DARWIN EU® - Assessing the potential association between venlafaxine and heart failure in adults

Study identification

• EU PAS number:
  EUPAS1000000974
• Study ID:
  1000000974
• Official title and acronym:
  DARWIN EU® - Assessing the potential association between venlafaxine and heart failure in adults
• DARWIN EU® study:
  Yes
• Study countries:
  Denmark

  Finland

  Spain

  Sweden

  United Kingdom
• Study description:
  Venlafaxine is a dual-acting serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of depression, prevention of relapse and prevention of recurrence of depression, anxiety or generalized anxiety disorder, social anxiety disorder, and panic disorder. ; Venlafaxine has a dose-dependent pharmacodynamic profile. At lower doses it primarily inhibits serotonin reuptake, while at higher doses (≥150 mg/day), it additionally inhibits norepinephrine reuptake and exerts weak inhibitory effects on dopamine reuptake.; Several cardiovascular effects are already labelled in section 4.8 of the Summaries of product characteristics (SmPC) in Europe, e.g., tachycardia and hypertension, Torsade de pointes, ventricular tachycardia, ventricular fibrillation, prolonged QT, and stress cardiomyopathy (Takotsubo cardiomyopathy).; A published case series and spontaneously reported cases (e.g., EudraVigilance, Vigibase, company global pharmacovigilance safety database) suggest an association between venlafaxine and cardiotoxicity (heart failure, cardiomyopathy other than Takotsubo). An observational study using high-quality data from the DARWIN EU® network could add important further evidence to evaluate the potential association.; The European Medicines Agency (EMA) has therefore requested a study to estimate the association between venlafaxine and heart failure/cardiomyopathy, using mirtazapine, which is indicated for the treatment of depression, as active comparator.;
• Study status:
  Ongoing

Research institutions and networks

Institutions

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Italy

Netherlands

Norway

Portugal

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned:02/12/2025

Actual:02/12/2025

Study start date

Planned:27/03/2026

Actual:27/03/2026

Date of final study report

Planned:26/06/2026

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable