Multi-country study Publications

• Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study.Abstract

  OBJECTIVES: To investigate the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs) and estimate the risk of hospital admission for heart failure with use of individual NSAIDs. DESIGN: Nested case-control study. SETTING: Five poplation based healthcare databases from four European countries (the Netherlands, Italy, Germany, and the United Kingdom)

  Arfe A, Scotti L, Varas-Lorenzo C, Nicotra F, Zambon A, Kollhorst B, Schink T, Garbe E, Herings R, Straatman H, Schade R, Villa M, Lucchi S, Valkhoff V, Romio S, Thiessard F, Schuemie M, Pariente A, Sturkenboom M, Corrao G, SafetyofNon-steroidalAnti-inflammatoryDrugsProject Consortium. BMJ. 2016 354 i4857.

• Identifying Cases of Type 2 Diabetes in Heterogeneous Data Sources: Strategy from the EMIF Project.Abstract

  Due to the heterogeneity of existing European sources of observational healthcare data, data source-tailored choices are needed to execute multi-data source, multi-national epidemiological studies. This makes transparent documentation paramount. Inthis proof-of-concept study, a novel standard data derivation procedure was tested in a set of heterogeneous data sources

  Roberto G, Leal I, Sattar N, Loomis AK, Avillach P, Egger P, van Wijngaarden R, Ansell D, Reisberg S, Tammesoo ML, Alavere H, Pasqua A, Peder sen L, Cunningham J, Tramontan L, Mayer MA, Herings R, Coloma P, Lapi F, Sturkenboom M, van der Lei J, Schuemie MJ, Rijnbeek P, Gini R. PLoS One. 2016 11 (8): e0160648.

• Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.Abstract

  BACKGROUND AND OBJECTIVE: Spontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data sources is essential to enable better detecion, strengthening and validation of signals. In this study, we investigated the potential of electronic healthcare records (EHRs) to be used alongside an SRS as an independent system, with the aim of improving signal detection

  Pacurariu AC, Straus SM, Trifiro G, Schuemie MJ, Gini R, Herings R, Mazzaglia G, Picelli G, Scotti L, Peder sen L, Arlett P, van der Lei J, Sturkenboom MC, Coloma PM. Drug Saf. 2015 Dec; 38 (12): 1201-10.

• Trends in paediatric macrolide use in five European countries-a population-based study.Abstract

  PURPOSE: The study aims to analyse overall as well as subgroup-specific outpatient paediatric macrolide use in five European countries, including time trends of macrolide prescription rates, and to provide potential targets for future interventionsaiming to promote judicious macrolide use. METHODS: Macrolide prescription rates per 1000 person years to paediatric outpatients (

  Holstiege J, Ender s D, Schink T, Innocenti F, Oteri A, Bezemer I, Kaguelidou F, Molokhia M, Poluzzi E, Puccini A, Ulrichsen SP, Sturkenboom MC, Trifiro G, Garbe E. Eur J Clin Pharmacol. 2015 Aug; 71 (8): 991-9.

• The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study.Abstract

  AIM: Electronic healthcare record (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In tis paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0-18 years)

  deBie S, Coloma PM, Ferrajolo C, Verhamme KM, Trifiro G, Schuemie MJ, Straus SM, Gini R, Herings R, Mazzaglia G, Picelli G, Ghirardi A, Peder sen L, Stricker BH, van der Lei J, Sturkenboom MC, consortium Eu-Adr. Br J Clin Pharmacol. 2015 Aug; 80 (2): 304-14.

• Antibiotic use varies substantially among adults: a cross-national study from five European Countries in the ARITMO project.Abstract

  PURPOSE: To examine patterns of outpatient and community antibiotic use among adults in five European countries. METHODS: We used healthcare data of 28.8 million adults from six population-based ARITMO project databases to ascertain information onystemic antibiotic use in Denmark (2000-2008), the Netherlands (1999-2010), Italy (2000-2010), the UK (1996-2009), and Germany (2004-2008)

  Mor A, Froslev T, Thomsen RW, Oteri A, Rijnbeek P, Schink T, Garbe E, Pecchioli S, Innocenti F, Bezemer I, Poluzzi E, Sturkenboom MC, Trifiro G, Sogaard M. Infection. 2015 Aug; 43 (4): 453-72.

• Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection.Abstract

  Background Electronic reporting and processing of suspected adverse drug reactions (ADRs) is increasing and has facilitated automated screening procedures. It is crucial for healthcare professionals to understand the nature and proper use of data aailable in pharmacovigilance practice. Objectives To (a) compare performance of EU-ADR [electronic healthcare record (EHR) exemplar] and FAERS [spontaneous reporting system (SRS) exemplar] databases in detecting signals using “positive” and “negative” drug-event reference sets; and (b) evaluate the impact of timing bias on sensitivity thresholds by comparing all data to data restricted to the time before a warning/regulatory action

  Patadia VK, Schuemie MJ, Coloma P, Herings R, van der Lei J, Straus S, Sturkenboom M, Trifiro G. Int J Clin Pharm. 2015 Feb; 37 (1): 94-104.

• Using real-world healthcare data for pharmacovigilance signal detection – the experience of the EU-ADR project.Abstract

  A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA’s Adverse Event Reporting System and WHO’s Vigibase is reported. The study compard drug safety signals found in the EU-ADR and SRS databases

  Patadia VK, Coloma P, Schuemie MJ, Herings R, Gini R, Mazzaglia G, Picelli G, Fornari C, Peder sen L, van der Lei J, Sturkenboom M, Trifiro G, consortium Eu-Adr. Expert Rev Clin Pharmacol. 2015 Jan; 8 (1): 95-102.

• Risk of upper gastrointestinal bleeding from different drug combinations.Abstract

  BACKGROUND & AIMS: Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin increases the risk of upper gastrointestinal bleeding (UGIB). Guidelines suggest avoiding certain drug combinations, yet little is known abouthe magnitude of their interactions. We estimated the risk of UGIB during concomitant use of nonselective (ns)NSAIDs, cyclooxygenase -2 selective inhibitors (COX-2 inhibitors), and low-dose aspirin with other drugs

  Masclee GM, Valkhoff VE, Coloma PM, deRidder M, Romio S, Schuemie MJ, Herings R, Gini R, Mazzaglia G, Picelli G, Scotti L, Peder sen L, Kuipers EJ, van der Lei J, Sturkenboom MC. Gastroenterology. 2014 Oct; 147 (4): 784-792 e9.

• Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network.Abstract

  BACKGROUND: Data mining in spontaneous reporting databases has shown that drug-induced liver injury is infrequently reported in children. OBJECTIVES: Our objectives were to (i) identify drugs potentially associated with acute liver injury (ALI) inhildren and adolescents using electronic healthcare record (EHR) data; and (ii) to evaluate the significance and novelty of these associations

  Ferrajolo C, Coloma PM, Verhamme KM, Schuemie MJ, deBie S, Gini R, Herings R, Mazzaglia G, Picelli G, Giaquinto C, Scotti L, Avillach P, Peder sen L, Rossi F, Capuano A, van der Lei J, Trifiro G, Sturkenboom MC, consortium Eu-Adr. Drug Saf. 2014 Feb; 37 (2): 99-108.