Real world evidence

Risk of diabetes and cardiovascular diseases in women with vaginal bleeding before 20 gestational weeks - Danish population-based cohort study

Women’s reproductive health is associated with cardiovascular morbidity. However, an association of vaginal bleeding (VB) in pregnancy with diabetes and cardiovascular outcomes has scarcely been investigated. We conducted a population-based cohort …

Association between vaginal bleeding in pregnancy that resulted in delivery and risk of cancer– a Danish registry-based cohort study

Vaginal bleeding (VB) before 20 gestational weeks of a viable pregnancy is a manifestation of a threatened miscarriage. VB is associated with increased levels of pro-inflammatory cytokines such as interferon-gamma, tumour necrosis factor-alpha and …

Association between pregnancy affected by vaginal bleeding and women's mortality – a Danish cohort study

We aimed to investigate the association between vaginal bleeding (VB) in pregnancy and women's mortality, using VB-unaffected pregnancies, terminations and miscarriages as comparators. This was an observational cohort study using nationwide …

Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population‑based cohort study in four Nordic countries

Prenatal pregabalin exposure compared with no exposure showed a 1.1-fold association (95% CI 0.98–1.32) with the prevalence of any major congenital malformation among live and stillborn offspring, and a 1.7-fold association (95% CI 1.02–2.91) with stillbirth; the association was attenuated in Mantel–Haenszel meta-analysis for the latter outcome. We found no association between prenatal pregabalin exposure and risks of birth outcomes other than major congenital malformations or stillbirth. Prenatal exposure to pregabalin compared with no exposure to pregabalin and active comparators showed a 1.3-fold association (95% CI 1.03–1.63) with attention deficit/hyperactivity disorder; the association was attenuated in the analyses using active comparators and Mantel–Haenszel meta-analysis. There was no evidence of an association with other examined neurodevelopmental postnatal outcomes.

Risk of Major Cardiovascular and Cerebrovascular Events in Users of Lisdexamfetamine and Other Medications for Attention-Deficit Hyperactivity Disorder in Denmark and Sweden - A Population-Based Cohort Study

To our knowledge, this is the first population-based observational study using routinely collected administrative data from clinical practice to investigate the cardiovascular and cerebrovascular risk associated with exposure to LDX. Results of the current study suggest that there is little to no increased risk of cardiovascular and cerebrovascular events among patients treated with LDX compared with patients previously treated with other ADHD medications.