Triptan use and risk of cardiovascular events: a nested-case-control study from the French health system database.

BACKGROUND: The use of triptans (5-HT agonists) in the treatment of migraine is associated with a potential increasing risk of cardiovascular events and raises the question of the relationship between overuse and the occurrence of ischemic events. OBJECTIVE: The aim of this study was to examine the association between the intensity of triptan use and occurrence of an cardiac event. METHODS: Using the reimbursed drug prescription database of the National French Health Insurance System in the Midi-Pyrenees area, we identified subjects receiving at least one triptan in the second semester of 2002. From this population, we selected new users and retrieved all reimbursed care data up to 31 December 2003. We estimated the patterns of triptan exposure by calculating the number of defined daily doses (DDD) received per 30-day period. Another reimbursed health care database was used to identify as cases of cardiac outcomes those patients receiving care for the management of a possible heart ischemic event. Each case was randomly matched on age and gender with four controls free of any cardiovascular event before the index date. A conditional logistic regression was performed to assess the relationship between cardiac outcomes and exposure to triptans in the 30 days before the index date. RESULTS: The cohort of new users of triptans included 8625 subjects, 4414 (51.18%) of whom received only one dispensation for triptans during the follow-up period (median duration: 427 days). For the remaining subjects, the peak of triptans delivery was /=30 DDD for 1.92%. Fifty-seven users (0.66%) presented a cardiac history and 1388 patients (16.09%) had cardiovascular risk factors. We identified 155 incident cases of cardiac outcomes during the follow-up and compared these to 620 matched controls. Cases were older and presented more frequently with cardiac history or cardiovascular risk factors than the other users of triptans. The distribution exposure to triptans did not significantly differ between cases and controls with an odds ratio for an exposure 8 DDD equal to 1.14 [95% CI (0.58-2.27)]. CONCLUSION: The proportion of patients showing an overuse of triptans (more than 15 DDD for 30 days) reached 12% in this cohort of new users of triptans. However, we did not find any relationship between the overuse of triptans and cardiac outcomes. This study also shows that some patients with cardiovascular risk factors are actually treated by triptans. These patients are more likely to present a cardiac outcome potentially related to an ischemic event after the introduction of triptan.

Upper gastrointestinal adverse drug reactions and cyclo-oxygenase-2 inhibitors (celecoxib and rofecoxib): a case/non-case study from the French Pharmacovigilance Database.

OBJECTIVE: To evaluate the gastrointestinal safety of cyclo-oxygenase-2 inhibitors under their real conditions of use. DESIGN. Case/non-case study. SETTING: Adverse drug reactions (ADRs) in adults recorded in the French Pharmacovigilance Database between 25 May 2000 and 31 December 2002. MATERIALS: Cases were all reports of "serious" oeso-gastro-duodenal ADRs (oeso-gastro-duodenal ulcers, oesophagitis, gastritis, duodenitis). Five non-cases were randomly selected for one case from all other non oeso-gastro-duodenal reports in the database after matching them for age, gender and period of occurrence. ANALYSIS: Coxib exposure was compared among cases and non-cases, with adjustment for matching factors: French Regional Pharmacovigilance Centres that collected ADRs, reporter health professional's characteristics and exposures to non-selective non-steroidal anti-inflammatory, aspirin, anticoagulant, antiplatelet and gastroprotective drugs. RESULTS: Included in the study were 505 cases and 2,525 non-cases. A positive association was found between occurrence of oeso-gastro-duodenal ADRs and coxib (adjusted odds ratio 14.9 [95% CI 9.3-23.7]), diclofenac (9.2 [3.8-22.2]), ibuprofen (7.3 [3.2-16.6]) or oxicam (25.3 [11.9-53.6]) use. CONCLUSION: Despite the compulsory limits of the case/non-case methodology, the present study shows that coxibs did induce "serious" gastrointestinal ADRs in real clinical practice. These results underline the need for pharmacoepidemiological studies under real conditions of use in order to verify (or not) the conclusions of clinical trials.

[Vascular risk factors and Alzheimer's disease]. / Facteurs de risque vasculaire et maladie d'Alzheimer.

BACKGROUND AND OBJECTIVE: Recent epidemiological study and clinico-pathologic data suggest overlaps between Alzheimer disease and cerebrovascular lesions that may magnify the effect of mild Alzheimer disease pathology and promote progression of cognitive decline. There is now strong epidemiologic evidence supporting an association between Alzheimer disease and two major vascular risk factors--blood pressure and diabetes. The major objective of this study is to analyse the impact of vascular risk factors on natural history of Alzheimer's disease. METHODS: Descriptive analyse of the vascular risk factors on 520 Alzheimer's disease patients issue from the population of the "Programme Hospitalier de Recherche Clinique: "Réseau sur la maladie d'Alzheimer français". RESULTS: The description of the vascular risk factors in the Alzheimer's disease patients from the "Programme Hospitalier de Recherche Clinique. "Réseau sur la maladie d'Alzheimer Français" was made and the projects and perspectives of analyses based on the longitudinal data were discussed. 45% of subjects have high blood pressure, they were significantly older (p < 0.05), have more frequent impairment of ADLs (p < 0.05), and one-leg balance impairment (p < 0.05). 10% of patients have diabetes and 23.95% hypercholesterolemia. CONCLUSIONS: The first data on vascular risk factors of the "Programme Hospitalier de Recherche Clinique: "Réseau sur la maladie d'Alzheimer français"" are the first step on comprehension of the impact of vascular risk factors and their traitments on Alzheimer's disease.