Study identification

EU PAS number

EUPAS9871

Study ID

28831

Official title and acronym

Evaluation of the Effectiveness of Risk Minimization Measures: Trimetazidine Drug Utilization Study in European Countries using databases – analysis for France, Hungary, Romania and Spain

DARWIN EU® study

No

Study countries

France
Hungary
Romania
Spain

Study description

TMZ-containing medicinal products were indicated in EU for various cardiology, ophthalmology and otolaryngology indications. Otolaryngology and ophthalmology indications included:i. Ancillary symptomatic treatment of vertigo and tinnitus andii. Ancillary treatment of visual acuity decrease and visual field disturbances due to vascular reasonsOn 22 April 2011, France had requested the Committee for Medicinal Products for Human Use (CHMP) to give its opinion under Article 31 of Directive 2001/83/EC on whether the marketing authorization for TMZ-containing medicinal products will be maintained, varied, suspended or withdrawn.The review conducted by the CHMP concluded that the evidence of the efficacy and safety in the ophthalmology and otolaryngology indications, initially suggested by the studies on the basis of multiple assessments was considered weak due to the methodology applied to the investigation and was no longer recommended since September 2012 (3).Potential prescribers were informed of this change in the indication of TMZ through “Direct Healthcare Professional Communications” (DHPCs) and other appropriate notifications. The drug utilization study presented here is designed to evaluate the effectiveness of these risk minimization measures (RMM) on the use of TMZ in targeted countries based on information from prescription databases. In a parallel protocol, a survey will be conducted to provide information on the knowledge, attitude and behaviour of the physicians in the targeted countries about the content of the DHPC and the updated SMPC are evaluated.

Study status

Finalised
Research institutions and networks

Institutions

NA

Contact details

Toussi Massoud

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Consoritum headed by Lupin Pharma
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)