Status: Finalised First registered on: 05/09/2016
Last updated on: 13/02/2019
1. Study identification
EU PAS Register NumberEUPAS15048
Official titleAtrial fibrillation and heart failure associated to gabapentin and pregabalin
Study title acronym
Study typeObservational study
Brief description of the studyBased 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 study Six 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 database The reports of cardiac arrhythmia and HF attributed to GP or PG will be identified and their clinical course will be examined.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsFICF
Department/Research group
Organisation/affiliationFundació Institut Català de Farmacologia
Website/Homepagewww.icf.uab.cat
Details of (Primary) lead investigator
Title Professor
Last name Laporte
First name Joan-Ramon
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

FICF
Gerència de Farmàcia, CatSalut, Travessera de Les Corts 139, Barcelona
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/12/201429/12/2014
Start date of data collection04/05/201504/05/2015
Start date of data analysis04/05/201504/05/2015
Date of interim report, if expected01/03/201601/03/2016
Date of final study report25/07/201625/07/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyCatalan Health Service100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Laporte
First name Joan-Ramon
Address line 1Vall d'Hebron 119-129
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08035 
CountrySpain
Phone number (incl. country code)34934894106 
Alternative phone number 
Fax number (incl. country code) 
Email address jrl@icf.uab.cat
Public Enquiries
Title Professor 
Last name Laporte 
First name Joan-Ramon 
Address line 1Vall d'Hebron 119-129 
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08035 
CountrySpain 
Phone number (incl. country code)34934894106 
Alternative phone number 
Fax number (incl. country code) 
Email address jrl@icf.uab.cat 
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