Multi-country study

Pioglitazone and risk of mortality in patients with type 2 diabetes: results from a European multidatabase cohort study

OBJECTIVES: Estimate and compare the risk of mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of disease progression. DESIGN: Retrospective chort study. SETTING: Pooled analysis of clinical data collected from primary and/or secondary care settings in four European countries: Finland, The Netherlands, Sweden and the UK

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Prescribing pattern of antipsychotic drugs during the years 1996-2010: a population-based database study in Europe with a focus on torsadogenic drugs

INTRODUCTION: Antipsychotic drugs (APDs) are used to treat several mental illnesses. Some APDs have long been known to be associated with QT prolongation, potentially leading to torsades de pointes (TdP) and sudden cardiac death (SCD). In 2005, thiridazine was withdrawn because of the risk of SCD, bringing further attention to the arrhythmogenic potential of APDs

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Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study

Analyses of healthcare data from 30 million individuals in three countries showed that current use of bisphosphonates may be associated with a small increased risk of cardiac valvulopathy (vs. those not exposed within the previous year), although cnfounding cannot be entirely ruled out. The observed tendency for decreased valvulopathy risk with cumulative duration of bisphosphonate use >6 months may even indicate a protective effect with prolonged use

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Use of oral contraceptives in three European countries: a population-based multi-database study

OBJECTIVES: The aim of the study was to assess the prevalence of oral contraceptive (OC) use, user characteristics and prescribing patterns by accessing health care databases of three European countries. METHODS: A retrospective study was performedfrom 2009 to 2010 in three general practice (GP) databases from the Netherlands, UK and Italy and in one database of linked pharmacy and hospitalisation data in the Netherlands

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Pioglitazone use and risk of bladder cancer in patients with type 2 diabetes: retrospective cohort study using datasets from four European countries

OBJECTIVE: To evaluate the association between pioglitazone use and bladder cancer risk in patients with type 2 diabetes. DESIGN: Retrospective cohort study using propensity score matched cohorts. SETTINGS: Healthcare databases from Finland, the Neherlands, Sweden, and the United Kingdom. Data comprised country specific datasets of linked records on prescriptions, hospitals, general practitioners, cancer, and deaths

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

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)

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

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

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

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)

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