Arrhythmogenic Potential of Drugs (ARITMO) project

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20755
• EU PAS number:
  EUPAS2361
• Study ID:
  20755
• Official title and acronym:
  Arrhythmogenic Potential of Drugs (ARITMO) project
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Italy

  Netherlands

  United Kingdom
• Study description:
  Cardiac ventricular arrhythmia as a side effect of anti-arrhythmic and non-antiarrhythmic drugs has become a major pharmacological safety concern for the pharmaceutical industry and the health regulatory authorities.The overall objective of the ARITMO project is to analyse the ventricular arrhythmogenic potential of individual drugs belonging to the following classes (> 400 compounds): antipsychotics (ATC - Anatomical Therapeutic Chemical classification: N05A), anti-infectives (antibacterials (J01), antimycotics (J02), antivirals (J05), and antiprotozoals (P01)) and H1-antihistamines (R06). The aim of observational database study is to investigate the pro-arrhitmic risk associated to the medications belonging to the following classes: anti-infectives, antihistamines and antipsychotics. In detail, the primary objective is to estimate the rates and relative risks of (a) ventricular arrhythmia (VA) and (b) sudden unexpected death (SUD)/sudden cardiac death (SCD) associated with the most frequently prescribed individual anti-infectives, antihistamines and antipsychotics. To estimate the comparative risks of the study drugs, different comparators will be selected for each drug class of interest.Secondary objectives of the study are:- to explore the effect of dose and duration of use and route of administration on the association between study outcomes and drugs of interest,- to identify demographic and clinical predictors for the specific drug-induced arrhythmias- to describe the prescribing pattern of the study drugs in different databases For each of the two outcomes (VA and SCD/SUD) matched, nested case control studies will be conducted separately to assess the rates and the relative risk associated with anti-infectives, antihistamines and antipsychotics. As regard the anti-infectives, different case control subsets will be created for each drug subgroup (i.e. antibiotics, antivirals, antimycotics and antiprotozoals).
• Study status:
  Finalised

Research institutions and networks

Institutions

Erasmus Medical Centre Rotterdam

N/A

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

Netherlands

Department of Pharmacology, University of Bologna (UNIBO)

Italy

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Società Italiana di Medicina Generale e delle Cure Primarie (SIMG)

AARHUS university Denmark, Uni-HB Germany

Networks

Arrhythmogenic potential of drugs (ARITMO)

Study timelines

Date when funding contract was signed

Planned: 04/01/2010

Actual: 04/01/2010

Study start date

Planned: 01/01/1996

Actual: 01/01/1997

Data analysis start date

Planned: 04/01/2010

Actual: 04/01/2010

Date of final study report

Planned: 30/09/2013

Actual: 08/08/2013

Sources of funding

EU institutional research programme

More details on funding

VII Framework Programme

Study protocol

Initial protocol

Aritmo_Deliverable5.2

Updated protocol

Aritmo_Deliverable5.2_amended

Regulatory

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