The European Medicines Agency (EMA) has recommended restricting the use of trimetazidine-containing medicines in the treatment of patients with angina pectoris to second-line, add-on therapy. For all other indications the Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines were not sufficiently demonstrated and did not outweigh the risks.
The CHMP therefore recommended their deletion from the marketing authorisation. There is no need for an urgent change in treatment, but doctors should review their patients’ treatment at their next routine appointment.
Agency stated that the doctors should no longer prescribe trimetazidine for the treatment of patients with tinnitus, vertigo or disturbances in vision. Patients who are taking trimetazidine in these indications should discuss alternatives with their doctor.
However they have mentioned that doctors can continue to prescribe trimetazidine for the treatment of angina pectoris, but only as an add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line anti-anginal therapies.
The review was initiated by France, mainly because of concerns that the efficacy of trimetazidine was not sufficiently demonstrated. It also looked at reports regarding the occurrence of movement disorders such as Parkinsonian symptoms, restless leg syndrome, tremors and gait instability associated with the medicine. Although patients usually recovered fully within four months after treatment with trimetazidine was discontinued, the Committee recommended new contraindications and warnings to reduce and manage the possible risk of movement disorders associated with the use of this medicine.
Doctors are advised not to prescribe the medicine to patients with Parkinson disease, Parkinsonian symptoms, tremors, restless leg syndrome orother related movement disorders, nor to patients with severe renal impairment.
Doctors should exercise caution when prescribing trimetazidine to patients with moderate renal impairment and to elderly patients, and consider dose reduction in these patients.
Trimetazidine should be discontinued permanently in patients who develop movement disorders such as Parkinsonian symptoms. If Parkinsonian symptoms persist for more than four months after discontinuation, a neurologist’s opinion should be sought.
The CHMP’s opinion will be sent to the European Commission for the adoption of a binding decision throughout the European Union.