthma; start
at low doses; monitor closely for deterioration of symptoms;
discontinue in absence of benefit; consider stepping
down when good control has been achieved.
There
is no difference between the efficacy of inhaled steroids
with long-acting beta agonists given via fixed dose
combination inhalers or via separate inhalers. Nor have
combination devices been shown to improve compliance
in the medium to long-term. Fixed dose combinations
may have advantages for individual patients, however.
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Prescribing Data
(Reporting quarter = April-June 2007, Index quarter
= April- June 2002)
Prescribing
of short-acting ß2 agonists has not significantly
changed over the last 5 years (4.4 million items and
£22.4 million, quarter to June 2007), both prescribing
and costs increasing by less than 2%. Salbutamol represents
95% of all items for short-acting ß2 agonists
and 90% of cost. Prescribing of single preparation LABAs
has decreased by just over 30% to 400,000 items at a
cost of £16.4 million per quarter. Salmeterol
is the most commonly prescribed LABA accounting for
approximately 90% of all items and cost.
Prescribing
of inhaled corticosteroids as single preparations has
decreased by 26% over the last 5 years to 2.0 million
items, cost has fallen by 46% to £31.8 million
per quarter. Beclometasone is still most commonly prescribed
(1.6 million items, £19.1 million). Prescribing
of fluticasone has fallen by 47% to 216,000 items while
costs have fallen by 57% to £6.8 million. Prescribing
and cost of budesonide have decreased by almost half
to 180,000 items and £5.5 million, per quarter.
Compound corticosteroid preparations account for 46%
of all inhaled corticosteroid prescribing and 75% of
the cost. Fluticasone with salmeterol accounts for 75%
of compound corticosteroid preparations (1.3 million
items and £72.7 million).
In
the last 5 years, prescribing of antimuscarinic bronchodilators
has increased by 60% to 768,000 items while costs have
almost quadrupled to £22.5 million. At 466,000
items, tiotropium now accounts for 61% of all antimuscarinic
bronchodilator prescribing, and 84% of the cost (£19
million). Prescribing of ipratropium has decreased by
34% to 302,000 items costing £3.5 million per
quarter. Compound bronchodilator prescribing has fallen
slightly (6%) to 356,000 items, whereas cost has decreased
by a quarter to £4.5 million. Over 99% of these
items are for Combivent®.
Prescribing
of aminophylline and theophylline have decreased by
25% (102,000 items) and 16% (126,000 items) respectively
over the last 5 years, costing £348,000 and £543,000
per quarter. Prescribing of leukotriene receptor antagonists
has more than doubled in the last 5 years to 239,000
items at a cost of £7.9 million per quarter. Montelukast
accounts for 96% of prescribing and spending on leukotriene
receptor antagonists. Mucolytic prescribing has increased
over the last 5 years to 119,000 items at a cost of
£3.5 million per quarter. Carbocisteine is most
commonly prescribed (105,000 items).
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SUMMARY
• COPD may be far more common
than recorded prevalence suggests. Spirometry should
be offered to all current or past smokers over 35
with compatible symptoms.
• There is little evidence on which to base
the choice between anticholinergics or ß2 agonists
in COPD, whether short- or long-acting. “N of
1” trials are recommended.
• Inhaled corticosteroids should only be prescribed
to reduce the frequency of exacerbations in COPD.
• LABAs should only be prescribed to people
with asthma when standard doses of inhaled steroids
have failed to control symptoms.
• Use of a single combination device for both
maintenance and relief of symptoms of asthma has not
been shown to be superior to conventional treatment.
1Trends in avoidable mortality in England and Wales, 1993–2005. Health Statistics
Quarterly 34 (2007)
2The Burden Of Lung Disease, 2nd Edition. British Thoracic Society (2006).
3Seamark DA et al. Home or surgery based screening for chronic obstructive pulmonary
disease (COPD)? Primary Care Respiratory Journal 2001;10:30-3.
4CG12: Chronic obstructive pulmonary disease. NICE (2004).
5PHIG 1: Brief interventions and referral for smoking cessation in primary care and other settings. NICE (2006).
6Appleton S et al. Ipratropium bromide versus short acting beta-2 agonists for stable chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2006,
Issue 2. Art. No.: CD001387. DOI: 10.1002/14651858.CD001387.pub2.
7Calverley
PMA et al. Salmeterol and fluticasone propionate and
survival in chronic obstructive pulmonary disease. N
Engl J Med 2007;356:775–89
8Ernst
P et al. Inhaled Corticosteroid Use in Chronic Obstructive
Pulmonary Disease and the Risk of Hospitalization for
Pneumonia. Am J Respir Crit Care Med 2007; 176: 162–66.
9Where
Do We Stand? Asthma in the UK today. Asthma UK (2004).
10Cohen
S, Taitz J, Jaffé A. Paediatric prescribing of
asthma drugs in the UK: are we sticking to the guideline?
Arch Dis Child. 2007 Oct;92(10):847-9.
11Salpeter
SR et al. Meta-analysis: effect of long-acting beta-agonists
on severe asthma exacerbations and asthma-related deaths.
Ann Intern Med. 2006 Jun 20;144(12):904-12.
12British
Guideline on the Management of Asthma, Revised Edition.
British Thoracic Society / Scottish Intercollegiate
Guidelines Network (2007).
13Kuna
P et al. Effect of budesonide/formoterol maintenance
and reliever therapy on asthma exacerbations. Int J
Clin Pract 2007; 61, 5: 725-736
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