Европейское агентство по лекарственным средствам просит страны-члены
Европейского Союза ограничить применение триметазидина и даже вовсе от
него отказаться, так как эффективность его подтверждена недостаточно,
а польза не превышает риск.
European Medicines Agency recommends restricting use of
trimetazidine-containing medicines
Restricted indication for patients with stable angina pectoris and
deletion of existing indications for treatment of vertigo, tinnitus
and vision disturbance
The European Medicines Agency 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.
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.
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's disease, Parkinsonian symptoms, tremors, restless-leg
syndrome or other 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.