The European Medicines Agency confirms the positive benefit-risk balance of Vastarel* as add-on to first line therapy in the treatment of stable angina

22/06/2012

Press release dedicated to medical journalists only

In its press release of 22 June 2012, the European Medicines Agency** confirms the positive benefit-risk balance of Vastarel (trimetazidine): “Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by, or intolerant to, first-line antianginal therapies.” Vastarel’s indications in the symptomatic treatment of vertigo and tinnitus and in the adjuvant treatment of hearing loss and visual field loss of vascular origin were considered as insufficiently documented in view of current guidelines and were not maintained. To improve patient management, the existing precautions and contraindications have been reinforced:

    - As trimetazidine may induce or worsen extrapyramidal symptoms (tremor, akinesia, hypertonia), it is now contraindicated in patients with Parkinson’s disease or parkinsonian symptoms. The onset of these symptoms, which are of low incidence and reversible after withdrawal of treatment, should lead to discontinuation of trimetazidine.
    -Caution should be exercised when prescribing trimetazidine to patients with moderate renal impairment and elderly patients with age-related moderate renal insufficiency. Dosage reduction should be considered in these patients. Vastarel is contraindicated in patients with severe renal impairment.

This European Medicines Agency decision therefore brings Vastarel in line with its position defined by the European Society of Cardiology guidelines*** for the symptomatic treatment of patients with stable angina and confirms its efficacy in this indication, while improving patient management.

    *Vastarel is available either as Vastarel 20 mg/mL, oral solution, Vastarel 20 mg, film- coated tablet or Vastarel 35 mg MR, modified-release film-coated tablet.
    **EMA/CHMP/417861/2012
    ***ESC: Fox K, Alonso Garcia MA, Ardissino D et al. Eur Heart J 2006; 27:1341-81: Guidelines on the management of stable angina pectoris: executive summary