Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data sources and epidemiological design

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6882
• EU PAS number:
  EUPAS2561
• Study ID:
  6882
• Official title and acronym:
  Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data sources and epidemiological design
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Netherlands

  Spain

  United Kingdom
• Study description:
  The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Work Package 2 and Working Group 1. The primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on 5 key Drug / adverse events (D-AEs) pairs performed in different databases will be evaluated. The Use of inhaled long acting beta2 adrenoceptor agonists associated with the risk of myocardial infarction is one of the key D-Ae pair of interest. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of studying the association under investigation.
• Study status:
  Ongoing

Research institution and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

European Medicines Agency (EMA)

Novartis Pharmaceuticals

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices, AEMPS)

Spain

Ludwig-Maximilians-University Munich

Agencia Espanola de Medicamentos y Productos Sanitarios (AEMPS) Spain, Lægemiddelstyrelsen (DKMA) Denmark, Ludwig-Maximilians-Universität-München (LMU Muenchen) Germany, European Medicines Agency (EMA) United Kingdom, Novartis Pharma AG (Novartis) Switzerland

Networks

PROTECT

Belgium

Denmark

France

Germany

Italy

Netherlands

Poland

Spain

Sweden

Switzerland

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 19/08/2009

Actual: 19/08/2009

Study start date

Planned: 03/10/2011

Actual: 03/10/2011

Date of final study report

Planned: 01/02/2013

Sources of funding

EU institutional research programme

Pharmaceutical company and other private sector 

More details on funding

Amgen, AstraZeneca, Genzyme, GSK, MerckSerono, Novartis, Roche, Pfizer, Innovative Medicines Initiative (IMI)

Study protocol

Initial protocol

PROTECT_WP2 Final protocol Beta2_AMI 30 March 2012_Amendment1_22Aug2012

Updated protocol

PROTECT_WP2 Final protocol Beta2_AMI_Amendment2_clean_Version_withAppendix2_130220

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable