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OBJECTIVE: Caution has been advocated recently when using Janus kinase inhibitors (JAKi) in rheumatoid arthritis (RA) patients with an unfavorable cardiovascular risk profile. We aimed to compare the incidences in cardiovascular events between JAKi or bDMARDs in a large population of RA patients. METHODS: RA patients starting a new bDMARD or JAKi between August 1st 2018 and January 31st 2022 have been selected from IQVIA's Dutch Real-World Data Longitudinal Prescription database, covering about 63% of outpatient prescriptions in the Netherlands. Study outcome was a cardiovascular event, defined as the start of platelet aggregation inhibitors during study period. The incidence densities of cardiovascular events were compared between JAKi and bDMARDs using multilevel Poisson regression, adjusted for exposition time and confounders. RESULTS: 15 191 unique patients were included, with 28 481 patient-years on treatment with either JAKi (2,373) or bDMARDs (26 108). Most patients were female (72%) and median age was 62 years. We found 36 cardiovascular events (1.52 events/100 patient years) during therapy with JAKi and 383 events (1.47 events/100 patient years) during therapy with bDMARDs, respectively, resulting in an adjusted incidence rate ratio (IRR) of 0.99 for JAKi compared with bDMARDs (95% confidence interval (CI), 0.70-1.41). Sub-analyses in patients >65 years, by sex, or separately for tofacitinib and baricitinib, yielded similar results. CONCLUSION: In a large Dutch general RA population, the risk of cardiovascular events seems not different between JAKi users and those using bDMARDs, although a small increase in higher risk patients cannot be excluded.
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STUDY QUESTION: Are patients' characteristics, such as anti-Müllerian hormone (AMH) and BMI, reliable factors to predict ovarian response in couples with unexplained subfertility undergoing IUI with ovarian hyperstimulation (IUI-OH)? SUMMARY ANSWER: We observed no solid relationship between serum AMH and ovarian response. WHAT IS KNOWN ALREADY: Ovarian stimulation during IUI treatment could lead to a higher chance of pregnancy, but also a higher incidence of multiple pregnancies, unless strict cancellation criteria are being used. Several factors could influence the result of the stimulation, such as age, BMI and hormonal status of the female. In IVF treatment, AMH has shown to be a useful predictor of ovarian stimulation to optimize the outcome; however, in a milder stimulation protocol, such as IUI, this has not been investigated. STUDY DESIGN, SIZE, DURATION: We performed a prospective cohort study and evaluated the first IUI stimulation cycle of 492 patients. The study was conducted between 2012 and 2017. Follow-up ended if patients were not pregnant after the first cycle. If pregnancy did occur, follow-up lasted until delivery. PARTICIPANTS/MATERIALS, SETTING, METHODS: PRORAILS is a large multicentre nationwide cohort study executed in the Netherlands. Eligible women aged 18-43 years who were diagnosed with unexplained subfertility or mild male subfertility according to the Dutch guideline, with a regular indication for IUI-OH, were asked to participate. Ovarian response was assessed using a transvaginal ultrasound 5-7 days after initiation of the stimulation and was repeated according to the size of the leading follicles. Ovarian response was defined as optimal or suboptimal based on the total number of dominant follicles >15 mm. A successful stimulation was defined as the presence of two to three follicles >15 mm on the day of hCG administration. Serum AMH (µg/l) was measured by ELISA, and samples were taken on day 2, 3 or 4 of the menstrual cycle. Poisson regression was used to estimate the risk of a suboptimal ovarian response. MAIN RESULTS AND THE ROLE OF CHANCE: Of the 492 participants, the mean age was 33 years and the mean subfertility duration was 2.5 years. The median serum AMH was 2.1 (µg/l). The majority of patients had a suboptimal response: 326 women (66%), of whom 224 (45%) had a hypo response (defined as
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Infertilidade , Síndrome de Hiperestimulação Ovariana , Adulto , Hormônio Antimülleriano , Estudos de Coortes , Feminino , Fertilização in vitro/métodos , Hormônio Foliculoestimulante/uso terapêutico , Humanos , Infertilidade/terapia , Inseminação Artificial , Masculino , Indução da Ovulação/métodos , Gravidez , Taxa de Gravidez , Estudos ProspectivosRESUMO
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.
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COVID-19/prevenção & controle , Controle de Doenças Transmissíveis , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Pandemias/prevenção & controle , Qualidade de Vida , Adolescente , Adulto , Bélgica/epidemiologia , COVID-19/epidemiologia , COVID-19/psicologia , Criança , Estudos Transversais , Feminino , Humanos , Países Baixos/epidemiologia , SARS-CoV-2 , Inquéritos e Questionários , Adulto JovemRESUMO
BACKGROUND: 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.
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Psoríase , Qualidade de Vida , Masculino , Humanos , Adulto , Pessoa de Meia-Idade , Feminino , Estudos Transversais , Psoríase/patologia , Eficiência , Inquéritos e Questionários , Índice de Gravidade de DoençaRESUMO
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.
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Antagonistas dos Receptores H2 da Histamina , Ranitidina , Humanos , Feminino , Masculino , Ranitidina/efeitos adversos , Estudos Retrospectivos , Estudos de Coortes , Antagonistas dos Receptores H2 da Histamina/efeitos adversos , Inibidores da Bomba de Prótons/efeitos adversos , Uso de MedicamentosRESUMO
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.
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Antibacterianos , Fluoroquinolonas , Humanos , Fluoroquinolonas/efeitos adversos , Antibacterianos/efeitos adversos , União Europeia , Estudos Retrospectivos , Estudos de CoortesRESUMO
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 1-year DOAC nonadherence in patients with AF and a treatment indication of at least 1 year in the Dutch health care setting, and to identify predictors of nonadherence. 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 1-year nonadherence was assessed by the proportion of days covered; the threshold was set at <80%. Robust Poisson regression analyses were performed to identify predictors of nonadherence. Results A total of 46,211 patients were included and the 1-year nonadherence was 6.5%. We identified male sex (risk ratio [RR] 1.23, 95% confidence interval [CI]: 1.15-1.33), younger age (age ≥60 to <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 1-year nonadherence. Conclusion One-year nonadherence to DOACs was low yet relevant in patients with AF newly prescribed a DOAC. Understanding the predictors for nonadherence may help identify patients at risk.
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Background: Cognitive dysfunction is common in multiple sclerosis and may worsen with reduced treatment adherence. We examined longitudinal relationships between anxiety, depression, fatigue, disability and adherence with cognitive status in patients with relapsing-remitting multiple sclerosis (MS) treated with interferon beta-1a in four countries. Methods: The Confidence study is a prospective study in 165 people with MS with four visits (baseline/12/24/36 months). Physical and psychological symptoms were assessed using standardized questionnaires. Adherence was calculated as the number of injections divided by number of expected injections. Cognitive status was assessed by the Brief Repeatable Battery of Neuropsychological Tests and converted to a global Z-score. Results: At baseline, mean age was 35.7 ± 11 years and 66% were female (n = 109). Adherence to treatment was very high throughout the study (>99%). A depression score ≥ 8 was significantly associated with a higher risk of low cognitive status compared with a lower score (0-7): relative risk 1.79 (1.14-2.83) adjusted for education and time since diagnosis. The P-value-for-time was not significant (P = 0.304) meaning that associations existed since baseline and remained stable during follow-up. Conclusion: Our findings provide evidence for a longitudinal association between depression and low cognitive status in patients treated with interferon beta-1a in routine medical practice.
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AIMS AND OBJECTIVES: The purpose of this study is to compare five commonly used malnutrition screening tools against an acknowledged definition of malnutrition in one hospital inpatient sample. BACKGROUND: Early identification and intervention of malnutrition in hospital patients may prevent later complications. Several screening tools have reported their diagnostic accuracy, but the criterion validity of these tools is unknown. DESIGN: A cross sectional study. METHODS: We compared quick-and easy screening tools [Malnutrition Screening Tool (MST), Short Nutritional Assessment Questionnaire (SNAQ) and Mini-Nutritional Assessment Short Form (MNA-SF)] and more comprehensive malnutrition screening tools [Malnutrition Universal Screening Tool (MUST) and Nutritional Risk Screening 2002 (NRS-2002)] to an acknowledged definition of malnutrition (including low Body Mass Index and unintentional weight loss) in one sample of 275 adult hospital inpatients. Sensitivity, specificity, positive predictive value and negative predictive value were determined. A sensitivity and specificity of ≥ 70% was set as a prerequisite for adequate performance of a screening tool. RESULTS: According to the acknowledged definition of malnutrition 5% of patients were at moderate risk of malnutrition and 25% were at severe risk. The comprehensive malnutrition screening tools (MUST, NRS-2002) and the quick-and-easy malnutrition screening tools (MST and SNAQ) showed sensitivities and specificities of ≥70%. However, 47% of data were missing on the MUST questionnaire and 41% were missing on MNA-SF. The MNA-SF showed excellent sensitivity, but poor specificity for the older subpopulation. CONCLUSIONS: The quick-and-easy malnutrition screening tools (MST and SNAQ) are suitable for use in an hospital inpatient setting. They performed as well as the comprehensive malnutrition screening tools (MUST and NRS-2002) on criterion validity. However, MUST was found to be less applicable due to the high rate of missing values. The MNA-SF appeared to be not useful because of it low specificity. RELEVANCE TO CLINICAL PRACTICE: Insight in what is the most valid and practical nutritional screening tool to use in hospital practice will increase effective recognition and treatment of malnutrition.