Evaluation of the effectiveness of risk minimization measures for trimetazidine: A cross sectional joint PASS survey among physicians in selected European countries

Pharmacoepidemiol Drug Saf. 2018 Dec;27(12):1385-1392. doi: 10.1002/pds.4675. Epub 2018 Oct 31.


Purpose: In 2012, the Committee for Medicinal Products for Human Use (CHMP) restricted prescription of trimetazidine (TMZ) to "add-on therapy for patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line therapies." TMZ was no longer indicated for ophthalmology and otolaryngology. Risk minimization measure (RMM) was communicated to physicians. The survey presented here evaluated effectiveness of the RMM and assessed physicians knowledge and compliance with RMM. It also analyzed actual prescribing pattern of TMZ.

Methods: A cross sectional, web-based survey was developed and conducted among prescribing physicians of TMZ across 12 European countries. Physicians' samples were weighted to account for the actual proportion of specialties within and across countries.

Results: Using weighted samples, data from 1123 physicians and 8332 prescriptions were analyzed. Most (74.0%) of the physicians assumed stable angina pectoris to be an indication for TMZ. Three quarter of (75.7%) of these physicians were aware of the approved indication. Vertigo (62.1%), tinnitus (42.5%), declined visual acuity, and visual field disturbances (45.1%) were also presumed to be approved indications for TMZ, and physicians actually prescribed for these indications. Only 29.8% of the physicians remembered receiving RMM communications regarding TMZ. Most (90.5%) of the physicians expressed their interest to know and comply with the safety communications. Of all prescriptions, 33.9% were issued for add-on therapy for patients with stable angina pectoris.

Conclusions: RMM for TMZ prescription have been moderately effective. Improvement in physician's compliance with safety information of TMZ is necessary for patient's safety.

Keywords: PASS; ophthalmology; otolaryngology; pharmacoepidemiology; risk minimization measures; stable angina pectoris; trimetazidine.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Angina, Stable / drug therapy*
  • Clinical Competence / statistics & numerical data
  • Cross-Sectional Studies
  • Europe
  • Guideline Adherence / statistics & numerical data
  • Humans
  • Internet
  • Middle Aged
  • Patient Safety / standards
  • Physicians / statistics & numerical data*
  • Practice Guidelines as Topic
  • Risk Management / methods*
  • Risk Management / standards
  • Surveys and Questionnaires / statistics & numerical data
  • Trimetazidine / administration & dosage
  • Trimetazidine / adverse effects*
  • Vasodilator Agents / administration & dosage
  • Vasodilator Agents / adverse effects*


  • Vasodilator Agents
  • Trimetazidine