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Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database

Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01390909
Enrollment
12386
Registered
2011-07-11
Start date
2010-05-31
Completion date
2011-01-31
Last updated
2012-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

epilepsy, anti-epileptic drug, polytherapy, adherence, Medicaid

Brief summary

Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy; however, complete seizure control remains elusive for many patients. Uncontrolled or refractory epilepsy is associated with a higher risk of mortality, physical injuries, and depression or anxiety compared with patients with controlled epilepsy. Higher resource utilization for patients with poor control is likely to be associated with higher economic costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists, recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one seizure per month and 2.) a history of drug failures. The objective of this study is to identify patients with uncontrolled epilepsy in both a Medicaid database and a private health plan database, to describe patient characteristics and AED treatment patterns between cohorts of patients with uncontrolled versus well-controlled epilepsy, and to evaluate the economic burden of uncontrolled versus well-controlled epilepsy. For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter 1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and medical and pharmacy claims in an private health plan database. The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy (at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1 epilepsy-related inpatient or emergency department (ED) visit within 365 days), well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits), and intermediate epilepsy (not classified as uncontrolled or well-controlled).

Interventions

Prescription claim for at least one AED including lamotrigine, tiagabine, pregabalin, ethosuximide, lacosamide, phenytoin, carbamazepine, valproic acid, felbamate, levetiracetam, zonisamide, primidone, oxcarbazepine, vigabatrin, phenobarbital, gabapentin, topiramate.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* At least 18 years of age at the initiation of anti-epileptic drug (AED) treatment as noted in the database * A record of at least one medical visit with a diagnosis of epilepsy (ICD-9-CM 345.xx) or at least two diagnoses of non-febrile convulsions (ICD-9-CM 780.30 or 780.39) occuring more than 30 days apart * At least one pharmacy claim for an anti-epileptic drug (AED) * Continuous enrollment throughout the observation period (minimum of 365 days). Patients with gaps in Medicaid enrollment will be observed only during their period of continuous enrollment, provided that all the above criteria are met

Exclusion criteria

* Age less than 18 years

Design outcomes

Primary

MeasureTime frameDescription
Average Annualized Costs1 yearAverage annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.

Participant flow

Participants by arm

ArmCount
Medicaid, Well Controlled
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
3,454
Medicaid, Uncontrolled
Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (3454 participants) were matched with participant records in the Medicaid, well-controlled cohort.
3,552
Medicaid, Intermediate
Database records for participants who are not classified as uncontrolled or well controlled
3,552
Private, Well Controlled
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
602
Private, Uncontrolled
Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (602 participants) were matched with participant records in the Medicaid, well-controlled cohort.
613
Private, Intermediate
Database records for participants who are not classified as uncontrolled or well controlled
613
Total12,386

Baseline characteristics

CharacteristicMedicaid, Well ControlledMedicaid, UncontrolledMedicaid, IntermediatePrivate, Well ControlledPrivate, UncontrolledPrivate, IntermediateTotal
Age Continuous
Overall Study
41.5 Years
STANDARD_DEVIATION 15.4
41.3 Years
STANDARD_DEVIATION 14.1
41.2 Years
STANDARD_DEVIATION 14.6
54.2 Years
STANDARD_DEVIATION 17.1
54.1 Years
STANDARD_DEVIATION 17.3
54.6 Years
STANDARD_DEVIATION 16.7
43.2 Years
STANDARD_DEVIATION 6.5
Age Continuous
Subgroup
NA Years41.4 Years
STANDARD_DEVIATION 14.2
NA YearsNA Years54.0 Years
STANDARD_DEVIATION 17.4
NA Years43.3 Years
STANDARD_DEVIATION 6.3
Charlson Comorbidity Index (CCI) Scores
Overall Study
0.98 scores on a scale
STANDARD_DEVIATION 1.83
1.09 scores on a scale
STANDARD_DEVIATION 1.84
1.00 scores on a scale
STANDARD_DEVIATION 1.78
1.13 scores on a scale
STANDARD_DEVIATION 1.65
1.32 scores on a scale
STANDARD_DEVIATION 1.91
1.20 scores on a scale
STANDARD_DEVIATION 1.82
1.05 scores on a scale
STANDARD_DEVIATION 0.11
Charlson Comorbidity Index (CCI) Scores
Subgroup
NA scores on a scale1.08 scores on a scale
STANDARD_DEVIATION 1.83
NA scores on a scaleNA scores on a scale1.29 scores on a scale
STANDARD_DEVIATION 1.88
NA scores on a scale1.11 scores on a scale
STANDARD_DEVIATION 1.66
Number of Days of Observation
Overall Study
2184 days of observation
STANDARD_DEVIATION 1181
2296 days of observation
STANDARD_DEVIATION 1132
2502 days of observation
STANDARD_DEVIATION 1124
1572 days of observation
STANDARD_DEVIATION 847
1478 days of observation
STANDARD_DEVIATION 749
1739 days of observation
STANDARD_DEVIATION 792
2221 days of observation
STANDARD_DEVIATION 385
Number of Days of Observation
Subgroup
NA days of observation2290 days of observation
STANDARD_DEVIATION 1133
NA days of observationNA days of observation1485 days of observation
STANDARD_DEVIATION 751
NA days of observation2170.5 days of observation
STANDARD_DEVIATION 402.5
Number of participant records with diagnosis codes for the indicated diseases or disorders
Alzheimer's Disease, Overall Study
94 participant records93 participant records84 participant records12 participant records20 participant records19 participant records322 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Alzheimer's Disease Subgroup
NA participant records93 participant recordsNA participant recordsNA participant records20 participant recordsNA participant records113 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Anxiety Disorders, Overall Study
356 participant records447 participant records440 participant records32 participant records41 participant records28 participant records1344 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Anxiety Disorders, Subgroup
NA participant records410 participant recordsNA participant recordsNA participant records38 participant recordsNA participant records448 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Bipolar Disorder, Overall Study
428 participant records439 participant records472 participant records22 participant records18 participant records15 participant records1394 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Bipolar Disorder, Subgroup
NA participant records397 participant recordsNA participant recordsNA participant records17 participant recordsNA participant records414 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Brain Tumor, Overall Study
53 participant records63 participant records40 participant records38 participant records50 participant records43 participant records287 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Brain Tumor, Subgroup
NA participant records62 participant recordsNA participant recordsNA participant records44 participant recordsNA participant records106 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Depression, Overall Study
821 participant records890 participant records897 participant records90 participant records95 participant records102 participant records2895 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Depression, Subgroup
NA participant records833 participant recordsNA participant recordsNA participant records90 participant recordsNA participant records923 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Meningitis, Overall Study
12 participant records16 participant records13 participant records11 participant records10 participant records6 participant records68 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Meningitis, Subgroup
NA participant records15 participant recordsNA participant recordsNA participant records9 participant recordsNA participant records24 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Mental Retardation, Overall Study
482 participant records322 participant records434 participant records5 participant records11 participant records8 participant records1262 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Mental Retardation, Subgroup
NA participant records312 participant recordsNA participant recordsNA participant records11 participant recordsNA participant records323 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Migraine, Overall Study
198 participant records262 participant records262 participant records41 participant records42 participant records35 participant records840 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Migraine, Subgroup
NA participant records239 participant recordsNA participant recordsNA participant records41 participant recordsNA participant records280 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Personality Disorder, Overall Study
951 participant records1062 participant records1024 participant records51 participant records68 participant records58 participant records3214 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Personality Disorder, Subgroup
NA participant records1001 participant recordsNA participant recordsNA participant records67 participant recordsNA participant records1068 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Psychosis, Overall Study
809 participant records794 participant records816 participant records62 participant records65 participant records65 participant records2611 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Psychosis, Subgroup
NA participant records754 participant recordsNA participant recordsNA participant records65 participant recordsNA participant records819 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Stroke, Overall Study
267 participant records303 participant records264 participant records123 participant records134 participant records154 participant records1245 participant records
Number of participant records with diagnosis codes for the indicated diseases or disorders
Stroke, Subgroup
NA participant records302 participant recordsNA participant recordsNA participant records128 participant recordsNA participant records430 participant records
Sex/Gender, Customized
Female, Overall Study
2106 Participants2171 Participants2159 Participants341 Participants351 Participants332 Participants7460 Participants
Sex/Gender, Customized
Female, Subgroup
NA Participants2091 ParticipantsNA ParticipantsNA Participants345 ParticipantsNA Participants2436 Participants
Sex/Gender, Customized
Male, Overall Study
1348 Participants1381 Participants1393 Participants261 Participants262 Participants281 Participants4926 Participants
Sex/Gender, Customized
Male, Subgroup
NA Participants345 ParticipantsNA ParticipantsNA Participants257 ParticipantsNA Participants602 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

Average Annualized Costs

Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.

Time frame: 1 year

Population: For Arms 1 - 4, Medicaid-enrolled participants with uncontrolled epilepsy (see Arm Descriptions for Arm Title 1 and Arm Title 3) or matched participants with well-controlled or intermediate epilepsy. For Arms 5 - 8, privately-insured participants with uncontrolled epilepsy or matched participants with well-controlled or intermediate epilepsy.

ArmMeasureGroupValue (MEAN)Dispersion
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsOther Healthcare Costs; Ep Rel1502 United States dollarsStandard Deviation 14424
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsOutpatient Visits; Ep Rel467 United States dollarsStandard Deviation 2218
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsHospitalizations; Ep Rel4102 United States dollarsStandard Deviation 19775
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsNeurology Visits; Ep Rel60 United States dollarsStandard Deviation 712
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsAEDs1352 United States dollarsStandard Deviation 4580
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsHospitalizations; AMC6902 United States dollarsStandard Deviation 31181
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsOutpatient Visits; AMC2416 United States dollarsStandard Deviation 11759
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsTotal Healthcare Costs; AMC38708 United States dollarsStandard Deviation 114904
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsED Visits; Ep Rel109 United States dollarsStandard Deviation 610
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsNeurology Visits; AMC86 United States dollarsStandard Deviation 850
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsNon-AEDs5615 United States dollarsStandard Deviation 15730
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsOther Healthcare Services; AMC22022 United States dollarsStandard Deviation 106033
Medicaid, Uncontrolled, SubgroupAverage Annualized CostsED Visits; AMC400 United States dollarsStandard Deviation 1496
Medicaid, Well ControlledAverage Annualized CostsOther Healthcare Services; AMC23202 United States dollarsStandard Deviation 103595
Medicaid, Well ControlledAverage Annualized CostsNeurology Visits; AMC21 United States dollarsStandard Deviation 425
Medicaid, Well ControlledAverage Annualized CostsTotal Healthcare Costs; AMC29635 United States dollarsStandard Deviation 105644
Medicaid, Well ControlledAverage Annualized CostsOther Healthcare Costs; Ep Rel754 United States dollarsStandard Deviation 10724
Medicaid, Well ControlledAverage Annualized CostsNon-AEDs3657 United States dollarsStandard Deviation 11702
Medicaid, Well ControlledAverage Annualized CostsNeurology Visits; Ep Rel9 United States dollarsStandard Deviation 143
Medicaid, Well ControlledAverage Annualized CostsHospitalizations; AMC958 United States dollarsStandard Deviation 9518
Medicaid, Well ControlledAverage Annualized CostsOutpatient Visits; Ep Rel68 United States dollarsStandard Deviation 490
Medicaid, Well ControlledAverage Annualized CostsED Visits; Ep RelNA United States dollars
Medicaid, Well ControlledAverage Annualized CostsED Visits; AMC97 United States dollarsStandard Deviation 731
Medicaid, Well ControlledAverage Annualized CostsAEDs462 United States dollarsStandard Deviation 2072
Medicaid, Well ControlledAverage Annualized CostsHospitalizations; Ep RelNA United States dollars
Medicaid, Well ControlledAverage Annualized CostsOutpatient Visits; AMC1258 United States dollarsStandard Deviation 9953
Medicaid, UncontrolledAverage Annualized CostsNon-AEDs5725 United States dollarsStandard Deviation 16016
Medicaid, UncontrolledAverage Annualized CostsOther Healthcare Services; AMC22113 United States dollarsStandard Deviation 107291
Medicaid, UncontrolledAverage Annualized CostsED Visits; AMC421 United States dollarsStandard Deviation 1661
Medicaid, UncontrolledAverage Annualized CostsOutpatient Visits; AMC2466 United States dollarsStandard Deviation 11829
Medicaid, UncontrolledAverage Annualized CostsOther Healthcare Costs; Ep Rel1475 United States dollarsStandard Deviation 14265
Medicaid, UncontrolledAverage Annualized CostsHospitalizations; Ep Rel4135 United States dollarsStandard Deviation 19915
Medicaid, UncontrolledAverage Annualized CostsAEDs1357 United States dollarsStandard Deviation 4590
Medicaid, UncontrolledAverage Annualized CostsHospitalizations; AMC7041 United States dollarsStandard Deviation 31499
Medicaid, UncontrolledAverage Annualized CostsOutpatient Visits; Ep Rel469 United States dollarsStandard Deviation 2239
Medicaid, UncontrolledAverage Annualized CostsTotal Healthcare Costs; AMC39123 United States dollarsStandard Deviation 116204
Medicaid, UncontrolledAverage Annualized CostsNeurology Visits; Ep Rel59 United States dollarsStandard Deviation 703
Medicaid, UncontrolledAverage Annualized CostsED Visits; Ep Rel111 United States dollarsStandard Deviation 616
Medicaid, UncontrolledAverage Annualized CostsNeurology Visits; AMC86 United States dollarsStandard Deviation 839
Medicaid, IntermediateAverage Annualized CostsNon-AEDs4801 United States dollarsStandard Deviation 15357
Medicaid, IntermediateAverage Annualized CostsAEDs1050 United States dollarsStandard Deviation 4297
Medicaid, IntermediateAverage Annualized CostsHospitalizations; AMC3513 United States dollarsStandard Deviation 22265
Medicaid, IntermediateAverage Annualized CostsED Visits; AMC242 United States dollarsStandard Deviation 1371
Medicaid, IntermediateAverage Annualized CostsOutpatient Visits; AMC1804 United States dollarsStandard Deviation 11649
Medicaid, IntermediateAverage Annualized CostsNeurology Visits; AMC52 United States dollarsStandard Deviation 666
Medicaid, IntermediateAverage Annualized CostsOther Healthcare Services; AMC23428 United States dollarsStandard Deviation 119218
Medicaid, IntermediateAverage Annualized CostsHospitalizations; Ep Rel1702 United States dollarsStandard Deviation 13344
Medicaid, IntermediateAverage Annualized CostsED Visits; Ep Rel46 United States dollarsStandard Deviation 540
Medicaid, IntermediateAverage Annualized CostsOutpatient Visits; Ep Rel248 United States dollarsStandard Deviation 1660
Medicaid, IntermediateAverage Annualized CostsNeurology Visits; Ep Rel33 United States dollarsStandard Deviation 472
Medicaid, IntermediateAverage Annualized CostsOther Healthcare Costs; Ep Rel1273 United States dollarsStandard Deviation 14072
Medicaid, IntermediateAverage Annualized CostsTotal Healthcare Costs; AMC34839 United States dollarsStandard Deviation 123866
Private, Uncontrolled, SubgroupAverage Annualized CostsTotal Healthcare Costs; AMC24853 United States dollarsStandard Deviation 81299
Private, Uncontrolled, SubgroupAverage Annualized CostsED Visits; AMC586 United States dollarsStandard Deviation 4392
Private, Uncontrolled, SubgroupAverage Annualized CostsHospitalizations; AMC11308 United States dollarsStandard Deviation 62399
Private, Uncontrolled, SubgroupAverage Annualized CostsED Visits; Ep Rel152 United States dollarsStandard Deviation 972
Private, Uncontrolled, SubgroupAverage Annualized CostsOutpatient Visits; AMC5757 United States dollarsStandard Deviation 24888
Private, Uncontrolled, SubgroupAverage Annualized CostsNeurology Visits; AMC556 United States dollarsStandard Deviation 4306
Private, Uncontrolled, SubgroupAverage Annualized CostsOther Healthcare Costs; Ep Rel103 United States dollarsStandard Deviation 752
Private, Uncontrolled, SubgroupAverage Annualized CostsNeurology Visits; Ep Rel235 United States dollarsStandard Deviation 1797
Private, Uncontrolled, SubgroupAverage Annualized CostsOther Healthcare Services; AMC1008 United States dollarsStandard Deviation 5428
Private, Uncontrolled, SubgroupAverage Annualized CostsNon-AEDs4497 United States dollarsStandard Deviation 11374
Private, Uncontrolled, SubgroupAverage Annualized CostsHospitalizations; Ep Rel6700 United States dollarsStandard Deviation 48095
Private, Uncontrolled, SubgroupAverage Annualized CostsAEDs1697 United States dollarsStandard Deviation 3979
Private, Uncontrolled, SubgroupAverage Annualized CostsOutpatient Visits; Ep Rel703 United States dollarsStandard Deviation 3072
Private, Well ControlledAverage Annualized CostsOutpatient Visits; AMC3061 United States dollarsStandard Deviation 13353
Private, Well ControlledAverage Annualized CostsOther Healthcare Services; AMC436 United States dollarsStandard Deviation 4444
Private, Well ControlledAverage Annualized CostsED Visits; AMC76 United States dollarsStandard Deviation 804
Private, Well ControlledAverage Annualized CostsHospitalizations; Ep RelNA United States dollars
Private, Well ControlledAverage Annualized CostsED Visits; Ep RelNA United States dollars
Private, Well ControlledAverage Annualized CostsHospitalizations; AMC1697 United States dollarsStandard Deviation 12292
Private, Well ControlledAverage Annualized CostsOutpatient Visits; Ep Rel179 United States dollarsStandard Deviation 1042
Private, Well ControlledAverage Annualized CostsNon-AEDs3096 United States dollarsStandard Deviation 10692
Private, Well ControlledAverage Annualized CostsTotal Healthcare Costs; AMC9005 United States dollarsStandard Deviation 28038
Private, Well ControlledAverage Annualized CostsNeurology Visits; Ep Rel68 United States dollarsStandard Deviation 577
Private, Well ControlledAverage Annualized CostsOther Healthcare Costs; Ep Rel17 United States dollarsStandard Deviation 204
Private, Well ControlledAverage Annualized CostsAEDs639 United States dollarsStandard Deviation 2248
Private, Well ControlledAverage Annualized CostsNeurology Visits; AMC175 United States dollarsStandard Deviation 1593
Private, UncontrolledAverage Annualized CostsOutpatient Visits; Ep Rel702 United States dollarsStandard Deviation 3082
Private, UncontrolledAverage Annualized CostsAEDs1713 United States dollarsStandard Deviation 3989
Private, UncontrolledAverage Annualized CostsTotal Healthcare Costs; AMC26057 United States dollarsStandard Deviation 100777
Private, UncontrolledAverage Annualized CostsOther Healthcare Costs; Ep Rel102 United States dollarsStandard Deviation 746
Private, UncontrolledAverage Annualized CostsOther Healthcare Services; AMC1026 United States dollarsStandard Deviation 5472
Private, UncontrolledAverage Annualized CostsHospitalizations; AMC12357 United States dollarsStandard Deviation 84898
Private, UncontrolledAverage Annualized CostsED Visits; AMC603 United States dollarsStandard Deviation 4422
Private, UncontrolledAverage Annualized CostsED Visits; Ep Rel153 United States dollarsStandard Deviation 968
Private, UncontrolledAverage Annualized CostsNeurology Visits; AMC566 United States dollarsStandard Deviation 4352
Private, UncontrolledAverage Annualized CostsNeurology Visits; Ep Rel237 United States dollarsStandard Deviation 1845
Private, UncontrolledAverage Annualized CostsOutpatient Visits; AMC5771 United States dollarsStandard Deviation 24883
Private, UncontrolledAverage Annualized CostsNon-AEDs4587 United States dollarsStandard Deviation 11972
Private, UncontrolledAverage Annualized CostsHospitalizations; Ep Rel7646 United States dollarsStandard Deviation 70525
Private, IntermediateAverage Annualized CostsHospitalizations; Ep Rel2413 United States dollarsStandard Deviation 23487
Private, IntermediateAverage Annualized CostsOutpatient Visits; Ep Rel479 United States dollarsStandard Deviation 6624
Private, IntermediateAverage Annualized CostsOther Healthcare Services; AMC645 United States dollarsStandard Deviation 3910
Private, IntermediateAverage Annualized CostsNeurology Visits; Ep Rel165 United States dollarsStandard Deviation 1670
Private, IntermediateAverage Annualized CostsNeurology Visits; AMC442 United States dollarsStandard Deviation 4263
Private, IntermediateAverage Annualized CostsAEDs1299 United States dollarsStandard Deviation 3949
Private, IntermediateAverage Annualized CostsED Visits; AMC254 United States dollarsStandard Deviation 2898
Private, IntermediateAverage Annualized CostsTotal Healthcare Costs; AMC17719 United States dollarsStandard Deviation 69241
Private, IntermediateAverage Annualized CostsOther Healthcare Costs; Ep Rel42 United States dollarsStandard Deviation 472
Private, IntermediateAverage Annualized CostsED Visits; Ep Rel39 United States dollarsStandard Deviation 635
Private, IntermediateAverage Annualized CostsOutpatient Visits; AMC5780 United States dollarsStandard Deviation 37154
Private, IntermediateAverage Annualized CostsHospitalizations; AMC5858 United States dollarsStandard Deviation 37310
Private, IntermediateAverage Annualized CostsNon-AEDs3883 United States dollarsStandard Deviation 9436
p-value: <0.000195% CI: [786, 921]Ordinary Least Squares Regression
p-value: <0.000195% CI: [1636, 2112]Ordinary Least Squares Regression
p-value: <0.000195% CI: [5257, 6077]Ordinary Least Squares Regression
p-value: <0.000195% CI: [251, 295]Ordinary Least Squares Regression
p-value: <0.000195% CI: [819, 1211]Ordinary Least Squares Regression
p-value: <0.000195% CI: [48, 72]Ordinary Least Squares Regression
p-value: 0.00895% CI: [834, 4281]Ordinary Least Squares Regression
p-value: <0.000195% CI: [3776, 4305]Ordinary Least Squares Regression
p-value: <0.000195% CI: [97, 114]Ordinary Least Squares Regression
p-value: <0.000195% CI: [358, 413]Ordinary Least Squares Regression
p-value: <0.000195% CI: [40, 56]Ordinary Least Squares Regression
p-value: <0.000195% CI: [584, 1192]Ordinary Least Squares Regression
p-value: <0.000195% CI: [10482, 14083]Ordinary Least Squares Regression
p-value: <0.000195% CI: [245, 398]Ordinary Least Squares Regression
p-value: <0.000195% CI: [556, 1078]Ordinary Least Squares Regression
p-value: <0.000195% CI: [2790, 3714]Ordinary Least Squares Regression
p-value: <0.000195% CI: [138, 190]Ordinary Least Squares Regression
p-value: <0.000195% CI: [409, 819]Ordinary Least Squares Regression
p-value: <0.000195% CI: [18, 42]Ordinary Least Squares Regression
p-value: 0.762895% CI: [-1367, 1798]Ordinary Least Squares Regression
p-value: <0.000195% CI: [2016, 2603]Ordinary Least Squares Regression
p-value: <0.000195% CI: [52, 74]Ordinary Least Squares Regression
p-value: <0.000195% CI: [179, 245]Ordinary Least Squares Regression
p-value: <0.000195% CI: [15, 33]Ordinary Least Squares Regression
p-value: 0.058195% CI: [-19, 581]Ordinary Least Squares Regression
p-value: <0.000195% CI: [3672, 7142]Ordinary Least Squares Regression
p-value: <0.000195% CI: [836, 1191]Ordinary Least Squares Regression
p-value: <0.000195% CI: [564, 1486]Ordinary Least Squares Regression
p-value: <0.000195% CI: [7346, 11125]Ordinary Least Squares Regression
p-value: <0.000195% CI: [326, 622]Ordinary Least Squares Regression
p-value: <0.000195% CI: [1587, 3290]Ordinary Least Squares Regression
p-value: <0.000195% CI: [225, 525]Ordinary Least Squares Regression
p-value: <0.000195% CI: [234, 768]Ordinary Least Squares Regression
p-value: <0.000195% CI: [5329, 7927]Ordinary Least Squares Regression
p-value: <0.000195% CI: [112, 199]Ordinary Least Squares Regression
p-value: <0.000195% CI: [401, 645]Ordinary Least Squares Regression
p-value: <0.000195% CI: [97, 231]Ordinary Least Squares Regression
p-value: <0.000195% CI: [58, 113]Ordinary Least Squares Regression
p-value: <0.000195% CI: [12019, 17097]Ordinary Least Squares Regression
p-value: <0.000195% CI: [210, 630]Ordinary Least Squares Regression
p-value: <0.000195% CI: [217, 1131]Ordinary Least Squares Regression
p-value: <0.000195% CI: [3442, 8795]Ordinary Least Squares Regression
p-value: 0.00295% CI: [81, 425]Ordinary Least Squares Regression
p-value: 0.96795% CI: [-991, 944]Ordinary Least Squares Regression
p-value: 0.256395% CI: [-77, 302]Ordinary Least Squares Regression
p-value: 0.0195% CI: [90, 588]Ordinary Least Squares Regression
p-value: <0.000195% CI: [3168, 7335]Ordinary Least Squares Regression
p-value: <0.000195% CI: [70, 166]Ordinary Least Squares Regression
p-value: 0.0195% CI: [70, 403]Ordinary Least Squares Regression
p-value: 0.106195% CI: [-22, 145]Ordinary Least Squares Regression
p-value: <0.000195% CI: [28, 93]Ordinary Least Squares Regression
p-value: <0.000195% CI: [4571, 10989]Ordinary Least Squares Regression

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026