Atrial fibrillation and heart failure associated to gabapentin and pregabalin

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03AX12) gabapentin

  gabapentin

  (N03AX16) pregabalin

  pregabalin
• Medical condition to be studied:
  Atrial fibrillation

  Cardiac failure acute

Population studied

• Short description of the study population:
  Patients ≥ 65 years of age starting treatment with either gabapentin or pregabalin between January 1 and March 31, 2015, free of cardiovascular disease, and who did not receive the alternate study medications.
• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  29000

Study design details

• Main study objective:
  To evaluate the association between exposure to gabapentin or pregabalin and the risk of atrial fibrillation or heart failure.
• Outcomes:
  For atrial fibrillation (AF) the primary variable will be a first claim of an oral anticoagulant (or an antiplatelet agent. For heart failure (HF) the primary variable will be a first claim of a diuretic. For atrial fibrillation 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 the secondary variable will be a combination of claims of various cardiovascular drug groups.
• Data analysis plan:
  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 and their corresponding two-sided 95% confidence intervals of AF and of HF will be computed. Stratified analyses will be performed by age, co-treatments and dose.