Atrial fibrillation and heart failure associated to gabapentin and pregabalin

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28035
• 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

Fundació Institut Català de Farmacologia (FICF)

Spain

Fundació Institut Català de Farmacologia (FICF)

Spain

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

Study timelines

Date when funding contract was signed

Planned: 29/12/2014

Actual: 29/12/2014

Study start date

Planned: 04/05/2015

Actual: 04/05/2015

Data analysis start date

Planned: 04/05/2015

Actual: 04/05/2015

Date of interim report, if expected

Planned: 01/03/2016

Actual: 01/03/2016

Date of final study report

Planned: 25/07/2016

Actual: 25/07/2016

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