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Objectives To assess the infant risk of major congenital malformations (MCM) associated with first-trimester exposure to hydroxychloroquine (HCQ) among mothers with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Methods This population-based cohort study utilized Swedish nationwide registers and included all singleton births (2006–2021) among individuals with prevalent SLE or RA in Sweden. The exposure was filling ≥1 HCQ prescription during the first trimester. The outcome was infant MCM within 1 year of birth. Inverse probability of treatment weighting was applied to adjust for potential confounders (e.g. maternal smoking, body mass index, pregestational diabetes and corticosteroids). Modified Poisson regression models with robust variance were used to estimate risk ratios (RR) and 95% CI. Results We included 1007 births (453 exposed) and 2500 births (144 exposed) in the SLE and RA cohorts, respectively. The MCM risks in the SLE overall cohort, exposed and unexposed groups were 3.6%, 3.7% and 3.4%, respectively. The corresponding figures in the RA cohort were 4.4%, 5.6% and 4.3%, respectively. The adjusted RRs (95% CI) were 1.29 (0.65, 2.56) in the SLE cohort, 1.32 (0.56, 3.13) in the RA cohort and 1.30 (0.76, 2.23) in the pooled analysis. The adjusted risk difference (exposed vs unexposed) was small (0.9% in SLE and 1.3% in RA). Sensitivity analyses examining different exposure and outcome windows yielded similar findings. Conclusion First-trimester exposure to HCQ was not associated with a significantly increased risk of MCM. HCQ's benefits may outweigh the risks in managing SLE or RA during pregnancy. [ABSTRACT FROM AUTHOR]

Aim: We investigated the eligibility for vericiguat in a real‐world heart failure (HF) population based on trial, guideline and label criteria. Methods and results: From the Swedish HF registry, 23 573 patients with HF with reduced ejection fraction (HFrEF) enrolled between 2000 and 2018, with a HF duration ≥6 months, were considered. Eligibility for vericiguat was calculated based on criteria from (i) the Vericiguat Global Study in Subjects with Heart Failure and Reduced Ejection Fraction (VICTORIA) trial; (ii) European and American guidelines on HF; (iii) product labelling according to the Food and Drug Administration and European Medicines Agency. Estimated eligibility for vericiguat in the trial, guidelines, and label scenarios was 21.4%, 47.4%, and 47.4%, respectively. Prior HF hospitalization within 6 months was the criterion limiting eligibility the most in all scenarios (met by 49.1% of the population). In the trial scenario, other criteria meaningfully limiting eligibility were elevated N‐terminal pro‐B‐type natriuretic peptide levels and nitrate use. In all scenarios, eligibility was higher among patients hospitalized for HF at baseline (44.3% vs. 21.4% [trial scenario] and 97.3% vs. 47.4% [guideline/label scenarios] for hospitalized vs. non‐hospitalized patients). Overall, eligible patients were older, had more severe HF, more comorbidities, and consequently higher cardiovascular mortality and HF hospitalization rates compared with ineligible patients across all scenarios. Conclusion: In a large and contemporary real‐world HFrEF cohort, we estimated that 21.4% of patients would be eligible for vericiguat according to the VICTORIA trial selection criteria, 47.4% based on guidelines and labelling. Eligibility for vericiguat translated into the selection of a population at high risk of morbidity/mortality. [ABSTRACT FROM AUTHOR]

Background: Good knowledge and appropriate attitude and practice about antibiotic use and resistance among the general population, are significant contributors to minimize the development of antibiotic resistance. We aimed to study the knowledge, attitude, and practice (KAP) regarding antibiotic use, resistance to upper respiratory tract infections (URTI), and associated factors with KAP, among the population attending a mass gathering in India. Methods: A cross-sectional study was conducted in 2016 during a mass gathering held in Ujjain city of Central India. A self-administered, pre-tested questionnaire consisting of 28 questions was used to collect data on demographic characteristics, KAP related to antibiotic use, resistance, and URTI. Descriptive analyses were used to describe participants' responses. Participants were divided into poor or good knowledge and appropriate or inappropriate groups of attitude and practice. Multivariable logistic regression models were used to examine the associations between demographic characteristics, URTI knowledge, and each domain of KAP. All statistical analyses were performed using Stata 16.0. The significance level was set at 5%. Results: A total of 1915 participants consented to participate (response rate 92.7%) with a mean age of 39.3 (±14.7). Complete data on socio-demographics were available for 1619 participants. Of these, 59% were male, and 61% had an education level below high school. Eighty-nine percent of participants had poor knowledge about URTI. A majority of the respondents defined antibiotics incorrectly (93%) and were classified as having poor knowledge (97%). Most of the participants (63%) could not mention any contributors to the irrational use of antibiotics. Appropriate attitudes were observed in 40% of participants, 87% denied to comply with the prescribed course of antibiotics and 88.5% had inappropriate responses for practice. Age of the respondent, sex, education, occupation, and knowledge about URTI, were the main factors associated with the KAP. Conclusions: KAP about antibiotic use and resistance among the general population in India was poor. Knowledge about URTI is strongly associated with KAP. Community interventions, i.e., educational campaigns, should be designed and implemented promptly considering the differences in demographics of the target audience. [ABSTRACT FROM AUTHOR]