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 institution and networks

Institutions

N/A
AARHUS university Denmark, Uni-HB Germany

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EU institutional research programme

More details on funding

VII Framework Programme
Study protocol
Initial protocol

Aritmo_Deliverable5.2

English (1.07 MB - PDF)View document
Updated protocol

Aritmo_Deliverable5.2_amended

English (1.99 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable