IQVIA™ Real-World Insights Bibliography

Empagliflozin cardiovascular and renal effectiveness and safety compared to dipeptidyl peptidase-4 inhibitors across 11 countries in Europe and Asia: Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study
Author(s): Avraham Karasik (1), Stefanie Lanzinger (2,3), Elise Chia-Hui Tan (4), Daisuke Yabe (5,6,7 8), Dae Jung Kim (9), Wayne H-H Sheu (10), Cheli Melzer-Cohen (1), Reinhard W. Holl (2), Kyoung-Hwa Ha (9), Kamlesh Khunti (11), Francesco Zaccardi (11), Anuradhaa Subramanian (12), Krishnarajah Nirantharakumar (12,13,14), Thomas Nyström (15), Leo Niskanen (16), Majken Linnemann Jensen (17), Fabian Hoti (18), Riho Klement (19), Anouk Déruaz-Luyet (20), Moe H.Kyaw (21), Lisette Koeneman (22), Dorte Vistisen (23, 24) Bendix Carstensen (23), Sigrun Halvorsen (25), Gisle Langslet (26), Soulmaz Fazeli Farsani (20), Elisabetta Patorno (27), Júlio Núñez (28), EMPRISE Europe and Asia Study Group
Affiliations(s): "1 Maccabi Institute for Research and Innovation Center, Tel Aviv University, Tel Aviv, Israel 2 Institute for Epidemiology and Medical Biometry, ZIBMT, Ulm University, Ulm, Germany 3 German Centre for Diabetes Research (DZD), München-Neuherberg, Germany 4 Department of Health Service Administration, China Medical University, Taichung, Taiwan 5 Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kyoto, Japan 6 Department of Diabetes, Metabolism and Endocrinology/Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan 7 Center for Healthcare Information Technology, Tokai National Higher Education and Research System, Nagoya, Japan 8 Preemptive Food Research Center, Gifu University Institute for Advanced Study, Gifu, Japan 9 Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South Korea 10 Division of Endocrinology and Metabolism, Taipei Veterans General Hospital, Taipei, Taiwan 11 Leicester Real World Evidence Unit, Leicester Diabetes Centre, University of Leicester, Leicester, UK 12 Institute of Applied Health Research, University of Birmingham, Birmingham, UK 13 Midlands Health Data Research UK, Birmingham, UK 14 DEMAND Hub, University of Birmingham, Birmingham, UK 15 Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Sweden 16 Päijät-Häme Joint Authority for Health and Wellbeing, Päijät-Häme Central Hospital, Lahti Finland and University of Eastern Finland, Kuopio, Finland 17 IQVIA Solutions Denmark A/S, Copenhagen, Denmark 18 IQVIA, Espoo, Finland 19 IQVIA, Tartu, Estonia 20 Boehringer Ingelheim International GmbH, Ingelheim, Germany 21 Boehringer Ingelheim International GmbH, US 22 Lilly Deutschland GmbH, Bad Homburg, Germany 23 Steno Diabetes Center Copenhagen, Herlev, Denmark 24 Department of Public Health, University of Copenhagen, Copenhagen, Denmark 25 Department of Cardiology, Oslo University Hospital Ullevål, and University of Oslo, Oslo, Norway 26 Lipid Clinic, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway 27 Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA 28 Department of Cardiology, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBER Cardiovascular, Valencia, Spain"
Publication(s):  "Diabetes & Metabolism. 2023 Jan; 101418; ISSN 1262-3636 Virtual Conference: American Diabetes Association, 25-29 June 2021 and EASD 27 September -01 October"
Document Type(s): Article,
Countries: Denmark, Finland, Germany, Norway, Spain, Sweden, UK,
Click here for the abstract
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Cardiovascular disease, Diabetes, Drug safety, Drug Utlization Study,
2023
  L:
A:
English
Clinical setting: hospital, Clinical setting: Primary care,
  Add to report
 
 
The CLARION study: first report on safety findings in patients newly initiating treatment with cladribine tablets or fingolimod for multiple sclerosis
Author(s): Helmut Butzkueven, Jan Hillert, Merja Soilu-Hänninen, Tjalf Ziemssen, Jens Kuhle, Stig Wergeland, Melinda Magyari, Joseph R. Berger, Nicholas Moore, Aida Aydemir, Irene Bezemer & Meritxell Sabidó
Affiliations(s): "a Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia; b The Alfred Hospital, Melbourne, VIC, Australia; c Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; d Turku University Hospital Neurocenter and Division of Clinical Neurosciences, University of Turku, Turku, Finland; e Center of Clinical Neuroscience, Department of Neurology, Dresden University of Technology, Dresden, Germany; f Multiple Sclerosis Center and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), Departments of Biomedicine and Clinical Research, University Hospital and University of Basel, Basel, Switzerland; g Department of Neurology, University Hospital and University of Basel, Basel, Switzerland; h Norwegian MS Registry and Biobank, Department of Neurology, Haukeland University Hospital, Bergen, Norway; i Department of Clinical Medicine, University of Bergen, Bergen, Norway; j Danish Multiple Sclerosis Center and the Danish Multiple Sclerosis Registry, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; k Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; l Bordeaux PharmacoEpi (BPE), Universit�e de Bordeaux, Bordeaux, France; m EMD Serono Research & Development Institute, Inc, Billerica, MA, USA, an affiliate of Merck KGaA; n Global Epidemiology, IQVIA, Amsterdam, The Netherlands; o Merck Healthcare KGaA, Darmstadt, Germany"
Publication(s): 
Document Type(s): Article,
Countries: Australia, Denmark, Finland, Germany, Norway, Sweden, Switzerland, Turkey,
Click here for the abstract
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Comparative Effectiveness & Health Technology Assessment, Drug safety, Neurological disorders,
2023
  L:
A:
English
clinical setting: Secondary care, Epidemiological study, Population Based Study,
  Add to report
 
 
The CLARION study design and status update: a long-term, registry-based study evaluating adverse events of special interest in patients with relapsing multiple sclerosis newly started on cladribine tablets
Author(s): Helmut Butzkueven 1 2, Nicholas Moore 3, Aida Aydemir 4, Jaak Sõnajalg 5, Irene Bezemer 6, Pasi Korhonen 7, Meritxell Sabidó 8, CLARION Study Group
Affiliations(s): 1Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Australia. 2The Alfred Hospital, Melbourne, Australia. 3Bordeaux PharmacoEpi (BPE), Université de Bordeaux, Bordeaux, France. 4Global Biostatistics, EMD Serono Research & Development Institute, Inc, Billerica, MA, USA (an affiliate of Merck KGaA). 5Global Database Studies, IQVIA, Tartu, Estonia. 6Global Epidemiology and Outcomes Research, IQVIA, Amsterdam, The Netherlands. 7IQVIA (former EPID Research), Espoo, Finland. 8Global Epidemiology, Merck Healthcare KGaA, Darmstadt, Germany.
Publication(s):  Current Medical Research and Opinion, DOI: 10.1080/03007995.2022.2059977
Document Type(s): Article,
Countries: Australia, Denmark, Finland, Germany, Norway, Sweden, Switzerland, Turkey,
Click here for the abstract
C:
Y:
Drug safety, Neurological disorders,
2022
  L:
A:
English
clinical setting: Secondary care, Epidemiological study, Observational study, Population Based Study, Retrospective database analysis,
  Add to report
 
 
Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018
Author(s): Janet Sultana 1 2, Salvatore Crisafulli 3, Mariana Almas 4, Ippazio Cosimo Antonazzo 5 6, Esme Baan 7, Claudia Bartolini 6, Maria Paola Bertuccio 3, Fedele Bonifazi 8 9, Annalisa Capuano 10 11, Antonella Didio 8 9, Vera Ehrenstein 12, Mariagrazia Felisi 8 13, Carmen Ferrajolo 10 11, Andrea Fontana 14, Remy Francisca 7, Annie Fourrier-Reglat 15, Joan Fortuny 16, Rosa Gini 6, Giulia Hyeraci 6, Christel Hoeve 7, Christos Kontogiorgis 17, Valentina Isgrò 18, Panagiotis-Nikolaos Lalagkas 17, Luca L'Abbate 18, Deborah Layton 19, Annalisa Landi 8 9, Silvia Narduzzi 19, Leonardo Roque Pereira 20, Georgios Poulentzas 17, Concetta Rafaniello 10 11, Giuseppe Roberto 6, Giulia Scondotto 3, Liberata Sportiello 10 11, Maddalena Toma 8 9, Massoud Toussi 19, Katia Verhamme 7, Elisabetta Volpe 8 9, Gianluca Trifirò 18,
Affiliations(s): Pharmacy Department, Mater Dei Hospital, Msida, Malta. 2Exeter College of Medicine and Health, Exeter, UK. 3Department of Medicine, University of Verona, Verona, Italy. 4Real World Solutions Department, IQVIA, Lisbon, Portugal. 5Research Centre on Public Health (CESP), University of Milan-Bicocca, Milan, Italy. 6Agenzia Regionale di Sanità della Toscana, Florence, Italy. 7Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, The Netherlands. 8TEDDY European Network of Excellence for Paediatric Clinical Research, Pavia, Italy. 9Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Bari, Italy. 10Department of Experimental Medicine, University of Campania "Vanvitelli", Naples, Italy. 11Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Naples, Italy. 12Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark. 13CVBF Consorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy. 14Unit of Biostatistics, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. 15Univ. Bordeaux, INSERM, Bordeaux Population Health Research Center, Team of Pharmacoepidemiology, UMR 1219, Bordeaux, France. 16RTI Health Solutions, Barcelona, Spain. 17Democritus University of Thrace, Alexandroupolis, Greece. 18Department of Diagnostics and Public Health, University of Verona, Verona, Italy. 19Data Science Hub, Real World Solutions, IQVIA, London, UK. 20Department of Datascience & Biostatistics, University Medical Center Utrecht, Utrecht, The Netherlands.
Publication(s):  Pharmacoepidemiol Drug Saf . 2022 Jun;31(6):689-705. doi: 10.1002/pds.5413. Epub 2022 Feb 11.
Document Type(s): Article,
Countries: Denmark, France, Italy, Netherlands, Portugal, Spain, UK,
Click here for the abstract
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Drug safety, Drug Utlization Study,
2022
  L:
A:
English
Database Study, Review,
  Add to report
 
 
Validation of safety outcomes in routinely collected data: lessons learned from a multinational post-approval safety study
Author(s): Arena PJ, Huang K, Löfling L, Bahmanyar S, Mo J, Schachterle SE, Nunes AP, Smits E, Juuti R, Hoti F, Korhonen P, Adelborg K, Sundbøll J, Rasmussen TR, Løkke A, Ehrenstein V.
Affiliations(s): "Pfizer Inc., New York, New York, United States of America. Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, California, United States of America. EPID Research (an IQVIA company), Espoo, Finland."
Publication(s):  Pharmacoepidemiol Drug Saf. 2022 Dec 10. doi: 10.1002/pds.5582
Document Type(s): Article,
Countries: Denmark, Finland, Netherlands , Sweden, USA,
Click here for the abstract
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Database Validity and methodology, Drug safety, Oncology,
2022
  L:
A:
English
Clinical setting: hospital, Clinical setting: Primary care, clinical setting: Secondary care, Retrospective database analysis,
  Add to report
 
 
The Cost-Effectiveness of Empagliflozin Versus Liraglutide Treatment in People with Type 2 Diabetes and Established Cardiovascular Disease
Author(s): Lars Holger Ehlers 1, Mark Lamotte 2, Sofia Monteiro 3, Susanne Sandgaard 4, Pia Holmgaard 4, Evan C Frary 4, Niels Ejskjaer 5 6 7
Affiliations(s): 1Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. 2IQVIA Real World Solutions, Zaventem, Belgium. 3IQVIA Real World Solutions, London, UK. 4Boehringer Ingelheim Danmark A/S, København Ø, Hovedstaden, Denmark. 5Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. n.ejskjaer@rn.dk. 6Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark. n.ejskjaer@rn.dk. 7Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark. n.ejskjaer@rn.dk.
Publication(s):  Diabetes Therapy https://doi.org/10.1007/s13300-021-01040-y
IQVIA HEOR Zaventem Brussels
PMID: 33856655 PMCID: PMC8099952 DOI: 10.1007/s13300-021-01040-y
Document Type(s): 
Countries: Denmark,
Click here for the abstract
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Y:
Diabetes, Health economics,
2021
  L:
A:
English
Clinical setting: Primary care, Cost effectiveness,
  Add to report
 
 
Comparison of electronic self-reported prescription medication use during pregnancy with the national prescription register in Denmark
Author(s): Maja Laursen 1, Christine E Hallgreen 2 3, Nancy Dreyer 4, Alison Bourke 5, Shahrul Mt-Isa 2 6, Stella Blackburn 5
Affiliations(s): 1The Danish Health Data Authority, Copenhagen, Denmark. 2School of Public Health, Imperial College London, London, UK. 3Copenhagen Center for Regulatory Science, Department of Pharmacy, SUND, University of Copenhagen, Copenhagen, Denmark. 4IQVIA Real-World and Analytic Solutions, Boston, Massachusetts. 5IQVIA Real-World and Analytic Solutions, London, UK. 6Biostatistics and Research Decision Sciences, MSD Research Laboratories, London, UK.
Publication(s):  Pharmacoepidemiol Drug Saf . 2020 Mar;29(3):328-336. doi: 10.1002/pds.4937. Epub 2019 Dec 6.
Document Type(s): Article,
Countries: Denmark, UK, USA,
Click here for the abstract
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Patient Registries & Real-World Study Methods, Pregnancy,
2020
  L:
A:
English
Epidemiological study, Methodology, Patient questionnaire, Real World Data,
  Add to report
 
 
External Validation of the Core Obesity Model to Assess the Cost Effectiveness of Weight Management Interventions
Author(s): Sandra Lopes 1, Pierre Johansen 2, Mark Lamotte 3, Phil McEwan 4, Anamaria-Vera Olivieri 5, Volker Foos 4
Affiliations(s): 1Novo Nordisk A/S, Søborg, Denmark. snlb@novonordisk.com. 2Novo Nordisk A/S, Søborg, Denmark. 3IQVIA, Zaventem, Belgium. 4Health Economics and Outcomes Research Ltd, Cardiff, UK. 5IQVIA, Basel, Switzerland.
Publication(s):  Pharmacoeconomics 2020 https://doi.org/10.1007/s40273-020-00941-3 + Pharmacoeconomics. 2021 Jan;39(1):137-138. doi: 10.1007/s40273-020-00982-8. Epub 2020 Nov 30
Document Type(s): Article,
Countries: Belgium, Denmark, Switzerland, UK,
Click here for the abstract
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Y:
Health economics, Obesity,
2020
  L:
A:
English
Clinical setting: Primary care, Cost effectiveness,
  Add to report
 
 
The Cost-Effectiveness of Empagliflozin in Type 2 Diabetes in Denmark, Incorporating Cardiovascular Outcomes
Author(s): Ehlers LH, Lamotte M, Monteiro S, Sandgaard S, Holmgaard P, Frary EC, Staehr P, Ejskjaer N.
Affiliations(s): IQVIA HEOR Zaventem Brussels
Publication(s):  ISPOR Europe 2020 Virtual conference Milano Nov 16-19 Abstract ID# 107114
Document Type(s): Poster,
Countries: Denmark,
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Y:
Diabetes, Health economics,
2020
  L:
A:
English
Clinical setting: Primary care, Cost effectiveness,
  Add to report
 
 
A Survey Among Health Care Professionals to Assess Their Knowledge and Understanding on Darzalex® (Daratumumab) Educational Materials Regarding the Risk of Interference for Blood Typing in 12 European Countries
Author(s): Mathieu Rosé, Intissar Bourahla, Alessandro Ghiddi, Assem Al-Akabawi, Edmond Chan, Massoud Toussi
Affiliations(s): IQVIA, Courbevoie, France; Janssen EMEA, Medical Affairs, Italy; Janssen EMEA, Medical Affairs, UK
Publication(s):  Presented at ISPE’s 35th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2019), August 24–28, 2019 at the Pennsylvania Convention Center, Philadelphia, PA, USA.
Document Type(s): Poster,
Countries: Austria, Czech, Denmark, Finland, France, Germany, Hungary, Norway, Slovakia, Spain, Sweden, Switzerland,
Click here for the abstract
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Hematology, Oncology,
2019
  L:
A:
English
Public Health, Survey research,
  Add to report
 
 
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