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Observed-over-Expected analysis as additional method for pharmacovigilance signal detection in large-scaled spontaneous adverse event reporting

The large-scale COVID-19 vaccination campaigns in 2021 and 2022 led to a rapid increase in numbers of received adverse event reports in spontaneous reporting systems. As background incidences of naturally occurring medical events became increasingly relevant for causality assessment of potential associations with the vaccines, a novel approach for signal detection was warranted. The O/E method is a useful approach for signal detection of potential adverse reactions when handling large numbers of ICSRs. Further research is needed to attest to the causality on a clinical basis.

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Completeness and Representativeness of the PHARMO General Practitioner (GP) Data: A Comparison with National Statistics

The PHARMO GP data are representative of the Dutch population with regard to the demographic characteristics and diagnoses in primary care. Medication data in the PHARMO GP data are more complete than national statistics, and differences are related to reimbursement. Use of the data and interpretation of results based on these sources should be done with experts on the data sources, the Dutch healthcare system and (pharmaco)epidemiology.

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Risk of candidiasis associated with interleukin-17 inhibitors: A real-world observational study of multiple independent sources

Biologics directed against the T-helper (Th)-17 pathway have been approved for several inflammatory diseases. Interleukin (IL)-17 is involved in anti- Candida host defense, and clinical trials suggested increased candidiasis incidence during IL-17 inhibitor therapy. We describe the worldwide epidemiology of candidiasis during Th17 inhibitor therapy, and immunological mechanisms involved in candidiasis susceptibility.

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Effect of reimbursement restriction policy on the use of benzodiazepines in the Netherlands: an interrupted time series analysis

OBJECTIVES: Use of benzodiazepines has health risks. Reimbursement was restricted in the Netherlands from January 2009 onwards with the goal to reduce chronic use and healthcare expenditures. The aim of this study is to assess the initial and long-erm effects of this policy on benzodiazepine use. DESIGN: Interrupted time series analysis, segmented regression models, Kaplan-Meier survival analysis and Cox proportional hazards analysis

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Ophthalmic nepafenac use in the Netherlands and Denmark

PURPOSE: To describe nepafenac use in the Netherlands and Denmark with reference to its approved indications. For context, we also describe the use of ketorolac and diclofenac. METHODS: We identified users in the PHARMO Database Network (the Netherands, 2008-2013) and the Danish national health registers (Denmark, 1994-2014)

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Increased overall drug utilization in patients with psoriasis: a case-control study based on Dutch general practitioner data

BACKGROUND: Medication use in patients with psoriasis has been studied mostly in the context of psoriasis comorbidities. OBJECTIVES: To investigate detailed drug utilization in patients with psoriasis compared with controls in a population-based saple. METHODS: This was a case-control study based on drug prescriptions derived from a Dutch general practitioner database where patients with psoriasis and controls without psoriasis were matched 1 : 1 for age, sex, general practitioner and duration offollow-up, between 2002 and 2012

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Gastrointestinal toxicity among patients taking selective COX-2 inhibitors or conventional NSAIDs, alone or combined with proton pump inhibitors: a case-control study

PURPOSE: To assess the risk of gastrointestinal perforation, ulcers, or bleeding (PUB) associated with the use of conventional nonsteroidal anti-inflammatory drugs (NSAIDs) with proton pump inhibitors (PPIs) and selective COX-2 inhibitors, with orithout PPIs compared with conventional NSAIDs. METHODS: A case-control study was performed within conventional NSAIDs and/or selective COX-2 inhibitors users identified from the Dutch PHARMO Record Linkage System in the period 1998-2012

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Increased Antidepressant Drug Exposure in Psoriasis Patients: A Longitudinal Population-based Cohort Study

Psoriasis has a major impact on health-related quality of life. The present cohort study investigated the use of antidepressant drugs in psoriasis patients and a reference cohort, using pharmacy and hospitalization data from 1998 to 2008 for more tan 2.5 million Dutch residents. Multivariate Cox regression was used to compare the risk of first antidepressant use, and Poisson regression to compare the number of episodes of antidepressant use

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