Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine:A Network Analysis of Data from Six European National Databases

Introduction: Ranitidine, a histamine H2-receptor antagonist (H2RA), is indicated in the management of gastric acid-related disorders. In 2020, the European Medicines Agency (EMA) recommended suspension of all ranitidine-containing medicines in the European Union (EU) due to the presence of N-nitrosodimethylamine (NDMA) impurities, which were considered to be carcinogenic. The aim of this study was to investigate the impact of regulatory intervention on use patterns of ranitidine-containing medicines and their therapeutic alternatives. Objectives: The aim was to study drug utilisation patterns of ranitidine and report discernible trends in treatment discontinuation and switching to alternative medications. Methods: This retrospective, population-based cohort study was conducted using primary care records from six European countries between 2017 and 2023. To explore drug utilisation patterns, we calculated (1) incident use of ranitidine, other H2RAs, and other alternative drugs for the treatment of gastric ulcer and/or gastric bleeding; (2) ranitidine discontinuation; and (3) switching from ranitidine to alternative drugs (H2RAs, proton-pump inhibitors [PPIs], and other medicinal products for acid-related disorders). Results: During the study period, 385,273 new ranitidine users were observed, with most users being female and aged 18–74 years. Ranitidine was the most commonly prescribed H2RA in the pre-referral period (September 2017–August 2019), with incidence rates between 0.8 and 9.0/1000 person years (PY). A steep decline to 0.3–3.8/1000 PY was observed in the referral period (September 2019–March 2020), eventually dropping to 0.0–0.4/1000 PY in the post-referral period (April 2020–March 2022). Switching from ranitidine to alternative drugs increased in the post-referral period, with the majority of patients switching to PPIs. Discontinuation of ranitidine use ranged from 270 to 380/1000 users in 2017 and decreased over time. Conclusions:Ranitidine was commonly used prior to referral, but it was subsequently discontinued and replaced primarily with PPIs.</p

Magnesium intake and vascular structure and function:the Hoorn Study

PURPOSE: Circulating and dietary magnesium have been shown to be inversely associated with the prevalence of cardiovascular disease (CVD) and mortality in both high and low-risk populations. We aimed to examine the association between dietary magnesium intake and several measures of vascular structure and function in a prospective cohort. METHODS: We included 789 participants who participated in the vascular screening sub-cohort of the Hoorn Study, a population-based, prospective cohort study. Baseline dietary magnesium intake was estimated with a validated food frequency questionnaire and categorised in energy-adjusted magnesium intake tertiles. Several measurements of vascular structure and function were performed at baseline and most measurements were repeated after 8 years of follow-up (n = 432). Multivariable linear and logistic regression was performed to study the cross-sectional and longitudinal associations of magnesium intake and intima-media thickness (IMT), augmentation index (Aix), pulse wave velocity (PWV), flow-mediated dilatation (FMD), and peripheral arterial disease (PAD). RESULTS: Mean absolute magnesium intake was 328 ± 83 mg/day and prior CVD and DM2 was present in 55 and 41% of the participants, respectively. Multivariable regression analyses did not demonstrate associations between magnesium intake and any of the vascular outcomes. Participants in the highest compared to the lowest magnesium intake tertile demonstrated in fully adjusted cross-sectional analyses a PWV of −0.21 m/s (95% confidence interval −1.95, 1.52), a FMD of −0.03% (−0.89, 0.83) and in longitudinal analyses an IMT of 0.01 mm (−0.03, 0.06), an Aix of 0.70% (−1.69, 3.07) and an odds ratio of 0.84 (0.23, 3.11) for PAD CONCLUSION: We did not find associations between dietary magnesium intake and multiple markers of vascular structure and function, in either cross-sectional or longitudinal analyses. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00394-021-02667-0

Concerns, quality of life, access to care and productivity of the general population during the first 8?weeks of the coronavirus lockdown in Belgium and the Netherlands

Background : The COVID-19 pandemic has a disruptive impact on our society. We therefore conducted a population survey to describe: 1) stress, concerns and quality of life 2) access to healthcare and cancelled/delayed healthcare and 3) productivity during the first 8 weeks of the coronavirus lockdown in the general population. Methods : An online cross-sectional survey was conducted in a representative sample after 8 weeks of the coronavirus lockdown in Belgium and the Netherlands. The survey included a series of three validated questionnaires about quality of life delayed/cancelled medical care and productivity loss using validated questionnaires. Results : In total, 2099 Belgian and 2058 Dutch respondents completed the survey with a mean age of 46.4 and 42.0 years, respectively. Half of the respondents were female in both countries. A small proportion tested positive for COVID-19, 1.4% vs 4.7%, respectively. The majority of respondents with a medical condition was worried about their current health state due to the pandemic (53%) vs (63%), respectively. Respondents experienced postponed/cancelled care (26%) and were concerned about the availability of medication (32%) for both countries. Productivity losses due to the COVID-19 restrictions were calculated in absenteeism (36%) and presenteeism (30%) for Belgium, and (19%) and (35%) for the Netherlands. Most concerns and productivity losses were reported by respondents with children < 12 years, respondents aged 18–35 and respondents with an (expected) COVID-19 infection. Conclusions : This study describes stress, quality of life, medical resource loss and productivity losses in Belgium and the Netherlands after 8 weeks of coronavirus lockdown. The results underline the burden on society

Concerns, quality of life, access to care and productivity of the general population during the first 8 weeks of the coronavirus lockdown in Belgium and the Netherlands

Abstract Background The COVID-19 pandemic has a disruptive impact on our society. We therefore conducted a population survey to describe: 1) stress, concerns and quality of life 2) access to healthcare and cancelled/delayed healthcare and 3) productivity during the first 8 weeks of the coronavirus lockdown in the general population. Methods An online cross-sectional survey was conducted in a representative sample after 8 weeks of the coronavirus lockdown in Belgium and the Netherlands. The survey included a series of three validated questionnaires about quality of life delayed/cancelled medical care and productivity loss using validated questionnaires. Results In total, 2099 Belgian and 2058 Dutch respondents completed the survey with a mean age of 46.4 and 42.0 years, respectively. Half of the respondents were female in both countries. A small proportion tested positive for COVID-19, 1.4% vs 4.7%, respectively. The majority of respondents with a medical condition was worried about their current health state due to the pandemic (53%) vs (63%), respectively. Respondents experienced postponed/cancelled care (26%) and were concerned about the availability of medication (32%) for both countries. Productivity losses due to the COVID-19 restrictions were calculated in absenteeism (36%) and presenteeism (30%) for Belgium, and (19%) and (35%) for the Netherlands. Most concerns and productivity losses were reported by respondents with childre

Concerns, quality of life, access to care and productivity of the general population during the first 8 weeks of the coronavirus lockdown in Belgium and the Netherlands

Abstract Background The COVID-19 pandemic has a disruptive impact on our society. We therefore conducted a population survey to describe: 1) stress, concerns and quality of life 2) access to healthcare and cancelled/delayed healthcare and 3) productivity during the first 8 weeks of the coronavirus lockdown in the general population. Methods An online cross-sectional survey was conducted in a representative sample after 8 weeks of the coronavirus lockdown in Belgium and the Netherlands. The survey included a series of three validated questionnaires about quality of life delayed/cancelled medical care and productivity loss using validated questionnaires. Results In total, 2099 Belgian and 2058 Dutch respondents completed the survey with a mean age of 46.4 and 42.0 years, respectively. Half of the respondents were female in both countries. A small proportion tested positive for COVID-19, 1.4% vs 4.7%, respectively. The majority of respondents with a medical condition was worried about their current health state due to the pandemic (53%) vs (63%), respectively. Respondents experienced postponed/cancelled care (26%) and were concerned about the availability of medication (32%) for both countries. Productivity losses due to the COVID-19 restrictions were calculated in absenteeism (36%) and presenteeism (30%) for Belgium, and (19%) and (35%) for the Netherlands. Most concerns and productivity losses were reported by respondents with childre

Real world insights for psoriasis: the association of severity of skin lesions with work productivity, medical consumption costs and quality of life

AbstractBackground Psoriasis is a prevalent, chronic skin disease with a potential impact on work productivity, medical consumption costs, and quality of life. The influence of the extent of skin lesions on these outcomes is not well known.Objective We determined associations of self-reported skin lesions with self-reported work productivity, medical consumption costs, and health-related quality of life in respondents with psoriasis.Methods In this cross-sectional study, we included respondents with self-reported psoriasis in the Netherlands in an online questionnaire. We assessed the self-reported percentage body surface area (BSA) of psoriasis lesions. We used validated instruments to assess work productivity (WPAI-PsO), medical consumption costs (iMCQ), and health-related quality of life (EQ-5D-5L and the DLQI). We used ordinal logistic regression to associate BSA categories >1% versus 0-1% with outcomes adjusted for multiple confounders.Results We included 501 respondents with a mean age of 43 ± 12 years; 64% were men. Median BSA was 2% (interquartile range 1–5%). A higher BSA was associated with higher overall work impairment due to psoriasis (common odds ratio [cOR] 2.44, 95% confidence interval [CI] 1.40–4.29; n = 205), higher medical consumption costs (cOR 2.06, 95% CI 1.45–2.94) and lower health-related quality of life. Associations were strongest with a BSA cutoff of 0% or 1% compared to 2% or higher categories.Discussion In our study, having few to no lesions in psoriasis was associated with lower overall work impairment due to psoriasis, lower medical consumption costs, and higher health-related quality of life

Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use:Post-Referral Prescribing Trends

Introduction: Concerns of the persistence and severity of the adverse effects of fluoroquinolones, mainly involving the nervous system, muscles and joints, resulted in the 2018 referral procedure led by the European Medicines Agency (EMA). They advised to stop prescribing fluoroquinolones for infections of mild severity or of a presumed self-limiting course and for prevention of infections, plus to restrict prescriptions in cases of milder infections where other treatment options are available, and restrict in at-risk populations. We aimed to examine whether the impact of EMA regulatory interventions implemented throughout 2018–2019 had an impact on fluoroquinolone prescribing rates. Methods: A retrospective population-based cohort study was conducted using electronic health care records from six European countries between 2016 and 2021. We analysed monthly incident fluoroquinolone use rates overall and for each fluoroquinolone active substance through flexible modelling via segmented regression to detect time points of trend changes, in monthly percentage change (MPC). Results: The incidence of fluoroquinolone use ranged from 0.7 to 8.0/1000 persons per month over all calendar years. While changes in fluoroquinolone prescriptions were observed over time across countries, these were inconsistent and did not seem to be temporally related to EMA interventions (e.g., Belgium: February/May 2018, MPC − 33.3%, 95% confidence interval [CI] − 35.9 to − 30.7; Germany: February/May 2019, MPC − 12.6%, 95% CI − 13.7 to − 11.6]; UK: January/April 2016, MPC − 4.9%, 95% CI − 6.2 to − 3.6). Conclusion: The regulatory action associated with the 2018 referral did not seem to have relevant effects on fluoroquinolone prescribing in primary care.</p

Prevalence and Predictors of Non-Adherence to Direct Oral Anticoagulant Treatment in Patients with Atrial Fibrillation

BACKGROUND: For most patients with newly diagnosed atrial fibrillation (AF), direct oral anticoagulants (DOACs) are preferred over vitamin K antagonists. However, there is concern that the lack of monitoring may impair therapy adherence and therefore the anticoagulant effect. OBJECTIVE: To assess one-year DOAC non-adherence in patient with AF and a treatment indication of at least one year in the Dutch healthcare setting, and to identify predictors of non-adherence. METHODS: We performed a near-nationwide historical cohort study in patients with a novel DOAC indication for AF. Data were obtained from a pharmacy database, covering 65% of all outpatient prescriptions dispensed in the Netherlands. The one-year non-adherence was assessed by the proportion of days covered (PDC); the threshold was set at <80%. Robust Poisson regression analyses were performed to identify predictors of non-adherence. RESULTS: 46,211 patients were included and the one-year non-adherence was 6.5%. We identified male sex (risk ratio [RR] 1.23, 95%-confidence interval [CI] 1.15-1.33), younger age (age ≥60 - <70 years: RR 1.15, 95%CI 1.00-1.33, age <60 years: RR 2.22, 95%CI 1.92-2.57; reference age ≥85 years), a reduced DOAC dose (RR 1.10, 95%CI 1.00–1.22), a twice daily dosing regimen (RR 1.21, 95%CI 1.12-1.30) and treatment with apixaban (RR 1.16, 95%CI 1.06-1.26, reference rivaroxaban) or dabigatran (RR 1.25, 95%CI 1.14-1.37) as independent predictors of one-year non-adherence. CONCLUSION: One year non-adherence to DOACs was low yet relevant in patients with AF newly prescribed a DOAC. Understanding the predictors for non-adherence may help identify patients at risk