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A A losetron 2000 6/26 IBS Burden of IBS Burden of Illness Illness Ian M. Gralnek, MD, MSHS Ian M. Gralnek, MD, MSHS Director, UCLA Center for the Study of Director, UCLA Center for the Study of Digestive Health Care Quality and Digestive Health Care Quality and Outcomes Outcomes Department of Medicine Department of Medicine University of California at Los Angeles University of California at Los Angeles

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IBS Burden of IBS Burden of IllnessIllness

Ian M. Gralnek, MD, MSHSIan M. Gralnek, MD, MSHS

Director, UCLA Center for the Study of Director, UCLA Center for the Study of Digestive Health Care Quality and Digestive Health Care Quality and

OutcomesOutcomesDepartment of MedicineDepartment of Medicine

University of California at Los AngelesUniversity of California at Los Angeles

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Reference: Thompson et al. Reference: Thompson et al. GutGut. 1999;45(suppl 2):1143-1147.. 1999;45(suppl 2):1143-1147.

Hallmark Symptoms of Hallmark Symptoms of IBSIBS

•Chronic or recurrent GI symptomsChronic or recurrent GI symptoms– lower abdominal pain/discomfortlower abdominal pain/discomfort– altered bowel function (urgency, altered bowel function (urgency,

altered stool consistency, altered stool altered stool consistency, altered stool frequency, incomplete evacuation)frequency, incomplete evacuation)

– bloatingbloating

•Not explained by identifiable Not explained by identifiable structural or biochemical structural or biochemical abnormalitiesabnormalities

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Key Facts About IBSKey Facts About IBS•4-20% of the US population report 4-20% of the US population report symptoms consistent with IBSsymptoms consistent with IBS1,21,2

•Affects predominantly females Affects predominantly females (~70% of sufferers)(~70% of sufferers)33

•Can cause great discomfort, Can cause great discomfort, sometimes intermittent or sometimes intermittent or continuous, for many decades in a continuous, for many decades in a patient’s lifepatient’s life44

•Can significantly disrupt daily lifeCan significantly disrupt daily life55

References: 1.References: 1. Drossman et al. Drossman et al. Dig Dis SciDig Dis Sci 1993;38(9):1569-80. 2. Talley et 1993;38(9):1569-80. 2. Talley et al. al. Am J EpidAm J Epid 1995;142:76-83 1995;142:76-83 33. Sandler. . Sandler. GastroenterologyGastroenterology. August . August 1990;99:409-415. 1990;99:409-415. 4.4. Hahn et al. Hahn et al. Dig Dis Sci.Dig Dis Sci. December 1998;43:2715-2718. December 1998;43:2715-2718. 5.5. Hahn et al. Hahn et al. DigestionDigestion. 1999;60:77-81. . 1999;60:77-81.

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Key Facts About IBS Key Facts About IBS (continued)(continued)•Treatment optionsTreatment options11

– dietary modificationdietary modification– fiber supplementsfiber supplements– pharmacologic agentspharmacologic agents

•Success of treatment Success of treatment options in addressing options in addressing multiple symptoms of IBS multiple symptoms of IBS has been limitedhas been limited22

References:References: 1.1. Drossman. Drossman. Aliment Pharmacol TherAliment Pharmacol Ther. 1999;13(suppl 2):3-14. . 1999;13(suppl 2):3-14. 22. . Klein. Klein. Aliment Pharmacol Ther.Aliment Pharmacol Ther. 1988;13(suppl 2):15-30. 1988;13(suppl 2):15-30.

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Other88%

12%

IBS

28%

Other Other FunctioFunctio

nalnal13%13%

Other GIOther GI15%15%

IBD14%

PeptiPepticc

20%20%Liver10%

Primary Care Primary Care PracticePractice11

GastroenterolGastroenterology ogy

PracticePractice22

Prevalence of IBS Prevalence of IBS DiagnosisDiagnosis

References:References: 1.1. Everhart et al., Everhart et al., GastroenterologyGastroenterology, 1991:100; 998-1005. , 1991:100; 998-1005. 22. . Mitchell et al., Mitchell et al., GastroenterologyGastroenterology, 1987; 92:1282-4., 1987; 92:1282-4.

IBS

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Burden of Illness in IBSBurden of Illness in IBS

Direct Direct Medical Medical CostsCosts

ProductivitProductivity Lossy Loss

Health Health Related Related

Quality of Quality of LifeLife

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References:References: 1.1. Talley et al. Talley et al. GastroenterologyGastroenterology. December 1995;109:1736-. December 1995;109:1736-1741. 1741. 2.2. Drossman et al. Drossman et al. Dig Dis SciDig Dis Sci. September 1993;38:1569-1580.. September 1993;38:1569-1580.

Direct Medical Costs Direct Medical Costs Associated with IBSAssociated with IBS

• IBS sufferers incur 74% more direct IBS sufferers incur 74% more direct healthcare costs than non-IBS healthcare costs than non-IBS suffererssufferers11

•Extrapolated to US population; IBS Extrapolated to US population; IBS results in upward of $8 billion in direct results in upward of $8 billion in direct medical costs annuallymedical costs annually11

• IBS patients have more physician visits IBS patients have more physician visits for both GI and non-GI complaintsfor both GI and non-GI complaints22

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Productivity BurdenProductivity Burden(US Population)(US Population)

00

22

44

66

88

1010

1212

1414

IBSIBS(n=606)(n=606)

ControlControl(n=1625)(n=1625)

Days p

er

year

Days p

er

year

PP=0.0001=0.0001

Absenteeism from work or school Absenteeism from work or school during the last 12 monthsduring the last 12 months

Reference:Reference: Drossman et al. Drossman et al. Dig Dis Sci.Dig Dis Sci. September 1993;38:1569-1580. September 1993;38:1569-1580.

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Multidimensional ConstructMultidimensional Construct

PhysicalPhysical PsychologicaPsychologicall

SocialSocial

What is HRQOL?What is HRQOL?

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Why Measure HRQOL?Why Measure HRQOL?

•Physiologic endpoints Physiologic endpoints functional status and well-functional status and well-being being

•Can help define burden of Can help define burden of diseasedisease

•HRQOL outcomes matter to HRQOL outcomes matter to patientspatients

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30

40

50

60

70

80

90

Role-Role-Physical Physical

Bodily Bodily PainPain

VitalityVitality Social Social FunctioninFunctionin

gg

Role-Role-Emotional Emotional

Mental Mental HealthHealth

Mean

SF-3

6 s

core US NormUS Norm

IBSIBS

Adapted from Wells et al. Adapted from Wells et al. Aliment Pharmacol Ther.Aliment Pharmacol Ther. 1997;11:1019-1030. 1997;11:1019-1030.

Impact of IBS on Quality of Impact of IBS on Quality of Life Life

Compared with US NormsCompared with US Norms

General General HealthHealth

PhysicalPhysicalFunctioniFunctioni

ngng

100

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30

40

50

60

70

80

90

Mean

SF-3

6 s

core

US Norm

Diabetes type II

IBS

Clinical depression

Adapted from Wells et al. Adapted from Wells et al. Aliment Pharmacol Ther.Aliment Pharmacol Ther. 1997;11:1019-1030. 1997;11:1019-1030.

Impact of IBS on Quality of Impact of IBS on Quality of Life Life

Compared with Other Medical Compared with Other Medical ConditionsConditions

Role-Role-Physical Physical

Bodily Bodily PainPain

VitalityVitality Social Social FunctioninFunctionin

gg

Role-Role-Emotional Emotional

Mental Mental HealthHealth

General General HealthHealth

PhysicalPhysicalFunctioniFunctioni

ngng

100

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Whitehead et al., Whitehead et al., Dig Dis SciDig Dis Sci, November 1996; 41:2248-2253. , November 1996; 41:2248-2253.

CHF

30

40

50

60

70

80

90

100

Role-Role-PhysicaPhysica

l l

BodilyBodilyPainPain

VitalityVitality Social Social FunctioningFunctioning

Role-Role-

EmotionalEmotional Mental Mental HealthHealth

General General HealthHealth

PhysicalPhysicalFunctioninFunctionin

gg

Mean

SF-3

6 S

core

Mean

SF-3

6 S

core

IBS

Impact of IBS on Quality of Impact of IBS on Quality of Life Life

Compared with Other Medical Compared with Other Medical ConditionsConditions

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HRQOL and Burden of HRQOL and Burden of Disease in IBSDisease in IBS

Gralnek IM et al., Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In , 2000 (In Press)Press)AIM: To compare the impact of IBS AIM: To compare the impact of IBS

on patients’ quality of life with on patients’ quality of life with that previously observed in the that previously observed in the general population and in selected general population and in selected chronic diseaseschronic diseases

•877 adult IBS patients meeting 877 adult IBS patients meeting Rome criteria or ≥3 Manning Rome criteria or ≥3 Manning criteriacriteria

•Administered the SF-36Administered the SF-36

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HRQOL and Burden of HRQOL and Burden of Disease in IBSDisease in IBS•Compared to SF-36 data in the Compared to SF-36 data in the

general population and in general population and in patients with chronic diseasespatients with chronic diseases– GERDGERD

– End-Stage Renal DiseaseEnd-Stage Renal Disease

– DiabetesDiabetes

– Clinical DepressionClinical Depression

•Adjusted for Age and GenderAdjusted for Age and Gender

•Adjusted for Multiple Adjusted for Multiple ComparisonsComparisons

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HRQOL in IBS Patients is HRQOL in IBS Patients is Significantly Worse Compared Significantly Worse Compared

to U.S. Populationto U.S. Population

Gralnek IM et al., Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press) , 2000 (In Press)

US Pop. (n = 2474)

30

40

50

60

70

80

90

Role-Role-PhysicaPhysica

ll**

BodilyBodily

PainPain**VitalityVitality** Social Social

FunctioningFunctioning

**

Role-Role-

EmotionalEmotional* * Mental Mental

HealthHealth**General General

HealthHealth**PhysicalPhysical

FunctioninFunctionin

gg**

*p<0.001

Mean

SF-3

6 S

core

Mean

SF-3

6 S

core

IBS (n = 877)

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HRQOL in IBS Patients is HRQOL in IBS Patients is Significantly Worse Compared Significantly Worse Compared

with GERDwith GERD

Gralnek IM et al., Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press) , 2000 (In Press)

30

40

50

60

70

80

90

Role-Role-PhysicaPhysica

ll**

BodilyBodily

PainPain**VitalityVitality** Social Social

FunctioningFunctioning

**

Role-Role-

EmotionalEmotional**

Mental Mental

HealthHealth**General General

HealthHealth**PhysicalPhysical

FunctioninFunctionin

gg

*p<0.001

Mean

SF-3

6 S

core

Mean

SF-3

6 S

core GERD (n = GERD (n =

516)516)

IBS (n = IBS (n = 877)877)

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HRQOL in IBS Patients HRQOL in IBS Patients Compared with Other DiseasesCompared with Other Diseases

Gralnek IM et al., Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press) , 2000 (In Press)

30

40

50

60

70

80

90

Role-Role-PhysicaPhysica

l l

BodilyBodilyPainPain

VitalityVitality Social Social FunctioningFunctioning

Role-Role-EmotionalEmotional

Mental Mental HealthHealth

General General HealthHealth

PhysicalPhysicalFunctioninFunctionin

gg

Mean

SF-3

6 S

core

Mean

SF-3

6 S

core

ESRD (n = 165)

IBS (n = 877)

Diabetes (n = 541)

Depression(n = 502)

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0

10

20

30

40

50

60

US Pop.(n=2474)

GERD(n=471)

DEPRESSION(n=502)

IBS (n=858)

DIABETES(n=541)

ESRD(n=165)

* P < 0.002 - Significantly different * P < 0.002 - Significantly different from IBSfrom IBS

**

*

*

SF-36 Physical SF-36 Physical Component Summary Component Summary

ScoresScores

Gralnek IM et al., Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press) , 2000 (In Press)

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0

10

20

30

40

50

60

US Pop.(n=2474)

DIABETES(n=541)

GERD(n=471)

ESRD(n=165)

IBS (n=858)

DEPRESSION(n=502)

* ** *

*

* P < 0.002 - Significantly different from IBS

SF-36 Mental Component SF-36 Mental Component Summary ScoresSummary Scores

Gralnek IM et al., Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press) , 2000 (In Press)

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IBS Burden of IllnessIBS Burden of Illness

Significant Disease Significant Disease BurdenBurden

• Increased Direct Medical Increased Direct Medical CostsCosts

•Reduced ProductivityReduced Productivity

• Impact on Quality of LifeImpact on Quality of Life