Risk of Urinary Retention With Retigabine
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Purpose
A prospective cohort study of antiepileptic drug (AED) polytherapy-treated epilepsy patients within the HealthCore Integrated Research Database (HIRD) will be conducted. Following the launch of Ezogabine (EZG), patients initiating a new AED polytherapy regimen will be followed until the earliest of an episode of urinary retention (UR), change in their AED regimen, end of follow-up, or end of study (when the specified sample size of EZG AED polytherapy users has been attained). After the end of study, the incidence of UR during exposures to EZG and non-EZG AED polytherapies will be compared. Polytherapy will be defined as treatment regimen containing at least two different AEDs.
A prospective cohort study of patients who receive EZG under circumstances not indicated in the product label within the HIRD will also be conducted. Following the launch of EZG, epilepsy patients initiating AED monotherapy with EZG as well as non-epilepsy patients initiating EZG for another disease will be followed until the earliest of an episode of UR, change in their AED regimen (if applicable), end of follow-up, or end of study. The incidence of UR during exposure to EZG under circumstances not indicated in the product label will be described. A descriptive analysis of the patients will also be included.
To meet the other secondary objective, non-EZG AED monotherapy users will be identified in the prospective cohort and incidence of UR will be calculated to determine if there is a difference in UR risk between monotherapy and polytherapy AED use.
| Condition | Intervention |
|---|---|
|
Epilepsy Urinary Retention |
Drug: Non-EZG containing AED polytherapy Drug: EZG containing AED polytherapy Drug: Non-EZG AED monotherapy Drug: EZG AED monotherapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Post Marketing Surveillance Study to Monitor the Risk of Urinary Retention in Retigabine Users |
- The risk and time to onset of UR associated with post-marketing use of EZG AED polytherapy, and the incremental risk compared with non-EZG AED polytherapy use. [ Time Frame: From initiation of a new AED polytherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years. ] [ Designated as safety issue: Yes ]
- The risk and time to onset of UR among patients using EZG vs. non-EZG AED polytherapy [ Time Frame: From initiation of a new AED polytherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years. ] [ Designated as safety issue: Yes ]
- The risk of UR associated with post-marketing use of EZG under circumstances not indicated in the product label [ Time Frame: From initiation of a new AED polytherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years. ] [ Designated as safety issue: Yes ]
- The risk of UR among non-EZG AED monotherapy patients and the differential risk in UR for monotherapy versus polytherapy-treated patients [ Time Frame: From initiation of a new AED monotherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients with urinary retention
Patients with urinary retention
|
Drug: Non-EZG containing AED polytherapy
AED polytherapy without EZG
Drug: EZG containing AED polytherapy
AED polytherapy including EZG
Drug: Non-EZG AED monotherapy
AED monotherapy without EZG
Drug: EZG AED monotherapy
Any off-label use of EZG as monotherapy
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The study cohorts of interest will be identified from the HealthCore Integrated Research Database (HIRD). The HIRD contains fully adjudicated paid claims from the largest commercially insured population in the US, with dates of service for all non-capitated ambulatory, emergency department, inpatient, and outpatient encounters (including administrative claims for laboratory tests) for members with eligibility at the time of service.
Inclusion Criteria:
Prospective Cohort (indicated use)
Patients with at least one medical claim carrying an ICD-9 code for epilepsy. The following ICD-9 codes will be used to identify patients with epilepsy:
- 345 Epilepsy and recurrent seizures
- 780.3 Convulsions
- 780.39 Other convulsions
- Patients initiating a new AED monotherapy* or polytherapy** following the launch of EZG.
- At least 6 months of continuous healthcare plan enrolment before initiation of the new AED (monotherapy or polytherapy) following the launch of EZG. This will allow an assessment of baseline co-morbidities and concomitant medication use.
- Aged ≥18 years at initiation of the new AED (monotherapy or polytherapy).
Prospective Cohort (non-indicated use)
- Epilepsy patients initiating EZG AED monotherapy
- Patients <18 years old initiating EZG for epilepsy
- Patients initiating EZG for any reason other than epilepsy
- Patients initiating EZG AED polytherapy with less than six months of continuous healthcare enrolment who were excluded from the cohort described under the primary objective
Retrospective Cohort
Patients with at least one medical claim carrying an ICD-9 code for epilepsy in the three year period preceding the launch of EZG. The following ICD-9 codes will be used to identify patients with epilepsy:
- 345 Epilepsy and recurrent seizures
- 780.3 Convulsions
- 780.39 Other convulsions
- Patients initiating a new AED monotherapy* or polytherapy** regimen in the three year period preceding the launch of EZG.
- At least 6 months of continuous healthcare plan enrolment before initiation of the new AED regimen (monotherapy or polytherapy) during the three year period preceding the launch of EZG. This will allow an assessment of baseline co-morbidities and concomitant medication use.
Aged ≥18 years at initiation of the new AED (monotherapy or polytherapy).
- This will include patients substituting an AED monotherapy. **This will include patients switching from a monotherapy to polytherapy regimen and those substituting an AED within an existing polytherapy regimen.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01462656 History of Changes |
| Other Study ID Numbers: | 115981, WEUKSTV4551, EPI40621 |
| Study First Received: | July 21, 2011 |
| Last Updated: | May 24, 2012 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
anti-epileptic drug ezogabine AED polytherapy epilepsy |
AED monotherapy retigabine urinary retention |
Additional relevant MeSH terms:
|
Epilepsy Urinary Retention Brain Diseases Central Nervous System Diseases Nervous System Diseases Urination Disorders |
Urologic Diseases D 23129 Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013