Study identification

EU PAS number

EUPAS15048

Study ID

28035

Official title and acronym

Atrial fibrillation and heart failure associated to gabapentin and pregabalin

DARWIN EU® study

No

Study countries

Spain

Study description

Based on a pilot study performed in 2014, a cohort study and a review of the database of voluntary reporting of the Spanish System of Pharmacovigilance (SSPh) will be performed.Cohort studySix cohorts of all individuals ≥65 years-old and naïve of cardiovascular medications starting treatment with gabapentin (GP), pregabalin (PG), alprazolam, diazepam, an NSAID, or an analgesic opiate (reference group) between 1 January and 31 March 2015 will be studied. Patients with previous use of cardiovascular medications or antithrombotic drugs in the six months before the index date will be excluded. The index date will be the date of the prescription claim of the drug qualifying for being a member of the corresponding cohort.For atrial fibrillation (AF) the primary variable will be a first claim of an oral anticoagulant or an antiplatelet agent. Secondary variables will be first claims of an OAC or an APA plus an antiarrhythmic drug, an OAC, any cardiovascular medicine or an OAC or an APA, and the former except statins. For heart failure (HF) the primary variable will be a first claim of a diuretic. The secondary variable will be a combination of claims of the following: cardiac glycosides, antiarrhythmic drugs of class I or class III, diuretics, ß-adrenergic blocking agents, selective Ca channel blockers with direct cardiac effects, ACEI, ARB-2, or vasodilating agents.Patients will be stratified into three groups: those who start treatment with the medication of interest without an NSAID, those who start with both the medication of interest and an NSAID, and those to whom the medication of interest is added to an NSAID already dispensed in the 6 months before.Relative risks of AF and of HF will be computed. Stratified analyses will be performed by age, sex, co-treatments, and dose.Analysis of the SSPh databaseThe reports of cardiac arrhythmia and HF attributed to GP or PG will be identified and their clinical course will be examined.

Study status

Finalised
Research institutions and networks

Institutions

Gerència de Farmàcia, CatSalut Travessera de Les Corts 139, Barcelona

Contact details

Joan-Ramon Laporte

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

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Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Other

More details on funding

Catalan Health Service
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable