Impact of EU regulatory label changes for diclofenac in people with cardiovascular disease in four countries: interrupted time series regression analysis
Objective: Due to cardiovascular safety concerns, the European Medicines Agency (EMA) recommended new contraindications and changes to product information for diclofenac across Europe in 2013. This study aims to measure their impact among targeted populations.
Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries
Biologics were approved for the treatment of advanced colorectal cancer (CRC) based on favorable benefit-risk-assessments from randomized controlled trials (RCTs), but evidence on their use in the real-world setting is scarce. Based on descriptive analyses we therefore aimed to assess characteristics and survival of CRC patients treated with biologics using large healthcare databases from three European countries (Netherlands, Italy, Germany).
Discovery of predictors of sudden cardiac arrest in diabetes: rationale and outline of the RESCUED (REcognition of Sudden Cardiac arrest vUlnErability in Diabetes) project
Aim To describe the study protocol of the REcognition of Sudden Cardiac arrest vUlnErability in Diabetes (RESCUED) project, which aims at identifying clinical, genetic and metabolic factors contributing to SCA risk in individuals with T2D, and to develop a prognostic model for the risk of SCA.
Platelet aggregation inhibitor prescription for newly diagnosed peripheral arterial disease in the Netherlands: a cohort study
Objectives: Pharmacological treatment of peripheral arterial disease (PAD) comprises of antiplatelet therapy (APT), blood pressure control and cholesterol optimisation. Guidelines provide class-I recommendations on the prescription, but there are little data on the actual prescription practices. Our study provides insight into the prescription of medication among patients with PAD in the Netherlands and reports a ‘real-world’ patient journey through primary and secondary care.
Impact of EMA regulatory label changes on systemic diclofenac initiation, discontinuation, and switching to other pain medicines in Scotland, England, Denmark, and The Netherlands
PURPOSE: In June 2013 a European Medicines Agency referral procedure concluded that diclofenac was associated with an elevated risk of acute cardiovascular events and contraindications, warnings, and changes to the product information were implemened across the European Union. This study measured the impact of the regulatory action on the prescribing of systemic diclofenac in Denmark, The Netherlands, England, and Scotland
No Evidence of Off-label Use of Olodaterol and Indacaterol in Denmark, France, and the Netherlands: A Drug Utilization Study
To characterize the use of olodaterol and indacaterol in clinical practice and to quantify the off-label use in asthma. Drug utilization study of new users of olodaterol or indacaterol between 2014 and 2017 in the PHARMO Database Network in the Neterlands, the Danish population registers, and the IMS Real-World Evidence Longitudinal Patient Database panels in France
Trends in mortality, cardiovascular complications, and risk factors in type 2 diabetes
BACKGROUND: Quality of diabetes care in the Netherlands ranked second in the Euro Diabetes Index 2014, but data on outcomes are lacking. We assessed trends in cardiovascular disease and mortality among type 2 diabetes (T2DM) patients in the contextof risk factor control. METHODS: Annual cohorts of adult T2DM patients were constructed from the PHARMO Database Network
The risk of developing cardiovascular disease is increased for prostate cancer patients who are pharmaceutically treated for depression
OBJECTIVE: To examine the associations between pharmaceutically treated anxiety and depression and incident cardiovascular disease (CVD) among 1-year prostate cancer survivors. PATIENTS AND METHODS: A registry-based cohort study design was used toescribe the risk of incident CVD in adult 1-year prostate cancer survivors without a history of CVD
Compliance with the guidelines for laboratory monitoring of patients treated with lithium: a retrospective follow-up study among ambulatory patients in the Netherlands
OBJECTIVES: Laboratory monitoring of patients using lithium is important to prevent harm and to increase effectiveness. The aim of this study is to determine compliance with the guidelines for laboratory monitoring of patients treated with lithiumverall and within subgroups. METHODS: Patients having at least one lithium dispensing for six months or longer between January 2010 and December 2015 were identified retrospectively using data from the Dutch PHARMO Database Network
Sex- and site-specific differences in colorectal cancer risk among people with type 2 diabetes
PURPOSE: The prevalence of colorectal cancer is higher among patients with type 2 diabetes mellitus (T2D) than among patients without diabetes. Furthermore, men are at higher risk for developing colorectal cancer than women in the general populatioand also subsite-specific risks differ per sex. The aim was to evaluate the impact of T2D on these associations