ARITMO

Arrhythmogenic potential of drugs

 Coordinatore ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM 

 Organization address address: 's Gravendijkwal 230
city: ROTTERDAM
postcode: 3015CE

contact info
Titolo: Prof.
Nome: Miriam Cjm
Cognome: Sturkenboom
Email: send email
Telefono: 31104088123
Fax: +31 10 70 447 22

 Nazionalità Coordinatore Netherlands [NL]
 Totale costo 3˙616˙797 €
 EC contributo 2˙748˙319 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2009-single-stage
 Funding Scheme CP-FP
 Anno di inizio 2010
 Periodo (anno-mese-giorno) 2010-01-01   -   2013-06-30

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

 Organization address address: 's Gravendijkwal 230
city: ROTTERDAM
postcode: 3015CE

contact info
Titolo: Prof.
Nome: Miriam Cjm
Cognome: Sturkenboom
Email: send email
Telefono: 31104088123
Fax: +31 10 70 447 22

NL (ROTTERDAM) coordinator 537˙804.00
2    ST GEORGE'S HOSPITAL MEDICAL SCHOOL

 Organization address address: Cranmer Terrace
city: LONDON
postcode: SW17 0RE

contact info
Titolo: Dr.
Nome: Paul
Cognome: Craven
Email: send email
Telefono: 442087000000
Fax: 442087000000

UK (LONDON) participant 293˙200.00
3    ALMA MATER STUDIORUM-UNIVERSITA DI BOLOGNA

 Organization address address: Via Zamboni 33
city: BOLOGNA
postcode: 40126

contact info
Titolo: Ms.
Nome: Verdiana
Cognome: Bandini
Email: send email
Telefono: 390512000000
Fax: 390512000000

IT (BOLOGNA) participant 272˙470.00
4    Drug Safety Research Trust

 Organization address address: "Blundell Lane, Bursledon Hal"
city: Southampton
postcode: SO31 1AA

contact info
Titolo: Mr.
Nome: Chris
Cognome: Atkinson
Email: send email
Telefono: +44 2380 408600
Fax: +44 2380 408609

UK (Southampton) participant 217˙600.00
5    FUNDACIO IMIM

 Organization address address: Doctor Aiguader 88
city: BARCELONA
postcode: 8003

contact info
Titolo: Mr.
Nome: Andreu
Cognome: Fort
Email: send email
Telefono: 34933160690
Fax: +34 933160572

ES (BARCELONA) participant 194˙974.00
6    UNIVERSITY OF NEWCASTLE UPON TYNE

 Organization address address: Kensington Terrace 6
city: NEWCASTLE UPON TYNE
postcode: NE1 7RU

contact info
Titolo: Ms.
Nome: Aleona
Cognome: Blinova
Email: send email
Telefono: +44 191 282 4528
Fax: +44 191 282 4524

UK (NEWCASTLE UPON TYNE) participant 157˙800.00
7    LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

 Organization address address: KEPPEL STREET
city: LONDON
postcode: WC1E7HT

contact info
Titolo: Ms.
Nome: Penny
Cognome: Ireland
Email: send email
Telefono: 442079000000
Fax: 442076000000

UK (LONDON) participant 148˙600.00
8    UNIVERSITE VICTOR SEGALEN BORDEAUX II

 Organization address address: RUE LEO SAIGNAT 146
city: BORDEAUX CEDEX
postcode: 33076

contact info
Titolo: Prof.
Nome: Nicholas
Cognome: Moore
Email: send email
Telefono: 33557571560
Fax: 3355757660

FR (BORDEAUX CEDEX) participant 120˙780.00
9    ASTRAZENECA AB

 Organization address address: Vastra Maelarhamnen
city: SODERTAELJE
postcode: 151 85

contact info
Titolo: Dr.
Nome: Scott
Cognome: Boyer
Email: send email
Telefono: 46317762882
Fax: 46317763792

SE (SODERTAELJE) participant 101˙465.00
10    CHARITE - UNIVERSITAETSMEDIZIN BERLIN

 Organization address address: Chariteplatz 1
city: BERLIN
postcode: 10117

contact info
Titolo: Prof.
Nome: Wilhelm
Cognome: Haverkamp
Email: send email
Telefono: +49 30 450 553 722
Fax: +49 30 450 553 994

DE (BERLIN) participant 97˙440.00
11    AARHUS UNIVERSITETSHOSPITAL

 Organization address address: NORREBROGADE 44
city: AARHUS
postcode: 8000

contact info
Titolo: Mr.
Nome: Jesper Dambo
Cognome: Nielsen
Email: send email
Telefono: +45 89424800
Fax: +45 89424801

DK (AARHUS) participant 84˙600.00
12    PHARMO COOPERATIE UA

 Organization address address: VAN DEVENTERLAAN 30-40
city: UTRECHT
postcode: 3528 AE

contact info
Titolo: Dr.
Nome: Ron Mc
Cognome: Herings
Email: send email
Telefono: 31302345620
Fax: 31302345568

NL (UTRECHT) participant 84˙600.00
13    UNIVERSITAET BREMEN

 Organization address address: Bibliothekstrasse 1
city: BREMEN
postcode: 28359

contact info
Titolo: Mr.
Nome: Sven
Cognome: Petersen
Email: send email
Telefono: +49421218 60568
Fax: +49421218 9860568

DE (BREMEN) participant 83˙614.78
14    SYNAPSE RESEARCH MANAGEMENT PARTNERS SL

 Organization address address: CALLE LLACUNA 162
city: BARCELONA
postcode: 8018

contact info
Titolo: Ms.
Nome: Eva
Cognome: Molero
Email: send email
Telefono: 34933006061

ES (BARCELONA) participant 80˙586.00
15    BIPS - INSTITUT FUR EPIDEMIOLOGIE UND PRAVENTIONSFORSCHUNG GMBH

 Organization address address: ACHTERSTRASSE 30
city: BREMEN
postcode: 28359

contact info
Nome: Xiaogang
Cognome: Gerns
Email: send email
Telefono: +49 421 218 56762
Fax: +49 421 218 56941

DE (BREMEN) participant 65˙905.22
16    UNIVERSITA DEGLI STUDI DI VERONA

 Organization address address: VIA DELL ARTIGLIERE 8
city: VERONA
postcode: 37129

contact info
Titolo: Dr.
Nome: Susanna
Cognome: Montalto
Email: send email
Telefono: +39 458027677
Fax: +39 458027679

IT (VERONA) participant 54˙720.00
17    Academisch Medisch Centrum bij de Universiteit van Amsterdam

 Organization address address: MEIBERGDREEF 9
city: AMSTERDAM
postcode: 1105AZ

contact info
Titolo: Dr.
Nome: Hanno L.
Cognome: Tan
Email: send email
Telefono: +31 205663264
Fax: +31 206976177

NL (AMSTERDAM) participant 52˙800.00
18    Fondazione Scientifica SIMG-ONLUS

 Organization address address: Via del Pignoncino 9-11
city: Firenze
postcode: 50142

contact info
Titolo: Dr.
Nome: Mazzaglia
Cognome: Giampiero
Email: send email
Telefono: 39055494900
Fax: 390557000000

IT (Firenze) participant 50˙400.00
19    FONDAZIONE SALVATORE MAUGERI CLINICA DEL LAVORO E DELLA RIABILITAZIONE

 Organization address address: Via Salvatore Maugeri 4
city: PAVIA
postcode: 27100

contact info
Titolo: Prof.
Nome: Silvia Giuliana
Cognome: Priori
Email: send email
Telefono: +39 0382 592051
Fax: +39 0382 592059

IT (PAVIA) participant 48˙960.00
20    PHARMO Institute N.V.

 Organization address address: Van Deventerlaan 30-40
city: Utrecht
postcode: 3528 AE

contact info
Titolo: Ms.
Nome: Heleen
Cognome: Van Engeland
Email: send email
Telefono: +31 30 7440 805
Fax: +31 30 7440 801

NL (Utrecht) participant 0.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

infective    prolong    antihistamines    necessarily    literature    antipsychotics    databases    arrhythmic    aritmo    drugs    interval    predict    decision    regulatory    decisions    evidence    drug    torsade    de    clinical    relationship    potentially    anti    predictive    compounds    tdp    qt    fatal    models    cardiac    genes    risk    agents    pointes    electrocardiogram    arrhythmogenic    dbs    preclinical    arrhythmia    analyzing    conducting   

 Obiettivo del progetto (Objective)

'The ability of some compounds to prolong the QT interval of the electrocardiogram and to precipitate Torsade de Pointes (TdP, a potentially fatal arrhythmia) has caused several regulatory interventions, including drug withdrawals. Specific guidelines have been implemented to detect QT liability of new compounds as early as possible. However there is growing evidence that an increase in the QT interval does not necessarily lead to TdP which further increased the regulatory and clinical difficulties. This proposal will assess the arrhythmogenic potential of antipsychotics, antihistamines and anti-infectives (> 250 compounds). It will fulfill this aim by: reviewing the literature on in-vitro and in-vivo preclinical evidence; conducting in-silico modeling to predict the arrhythmic potential through target profiling and docking molecules in existing atomistic models and predicting the effects on hERG K, Na, Ca\ channels; analyzing the information in national and international pharmacovigilance DBs of spontaneous reports; conducting prospective case control surveillance on symptomatic QT prolongation; conducting cohort studies in psychiatric and hematology patients; analyzing information from existing studies to assess the association between drug use and various arrhythmia outcomes; and collecting blood samples from cases and drug-matched controls to investigate potential effect modification by candidate genes and a hypothesis generating approach including more than 2000 genes. Healthcare DBs on 27 million persons in 5 countries will be used to calculate rates and relative risks of arrhythmic events during drug use. Predictions on arrhythmic potential will be compared with actual postmarketing risk to assess the predictive value of preclinical markers. All information will be integrated to allow for ranking the arrhythmic potential of all the 250 study drugs and creation of risk charts that will allow for more informed treatment and decision making.'

Introduzione (Teaser)

Many drugs have been taken off the market because they have been linked to a potentially fatal heart arrhythmia. A new project revisits these drugs to determine if there is a link with this serious, though rare, event.

Descrizione progetto (Article)

Concern has been expressed about drugs that prolong the QT interval of the electrocardiogram, precipitating torsade de pointes (Tdp), a potentially fatal arrhythmia. However, a growing body of evidence is showing that an increase in the QT interval does not necessarily lead to TdP, casting doubt on clinical and regulatory decisions that have been made.

The 'Arrhythmogenic potential of drugs' (ARITMO) project was designed to examine the relationship between medications and arrhythmia.

To date, it has assessed three classes of drugs: antipsychotics, antihistamines, and anti-infective agents. Literature reviews, databases with pharmacokinetic parameters, and databases with a cardiac safety profile were used to study the drugs.

In addition, researchers examined the relationship between these drugs and ventricular arrhythmia (VA) and sudden cardiac death (SCD). They also looked at patient profiles to see if they could find new parameters that would predict TdP. Finally, the investigators conducted genetic analyses.

Out of 450 drugs under study, a comparison between literature review and database analysis could be provided for 205 drugs: 26 antihistamines, 36 antipsychotics, and 143 anti-infective agents. ARITMO provided new information for 16 antihistamines and 20 antipsychotics and confirmed that anti-infective agents were generally in the low-risk category.

These and similar results have numerous implications. They can be used to help regulators make decisions about the risk associated with these drugs. They also can be used to prioritise drugs that should be evaluated. Finally, the findings can be used to quantify risk and validate preclinical predictive models.

The integrated evidence that has emerged from the ARITMO project will allow for better regulatory and clinical decision making. Furthermore, an infrastructure has been established that can be used for other drugs. This effort represents a collaborative network for doing research and delivering state-of-the-art results.

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