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

Abstract

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.

Trimetazidine Use in Parkinson’s Disease: Is It a Resolved Problem?

“…Although the EMA recommendations on TMZ use were introduced more than seven years ago, only a single study has attempted to investigate their impact on TMZ utilization thus far ( von Bredow et al, 2018 ). Of note, this study provides no data on possible changes in the trend of TMZ use in PD.…”

“…Eventually, no significant reduction appeared in the frequency of new TMZ initiations in the PD population. In the study by von Bredow et al (2018) , investigating 12 European countries, including Hungary, between 2014 and 2015, less than half (46.5%) of the asked physicians mentioned PD as a contraindication for TMZ treatment. This gap in knowledge of a great part of physicians prescribing TMZ may explain our findings in regard to new PD patient initiations on the drug.…”

“…Similarly to TMZ in PD, the EMA took regulatory actions for valproic acid (VPA) use in girls, women of childbearing age, and pregnant females based on postmarketing data. Although the efficacy of the restrictions on VPA use by the EMA has been thoroughly evaluated ( European Medicines Agency, 2014 ; Vajda et al, 2014 ; Wen et al, 2015 ; Liu et al, 2017 ; Karlsson Lind et al, 2018 ; Kinney et al, 2018 ; Virta et al, 2018 ; Jacob et al, 2019 ; Puteikis et al, 2019 ), only little efforts have been made to generate such information concerning the impact of the EMA warning on the clinical practice with TMZ thus far ( von Bredow et al, 2018 ). Therefore, we conducted a study in Hungary, a country in the European Union with a population of ∼10 million of which ∼400,000 inhabitants suffered from stable coronary heart disease in 2018 ( Pintér et al, 2019 ).…”

Effectiveness of risk minimisation measures for valproate: A cross‐sectional survey among physicians in Europe

“…Surveys studies are a robust and versatile way to evaluate RMMs and can also be used to measure self‐reported behaviour 12 . Previously published European region surveys for various approved products have helped in identification of physician speciality and/or region in which the RMMs should be strengthened or intensified, in addition to assessing the HCPs knowledge 13‐16 . Knowledge from these studies can help the national health authorities to facilitate the improvement of safety communication strategies 16 …”

Trimetazidine Use and the Risk of Parkinsonism: A Nationwide Population-Based Study

“…Although early recognition and prompt discontinuation of such drugs can be considered crucial for the management of parkinsonism, we believe the fact that TMZ has not been well documented as a parkinsonism-inducing medication in previous DIP-related studies [ 2 , 5 , 19 ] should be highlighted. Even after the indication for TMZ was restricted due to safety issues, many physicians still prescribed TMZ for vertigo and tinnitus off-label, and they were not aware of the latest safety information regarding TMZ [ 31 ]. Therefore, we believe that our study, demonstrating the significant risk of TMZ-associated parkinsonism, will help to raise awareness of TMZ-associated parkinsonism and the importance of recognizing DIP.…”