Multi-country study Publications

• Use of multiple international healthcare databases for the detection of rare drug-associated outcomes: a pharmacoepidemiological programme comparing rosuvastatin with other marketed statins.Abstract

  BACKGROUND: Statins (inhibitors of 3-hydroxy-3-methyl-glutaryl-CoA reductase) are associated with rare but serious adverse events involving the muscle, kidney and liver. To compare the safety profile of rosuvastatin with other marketed statins, foupharmacoepidemiological studies were conducted using different national healthcare databases

  Garcia Rodriguez LA, Herings R, Johansson S. Pharmacoepidemiol Drug Saf. 2010 Dec; 19 (12): 1218-24.

• Characteristics and drug utilization patterns of new users of rosuvastatin and other statins in four countries.Abstract

  AIM: This study was undertaken to increase understanding of the utilization of a newly introduced statin through evaluation of characteristics of ‘real-life’ patients in a pharmacoepidemiology program in the USA, the Netherlands, the UK and Canada.METHODS: This was an observational analysis of prospectively collected data from primary care patients classified as new users of rosuvastatin or any other statin

  McAfee AT, Rodriguez LA, Goettsch WG, Gonzalez-Perez A, Johansson S, Ming EE, Wallander MA, Herings RM. Minerva Cardioangiol. 2010 Dec; 58 (6): 611-22.

• Design and evaluation of a semantic approach for the homogeneous identification of events in eight patient databases: a contribution to the European EU-ADR project.Abstract

  The overall objective of the EU-ADR project is the design, development, and validation of a computerised system that exploits data from electronic health records and biomedical databases for the early detection of adverse drug reactions. Eight diffrent databases, containing health records of more than 30 million European citizens, are involved in the project

  Avillach P, Joubert M, Thiessard F, Trifiro G, Dufour JC, Pariente A, Mougin F, Polimeni G, Catania MA, Giaquinto C, Mazzaglia G, Fornari C, Herings R, Gini R, Hippisley-Cox J, Molokhia M, Peder sen L, Fourrier-Reglat A, Sturkenboom M, Fieschi M. Stud Health Technol Inform. 2010 160 (Pt 2): 1085-9.

• A Semantic Approach for the Homogeneous Identification of Events in Eight Patient Databases: A Contribution to the European eu-ADR Project.Abstract

  The overall objective of the eu-ADR project is the design, development, and validation of a computerised system that exploits data from electronic health records and biomedical databases for the early detection of adverse drug reactions. Eight diffrent databases, containing health records of more than 30 million European citizens, are involved in the project

  Avillach P, Mougin F, Joubert M, Thiessard F, Pariente A, Dufour JC, Trifiro G, Polimeni G, Catania MA, Giaquinto C, Mazzaglia G, Baio G, Herings R, Gini R, Hippisley-Cox J, Molokhia M, Peder sen L, Fourrier-Reglat A, Sturkenboom M, Fieschi M. Stud Health Technol Inform. 2009 150 190-4.

• Rosuvastatin safety: a comprehensive, international pharmacoepidemiology programme..Abstract

  Results from clinical trials and clinical practice have shown statins to be generally well tolerated with a low frequency of clinically relevant side effects. Nevertheless, there are rare occasions when adverse events (AEs), sometimes serious, mayccur. Rosuvastatin is the newest statin to be approved in the USA and many other countries

  Johansson S, EE Ming, MA Wallander , LA Rodriquez, Herings RM, Goettsch W, A Gonzales-Perez, AT McAfee, AM Walker. Pharmacoepidemiol Drug Saf. 2006 July; 15 (7): 454-61.