Optimizing the Management of Chronic Obstructive Pulmonary Disease (COPD) ©AstraZeneca LP. All...

Optimizing the Management of Chronic Optimizing the Management of Chronic Obstructive Pulmonary Disease (COPD)Obstructive Pulmonary Disease (COPD)

©AstraZeneca LP. All rights reserved. 275086 2/09

Top 5 Causes of Death: COPD on the RiseTop 5 Causes of Death: COPD on the Rise

Jemal A et al. JAMA. 2005;294:1255-1259.

-52%-52%

-3%-3%

-63%-63%

103%103%

-41%-41%

-80%-80%

-60%-60%

-40%-40%

-20%-20%

0%0%

20%20%

40%40%

60%60%

80%80%

100%100%

120%120%

% C

han

ge,

197

0-20

02%

Ch

ang

e, 1

970-

2002

Heart diseaseHeart disease

CancerCancer

StrokeStroke

COPDCOPD

AccidentsAccidents

Overall Health Care Costs Are Higher in Overall Health Care Costs Are Higher in Patients With COPD Patients With COPD

19270

3436

24982498

969969

58885888

27202720

00

50005000

1000010000

1500015000

2000020000

2500025000

3000030000

COPD cohortCOPD cohort

(n=8370)(n=8370)

Comparison cohortComparison cohort

(n=8370)(n=8370)

Mea

n H

ealt

h C

are

Co

stM

ean

Hea

lth

Car

e C

ost

per

Per

son

(U

S d

olla

rs)

per

Per

son

(U

S d

olla

rs)

Other health-care-related costs*Other health-care-related costs*

Outpatient costsOutpatient costs

Hospitalization costsHospitalization costs

*Included emergency room visits, physician visits, and pharmacy costs.†Each comparator was based on the mean of 3 controls from a data set including 25,110 patients.

Menzin J et al. Respir Med. 2008;102:1248-1256.

Where Can We ImproveWhere Can We ImproveCOPD Management?COPD Management?

COPD remains underdiagnosedCOPD remains underdiagnosed11

• Awareness of COPD guidelines suboptimalAwareness of COPD guidelines suboptimal22

• Spirometry used inconsistentlySpirometry used inconsistently22

• Mortality increasing among womenMortality increasing among women33

• Present in the fifth decade of life,Present in the fifth decade of life,44 though early symptoms may be missed though early symptoms may be missed22

Diagnosis and treatment may prevent or delay progression of lung functionDiagnosis and treatment may prevent or delay progression of lung functiondecline and symptomsdecline and symptoms55

• Spirometry is key to the diagnosis of COPDSpirometry is key to the diagnosis of COPD55

• Education represents an opportunity to improve outcomes for COPD patientsEducation represents an opportunity to improve outcomes for COPD patients2,52,5

1. Mannino DM et al. MMWR Surveillance Summary. 2002;51:1-16.2. Yawn BP, Wollan PC. Int J COPD. 2008;3:311-317.3. Deaths from chronic obstructive pulmonary disease—United States, 2000-2005. MMWR Morb Mortal Wkly Rep. 2008;57:1229-1232.4. American Association for Respiratory Care. http://www.aarc.org/resources/confronting_copd/exesum.pdf. Accessed February 11, 2009.5. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2008. http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989. Accessed November 21, 2008.

Early diagnosis and treatment Early diagnosis and treatment may lead to better outcomesmay lead to better outcomes55

Overview of COPD PathophysiologyOverview of COPD Pathophysiology

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2008. Available at: http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989. Accessed November 21, 2008.

EmphysemaEmphysema MucociliaryMucociliaryDysfunctionDysfunction

Structural Structural ChangesChanges

Systemic/ Extrapulmonary Systemic/ Extrapulmonary EffectsEffectsExacerbationsExacerbations

OxidativeOxidativeStressStress

SusceptibilitySusceptibilityGenesGenes GenderGender Proteinases/ Proteinases/

Cell MediatorsCell MediatorsCigaretteCigaretteSmokeSmoke

EnvironmentalEnvironmentalIrritantsIrritants

RespiratoryRespiratoryInfectionsInfections

LungLungInflammation,Inflammation,Hyperinflation,Hyperinflation,

Airway Obstruction,Airway Obstruction,Elastic Recoil LossElastic Recoil Loss

ChronicChronicBronchitisBronchitis

6363

8585

77

87878080

88

77778888

4545

9494 9898

3737

Inflammation Is PresentInflammation Is PresentEven in Early Stages of COPDEven in Early Stages of COPD

6767

5454

2525

55556666

3333

8484

7373

2929

1001009292

3232

00

2020

4040

6060

8080

100100

120120

PMNsPMNs MacrophagesMacrophages EosinophilsEosinophils CD4 CellsCD4 Cells CD8 CellsCD8 Cells B CellsB Cells

Airw

ays

With

Airw

ays

With

Mea

sura

ble

Cel

ls (%

)M

easu

rabl

e C

ells

(%)

Inflammatory CellsInflammatory Cells

GOLD Stage 0GOLD Stage 0 GOLD Stage IGOLD Stage I GOLD Stages II and IIIGOLD Stages II and III GOLD Stage IVGOLD Stage IV

Adapted from Hogg JC et al. N Engl J Med. 2004;350:2645-2653.

Airflow Obstruction in COPDAirflow Obstruction in COPDIs Partially ReversibleIs Partially Reversible

Postbronchodilator FEV1 measured after administration of 80 µg ipratropium and 400 µg albuterol.

Adapted with permission from Tashkin DP et al. Eur Resp J. 2008;31:742-750.

Change in FEVChange in FEV11 % %

1515

1010

55

00

Pat

ien

ts,

%P

atie

nts

, %

**

-30-30 -25-25 -20-20 -15-15 -10-10 -5-5 00 55 1010 1515 2020 2525 3030 3535 4040 4545 5050 5555 6060 6565 7070 7575 8080 8585 9090 9595 100100

Degree of ReversibilityDegree of Reversibility

*65.6% showed a ≥15% *65.6% showed a ≥15% increase in FEVincrease in FEV11

Spirometry Is Essential forSpirometry Is Essential forDiagnosing COPDDiagnosing COPD

Chronic symptoms = cough, sputum, and/or shortness of breathChronic symptoms = cough, sputum, and/or shortness of breathChronic symptoms = cough, sputum, and/or shortness of breathChronic symptoms = cough, sputum, and/or shortness of breath

Exposure to risk factors = tobacco, occupational irritants, and/or Exposure to risk factors = tobacco, occupational irritants, and/or indoor/outdoor pollutionindoor/outdoor pollution

Exposure to risk factors = tobacco, occupational irritants, and/or Exposure to risk factors = tobacco, occupational irritants, and/or indoor/outdoor pollutionindoor/outdoor pollution

Spirometry* to confirm COPD diagnosisSpirometry* to confirm COPD diagnosis • • FEVFEV11/FVC <0.70 /FVC <0.70 •• FEV FEV11 determines staging determines staging

Spirometry* to confirm COPD diagnosisSpirometry* to confirm COPD diagnosis • • FEVFEV11/FVC <0.70 /FVC <0.70 •• FEV FEV11 determines staging determines staging

If . . If . . ..

And . . .And . . .

Then . . .Then . . .

*Additional testing: chest x-ray, echocardiogram, arterial blood gas, sputum analysis, computed tomography (CT) scan.

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2008. http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989. Accessed November 21, 2008.

Spirometry Is a Useful Tool to AssessSpirometry Is a Useful Tool to AssessCOPD Severity and ProgressionCOPD Severity and Progression1,21,2

1. American Thoracic Society, European Respiratory Society. Standards for the diagnosis and management of patients with COPD. http://www.thoracic.org/sections/copd/. Accessed November 19, 2008.

2. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2008. http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989. Accessed November 21, 2008.

II IIII IIIIII IVIV

FEVFEV11/FVC <0.70 /FVC <0.70

FEVFEV11 ≥80% ≥80%

predictedpredicted

FEVFEV11/FVC <0.70/FVC <0.70

50% ≤ FEV50% ≤ FEV11 <80% <80%

predictedpredicted


30% ≤FEV30% ≤FEV11

<50% predicted<50% predicted


FEVFEV11 <30% <30%

predicted orpredicted orFEVFEV11 <50% <50%

predicted plus predicted plus chronic chronic respiratory failurerespiratory failure

Chronic cough and Chronic cough and sputum productionsputum production

Stage I symptomsStage I symptoms+ dyspnea+ dyspnea

Progressive Progressive dyspneadyspnea

Stage III symptoms Stage III symptoms + respiratory failure, + respiratory failure, right heart failure, right heart failure, weight loss, arterial weight loss, arterial hypoxemiahypoxemia

StageStage

SeveritySeverity

TypicalTypical

symptomssymptoms

Goals of COPD ManagementGoals of COPD Management

COPD management includes both pharmacologic and nonpharmacologic treatment.


• Relieve symptomsRelieve symptoms

• Minimize side effectsMinimize side effects

• Improve exercise toleranceImprove exercise tolerance

• Prevent and treat exacerbations and complicationsPrevent and treat exacerbations and complications

• Improve health statusImprove health status

• Prevent disease progressionPrevent disease progression

• Reduce mortalityReduce mortality

Short TermShort Term

Long TermLong Term

andand

Nonpharmacologic TherapyNonpharmacologic Therapyto Manage COPDto Manage COPD


Patient EducationPatient Education

Oxygen TherapyOxygen TherapySurgical and Non-Surgical and Non-

surgical Alternativessurgical AlternativesPulmonary Pulmonary

RehabilitationRehabilitation

Smoking CessationSmoking Cessation VaccinationVaccination

Pharmacologic Therapy to Manage COPD Pharmacologic Therapy to Manage COPD

AddAdd regular treatment with one or more long-acting bronchodilators (when regular treatment with one or more long-acting bronchodilators (when needed);needed); AddAdd rehabilitationrehabilitation

AddAdd inhaled glucocorticosteroids if repeated inhaled glucocorticosteroids if repeated exacerbationsexacerbations

Active reduction of risk factor(s); influenza vaccinationActive reduction of risk factor(s); influenza vaccination

AddAdd short-acting bronchodilator (when needed)short-acting bronchodilator (when needed)

AddAdd long-term oxygen long-term oxygen if if chronic respiratory chronic respiratory failure;failure;ConsiderConsider surgery surgery

II IIII IIIIII IVIV

Adapted from Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2008. http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989. Accessed November 21, 2008.


FEVFEV11 ≥80% predicted ≥80% predicted


50% ≤FEV50% ≤FEV11 <80% <80%

predictedpredicted


30% ≤FEV30% ≤FEV11 <50% <50%

predictedpredicted


FEVFEV11 <30% predicted <30% predicted

ororFEVFEV11 <50% predicted <50% predicted

plus chronic plus chronic respiratory failurerespiratory failure

StageStage

SeveritySeverity

SymbicortSymbicort®® (budesonide/formoterol fumarate (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for COPDdihydrate) Inhalation Aerosol for COPD

277761 5/09

• SYMBICORT 160/4.5 μg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

• Does not replace fast-acting inhalers and should not be used to treat acute symptoms of COPD

©AstraZeneca LP. All rights reserved.

SYMBICORT Has Been Extensively Studied in SYMBICORT Has Been Extensively Studied in Patients With Moderate to Very Severe COPDPatients With Moderate to Very Severe COPD

*Administered as 2 inhalations BID.†Monocomponents refers to administration of budesonide monotherapy, formoterol monotherapy, and budesonide + formoterol administered in separate devices, all administered as 2 inhalations BID.

1. Rennard SI et al. Drugs. 2009;69:549-565. 2. Tashkin DP et al. Drugs. 2008;68:1975-2000.

StudyDuration (weeks) N Purpose Was to Compare the Efficacy and Safety of...

SUNSUN11 5252 19641964 SYMBICORT pMDI 160/4.5 μg × 2 inhalations BID and SYMBICORT pMDI 80/4.5 μg × 2 inhalations BID versus formoterol* and placebo*

SHINESHINE22 2626 17041704 SYMBICORT pMDI 160/4.5 μg × 2 inhalations BID and SYMBICORT pMDI 80/4.5 μg × 2 inhalations BID versus its monocomponents† and placebo*

Overview of Key Phase III StudiesOverview of Key Phase III Studies

SUN and SHINE Study Design FeaturesSUN and SHINE Study Design Features

• Patients receiving concomitant medications prior to Patients receiving concomitant medications prior to study initiationstudy initiation1,21,2

– Allowed to remain on ICS during run-inAllowed to remain on ICS during run-in– Long-acting anticholinergics were changed to stable doses of Long-acting anticholinergics were changed to stable doses of

ipratropium during run-in and throughout the studyipratropium during run-in and throughout the study– Long-acting Long-acting ββ22-agonists (LABAs) were changed to short-acting-agonists (LABAs) were changed to short-acting

ββ22-agonists (SABAs) as needed-agonists (SABAs) as needed

• Subjects with underlying comorbidities were includedSubjects with underlying comorbidities were included1,21,2

– Hypertension (42%)Hypertension (42%)– Dyslipidemia (22%-24%)Dyslipidemia (22%-24%)– Cardiac disease (18%)Cardiac disease (18%)– Diabetes (10%-11%)Diabetes (10%-11%)

1. Rennard SI et al. Drugs. 2009;69:549-565. 2. Tashkin DP et al. Drugs. 2008;68:1975-2000.

SUN Assessed the Efficacy and Safety of SYMBICORT SUN Assessed the Efficacy and Safety of SYMBICORT Over 12 Months in Patients With COPDOver 12 Months in Patients With COPD1,21,2

1. Nelson HS et al. Poster 302 presented at: Chest 2008; October 25-30, 2008; Philadelphia, PA.2. Rennard SI et al. Drugs. 2009;69:549-565.

Run-in

SYMBICORT pMDI

160/4.5 µg 2 Inhalations BID

(n=494)

Formoterol DPI

4.5 µg 2 Inhalations BID

(n=495)

Placebo 2 Inhalations BID (n=481)

SYMBICORT pMDI

80/4.5 µg 2 Inhalations BID

5 6

4 6 13

7

9

8

12

FUVisit

Month

1 2 3 4

-0.5 0 1 2

Double-blind

(n=494)

Follow-up

RANDOMIZATION

COPD Efficacy Variables Included Measures COPD Efficacy Variables Included Measures of Stabilization and Bronchodilationof Stabilization and Bronchodilation1-31-3

1. Rennard SI et al. Drugs. 2009;69:549-565.2. Data on File, 272887, AZPLP.3. Tashkin DP et al. Drugs. 2008;68:1975-2000.

Variable Comparison Demonstrated

SYMBICORT Versus

Predose Predose FEVFEV11

160/4.5 µg x 2 160/4.5 µg x 2 inhalations BIDinhalations BID

and and


Formoterol 4.5 µg x 2 Formoterol 4.5 µg x 2 inhalations BID (SUN inhalations BID (SUN and SHINE)and SHINE)

Stabilizing, anti-inflammatory Stabilizing, anti-inflammatory effect, largely contributed by effect, largely contributed by budesonidebudesonide

1-hour 1-hour Postdose Postdose FEVFEV11

160/4.5 µg x 2 160/4.5 µg x 2 inhalations BID inhalations BID

and and


Budesonide 160 µg x 2 Budesonide 160 µg x 2 inhalations BID (SHINE) inhalations BID (SHINE) and Placebo (SUN)and Placebo (SUN)

Bronchodilatory effect, Bronchodilatory effect, largely contributed by largely contributed by formoterolformoterol

SUN Patient Demographic and Baseline SUN Patient Demographic and Baseline Clinical CharacteristicsClinical Characteristics1,21,2

Note: mean age was ~63 years and ~64% of subjects were male.*Safety analysis set. †Data were missing for 3 subjects.

1. Rennard SI et al. Drugs. 2009;69:549-565.2. Data on File, 275389 AZPLP.

Treatment Group, Mean

SYMBICORT 160/4.5 µg

(n=494)

SYMBICORT80/4.5 µg (n=494)

Formoterol 4.5 µg (n=495)

Placebo(n=481)

Total (N=1964)

FEVFEV11, L (SD), L (SD) 1.02 (0.39)1.02 (0.39) 1.04 (0.39)1.04 (0.39) 1.03 (0.40)1.03 (0.40) 1.08 (0.42)1.08 (0.42) 1.04 (0.40)1.04 (0.40)

Predicted FEVPredicted FEV11, % , % (SD) (SD)

33.8 (11.4)33.8 (11.4) 34.5 (11.5)34.5 (11.5) 33.7 (11.3)33.7 (11.3) 35.5 (11.9)35.5 (11.9) 34.4 (11.6)34.4 (11.6)

Reversibility ≥12% + Reversibility ≥12% + in FEV in FEV11 ≥0.2L, n (%) ≥0.2L, n (%) 150 (30.4)150 (30.4) 144 (29.1)144 (29.1) 158 (31.9)158 (31.9) 153 (31.8)153 (31.8) 605 (30.8)605 (30.8)

Postbronchodilator† Predicted FEV1, n (%)

<30%<30% 120 (24.3)120 (24.3) 94 (19.0)94 (19.0) 119 (24.0)119 (24.0) 90 (18.7)90 (18.7) 423 (21.5)423 (21.5)

≥≥30% to <50%30% to <50% 290 (58.7)290 (58.7) 314 (63.6)314 (63.6) 285 (57.6)285 (57.6) 298 (62.0)298 (62.0) 1187 (60.4)1187 (60.4)

≥≥50% to <80%50% to <80% 84 (17.0)84 (17.0) 85 (17.2)85 (17.2) 89 (18.0)89 (18.0) 91 (18.9)91 (18.9) 349 (17.8)349 (17.8)

≥≥80%80% 00 00 1 (0.2)1 (0.2) 1 (0.2)1 (0.2) 2 (0.1)2 (0.1)

SYMBICORT Significantly Improved Lung Function as SYMBICORT Significantly Improved Lung Function as Early as Day 1, Which Was Sustained Over 12 MonthsEarly as Day 1, Which Was Sustained Over 12 Months1,21,2

*P<.008 vs FM. (P value based on ANCOVA analysis)AOT = average of the randomized treatment period.

1. Rennard SI et al. Drugs. 2009;69:549-565.2. Data on File, 272887, AZPLP.

Ad

just

ed M

ean

Ch

ang

e F

rom

Bas

elin

e (m

L)

MonthAOT

-20

0

20

40

60

80

100

120

0 1 2 3 4 5 6 7 8 9 10 11 12

SYMBICORT 160/4.5 µg (n=471)


Placebo (n=436)

140

*

SUN: A 12-month Efficacy and Safety StudySUN: A 12-month Efficacy and Safety Study

Predose FEV1

SYMBICORT Rapidly Improved Lung Function SYMBICORT Rapidly Improved Lung Function Within 5 Minutes of the First and Subsequent DosesWithin 5 Minutes of the First and Subsequent Doses

Improvement in Serial FEVImprovement in Serial FEV11 Within 5 Minutes Within 5 MinutesSYMBICORT 160/4.5 µg x 2 Inhalations BID (n=121) SYMBICORT 160/4.5 µg x 2 Inhalations BID (n=121)

LOCF = last observation carried forward.

Data on File, 273071, AZPLP.

Mea

n P

erce

nt

Ch

ang

e F

rom

B

asel

ine

in F

EV

1

Baseline 0

5

10

15

20

35

25

30

2 4 6 8 10 12

Hours

15 330

Minutes

1Within 5Within 5Min PostdoseMin Postdose


Maintenance Effect

First Dose (day of randomization)

Last Dose (end of month 12, LOCF)

SYMBICORT Significantly Reduced Overall Daily COPD SYMBICORT Significantly Reduced Overall Daily COPD Symptoms by 35% Versus Formoterol Over 12 MonthsSymptoms by 35% Versus Formoterol Over 12 Months

Comparison is SYMBICORT 160/4.5 µg x 2 inhalations BID (n=489) versus formoterol 4.5 µg x 2 inhalations BID (n=489).Comparison is SYMBICORT 160/4.5 µg x 2 inhalations BID (n=489) versus formoterol 4.5 µg x 2 inhalations BID (n=489).

*P=.03.†P=.04.‡P=.15.Data on File, 273072, AZPLP.

Ad

just

ed M

ean

Ch

ang

eF

rom

Bas

elin

e (%

Imp

rove

men

t V

ersu

s F

orm

ote

rol)

OverallSymptoms* Breathlessness* Cough† Sputum‡

Symptoms50

40

20

10

035%35% 28%28% 33%33% 42%42%

30


SYMBICORT Reduced Total Daily Rescue SYMBICORT Reduced Total Daily Rescue Medication Use Over 12 MonthsMedication Use Over 12 Months

*P=.019.Data on File, 276830, AZPLP.

SYMBICORT

160/4.5 µg x 2 Inhalations BID Formoterol

4.5 µg x 2 Inhalations BID

-1.2

-1.0

-0.8

-0.6

-0.4

-0.2

0

LS

Mea

n C

han

ge

Fro

m B

ase

lin

e (i

nh

alat

ion

s/d

ay)

(n=490) (n=489)

*

Total Daily Rescue Medication UseTotal Daily Rescue Medication Use


SYMBICORT 160/4.5 µg

(n=771)%

Budesonide160 µg (n=275)

%


%

Placebo(n=781)

%

COPD-related COPD-related respiratory eventsrespiratory events

13.413.4 12.412.4 17.117.1 14.314.3

NasopharyngitisNasopharyngitis 7.37.3 3.33.3 5.85.8 4.94.9

Oral candidiasisOral candidiasis 6.06.0 4.44.4 1.21.2 1.81.8

BronchitisBronchitis 5.45.4 4.74.7 4.54.5 3.53.5

SinusitisSinusitis 3.53.5 1.51.5 3.13.1 1.81.8

Viral upper respiratory Viral upper respiratory tract infectiontract infection

3.53.5 1.81.8 3.63.6 2.72.7

PneumoniaPneumonia 2.32.3 1.81.8 2.62.6 3.33.3

Represents pooled data from both SUN and SHINE studies, at a dose of 2 inhalations BID.

Data on File, 273073, AZPLP.

Adverse Event Profile for SYMBICORTAdverse Event Profile for SYMBICORT

Adverse Events Reported by ≥3% of Subjects in Any Treatment GroupAdverse Events Reported by ≥3% of Subjects in Any Treatment Group

Other Safety Findings for SYMBICORT in COPDOther Safety Findings for SYMBICORT in COPD

• Vital signsVital signs

• Physical examinationPhysical examination

• ECGECG

• 24-hour urinary cortisol24-hour urinary cortisol

• Bone mineral density*Bone mineral density*

• Lenticular opacities and Lenticular opacities and intraocular pressure*intraocular pressure*

*As reported in SUN only.

1. Rennard SI et al. Poster 308 presented at: Chest 2008; October 25-30, 2008; Philadelphia, PA..2. Tashkin DP et al. Drugs. 2008;68:1975-2000.3. Rennard SI et al. Drugs. 2009;69:549-565.

No Clinically Important Differences Between SYMBICORT pMDI 160/4.5 µg and Placebo Were

Observed in the Following Parameters1-3

SYMBICORT:SYMBICORT:Important Safety InformationImportant Safety Information

• Particular care is needed for patients being transferred from systemically active corticosteroids to inhaled Particular care is needed for patients being transferred from systemically active corticosteroids to inhaled corticosteroidscorticosteroids

• Patients who are receiving SYMBICORT should not use additional formoterol or other long-acting inhaled betaPatients who are receiving SYMBICORT should not use additional formoterol or other long-acting inhaled beta22--agonists for any reasonagonists for any reason

• Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORTcorticosteroids, including budesonide, a component of SYMBICORT

• Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may affect Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may affect normal bone metabolism resulting in a loss of bone mineral densitynormal bone metabolism resulting in a loss of bone mineral density

• Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including budesonide, a component of SYMBICORTadministration of inhaled corticosteroids, including budesonide, a component of SYMBICORT

• Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known potent CYP3A4 inhibitorsand other known potent CYP3A4 inhibitors

• SYMBICORT should be administered with caution in patients being treated with MAO inhibitors or tricyclic SYMBICORT should be administered with caution in patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agentsantidepressants, or within 2 weeks of discontinuation of such agents

• WARNING: Long-acting betaWARNING: Long-acting beta22-adrenergic agonists may increase the risk of asthma-related death. Therefore, when -adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients with asthma not adequately controlled treating patients with asthma, SYMBICORT should only be used for patients with asthma not adequately controlled on other asthma-controller medications (eg, low- to medium-dose inhaled corticosteroids) or whose disease on other asthma-controller medications (eg, low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo-controlled severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting betaUS study that compared the safety of another long-acting beta22-adrenergic agonist (salmeterol) or placebo added -adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting betafinding with salmeterol may apply to formoterol (a long-acting beta22-adrenergic agonist), one of the active -adrenergic agonist), one of the active ingredients in SYMBICORT (see WARNINGS in full Prescribing Information)ingredients in SYMBICORT (see WARNINGS in full Prescribing Information)

Approved Dosage for Patients With COPD Approved Dosage for Patients With COPD

*Administered in the morning and in the evening.

SYMBICORT [package insert]. Wilmington, DE: AstraZeneca LP.

• SYMBICORT 160/4.5 μg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

• SYMBICORT is not a rescue medication and does NOT replace fast-acting inhalers

160/4.5 µg, 2 inhalations twice daily*

Rapid Improvement in Lung Function and Long-lasting Rapid Improvement in Lung Function and Long-lasting Control* With SYMBICORT Can Help Patients Do MoreControl* With SYMBICORT Can Help Patients Do More

• SYMBICORT significantly improved lung function as SYMBICORT significantly improved lung function as early asearly as day 1, which was day 1, which was sustained over 12 months sustained over 12 months11

• SYMBICORT rapidly improved lung function within SYMBICORT rapidly improved lung function within 5 minutes5 minutes†† of the first and subsequent doses of the first and subsequent doses22

• SYMBICORT significantly reduced overall daily COPD SYMBICORT significantly reduced overall daily COPD symptoms by 35% vs formoterol over 12 monthssymptoms by 35% vs formoterol over 12 months33

*In a 12-month clinical study, SYMBICORT improved predose FEV1, 1-hour postdose FEV1, serial FEV1 (to measure onset of effect), AM and PM peak expiratory flow (PEF), and reduced COPD symptoms and rescue albuterol use.†Significant bronchodilation (>15% improvement in FEV1) occurred within 5 minutes.

1. Data on File, 272887, AZPLP.2. Data on File, 273071, AZPLP. 3. Data on File, 273072, AZPLP.

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