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Risk of cardiovascular events after an exacerbation of chronic obstructive pulmonary disease: results from the EXACOS-CV cohort study using the PHARMO Data Network in the Netherlands.

Background People living with chronic obstructive pulmonary disease (COPD) have an increased risk of experienc‑
ing cardiovascular (CV) events, particularly after an exacerbation. Such CV burden is not yet known for incident COPD
patients. We examined the risk of severe CV events in incident COPD patients in periods following either moderate
and/or severe exacerbations.
Methods Persons aged≥40 years with an incident COPD diagnosis from the PHARMO Data Network were included.
Exposed time periods included 1–7, 8–14, 15–30, 31–180 and 181–365 days following an exacerbation. Moder‑
ate exacerbations were defned as those managed in outpatient settings; severe exacerbations as those requiring
hospitalisation. The outcome was a composite of time to frst severe CV event (acute coronary syndrome, heart failure
decompensation, cerebral ischaemia, or arrhythmia) or death. Hazard ratios (HR) were estimated for association
between each exposed period and outcome.
Results 8020 patients with newly diagnosed COPD were identifed. 2234 patients (28%) had≥1 exacerbation, 631
patients (8%) had a non-fatal CV event, and 461 patients (5%) died during a median follow-up of 36 months. The
risk of experiencing the composite outcome was increased following a moderate/severe exacerbation as compared
to time periods of stable disease [range of HR: from 15.3 (95% confdence interval 11.8–20.0) in days 1–7 to 1.3 (1.0–
1.8) in days 181–365]. After a moderate exacerbation, the risk was increased over the frst 180 days [HR 2.5 (1.3–4.8)
in days 1–7 to 1.6 (1.3–2.1) in days 31–180]. After a severe exacerbation, the risk increased substantially and remained
higher over the year following the exacerbation [HR 48.6 (36.9–64.0) in days 1–7 down to 1.6 (1.0–2.6) in days 181–
365]. Increase in risk concerned all categories of severe CV events.
Conclusions Among incident COPD patients, we observed a substantial risk increase of severe CV events or all-cause
death following either a moderate or severe exacerbation of COPD. Increase in risk was highest in the initial period

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5-year adherence to adjuvant endocrine treatment in Dutch women with early stage breast cancer: A population-based database study (2006–2016)

Abstract: BACKGROUND:Hormonal receptor (HR) positive breast tumors are common. Adjuvant hormonal therapy (AHT) with tamoxifen or Aromatase Inhibitors (AIs) is beneficial depending on the stage of the tumor. Despite the fact that AHT has been shown to improve survival and recurrence, Dutch adherence rates, which were mostly dependent on Tamoxifen prescriptions until 2006, plummeted from 80% after one year to 50% after five years. Nonadherence with AHT reduces its effectiveness. This research presents more recent adherence statistics (from 2006 to 2016), on a larger sample (7,996 vs 1,451), as well as factors that influence AHT adherence. In addition to tamoxifen data, AIs are now included. OBJECTIVE:As low use of adjuvant endocrine therapy is a potentially important and modifiable risk factor for poor outcome, it is important to monitor the rate as an indicator of women’s burden of disease and the direction of adherence trends. METHODS:The Netherlands Cancer Registry (NCR) was used to find women with early-stage breast cancer who started AHT within a year of surgery and were linked to the PHARMO Database Network (n = 8,679). The Kaplan-Meier approach was used to measure AHT adherence five years after treatment was started, with a 60-day gap between refills as our primary outcome. Furthermore, the Medication Possession Rate (MPR) was determined using a cutoff of ≥80%. Analysis was performed on influential factors of adherence. RESULTS:The proportion of persistent women declined over time to reach 46.6% at the end of the fifth year and 53.3% of the women had a MPR ≥80% during the fifth year. Older and being diagnosed in 2006-2010 were associated with AHT adherence. CONCLUSION: Dutch 5-year AHT adherence appears to remain poor. Improving AHT adherence in HR+ breast cancer survivors is a critical medical need.

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Increased Risk of Stroke Due to Non-adherence and Non-persistence with Direct Oral Anticoagulants (DOACs): Real-World Analyses Using a Nested Case-Control Study from The Netherlands, Italy and Germany

A high degree of adherence to direct oral anticoagulants is essential for reducing the risk of ischaemic stroke and systemic embolism in patients with atrial fibrillation, owing to the rapid decline in anticoagulation activity when doses are omitted (i.e. rebound effect).

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A study protocol of external validation of eight COVID-19 prognostic models for predicting mortality risk in older populations in a hospital, primary care, and nursing home setting

The COVID‑19 pandemic has a large impact worldwide and is known to particularly affect the older population. This paper outlines the protocol for external validation of prognostic models predicting mortality risk after presentation with COVID‑19 in the older population. These prognostic models were originally developed in an adult population and will be validated in an older population (≥ 70 years of age) in three healthcare settings: the hospital setting, the primary care setting, and the nursing home setting.

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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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