Parkinson’s disease
Conditions
Interventions
Pramipexole original drug group:NA
Pramipexole generic drug group:NA
Sponsors
Xuanwu Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The pramipexole hydrochloride tablets study included patients who received the original pramipexole hydrochloride tablets from 2019.1.1 to 2020.6.30 (identification phase) and the selected generic pramipexole hydrochloride tablets from 2021.7.1 to 2022.12.31 (identification phase). The pramipexole hydrochloride sustained-release tablets study was enrolled in patients who used pramipexole sustained-release tablets as the original or selected generic during the 2021.1-2023.4.30 (identification phase). The first prescription of pramipexole during this period was the enrollment day. The baseline period was 6 months before enrollment. Pramipexole hydrochloride tablets study original drug group: follow-up to 2020.12.31; generic drug group: follow-up until 2023.6.30. Pramipexole hydrochloride sustained-release tablets were followed up to 2023.10.31 in both the original and generic drug groups. Follow-up was conducted every 3 months after enrollment, and prescription information after the first prescription was collected to identify efficacy and safety outcome indicators. For time nodes without prescription records, prescription data from the most recent visit were used to estimate.
Exclusion criteria
Exclusion criteria: (1) pramipexole prescription records existed within 6 months before enrollment; (2) there was no record of pramipexole prescription within 1 year after enrollment or no record of pramipexole prescription during the follow-up period (< 1 year); (3) simultaneous use of original pramipexole and generic drugs; (4) patients with incomplete information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of levodopa equivalent dose over time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug events;Clinical ; | — |
Countries
China
Contacts
Public ContactLan Zhang
Xuanwu Hospital of Capital Medical University
Outcome results
None listed