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A A 11
Alosetron 2000 6/26
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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Alosetron 2000 6/26
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