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Management of COPD within primary care

June 2012

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sWhy are we looking at this?

• COPD exacerbations: 2nd most common cause of emergency admission and one of the most costly inpatient conditions to be treated by the NHS.1

o In the West Midlands:• 94,000 patients diagnosed with COPD (1.6% of population) • In last year, 31,795 emergency COPD admissions (~4% of all emergency

admissions)• 3-fold variation in emergency admission rates across West Mids CCGs• Annual prescribing spend on respiratory drugs: £106m (11% of total spend)

• Major cause of mortality: o DH estimates 23 000 deaths per year in UK attributable to COPD1

o Premature mortality almost double that of EU average2

• The missing millions? o Thought to be significant level of underdiagnosis1

o Early diagnosis and optimising interventions in primary care may improve outcomes and reduce costly admissions

• DH ‘Outcomes Strategy for COPD & asthma’ published in 20112

o Focus on earlier, accurate diagnosis, optimising phamacotherapy, and prolonging survival through appropriate interventions

o Optimising the management of COPD should also feature heavily in CCGs Long-term Conditions Strategy

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sWhat are we covering?

The following slides provide selected information on:

• Diagnosiso Recommendations from NICE/spirometry/MRC dyspnoea scale

• Smoking Cessation

• Pharmacological management of stable COPD o Recommendations from NICE on inhaled and oral therapieso Update on safety advice for tiotropiumo Selected points regarding the evidence for inhaled therapies

• Management of exacerbationso Management in primary care and when to admit to hospital

• Immunisations

• NICE recommendations on patient review and self-management

• Prescribing home oxygen

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sDiagnosis: key points from NICE3

• Consider a diagnosis of COPD for people who are over 35, and smokers or ex-smokers*, and have any of these symptoms:o exertional breathlessnesso chronic cougho regular sputum productiono frequent winter ‘bronchitis’o wheeze

• and do not have clinical features of asthma:o chronic unproductive cough, variable breathlessness, night-time

wakening

• Ask about presence of other features:o Weight loss, effort intolerance, waking at night, ankle swelling,

fatigue, occupational hazard, chest pain, haemoptysis (note: the last two are uncommon in COPD and raise the possibility of alternative diagnoses)

* although bear in mind a significant proportion of patients with COPD may have never smoked (~28% in a recent population study).4

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sDiagnosis: Spirometry

• If COPD seems likely, NICE recommend performing spirometry: o Post-bronchodilator spirometry recommended for COPD

• e.g. 15 mins after 400 mcg salbutamol; pMDI + spacer is suitable5

o Working definition of COPD: • Airflow obstruction defined as FEV1/FVC ratio < 0.7

• If FEV1 ≥ 80% predicted, a diagnosis of COPD should only be made in the presence of respiratory symptoms (breathlessness or cough)

o Post-bronchodilator spirometry also used to grade severity of obstruction and can help guide choice of appropriate inhaled therapy:

• Stage 1 - mild: FEV1 ≥ 80% predicted (symptoms also should be present to diagnose COPD in people with mild airflow obstruction).

• Stage 2 - moderate: FEV1 50-79%.

• Stage 3 - severe: FEV1 30-49%

• Stage 4 - very severe: FEV1 < 30% (or FEV1 < 50% but with respiratory failure).

o To help early identification, NICE also recommend spirometry in patients > 35 yrs, current or ex-smokers, with chronic cough. Also, consider screening patients with chronic bronchitis.

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sSpirometry

• Some points to consider in relation to spirometry…

o Have operators received adequate training in spirometry?

o Are operators confident to coach spirometry technique to patients and interpret readings?

o Are spirometers maintained and adequately calibrated?

o Bear in mind that the European Respiratory Society 1993 reference values recommended by NICE may lead to under-diagnosis in older people and are not applicable in black and Asian populations.3

• BTS COPD consortium guide ‘Spirometry in Practice’ recommends reducing predicted values by 7% for Asians and by 13% for Afro-Caribbeans and also includes calculations for elderly patients6

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sCOPD or asthma or both?

• Resolving the two conditions can be problematic, particularly in older patients. Conditions may co-exist (~ 20% of patients7)

• Findings that can help identify asthma (from NICE3):o On reversibility testing, there is a large (>400 ml) response to

bronchodilatorso A large (>400 ml) response to 2 weeks, 30 mg/day oral

prednisoloneo Serial peak flow measurements showing 20% or greater

diurnal/day-to-day variability

• Clinically significant COPD is not present if FEV1 and FEV1/FVC ration return to normal with drug treatment3

• Reconsider diagnosis of COPD if a patient reports a marked response to inhaled therapies3

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sDiagnosis: other tests3

• As part of initial diagnosis, NICE also recommends: o chest X-ray to exclude other diagnoses (investigate abnormalities

using a CT scan)o full blood count to identify anaemia or polycythaemiao BMI calculation

• Also consider screening for alpha-1 antitrypsin deficiency o Associated with 1-2% of cases; consider screening in younger

patients, minimal smoking, or family history

• Additional investigations may be needed in some circumstances, e.g. o Serial peak flow to help exclude asthmao transfer factor for carbon monoxide (TLCO) or CT scan, to

investigate symptoms that seem disproportionate to the spirometric impairment

o ECG/echocardiogram if features of cor pulmonale; o pulse oximetry to assess need for oxygeno sputum culture if purulence persistent

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sGrading dyspnoea

• NICE recommend use of MRC dyspnoea scale3,8

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• Can help identify patients who may benefit from pulmonary rehabilitation (PR)

• NICE recommend that PR should be made available to all patients who consider themselves functionally disabled (usually MRC 3 and over), including those who have had a recent hospitalisation for an acute exacerbation.

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sSmoking cessation

All COPD patients still smoking, regardless of age, should be encouraged to stop, and offered

help to do so, at every opportunity.3

• Smoking cessation has been shown to slow the deterioration in lung function in patients with COPD o Compared with continuation of smoking, rate of decline was

approximately halved in participants with mild-to-moderate COPD in one major prospective RCT who quit smoking9)

• Nicotine replacement, varenicline or bupropion may be offered, unless contraindicated, combined with appropriate support3

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sManagement of stable COPD3

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Routinely check a patient’s inhaler technique. Try to identify reasons for non-compliance with inhaled treatments.

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sEvidence: Risks/benefits of ICS

• High-dose ICS with LABA widely used in COPD, but are the benefits of the ICS component over-estimated?o Findings from TORCH:10

• 3-year RCT (n= 6,112) comparing LABA/ICS (salmeterol/fluticasone) with placebo, LABA (salmeterol) alone or ICS (fluticasone) alone

• No significant reduction in mortality with LABA/ICS compared with placebo • LABA/ICS significantly reduced annual rate of exacerbations compared with

LABA alone, but not severe exacerbations requiring hospitalisation• Pneumonia more frequent with LABA/ICS and ICS groups compared with

LABA or placebo (19% vs. 13%); NNH = 17

o Findings from 2010 Cochrane review - LABA/ICS vs LABA11

• Compared with LABA alone, LABA/ICS significantly reduced exacerbation rate (18%); also greater improvements in QOL and FEV1.

• No significant difference in mortality or hospitalisation rates• Pneumonia occurred more commonly with LABA/ICS: 58% increase

BOTTOM LINE: Benefits of ICS need to be viewed against increased risk of side-effects, particularly pneumonia.

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sTiotropium or LABA(/ICS)?

• For patients experiencing exacerbations or persistent breathlessness (despite use of SABA) there is a choice:o Either a LAMA (currently tiotropium) or a LABA (+ICS if FEV1 is

<50% predicted)

• Regarding the evidence: o NICE Guideline Development Group: concluded no strong

evidence to favour LABA over LAMA12

o 2010 Cochrane review: uncertainties in relative benefits of LABA/ICS vs. tiotropium due to shortcomings in trials13

o POET-COPD RCT (2011):14 tiotropium reduced risk of moderate/severe exacerbations compared with salmeterol, but use of ICS in study complicates application in context of NICE

o 2012 systematic review: Compared with tiotropium monotherapy, LABA/ICS associated with some improvements in FEV1, QOL and dyspnoea, but no difference in exacerbations, and higher risk of SAEs and pneumonia15  

BOTTOM LINE: No strong recommendations to guide choice, but consider suitability of device, tolerability, and adverse effects on ICS.

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sEvidence for triple therapy

• Triple therapy (LABA/ICS plus LAMA): o A new option recommended by NICE for patents with persistent

breathlessness or persistent exacerbations irrespective of FEV1

o Strength of evidence to support approach has been questionedo Based on most recent systematic review (2012):15

• compared with tiotropium alone, triple therapy associated with clinically significant improvements in lung function and QOL

• but non-statistically significant reduction in exacerbations (OR 0.57; 95% CI: 0.24 to 1.37, p = 0.21).

• authors concluded that the data “are still scarce and studies too short to generate a strong recommendation”.

o Also, Cochrane systematic review (2011):16

• studies inadequate for authors to draw firm conclusions about benefits of triple therapy on mortality, hospitalisation and pneumonia compared with tiotropium or LABA/ICS alone

• Small benefits seen in terms of effects on QOL and lung function tests

BOTTOM LINE: Triple therapy is a costly treatment option if used inappropriately, and there is uncertainty over long-term benefits

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sRecent safety advice for tiotropium

• MHRA (2010): discrepancies in safety findings for tiotropium Spiriva Handihaler and Respimat devices reported:17 o Numerical excess in mortality, which was statistically significant

in patients with known cardiac disorders, found in trials of Respimat▼

o Excess risk not apparent with Handihaler (e.g. 4-yr UPLIFT study tiotropium via Handihaler associated with lower mortality compared with placebo)

• BMJ meta-analysis (2011):18 o 46% excess risk of all-cause mortality with 5 mcg tiotropium via

Resipimat®▼ vs placebo (absolute difference = 0.8%; NNH = 124 (95%CI: 52 to 5682)

Current advice from MHRA:17 o Spiriva Respimat▼ should be used with caution in patients with known

cardiac rhythm disorderso Remind patients on tiotropium not to exceed the recommended doseso If switch to Handihaler® is being considered, provide training in inhaler

technique for the dry power formulation

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sNICE guidance: oral therapies for stable

COPD3

• Oral corticosteroids:o Use as regular maintenance therapy not normally recommended.o ..but some patients may require on-going treatment when use

cannot be withdrawn following an exacerbation, in which case…• Keep dose as low as possible• Monitor for osteoporosis and prescribe appropriate prophylaxis• Patients aged over 65 should receive prophylaxis without monitoring.

 Oral theophylline:o Reserved for use after trial of bronchodilators, or if unable to use

inhaled therapy.o May be combined with either an inhaled beta2-agonist or

antimuscarinic; narrow therapeutic window

• Oral mucolytics:o May be considered for patients with chronic productive cougho Perform trial - continue only if symptomatic improvement.o Do not prescribe routinely for exacerbations in stable COPD

• Anti-tussive therapy and prophylactic antibiotics are not recommended for stable COPD

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sManaging exacerbations - treat at home

or admit to hospital? 3

• Consider the following factors, as recommended by NICE

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sTreating exacerbations in primary care3

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• Increase use of SABAs

• Unless contraindicated, prescribe oral corticosteroids if significant increase in breathlessness, which is interfering with daily activitieso Prescribe prednisolone 30 mg daily for 7 to 14 days (no advantage

in >14 days)o Consider prophylaxis for osteoporosis in patients requiring

frequent course

• Prescribe antibiotics if more purulent sputumo Patients without more purulent sputum do not need antibiotics

unless consolidation on chest X-ray or clinical signs of pneumoniao Sputum culture not recommended in routine practice

recommended by NICE

• Measure oxygen saturation – if SaO2 < 90% treat in hospital

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sPatient review and self-management

• Patient reviewo Frequency of review:

• At least annual review in patients at Stages 1 to 3• At least twice yearly in Stage 4 patients

o Record FEV1 and FVC, BMI and MRC score at review (SaO2 also recommended for Stage 4 patients)

o Clinical assessment should include: • smoking status, desire to quit• treatment review, inhaler technique

• need for additional assistance (e.g pulmonary rehabilitation; O2)

• also nutritional state & presence of depression in Stage 4 patients

• Self-management of exacerbationso NICE advocates that patients at risk of an exacerbation should be

given a course of antibiotic and corticosteroid tablets to keep at home

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sImmunisations

• COPD patients should receive annual flu vaccine3

• Pneumococcal vaccination (one-off) also required for patients with COPD:3

o Re-vaccination not recommended but individuals who have previously received 12- or 14-valent PPV or 7-valent PCV should be immunised with 23-valent PPV to gain protection from additional serotypes. 20

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sSupplying oxygen – when to refer

• Home oxygen supply:o significant variation seen in spend across PCTso Home O2 has been a focus for improvement, e.g. referral of

patients to HOS-ARs to assess the initial and on-going needs

• NICE recommend to refer for O2 assessment:3

o Where airflow obstruction is very severe (FEV1 < 30% predicted)

o in patients with cyanosis, polycythaemia, peripheral oedema, or raised jugular venous pressure

o If oxygen sats ≤ 92% breathing airo Also, consider referring for assessment if FEV1 30-49% predicted

• Advise patients that O2 should be used for 15 hours per day – greater benefits seen for 20 hours per day

• Patients on O2 should be reviewed at least once per year by practitioners familiar with long-term O2

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sSupplying oxygen - changes

• Changes to the Home Oxygen Service are underway

• Home Oxygen Order Form (HOOF) has been separated into HOOF A and HOOF B

o HOOF A – designed to be completed by a healthcare professionals:

• Non specialists• For temporary orders (static supply only) • Can be used to discharge from hospital

o HOOF B:• To be completed ONLY by specialist/commissioned HOS assessment and

review service• For static and ambulatory supply

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sSupplying Oxygen – commissioning

issues• Commissioners will need to assess what services are provided

for patients currently needing oxygen and who will require oxygen assessment.

• A small poll of commissioners in the West Midlands has revealed:o Most provide oxygen assessment and review services for patients

with COPDo Most provide pulmonary rehabilitation services for patients with

COPDo Few (only 1 from the sample of 9 PCTs that responded) provide

services for patients with:• Heart failure• Paediatric assessment• Palliative care• Neurological conditions

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sSummary – final key points

• Diagnose earlier and accurately:o Based on clinical signs and quality-assured spirometry

• In relation to management/prevention of exacerbations: o Offer smoking cessation at every opportunityo Follow NICE sequential approach to pharmacotherapyo Check inhaler technique routinely; address non-compliance o Exacerbations: treat promptly; offer self-management adviceo Review patients regularlyo Offer vaccinationso Refer to pulmonary rehabilitation patients with MRC 3 or highero Long-term oxygen therapy: consider patient’s on-going

requirements

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sSummary

• A final point to consider…(reproduced from the NHS Companion Document on the Outcomes Strategy for COPD1)

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sReferences

1. An Outcomes Strategy for COPD and Asthma: NHS Companion Document. 2012. Department of Health. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_134000

2. Outcomes Strategy for COPD and asthma. Department of Health. 2011. http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_128428.pdf

3. Chronic obstructive pulmonary disease (updated). Clinical guideline CG101: June. National Institute for Health and Clinical Excellence. 2010. http://guidance.nice.org.uk/CG101

4. Lamprecht et al. COPD in never smokers: results from the population-based burden of obstructive lung disease study. Chest 2011;139:752-63.

5. Global Strategy for Diagnosis, Management, and Prevention of COPD (2011 update). Global Initiative for Chronic Obstructive Lung Disease. 2011. http://www.goldcopd.org/uploads/users/files/GOLD_Report_2011_Feb21.pdf

6. Spirometry in Practice. BTS COPD Consortium. www.brit-thoracic.org.uk/portals/0/.../spirometry_in_practice051.pdf

7. Zeki et al. The Asthma-COPD Overlap Syndrome: A Common Clinical Problem in the Elderly. J. Allergy 2011: doi:  10.1155/2011/861926

8. Fletcher CM et al. The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. BMJ 1959; 2:257-66

9. Scanlon et al. Smoking cessation and lung-function in mild-to-moderate COPD. Am J Respir Crit Care Med 2000; 161 (2):381-90

10. Calverley et al. Salmeterol and fluticasone propionate and survival in COPD. N Engl J Med 2007; 356:775-89

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sReferences (continued)

11. Nannini et al. Combined corticosteroid and long-acting beta-agonist in one inhaler versus long-acting beta-agonists for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD006829

12. CG101: COPD (update): full guideline. National Institute for Health and Clinical Excellence. 2010. http://www.nice.org.uk/nicemedia/live/13029/49425/49425.pdf

13. Welsh et al. Combination inhaled steroid and long-acting beta2-agonist versus tiotropium for COPD. Cochrane Database of Systematic Reviews 2010, Issue 5. Art. No.: CD007891

14. Vogelmeier et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011;364:1093–103

15. Rodrigo et al. Comparison of three combined pharmacological approaches with tiotropium monotherapy in stable moderate to severe COPD: A systematic review. Pulmon Pharmacol Therapeutics 2012; 25: 40-47

16. Karner et al. Combination inhaled steroid and long-acting beta2-agonist in addition to tiotropium versus tiotropium or combination alone for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2011, Issue 3. Art. No:CD008532.

17. Drug Safety Update, November 2010. Tiotropium: safety studies of Spiriva Respimat. Medicines and Healthcare Products Regulatory Agency. 2010 http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON099869

18. Celli et al. Mortality in the 4-Year trial of tiotropium (UPLIFT) in patients with COPD. Am J Respir Crit Care Med 2009; 180: 948–55

19. Singh et al. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ 2011;342:d3215

20. Immunisation against infectious disease (The Green Book) 2012 update. Department of Health. http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_133118.pdf 27