Binge-eating Disorder
Conditions
Brief summary
This study will check how and to whom Vyvanse is prescribed in Australia by retrospectively analyzing a prescription database with additional information provided by a physician survey.
Detailed description
This is a drug utilization study (DUS) using cross-sectional database analysis of participants who are prescribed lisdexamfetamine dimesylate for treatment of BED. The study will combine data from two sources of patient-level drug utilization data for lisdexamfetamine dimesylate: * NostraData database: Longitudinal participant level prescription dispensing database * Physician survey: De-identified participant data provided by representative psychiatrists and other physicians expected to treat participants with BED in Australia. In the NostraData database, actual drug dispensing data are collected, which allows for the generation of information on actual drug usage. However, these data do not contain certain participant variables, such as age and indication, needed to monitor potential off-label use. Therefore, these data must be supplemented with another data source. The physician survey will provide the data not included in the NostraData database. The DUS will enroll approximately 150 participants. This DUS will be conducted in Australia. The overall time for data collection in the study will be approximately 36 months after the launch date of lisdexamfetamine dimesylate.
Interventions
None listed
Sponsors
Shire
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Main prescription data analysis: \- At least one prescription for lisdexamfetamine dimesylate recorded in the NostraData database in Australia. For all sensitivity analyses (sensitivity analysis I, II and III): \- At least one prescription for lisdexamfetamine dimesylate recorded in the NostraData database in Australia during the defined observation period of the study. Physician survey: \- The physician prescribed lisdexamfetamine dimesylate for indications other than ADHD in the last 12 months for at least one participant. Participant population: \- Physician entered data for the participant until at least question 3 (treatment information (Q03); main indication).
Exclusion criteria
For all sensitivity analyses (sensitivity analysis I, II and III): * Evidence of use for lisdexamfetamine dimesylate for treatment of ADHD, as shown by prescription records for ADHD medication other than lisdexamfetamine dimesylate at any time. * Record of at least one lisdexamfetamine dimesylate prescription prior to launch of lisdexamfetamine dimesylate for BED (02/17/2018). Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Based on Indication of Use of Lisdexamfetamine Dimesylate | Up to 36 months | Number of participants based on indication of use of Lisdexamfetamine Dimesylate will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Based on Average Daily Dose | Up to 36 months | Number of participants based on average daily dose will be assessed. |
| Number of Participants Based on Maximum Daily Dose | Up to 36 months | Number of participants based on maximum daily dose will be assessed. |
| Number of Participants Based on Co-prescription | Up to 36 months | Number of participants based on co-prescription of lisdexamfetamine dimesylate with monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), guanfacine hydrochloride and other central nervous system (CNS) stimulants will be assessed. |
| Number of Participants Based on Patterns of Drug Use | Up to 36 months | Number of participants based on patterns of drug use will be assessed. |
| Number of Prescriptions of Lisdexamfetamine Dimesylate | Up to 36 months | Number of Prescriptions of lisdexamfetamine dimesylate will be evaluated. |
| Treatment Duration | Up to 36 months | Treatment duration will be defined as the length of time a participant remains on treatment. |
| Number of Participants Based on Co-diagnosis | Up to 36 months | Number of participants based on co-diagnosis (BED and other indications except ADHD) will be assessed. |
Countries
Australia
Outcome results
None listed