TRiptan Use and Serious Vascular Events in Elderly Over 65 Years

Study Overview
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Brief Summary
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This study will be conducted as a retrospective study of exposed and unexposed cohort of the French population included all beneficiaries aged 65 and older. Exposed patients will be matched to non exposed controls according age, gender and area of residence (ratio 1/4). Two exposed arms and two non exposed control arms will be planned. Triptan arm will be user of triptan defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months (new or incident users). Ergot arm will be user of ergot derivative defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months (new or incident users). This study involved data from the French National Health Insurance Information System (Système National dInformation Inter-Régimes de lAssurance Maladie ; SNIIRAM) linked with the French hospital discharge database (Programme de Médicalisation des Systèmes dInformations, PMSI). The SNIIRAM is a vast national medico-administrative database representing the most part of the French population, allowing to identify and to describe precisely all medication dispensations (name of drug, date of dispensing and quantity) including triptans and other reimbursed medications. The PMSI provides medical information about all patients admitted to hospital in France, including discharge diagnoses encoded according ICD-10, medical procedures and French diagnosis-related groups The research proposed is expected to provide an update and nationally-consolidated estimation of the cardiovascular risk is associated to triptans use in elderly population.

Conditions
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Migraine

Intervention / Treatment
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* Drug: Exposure to Triptan
* Drug: Exposure to Ergot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 65 and more Patients registered in the SNIIR-AM To avoid depletion of susceptibles bias, only incident users will be included. Incident users are defined by the lack of reimbursement for triptan (or ergot derivatives) prior six months of the study period. Exclusion Criteria: no exclusion criteria

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Triptan Arm<br>Users of triptan defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months (new or incident users) | Drug: Exposure to Triptan<br> <br> |
| Ergot Arm<br>Users of ergot derivative defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months (new or incident users) | Drug: Exposure to Ergot<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of the first vascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan. |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the mortality: number of all deaths | Assessment of the deaths, whatever the cause | Up to 4 years | 
| Assessment of the mortality with an underlying cardiovascular cause occuring in hospital |  | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triptan, Drug utilization, Elderly, Drug abuse, Cardiovascular disease