Triptan use and serious vascular events in elderly over 65 years (TRUE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27270
• EU PAS number:
  EUPAS8976
• Study ID:
  27270
• Official title and acronym:
  Triptan use and serious vascular events in elderly over 65 years (TRUE)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Triptans have improved the quality of life of acute migraine by providing higher efficacy and a more favorable profile of adverse drug reactions than ergotamine. Even though triptan are not recommended in older patients (over 65 years), some drug utilization studies have shown that older patients account for 5% to 10% of triptan users. To our knowledge, no specific vascular safety study has been performed among older patients exposed to triptan. The main objective of the TRUE study is to compare the incidence of cardiovascular events between a population of older triptan users (age > 65 years) and a control population. The study design is a retrospective comparative cohort study (exposed versus unexposed). We will use data from the French National Health Insurance information system (SNIIRAM) linked with the French Hospital discharge database (PMSI). We will include patients aged over 65 years, who are registered in SNIIRAM. For the exposed cohort, we will only include incident users of triptans. Exposed and unexposed cohorts will be matched (1:4 ratio) according to age, gender and area of residence. The events of interest are cardio-vascular events, death from all causes, and death related to a cario-vascular event. Data will be analyzed using Cox proportional hazards models, taking into account confounders.
• Study status:
  Finalised

Research institution and networks

Institutions

Department of Clinical Pharmacology and Pharmacosurveillance, University Hospital of Marseille

France

Pharmacologie En Population cohorteS biobanqueS (PEPSS), Hopitaux de Toulouse

France

Study timelines

Date when funding contract was signed

Actual: 18/10/2013

Study start date

Planned: 01/06/2015

Actual: 01/11/2015

Data analysis start date

Actual: 10/01/2016

Date of interim report, if expected

Actual: 20/12/2017

Date of final study report

Planned: 01/09/2017

Actual: 20/12/2017

Sources of funding

National competent authority (NCAs)

More details on funding

ANSM

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable