COPD Approved Presentation.PPTX

Chronic Obstructive Pulmonary Disease(COPD)

For use of a registered medical practioners only.

What is COPD?

Chronic obstructive pulmonary disease (COPD) is a

slowly progressive disease

involving the airways or pulmonary parenchyma (or both) that

results in airflow obstruction.

Qaseem A et al. Ann Intern Med. 2011;155:179-191

Prevalence of COPD - India

Jindal S et al. Ind J Chest Dis Allied Sc 2006; 48: 23-9.

As per Field surveys in urban and rural populations at Bangalore, Chandigarh, Delhi and Kanpur

Overall prevalence - 4.1%

Male:Female ratio - 1.56: 1

Smoking to non smoking COPD ratio - 2.65: 1

Bidi vs. cigarette smokers - 8.2% vs. 5.9%

Projected prevalence in 2016 in India

Murthy K. NCMH-Background papers-Burden of diseases in India, 2005

No. of cases in lakhs

193.4

222.1

Morbidity due to COPD

In a large-scale study in 2001 in Hyderabad city and

its surrounding municipalities

Rates of hospital admissions of cases with COPD

At the community level - 47.84/100,000

1864 years of age - 57.28/100,000

above 65 years of age - 546.17/100,000

Murthy K. NCMH-Background papers-Burden of diseases in India, 2005

Mortality due to COPD

COPD by 2020 would

rise to 3rd position as a cause of death

rise to 5th position as the cause of loss of disability adjusted life years (DALYs)

Jindal SK. Indian J Med Res, 2006;124: 619-630

Economic burden of COPD

United States in 2010

Total direct cost of medical care $29.5 billion per year (approx.)

Total economic costs estimated to be $49.9 billion

India in 2011

Total cost of treatment for COPD Rs 35,337.7 crore

Qaseem A et al. Ann Intern Med. 2011;155:179-191

Risk factors

Tobacco smoking

Indoor air pollution: Biomass fuels (dung, crop residues, firewood)

Outdoor air pollution: Worsen preexisting COPD

Occupational exposures: Toxic gases, dust, grain dust in farms

Pulmonary tuberculosis: Airway fibrosis, inflammation

Chronic asthma: Poorly treated chronic persistent severe asthma

Genetic factors: Alpha-1 antitrypsin deficiency, antioxidant genes being examined

Socioconomic status: IUGR, poor nutrition

Jindal SK. Indian J Med Res, 2006;124: 619-630

IUGR - Intrauterine Growth Retardation

Tobacco usage in India

17% of worlds smokers are in India.

Prevalence of smoking: 28.5% in males, 2.1% in females.

Forms: Cigarettes, bidis, hookah, chillum.

Cigarette smoke: Large number of free oxidant radicals that damage the airway epithelium.

Up to 50% of smokers can develop COPD.

Jindal SK. Indian J Med Res, 2006;124: 619-630

Pathophysiology of COPD

Key contributions to the progression of airway obstruction

Small airway wall tissue volume increase

Accumulation of mucous exudates

Infiltration of the airway wall by cells of innate and adaptive immune responses

Onoue S, et al. Expert Opin. Drug Deliv, 2009.6(8):793-811

Pathophysiology of COPD

Activation of inflammatory cells -

Neutrophils, T cells, Mast cells, Macrophages

Matrix-degrading proteases,

Matrix metalloproteases (MMP), free radicals

Damage to epithelium and underlying basement

partial repair

Onoue S, et al. Expert Opin. Drug Deliv, 2009.6(8):793-811

Continued

Lung in COPD has a large number of lymph follicles

Responsible for T cell-mediated immune response

Apoptotic cell death

(alveolar, bronchiolar and endothelial)

All these factors lead to pulmonary emphysema and irreversible reduction in the caliber of the small airways of the lung

Onoue S, et al. Expert Opin. Drug Deliv, 2009.6(8):793-811

COPD is a multicomponent disease with inflammation at its core1, 2

Agusti RGN et al. Respir Med 2005; 99:670-82

2. Wedzicha J, Donaldson G. Respir Care 2003;48: 1204-13

Structural changes

Mucociliary dysfunction

Airway inflammation

Systemic component

Airflow limitation

Symptoms

Exacerbations

Declining health status

Death

Classical

representation

of disease

progression

Clinical features

Progressive dyspnoea

Cough

Often discounted by the patient as an expected consequence of smoking.

Morning productive cough, often present on waking, but not disturbing sleep.

Often worse in winter months, after chest infection.

Initially intermittent, later present every day, often throughout the day.

Sputum production

Global Strategy for Diagnosis, Management, and Prevention of COPD http://www.goldcopd.org/ accessed on 3-02-2012

Continued..

Wheezing and chest tightness.

Chest pains may be due to ischemic heart disease or strain on intercostal muscles.

Swollen ankles may reflect cor pulmonale and right-sided heart failure.

Hemoptysis can occur during respiratory infection.

Weight loss and anorexia.

Muscle weakness and wasting.

Global Strategy for Diagnosis, Management, and Prevention of COPD http://www.goldcopd.org/ accessed on 3-02-2012

COPD has a significant impact on patients

Impact of COPD in Europe and North America in 2000 (n=3265)

Limitation in activities of daily living due to chronic obstructive

pulmonary disease in participants

0

20

40

60

80

100

Subjects limited (%)

Sports and recreation

Normal physical exertion

Social

Sleep

Household chores

Sex life

Family

*

*p 2 10

When assessing risk, choose the highest risk according to GOLD grade or exacerbation history

Assessment of COPD - GOLD Guidelines 2011 Risk assessment

Global Strategy for Diagnosis, Management, and Prevention of COPD http://www.goldcopd.org/ accessed on 3-02-2012

mMRC - Modified British Medical Research Council Questionnaire

25

The frequent exacerbator phenotype:

Exacerbation frequency is an independent disease phenotype.

Exacerbations become more frequent and more severe as COPD severity increases.

Frequent exacerbators have: Poorer quality of life, more GERD, higher WCC.

It is important to prevent exacerbations with adequate treatment.

The most reliable predictor of exacerbations in an individual patient is a past history of exacerbations

Hurst JR et al. N Engl J Med 2010; 363:1128 - 1138

1. Identification by self-report Permitting selective recruitment to clinical trials

2. Frequent exacerbators may be mild patients: Targeting prevention interventions to milder patients in the clinic

3. Frequent exacerbators are a therapeutic target: Novel Strategies for Exacerbation Prevention

26

Impact on

symptoms

and lung

function

Negative

impact on

quality of life

Consequences Of COPD Exacerbations

Increased

economic

costs

Accelerated

lung function

decline

Increased

Mortality

EXACERBATIONS

Management of COPD the aims

Reduce symptomsRelieve symptomsImprove exercise toleranceImprove health statusReduce riskPrevent disease progression Prevent and treat exacerbationsReduce mortality

Global Strategy for Diagnosis, Management, and Prevention of COPD http://www.goldcopd.org/ accessed on 3-02-2012

Therapeutic Options: COPD Medications

Beta2-agonists Short-acting beta2-agonists (SABA) Long-acting beta2-agonists (LABA)Anticholinergics Short-acting anticholinergics Long-acting anticholinergics (LAMA)Combination short-acting beta2-agonists + anticholinergic in one inhaler MethylxanthinesInhaled corticosteroids (ICS)Combination long-acting beta2-agonists + corticosteroids in one inhalerSystemic corticosteroidsPhosphodiesterase-4 inhibitors (PDE4I)

Global Strategy for Diagnosis, Management, and Prevention of COPD http://www.goldcopd.org/ accessed on 3-02-2012

29

SABA/SAMALAMAorLABAICS/LABAPDE4Symptom Reduction1234123412*341234Relieve symptomsImprove exercise toleranceImprove health status--------------------?--?--Risk Reduction1234123412*341234Prevent disease progression Prevent and treat exacerbationsReduce mortality-------------------------?-?-?----------

Overview of Medications for stable COPD

*Less than 60% FEV1

(pre bronchodilator)

Not on a

background of ICS

24/07/2012 11:03

30

Pharmacological First choice

GOLD 4ICS/LABA ICS/LABA 2 or more exac/ yearGOLD 3or LAMAor LAMAGOLD 2SABA or SAMA prnLABA or LAMALess than 2 exac/ yearGOLD 1mMRC 0-1mMRC > 2CAT 10

A

C

B

D

Global Strategy for Diagnosis, Management, and Prevention of COPD http://www.goldcopd.org/ accessed on 3-02-2012

Treatment of exacerbation

Inhaled bronchodilators

Systemic corticosteroids

Antibiotics

Theophylline

Oxygen therapy

Admit to ICU

Mechanical Ventilation

Global Strategy for Diagnosis, Management, and Prevention of COPD http://www.goldcopd.org/ accessed on 3-02-2012

Non Pharmacologic Therapies

Includes

Pulmonary rehabilitation

Motivation

Education

Nutrition counseling

Benefits

Improves exercise capacity

Reduces perceived intensity of breathlessness

Hospitalizations

Anxiety and depression

Improves survival

Global Strategy for Diagnosis, Management, and Prevention of COPD http://www.goldcopd.org/ accessed on 3-02-2012

Assessment of COPD requires assessment of symptoms, degree of airflow limitation, risk of exacerbations, and comorbidities

Combined assessment of symptoms and risk of exacerbations is the basis for non-pharmacologic and pharmacologic management of COPD

Treat COPD exacerbations to minimize their impact and to prevent the development of subsequent exacerbations

Look for comorbidities and if present treat to the same extent as if the patient did not have COPD

Summary

34

If we follow guidelines, healthcare expenditure for COPD may reduce...

Murthy K. NCMH-Background papers-Burden of diseases in India, 2005

For the use of Registered Medical Practitioners only

Abbreviated prescribing information for SERETIDETM ACCUHALERTM

Salmeterol and Fluticasone Propionate Accuhaler

Active Ingredient: Seretide Accuhaler 100, 250 and 500 is available as a moulded plastic device containing a foil strip with 60 blisters, each contains powder for inhalation providing Salmeterol Xinafoate IP equivalent to 50 mcg Salmeterol and Fluticasone Propionate IP, 100mcg, 250mcg and 500mcg respectively. Indications: Regular treatment of bronchial asthma, where use of a bronchodilator and an inhaled corticosteroid are appropriate including patients on effective maintenance doses of long-acting -agonists and inhaled corticosteroids, patients who are symptomatic on current inhaled corticosteroid therapy and patients on regular bronchodilator therapy who require inhaled corticosteroids. Regular treatment of Chronic Obstructive Pulmonary Disease (COPD) including chronic bronchitis. Dosage and Administration: Bronchial asthma: Adults and adolescents 12 years and older: One inhalation of 50/100, 50/250 or 50/500mcg twice daily. Adults 18 years and older: Doubling the dose of all strengths of Seretide for up to 14 days when additional short term inhaled corticosteroid therapy is needed. Children 4 years and older: One inhalation of 50/100mcg twice daily. No data available for use in children under 4 years. COPD: For adult patients, one inhalation 50/250 mcg to 50/500 mcg twice daily. Special patient groups: No need to adjust the dose in elderly patients or in those with renal or hepatic impairment. Administration: For inhalation only. Use regularly for optimum benefit, even when asymptomatic. Doctor should regularly reassess the patient. In bronchial asthma, dose should be titrated to the lowest dose (could include once daily dosage) at which effective control of symptoms is maintained. Contraindications: History of hypersensitivity to any of the ingredients. Warnings and Precautions: Not indicated for relief of acute symptoms. Patients should have their relief medication available at all times and should be reviewed by a physician if increasing use of short-acting bronchodilators to relieve symptoms, sudden and progressive deterioration in asthma control, increasing corticosteroid therapy or current dosage of Seretide fails to give adequate control of reversible obstructive airways disease. Additional corticosteroids and antibiotics for infective exacerbations of asthma or COPD. Do not stop treatment abruptly in asthma due to risk of exacerbation; titrate down under physician supervision. In COPD, cessation of therapy may be associated with symptomatic decompensation, should be supervised by a physician. Possibility of pneumonia in patients with COPD. Administer with caution in active or quiescent pulmonary tuberculosis, thyrotoxicosis, pre-existing cardiovascular disease, those predisposed to hypokalemia. High doses prescribed for long periods may result in Cushings syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Impaired adrenal response in emergency and elective situations that are likely to produce stress. Consider appropriate corticosteroid treatment. Monitor adrenocortical function regularly in patients transferring from systemic corticosteroid therapy to inhaled fluticasone propionate. Monitor height of children regularly in case of prolonged treatment. Very rare reports of increase in blood glucose levels; to be considered in diabetes mellitus. Concomitant use of fluticasone propionate and ritonavir should be avoided unless the potential

benefit to the patient outweighs the risk of systemic corticosteroid side-effects. African-American patients may be at greater risk of serious respiratory-related events or deaths. Caution should be exercised when co-administered with strong CYP3A4 inhibitors (e.g. ketoconazole). Interactions: Avoid -blockers (unless compelled to use). Inhibitors of P450 3A4 can produce great increase (ritonavir), minor increase (ketoconazole), negligible increase (erythromycin) in systemic exposure to fluticasone propionate. Ketoconazole can significantly increase plasma salmeterol exposure. Effects on Ability to Drive and Use Machines: None noted. Pregnancy and Lactation: Use if the expected benefit to the mother is greater than any possible risk to the foetus or child. Adverse Reactions: Paradoxical bronchospasm, tremor, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, extrasystoles), Cushings syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Common: muscle cramps, hoarseness/dysphonia, oropharyngeal irritation, headache (transient, reduce with regular therapy), candidiasis (thrush) of the mouth and throat, palpitations, pneumonia (in COPD patients).Uncommon: rash, contusions, cutaneous hypersensitivity reactions. Rare: hypersensitivity reactions (angioedema, mainly facial and oropharyngeal oedema), respiratory symptoms (dyspnoea and/or bronchospasm). Very rare: arthralgia, hypersensitivity reactions (anaphylactic reactions such as oedema, angioedema, bronchospasm, anaphylactic shock), hyperglycemia, anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children). Overdosage: Salmeterol: Tremor, headache, tachycardia, increases in systolic blood pressure and hypokalaemia. Antidote: Cardioselective -blocking agents, use with caution in patients with a history of bronchospasm. If Seretide needs to be withdrawn, provide appropriate replacement corticosteroid therapy. Fluticasone propionate: May lead to temporary suppression of the hypothalamic-pituitary-adrenal axis, does not usually require emergency action as normal adrenal function typically recovers within a few days. Salmeterol/Fluticasone propionate: If higher than approved doses are continued over prolonged periods, significant adrenocortical suppression is possible. Very rare reports of acute adrenal crisis (potential triggers: trauma, surgery, infection or any rapid reduction in the dosage of the inhaled fluticasone propionate component) mainly in children exposed to higher than approved doses over prolonged periods (several months or years). Observed features include hypoglycaemia associated with decreased consciousness and/or convulsions. Patients should not receive higher than approved doses of Seretide. Review therapy regularly and titrate down to the lowest approved dose at which effective control of disease is maintained.

Refer to full prescribing information before use.

Fullprescribing information available on request from GlaxoSmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road, Worli, Mumbai- 400030.

Version: SER/API/IN/2009/01 v02 dated 15 June 2011

Valid upto March 2014

IN/SFC/0019/12

Chart1"Have to stop even when walking at my own pace or walk slower than most people my age""Have to stop for breath every few minutes when walking even on level ground""Too breathless to leave the house"

Sheet1"Have to stop even when walking at my own pace or walk slower than most people my age""Have to stop for breath every few minutes when walking even on level ground""Too breathless to leave the house"MRC dyspnoea scale score75.199996948260.299999237135.7999992371