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Trimetazidine Use in Parkinson's Disease: Is It a Resolved Problem?
Dávid Pintér1, Dániel Bereczki2,3, András Ajtay2,3
1Department of Neurology, Medical School, University of Pécs, Pécs, Hungary 7623 david_pinter@outlook.com.
Eneuro
|April 17, 2021
Summary
European Medicines Agency (EMA) recommendations to avoid trimetazidine (TMZ) in Parkinson's disease (PD) led to a modest decrease in TMZ use in Hungary. The reduction was primarily due to increased discontinuation, not fewer new prescriptions, indicating moderate effectiveness.
Area of Science:
- Pharmacovigilance and Drug Safety
- Neurology
- Health Policy Analysis
Background:
- Trimetazidine (TMZ), an antianginal medication, is known to potentially exacerbate movement disorders.
- The European Medicines Agency (EMA) advised against its use in Parkinson's disease (PD) patients due to this risk.
- Understanding the real-world impact of such regulatory recommendations is crucial for patient safety.
Purpose of the Study:
- To evaluate the effect of EMA recommendations on trimetazidine (TMZ) prescription trends in Parkinson's disease (PD) patients in Hungary.
- To analyze changes in TMZ utilization patterns following the EMA's 2010 advisory.
- To determine the primary drivers (discontinuation vs. new prescriptions) of any observed changes in TMZ use.
Main Methods:
- Nationwide retrospective study utilizing health administrative data from Hungary (2010-2016).
- Interrupted time series analysis to assess trends in TMZ use before and after the EMA recommendation.
- Statistical analysis of prescription data, including discontinuation rates and new prescriptions.
Main Results:
- A significant decrease in TMZ use among PD patients was observed post-EMA recommendation, with a trend of -6.56% every six months.
- The primary driver for reduced TMZ use was an increased rate of discontinuation, rather than a significant reduction in new prescriptions.
- Despite recommendations, a considerable proportion (40%) of TMZ use was off-label, and the drug remained in use for both on- and off-label indications.
Conclusions:
- EMA recommendations had a moderately effective impact on reducing trimetazidine (TMZ) use in Parkinson's disease (PD) patients in Hungary.
- Increased discontinuation rates, not a decrease in new prescriptions, accounted for the observed decline in TMZ utilization.
- Continued use of TMZ in PD patients, including for off-label purposes, highlights the need for ongoing monitoring and adherence to safety guidelines.
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