Study type

Study topic

Herbal medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N02CA) Ergot alkaloids
(N02CC) Selective serotonin (5HT1) agonists
Population studied

Age groups

Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)
Study design details

Main study objective

To assess the risk of cardiovascular events associated with triptan exposure among patients aged 65 years and older.

Outcomes

The main outcome will be the first cardiovascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan. The secondary outcomes will be all-cause death and cardiovascular-related death.

Data analysis plan

Hazard ratio for cardiovascular events using a Cox proportional hazard model with covariates. Patients will be followed-up for 90 days after their inclusion in the cohort, and HR will be calculated based on this follow-up duration. A sensitivity analysis will be performed for other durations of follow-up (30 days, 90 days, 180 days). Covariates will be CMU, diabetes mellitus, COPD, dyslipidemia, hypertesion, and history of cardiovascular disease. Same approach will be performed for death (all-cause death and cardiovascular-related death). Nested case-control study will allow to study the association between triptan abuse and the onset of cardiovascular events. A logistic regression will be performed to compare the risk of cardiovascular events, all-cause death and cardiovascular-related death between patients unexposed to triptans and patients overusing triptans.
Documents
Study publications
Triptan Use and Serious Cardiovascular Events In Elderly Over 65 Years In Franc…
CO - 030: Triptan use and serious cardiovascular events in elderly over 65 year…
Triptan use in elderly over 65 years and the risk of hospitalization for seriou…