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.