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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390909
• Other study ID #: 113917
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: October 4, 2012
• Start date: May 2010
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12386
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Anti-epileptic drug (AED)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 year	No