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

NCT01390909 | Completed Results

• 1 other identifier: 113917
• Study Type: observational
• Target: 12,386
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Epilepsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Medicaid patients with uncontrolled epilepsy

Database records for patients with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the 365 days

Drug: Anti-epileptic drug (AED)

Medicaid patients with well-controlled epilepsy

Database records for patients with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits

Drug: Anti-epileptic drug (AED)

Medicaid patients with intermediate epilepsy

Database records for patients who are not classified as uncontrolled or well-controlled

Drug: Anti-epileptic drug (AED)

Patients in a private health plan with uncontrolled epilepsy

Database records for patients with 2 or more consecutive changes in AED therapy occuring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within 365 days

Drug: Anti-epileptic drug (AED)

Patients in a private health plan with well-controlled epileps

Database records for patients with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits

Drug: Anti-epileptic drug (AED)

Patients in a private health plan with intermediate epilepsy

Database records for patients who are not classified as uncontrolled or well-controlled

Drug: Anti-epileptic drug (AED)

Interventions

Anti-epileptic drug (AED) DRUG

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.

Also known as: Mysoline® is a registered trademark of Valeant Pharmaceuticals, Neurotin® is registered trademark of Pfizer, Inc, Vimpat® is a registered trademark of UCB Pharma, Tegretol® is a registered trademark of Novartis Pharmaceuticals, Trileptal® is a registered trademark of Novartis Pharmaceuticals, Sabril® is a registered trademark of Lundbeck Inc, Felbatol® is a registered trademark of MedPointe, Topamax® is a registered trademark of Ortho-McNeill-Janssen Pharmaceuticals, Depakote® is a registered trademark of Abbott Laboratories, Zonegran® is a registered trademark of Dainippon Pharmaceutical C. Ltd., Gabatril® is a registered trademark of Cephalon, Keppra® is registered trademark of UCB Pharma, Zarontin® is a registered trademark of Pfizer, Lamictal® is a registered trademark of GlaxoSmithKline, Luminal® is a registered trademark of Abbott Laboratories, Dilantin® is a registered trademark of Pfizer, Lyrica is registered trademark of Pfizer

Medicaid patients with intermediate epilepsy; Medicaid patients with uncontrolled epilepsy; Medicaid patients with well-controlled epilepsy; Patients in a private health plan with intermediate epilepsy; Patients in a private health plan with uncontrolled epilepsy; Patients in a private health plan with well-controlled epileps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The electronic records from adult patients with epilepsy who are enrolled in Medicaid in Florida, Iowa, Kansas, Missouri or New Jersey or in a private health plan database. Patient records will be classified into one of three mutually-exclusive cohorts: uncontrolled epilepsy, well-controlled epilepsy, and intermediate epilepsy (not classified as uncontrolled or well-controlled).

You may qualify if:

• 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

You may not qualify if:

• Age less than 18 years

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Epilepsy

Interventions

Anticonvulsants

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 11, 2011
• Study Start: May 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 8, 2012
• Results First Posted: February 14, 2012

Record last verified: 2012-06