Differences In Incidence Rates Research Articles

SGLT-2 inhibitors and mortality among patients with heart failure with reduced ejection fraction: linked database study.

To investigate the association between sodium-glucose cotransporter-2 (SGLT-2) inhibitor use and risk of all cause mortality among patients with heart failure with reduced ejection fraction. Linked database study. National registers in Denmark, July 2020 to June 2023. Patients with heart failure, aged ≥45 years, with left ventricular ejection fraction ≤40%. The primary outcome was all cause mortality comparing initiation and continued treatment with SGLT-2 inhibitors versus continued treatment with other standard-of-care heart failure drugs and non-use of SGLT-2 inhibitors; secondary outcomes were the composite of cardiovascular mortality or admission to hospital with heart failure and its individual components. Hazard ratios were estimated using Cox regression adjusted using inverse probability of treatment weighting based on propensity scores. The study included 6776 patients who started SGLT-2 inhibitors (79% dapagliflozin; 21% empagliflozin) and 14 686 patients who remained on other standard-of-care heart failure drugs and did not use SGLT-2 inhibitors. Most SGLT-2 inhibitor users were male (70%), the mean age was 71.2 (standard deviation 10.6) years, and 20% had type 2 diabetes. During follow-up, 374 deaths occurred among SGLT-2 inhibitor users (incidence rate 5.8 per 100 person years) and 1602 among non-users (8.5 per 100 person years). The weighted hazard ratio for all cause mortality was 0.75 (95% confidence interval 0.66 to 0.85); the weighted incidence rate difference was -1.6 (95% confidence interval -2.5 to -0.8) per 100 person years. Secondary outcomes showed a weighted hazard ratio of 0.94 (0.85 to 1.04) for cardiovascular mortality or hospital admission with heart failure, 0.77 (0.64 to 0.92) for cardiovascular mortality, and 1.03 (0.92 to 1.15) for hospital admission with heart failure. The weighted hazard ratios for all cause mortality were consistent in patients with and without diabetes (0.73 (0.58 to 0.91) and 0.73 (0.63 to 0.85); P=0.99). In this large database study among patients with heart failure with reduced ejection fraction, SGLT-2 inhibitor use was associated with a 25% lower risk of all cause mortality, supporting their effectiveness in routine clinical practice.

A European, Observational, 3-Year Cohort Comparative Study on the Safety of the Fixed Dose Combination Pravastatin 40 mg/Fenofibrate 160 mg vs. Statin Alone in Real Clinical Practice: The POSE Study.

The aim of the study was to provide valuable real-world long-term safety data of the fixed pravastatin 40 mg/fenofibrate 160 mg combination in comparison of monotherapy with statins of moderate intensity. POSE study was an observational, comparative study conducted in three European countries. Patients treated or planned to be treated with pravastatin 40 mg/fenofibrate 160 mg or with a moderate-intensity statin in monotherapy were assessed over 3 years. The main safety endpoints included the incidence of renal or urinary disorder, musculoskeletal or connective tissue disorder, hepatobiliary disorder and cardiovascular events. The study included 3075 patients treated for dyslipidaemia, with diabetes mellitus (47%), hypertension (56%) and/or established cardiovascular disease (61%). Over the 3 years of follow-up, the difference in incidence rate of safety events between the pravastatin 40 mg/fenofibrate 160 mg group and the statin group was not statistically significant (RR = 1.366 [95% CI = 0.967-1.929]). The most frequently occurring events were musculoskeletal and connective tissue disorders (AR = 0.030 in the pravastatin 40 mg/fenofibrate 160 mg group and 0.024 in the statin group), renal and urinary disorders (AR = 0.019 vs. 0.016, respectively) and aggravated diabetes mellitus (0.021 vs. 0.014). Most events occurred during the first year, then incidence decreased over the 3-year period. No statistically significant difference was observed between treatment groups regarding the cardiovascular events (RR = 1.209 [95% CI = 0.596-2.453]) and no new signal emerged from the long-term follow-up. This study demonstrates a reassuring long-term safety profile of the fixed pravastatin 40 mg/fenofibrate 160 mg combination in routine clinical practice, with low and similar incidence of events over the 3 years follow-up compared to a monotherapy with statins of moderate intensity.

Validation of the HFA-ICOS risk assessment tool with real-world data from a prospective cohort of breast cancer patients in treatment with anthracyclines and trastuzumab

Abstract Background The increasing prevalence of cancer therapy-related cardiovascular toxicity (CTRCD) poses a significant challenge to patient management, necessitating accurate risk assessments. Previous methodologies have struggled with precise risk stratification, partly due to varying definitions of CTRCD and the specificity of cancer treatments. Purpose This study aimed to evaluate the assessment tool proposed by the Heart Failure Association and the International Cardio-Oncology Society (HFA-ICOS) in predicting the risk of CTRCD in patients undergoing anthracycline and trastuzumab treatment for breast cancer at a national reference center. Methods A prospective cohort study was conducted, encompassing 172 patients treated from January 2022 to July 2023. Patients were assessed at baseline, three months, and six months post-treatment initiation, with exclusion criteria including baseline left ventricular ejection fraction (LVEF) <50%, history of heart failure, and stage IV breast cancer. The study utilized the HFA-ICOS tool for risk stratification and CTRCD was defined with the current criteria of the European Society of Cardiology guideline. Descriptive statistics were calculated, and incidence rates and Cox proportional-hazards models were developed according to the risk category. Results In our study, 138 (80.2%) patients were classified as low risk, 23 (13.4%) as moderate risk and 11 (6.4%) as high risk. We identified 81 (47.1%) patients that developed CTRCD in follow-up. Descriptive characteristics can be found in Table 1. The global incidence rate for CTRCD in our cohort was of 2.4 new cases per 1000 person-days, however no differences in incidence rates were found when stratifying by risk category (Figure 1A). Moreover, patients with moderate to high risk according to the HFA-ICOS tool did not show a significantly increased hazard ratio for cardiotoxicity (HR 0.41, 95%CI 0.15-1.12, p=0.082 and HR 1.39, 95%CI 0.50-3.86, p=0.5, respectively) as shown in Figure 1B. Conclusion While the HFA-ICOS tool provides a structured framework for assessing cardiotoxicity risk, its predictive value in this cohort was limited. The findings underscore the complexity of cancer therapy-related cardiotoxicity and the need for enhanced, individualized risk assessment tools. Future research should focus on refining risk prediction models, incorporating broader clinical and genetic factors to improve patient outcomes in cardio-oncology.Table 1.Clinical CharacteristicsFigure 1.Incidence rates and Cox models

Diabetes and sudden cardiac death in a nationwide, unselected population

Abstract Background and purpose Sudden cardiac death (SCD) remains a prominent cause of mortality, with individuals afflicted by diabetes mellitus (DM) bearing a heightened risk of ventricular arrhythmias and SCD. However, comprehensive investigations in a nationwide, unselected context are lacking. Therefore, this study aimed to compare the incidence rates (IR) of SCD among individuals with Type 1 Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus (T2DM) to the general population. Methods The study included the entire Danish population (approximately 5.5 million individuals) in 2010. SCD cases were identified through the detailed Danish death certificates and discharge summaries, yielding 6851 cases of SCD. The Danish Register of Medicinal Product Statistics, containing comprehensive prescription data from Danish pharmacies, facilitated the identification of individuals with T1DM and T2DM. Loss of life years was estimated for both T1DM and T2DM patients. Results Among the identified 6851 SCD cases, 272 (4%) were diagnosed with T1DM, and 833 (12%) with T2DM. Incidence rates of SCD were consistently elevated across all age groups for individuals with diabetes, compared to the general population (Figure 1). Patients with T1DM exhibited higher incidence rates than patients with T2DM (Figure 1). Notably, individuals aged 30-40 years with DM showed the greatest differences in incidence rates of SCD compared to the general population, with incidence rate ratios of 20.0 (95% confidence interval: 11.8-80.0) and 5.6 (95% confidence interval: 2.7-14.0) for T1DM and T2DM, respectively. On average, each 30-year-old patient with either T1DM or T2DM experiences a reduction of 3.7 and 3 life-years, respectively, due to the increased risk of SCD in these groups (Figure 2). Conclusion This nationwide study examines the incidence rates of SCD among individuals with and without a history of DM across all age brackets. Notably, patients with DM display consistently elevated incidence rates across age groups, with a particularly pronounced risk observed in those with T1DM. For both T1DM and T2DM, SCD is an important contributing factor to their shorter life expectancy compared to the general population. The heightened risk among individuals with DM underscores the importance of improved risk stratification for these patients.Incidence rates of SCDStacked cumulative incidence curves

Social disconnectedness and the rate of medical conditions: a Danish population-based cohort study

Abstract Background Lack of social connections has a serious impact on health, increasing the risk of medical conditions such as depression, dementia, and coronary heart disease. However, evidence is limited by a disease-specific focus. We aimed to provide a comprehensive overview of differences in incidence rates of a broad range of medical conditions according to social disconnectedness (i.e., loneliness, social isolation, and low social support). Methods We conducted a cohort study using data on loneliness, social isolation, low social support, and a composite measure from the 2013 and 2017 Danish National Health Survey. Survey data was linked with register data on 11 categories of medical conditions through 2021. Poisson regression was applied to estimate incidence rate ratios (IRRs), incidence rate differences, and explore interaction with pre-existing mental disorders. Results Among 162,497 survey participants, 7.6%, 3.5%, and 14.8% were identified as lonely, socially isolated, and with low social support, respectively. Lonely individuals and individuals with low social support had a higher incidence rate of all 11 categories of medical conditions (interquartile range of IRRs, loneliness 1.22-1.49 and low social support 1.10-1.14), whereas this was the case for nine categories among socially isolated individuals (interquartile range of IRRs, 1.01-1.31). Applying the composite measure, the highest IRR was 2.61 (95% CI, 2.34-2.88) for a mental disorder and the lowest 1.03 (95% CI, 0.95-1.10) for cancer. We found neither major sex differences nor substantial interaction with pre-existing mental disorders. Conclusions Our study confirms and extends the available evidence on social disconnectedness and the risk of medical conditions. The attained knowledge may be of significance for mapping group-specific preventative needs and guiding interventions and health practitioners aiming to reduce the disease burden among socially disconnected individuals. Key messages • Based on survey and register data from 162,497 individuals, our study suggests that social disconnectedness, especially loneliness, is a determinant of a broad range of medical conditions. • The findings may be of importance for identifying and targeting the disease burden among socially disconnected individuals.

The effects of angiotensin receptor-neprilysin inhibitors on clinical outcomes in heart failure with mildly reduced or preserved ejection fraction: real-world evidence from the CCA Database-HF Center

Abstract Background Recent clinical trials have demonstrated the potential efficacy and safety of angiotensin receptor-neprilysin inhibitors (ARNI) in patients with heart failure (HF) with mildly reduced or preserved ejection fraction. Nevertheless, the generalizability of these findings in real-world clinical settings remains to be determined. We aimed to compare the real-world effectiveness of ARNI versus angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB)on clinical outcomes in HF patients with mildly reduced or preserved ejection fraction. Methods Patient-level data was derived from the China Cardiovascular Association Database-HF Center Registry. We included exclusively a subpopulation of HF patients with left ventricular ejection fraction (LVEF) >40% and comorbid with hypertension. Patients prescripted with ARNI at discharge and sustaining to ARNI therapy during follow-up were categorized as the ARNI group, while those maintaining the usage of ACEI/ARB after discharge were designated as the ACEI/ARB group. In complete cases, the primary endpoint of all-cause mortality at one year was assessed by the 1:1 propensity score matching (PSM) method. Results In all HF patients with LVEF >40% comorbid with hypertension, the usage of ARNI has increased from 0.9% in 2017 to 37.2% in 2021. A total of 3348 patients in the ARNI group and 7688 patients in the ACEI/ARB group were identified for comparative effectiveness. After 1:1 PSM, 5482 patients were included in the primary analysis, with 2741 patients in each treatment arm. The proportion of patients receiving higher dosages of ARNI (200mg/d and 400mg/d) was 20.9%, 26.6%, 29.2%, and 30.3% at discharge, 1-month, 3-month, and 1-year, respectively. Over the 1-year follow-up, ARNI was associated with a 20% relative reduction in all-cause death compared to the ACEI/ARB therapy (10.5% vs. 12.9%, adjusted hazard ratio [HR], 0.80 [95% CI, 0.69-0.94], P=0.005). The absolute risk difference in all-cause death between ARNI and ACEI/ARB arms was 2.88 per 100 patient-years (incidence rate difference, -2.88 [95% CI, -4.86 to -0.9]). Cardiovascular death also tended to decrease in the ARNI group but with missed statistical significance (4.5% vs. 4.9%, adjusted HR, 0.89 [95% CI, 0.70-1.14], P=0.373). Treatment benefits were more significant in those with LVEF between 40-50% (adjusted HR, 0.62 [95% CI, 0.48-0.79]), 50-60% (adjusted HR, 0.85 [95% CI, 0.68-1.06]), but not observed in HF patients with LVEF>60% (adjusted HR, 1.80 [95% CI, 1.08-2.98]; Pinteraction<0.001). Conclusion In real-world clinical settings, treatment with ARNI was associated with a significant relative risk reduction in all-cause mortality compared with ACEI/ARB in HF patients with mildly reduced or preserved LVEF. The cardiovascular benefit was concentrated in patients with LVEF ≤60%.

Mass azithromycin for prevention of child mortality among children with acute malnutrition: A subgroup analysis of a cluster randomized controlled trial.

Children with acute malnutrition are at high risk of morality. Mass azithromycin distribution reduces all-cause mortality among children aged 1-59 months, and effects may be greater in underweight infants. Here, we evaluate the efficacy of azithromycin for reducing all-cause mortality in children aged 6-59 months with acute malnutrition (mid-upper arm circumference, MUAC, < 12.5 cm). Communities in Nouna District, Burkina Faso were 1:1 randomized to biannual mass distribution of single dose azithromycin or placebo to all children aged 1-59 months. Mortality was assessed during each census and treatment round. MUAC measurements were collected for all children. We evaluated the effect of azithromycin on mortality in subgroups of children aged 6-59 months defined by acute malnutrition (MUAC < 12.5 cm versus MUAC ≥ 12.5 cm). In children with MUAC < 12.5 cm, mortality rates were 51% lower among those living in azithromycin communities compared to placebo (incidence rate ratio 0.49, 95% confidence interval, CI, 0.25 to 0.99; incidence rate difference -18.1 deaths per 1,000 person-years, 95% CI -37.0 to -0.01), which was greater than the reduction in mortality among children with MUAC ≥ 12.5 cm (P-value for interaction on the relative scale = 0.09; P-value for interaction of the additive scale = 0.03). Children with acute malnutrition may benefit from single dose azithromycin above and beyond those without acute malnutrition. Trial registration: ClinicalTrials.gov NCT03676764; https://clinicaltrials.gov/study/NCT03676764.

Clinical prediction model of main adverse cardiovascular and cerebrovascular events for elderly patients with acute coronary syndrome

Abstract Background Age is an independent factor for adverse outcomes in acute coronary syndrome (ACS). With the accelerated aging process, there is an increasing incidence of ACS in the elderly; however, research on this population is underrepresented. Due to the unique presence of multiple diseases and organ changes in the elderly, specialized risk assessment tools are required. Purpose To explore the risk factors for poor prognosis of elderly patients with ACS and establishing a risk stratification tool. Methods The derivation cohort consisted of 1674 elderly ACS patients consecutively enrolled in a single center from January 2013 to December 2013. The validation cohort included 2333 elderly ACS patients consecutively enrolled in nine medical centers from January 2015 to May 2019. All patients were followed up for 2 years, and the study endpoint was defined as major adverse cardiovascular and cerebrovascular events (MACCE). Model selection was performed using Cox regression and the Akaike Information Criterion (AIC) to construct the final risk assessment model. The performance of the predictive model was evaluated in the derivation and validation cohorts using the c-index, receiver operating characteristic (ROC) curves, and calibration curves. Results A total of 1,674 elderly ACS patients (70.97±4.68 years, 23.24% female) were included in the derivation cohort, and 210 cases (12.54%) of MACCE were recorded during the 2-year follow-up period. In the validation cohort, there were 2,333 elderly ACS patients (72.13±5.82 years, 35.83% female), with 364 cases (15.60%) of MACCE documented during the 2-year follow-up. Initially, 25 variables were preliminarily selected based on the results of univariate Cox regression and the clinical importance of these variables. Subsequently, these variables were included in a multivariable Cox model, and model selection was performed based on the AIC, resulting in the final selection of 10 variables (including age, cardiac insufficiency, current smoker, DAPT use, history of PCI or CABG, IABP use, number of lesions, residual SYNTAX score, preoperative HGB, and preoperative PLT). Then we developed and validated a nomogram to predict the 2-year MACCE in elderly ACS patients based on the assessment of 10 clinically easily obtainable variables during hospitalization. In both the derivation and validation cohorts, the nomogram demonstrated good discriminative ability (AUC of 0.723 and 0.699, c-index of 0.727 and 0.661, respectively) and calibration (calibration curves closely approximating the 45-degree diagonal line). The Kaplan-Meier analysis reveals significant differences in MACCE incidence rates between groups stratified by the median predicted probability (p&amp;lt;0.001). Conclusion Our study developed and validated a practical nomogram for predicting the 2-year risk of MACCE in elderly patients with ACS.

Concussion Incidence by Type of Sport: Differences by Sex, Age Groups, Type of Session, and Level of Play An Overview of Systematic Reviews With Meta-analysis.

OBJECTIVES: To (1) summarize pooled prevalence and incidence rates of concussion by type of sport and (2) synthesize the differences in prevalence or incidence rates of concussion by type of sports in terms of sex, age, type of session, and level of competition. DESIGN: An overview of systematic reviews with meta-analysis. LITERATURE SEARCH: CINAHL, Embase, Epistemonikos, PubMed, Scopus, SPORTDiscus, and the Cochrane Library databases were searched. STUDY SELECTION CRITERIA: Systematic reviews with meta-analyses reporting pooled incidence or prevalence of sport-related concussion. DATA SYNTHESIS: AMSTAR 2 was used to assess the methodological quality of reviews. Overlap between reviews was calculated. RESULTS: Ten systematic reviews with meta-analysis were included, all evaluating incidence rates of concussion. There were no meta-analyses of concussion prevalence. Concussions seem to have a higher incidence in rugby, snowboarding, ice hockey, and American football. In reviews that explored sex-based differences across subgroups, there was a higher incidence rate of concussion in baseball-softball, basketball, and soccer in females compared to males. There were no age subgroups analyzed. The incidence of concussions was higher during games compared to practice in American football, ice hockey, rugby, and soccer. Amateur rugby had higher concussion rates compared to professional rugby. CONCLUSIONS: Rugby, snowboarding, ice hockey, and American football had the highest incidence rate of concussion when no other differences (eg, type of session) were considered. However, important methodological flaws were detected, such as the lack of use of the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system and subgroups for specific factors (eg, age groups). J Orthop Sports Phys Ther 2024;54(11):1-9. Epub 15 October 2024. doi:10.2519/jospt.2024.12677.

8418 Association of GLP-1 Receptor Agonists and SGLT-2 Inhibitors with Major Adverse Cardiovascular Events and Serious Liver Events among Patients with Type 2 Diabetes and MASLD

Abstract Disclosure: A. Kutz: None. D.J. Wexler: None. J. Liu: None. J.M. Paik: None. E. Patorno: None. Introduction and study question Little is known about the cardiovascular (CV) and hepatic effectiveness of glucagon-like peptide 1 receptor agonists (GLP-1 RA) and sodium–glucose cotransporter 2 inhibitors (SGLT-2i) in people with type 2 diabetes (T2D) and known metabolic dysfunction-associated steatotic liver disease (MASLD) in clinical practice. We assessed the comparative CV and hepatic effectiveness and the safety of GLP-1 RA and SGLT-2i in people with T2D and prevalent MASLD. Methodology Using pooled data from Medicare fee-for-service (2013–2020) and a large U.S. health insurance database (2013-June 2022), we conducted two propensity-score fine stratification weighted cohort studies including adults with T2D and a diagnosis of MASLD who initiated GLP-1RA, SGLT-2i, or dipeptidyl peptidase 4 inhibitors (DPP-4i, reference). Using Cox proportional hazards models, we assessed the primary CV effectiveness composite outcome of acute myocardial infarction, ischemic stroke, hospitalization for heart failure, or all-cause mortality. The primary hepatic effectiveness outcome was a composite of serious liver events (hospitalization for ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, bleeding esophageal varices, hepatic encephalopathy, or liver transplantation). The safety outcome was a composite of severe adverse events (lower limb amputation, non-vertebral fracture, emergency admission for hypoglycemia, or hospitalization for acute kidney injury, diabetic ketoacidosis [DKA], severe genital or urinary tract infection, acute pancreatitis, or biliary event). Major results Compared with DPP-4i (n=17,084 initiators), the hazard ratio (HR) for the primary CV outcome associated with GLP-1 RA (n=13,666 initiators) was 0.67 (95% CI, 0.56 to 0.81), corresponding to an incidence rate difference (IRD) per 1,000 person-years of -21.6 (95% CI, -26.7 to -16.6). The HR for the primary hepatic outcome was 0.47 (95% CI, 0.25 to 0.90), the IRD -2.1 (95% CI -3.4 to -0.9). Similar CV benefits were observed for SGLT-2i (n=11,108) vs DPP-4i (n=16,979), with a HR for the primary CV outcome of 0.82 (95% CI 0.70–0.96) and an IRD of -11.0 (95% CI -16.2 to -5.8). For the primary hepatic outcome, the HR was 0.81 (95% CI 0.45 to 1.44) and the IRD -1.1 (95% CI -2.4 to 0.3). Severe adverse events were not more frequent with GLP-1RA or SGLT-2i compared with DPP-4i. Interpretation and conclusion Among people with T2D and MASLD, the use of GLP-1 RA or SGLT-2i was associated with fewer CV events, vs DPP-4i, while GLP-1 RA also reduced serious liver events. Compared with DPP-4i, GLP-1RA or SGLT-2i were not associated with higher safety adverse event rates. Presentation: 6/2/2024

Educational and income inequalities across diseases in Denmark: a register-based cohort study

Educational attainment and income are often, but not always, associated with disease incidence. Existing research typically examines single diseases, resulting in disparate analyses with little comparability. In this study, we aimed to assess educational and income inequalities across diseases in Denmark. This register-based study included all Danish residents aged at least 30 years between Jan 1, 2013, and Dec 31, 2022, who were born after 1920, and with known educational attainment and income. We used a disease-wide approach to assess associations between education and income and the incidence of 751 diagnostic codes determined upon hospital admission. We estimated age-standardised incidence rates and incidence rate ratios (IRRs) using Poisson regression, adjusted for birth cohort and stratified by sex. Participants were followed up until time of diagnosis, death, emigration, or until Dec 31, 2022. 4 541 309 individuals aged 30 years and older were registered as living in Denmark between Jan 1, 2013, and Dec 31, 2022. 121 083 were excluded due to limited or missing information about educational attainment. 4 420 226 individuals were included in the analysis of educational inequalities (2 232 200 [50%] were female and 2 188 026 [50%] were male). 23 708 were excluded due to absence of income information, and 4 396 518 were included in the analysis of income inequalities (2 223 217 (51%) were female and 2 173 301 (49%) were male). Socioeconomic differences in incidence rates were observed across all disease groups; incidence rates of most diseases decreased with higher educational attainment and income. The magnitude of the socioeconomic inequalities varied substantially. Among non-communicable diseases, the strongest positive association with regard to education was observed in chronic obstructive pulmonary disease for female individuals (low education vs high education, IRR 2·7 [95% CI 2·4-3·0]) and schizophrenia for male inividuals (low education vs high education, IRR 4·4 [2·2-8·8]), and the strongest negative association was in melanoma and other skin cancers for females (low education vs high education, IRR 0·7 [0·7-0·8]) and melanoma and skin cancers for males (low education vs high education, 0·7 [0·6-0·8]). With regard to income, for females, the strongest positive association was observed in schizophrenia (quartile 1 [Q1] vs quartile 4 [Q4], IRR 10·1 [6·1-17·2]), whereas the strongest negative association was in melanoma and other skin cancers (Q1 vs Q4, IRR 0·5 [0·5-0·6]). For males, the strongest positive assocation was schizophrenia (Q1 vs Q4, IRR 18·4 [95% CI 8·5-39·9]) and the strongest negative association was also melanoma and other skin cancers (Q1 vs Q4, IRR 0·5 [0·5-0·6]). The most prevalent disease category, other digestive diseases, was also strongly positively associated with education (low education vs high education, IRR 1·6 [95% CI 1·6-1·6] for females; IRR 1·5 [1·4-1·5] for males) and income (Q1 vs Q4, IRR 1·5 [1·5-1·5] for females; IRR 1·3 [1·3-1·4] for males). Our study provides a detailed representation of the association between two socioeconomic indicators and disease incidence. A broad spectrum of diseases, and not only the most prevalent, show socioeconomic disparities. This finding highlights the need for not only policies that address specific diseases, but also universal policies addressing the root causes of socioeconomic disparities and their health consequences. The Novo Nordisk Foundation.

Comparative Risk of Neuropsychiatric Adverse Events Associated With Leukotriene-Receptor Antagonists Versus Inhaled Corticosteroids

Leukotriene-receptor antagonists (LTRA) and inhaled corticosteroids (ICS) are common controller medications for asthma, but limited studies examine their comparative risks on neuropsychiatric adverse events (NAEs) in asthma patients. To investigate the comparative risks of LTRA versus ICS on seven distinct categories of NAEs in asthma patients at a nationwide level. We conducted a nationwide cohort study during 2010-2021. Incident NAEs and its clinical subgroups (e.g., psychotic disorders, anxiety disorders, movement disorders, behavioral and emotional disorders, mood disorders, sleep-related disorders, and personality disorders) were assessed. Cox proportional hazards regressions were employed to quantify the comparative risks. There were 1,249,897 asthma patients aged 6-64 years. Incidence rates for NAEs were 25.10 per 1000 person-years among patients treated with LTRA, and 23.46 per 1000 person-years among those treated with ICS. The incidence rate difference was 1.64 [95%CI: 0.30-2.98] per 1000 person-years. Positive associations of NAEs and three clinical subgroups were found in patients treated with LTRA compared to ICS (hazard ratios (HR): 1.06 [95%CI: 1.00-1.12] for NAEs; HR: 1.88 [95%CI: 1.24-2.84] for psychotic disorders; HR: 1.10 [95%CI: 1.01-1.20] for anxiety disorders; and HR: 1.27 [95%CI: 1.02-1.58] for behavioral and emotional disorders), but not for movement disorders, mood disorders, sleep-related disorders, and personality disorders. This nationwide cohort study identified heightened risks, ranging from 6% to 88%, of NAEs and three clinical subgroups in asthma patients treated with LTRA compared to ICS. These findings underscore the necessity for clinicians to communicate with patients regarding potential neuropsychiatric harms when prescribing LTRA.

Differences in perinatal complications and serum hormone levels due to uterine endometrial preparation methods in frozen-thawed embryo transfer.

In frozen-thawed embryo transfer (FET), differences in endometrial preparation methods affect the incidence of perinatal complications. However, the underlying causes are unclear. We aimed to investigate whether serum E2, P4 levels are associated with perinatal complications. This is a retrospective cohort study, involving 306 successful FET pregnancies from 2017 to 2022. Participants were divided into Natural Cycle (NC) and Hormone Replacement Cycle (HRC) group. We compared serum hormone levels, maternal backgrounds, and perinatal outcomes and complications. Furthermore, within the HRC group, serum hormone levels were compared for perinatal complications previously reported to show differences in incidence rates depending on the method of endometrial preparation. HRC exhibited significantly higher serum E2 levels during the implantation period, but lower P4 levels during ovulation, implantation, and pregnancy test period compared with NC. HRC also had significantly higher rates of postpartum hemorrhage (PPH) and placenta accreta spectrum (PAS). There was no association found between perinatal complications more likely to occur in HRC and serum E2, P4 levels. In HRC, there were more occurrences of PPH and PAS. Although serum E2, P4 levels during FET did not correlate with perinatal complications.

Global Incidence and Prevalence in Uveal Melanoma

PurposeThe most common intraocular cancer in adults is uveal melanoma(UM). This study aimed to investigate and report the incidence and prognosis of UM in different regions of the world. MethodsWe retrieved relevant data on UM from the PubMed database and analyzed its global incidence and prognosis. All data was obtained from a national population-based registry, with publication dates ranging from 2013 to 2023. ResultsThe incidence rates of UM vary across different regions: in the United States, rates were 5.1 per million (1993-2008) and 5.2 per million (1973-2013); in Canada, rates ranged from 3.34 per million (1992-2010) to 5.09 per million (2011-2017); in South Korea, the rate was 0.42 per million (1999-2011); in New Zealand, it was 5.56 per million (2000-2020); in Australia, it was 7.6 per million (1982-2014); and in Europe, rates ranged from 3.1 to 5.8 per million (1995-2002). Among European countries, Sweden (5.6 per million (1960-2009)), Germany (6.41 per million (2009-2015)), Poland (6.67 per million (2010-2017)), and the United Kingdom (10 per million (1999-2010)). ConclusionsThe most common site of occurrence for UM is in the choroid. Limited data suggest a stable trend in UM incidence rates across the included countries, but significant differences in incidence rates exist among different countries and regions, with notably lower rates in Asian countries compared to Europe, North America, and Oceania. In general, the incidence rate in males is slightly higher compared to that in females.

Dynamic choice HIV prevention with cabotegravir long-acting injectable in rural Uganda and Kenya: a randomised trial extension

HIV infections are ongoing globally despite efficacious biomedical prevention options. We sought to determine whether an HIV prevention package providing choice of daily pills or long-acting injectable cabotegravir and opportunities to change prevention options could increase biomedical prevention coverage and reduce new HIV infections. This study was an extension of three randomised trials that used SEARCH dynamic choice HIV prevention to recruit adults (aged ≥15 years) at risk for HIV from antenatal, outpatient, and community settings in rural Uganda and Kenya. In this 48-week open-label extension, participants maintained their original (1:1) randomisation group; the option to choose cabotegravir long-acting injectable was added for intervention participants. Inclusion criteria for the extension were previous enrolment in a SEARCH dynamic choice HIV prevention trial, negative HIV rapid test, and residence in study region. The intervention provided person-centred choice of oral pre-exposure prophylaxis (PrEP) or post-exposure HIV prophylaxis (PEP) or cabotegravir long-acting injectable, with the option to switch according to participant preference. The control provided standard-of-care access to oral PrEP and PEP, but not cabotegravir long-acting injectable. Biomedical prevention coverage (proportion of follow-up covered by oral PrEP, PEP, or cabotegravir long-acting injectable; primary outcome) and HIV incidence (secondary outcome) were compared between groups using targeted minimum loss-based estimation. The trial (NCT05549726) is closed to recruitment. Of 1534 participants initially randomly assigned (from April 15, 2021 to Sept 29, 2022), 984 (487 in the intervention group and 497 in the standard-of-care group) reconsented to the extension (from Jan 2 to March 3, 2023). The mean proportion of follow-up covered by biomedical HIV prevention was 69·7% (95% CI 64·9-74·5) in the intervention group versus 13·3% (10·2-16·3) in the standard-of-care group, corresponding to an absolute difference of 56·4 percentage points (95% CI 50·8-62·1; p<0·0001). The intervention significantly improved coverage across prespecified subgroups (sex and age groups). During the study, 274 (56%) of 485 intervention participants used cabotegravir long-acting injectable, 255 (53%) used oral PrEP, and ten (2%) used PEP. Among cabotegravir long-acting injectable initiators, 118 (43%) of 274 were not previously using oral PrEP or PEP. There were seven incident HIV infections in 390 person-years of follow-up in the standard-of-care group and no infections in 400 person-years of follow-up in the intervention group (incidence rate difference per 100 person-years 1·8, 95% CI 0·4-3·2; p=0·014). Offering people the choice of HIV biomedical prevention options including cabotegravir long-acting injectable in a flexible model can increase prevention coverage and reduce incident HIV infections. HIV programmes should support dynamic choice HIV prevention programmes that include effective oral and injectable long-acting products. National Institutes of Health.

Comparing saccades in Visually Enhanced Vestibular-Ocular Reflex and video head impulse test in vestibular assessment

ObjectiveThis study aimed to develop and evaluate a novel software tool for robust analysis of the Visually Enhanced Vestibular-Ocular Reflex (VVOR) and video head impulse test (vHIT) saccades. MethodsA retrospective study was conducted on 94 patients with Meniere's Disease (MD), unilateral vestibular hypofunction (UVH), and vestibular migraine (VM). The MATLAB-based VVOR Analysis System and Saccades All in One software were utilized for data processing. New techniques, VVOR_diff and VVOR_cycle, were deployed for saccade parameter extraction. ResultsSaccade incidence rates, examined through vHIT, VVOR_diff, and VVOR_cycle, exhibited distinct patterns in MD, UVH, and VM patients. Frequent instances of multiple saccades within a single cycle were noted on the affected side in MD and UVH patients. Statistically significant differences in saccade gain and incidence rates between the affected and unaffected sides were evident in MD and UVH patients. Notably, high inter-method and intra-method correlations suggested consistency across different methods and potential interactions within one. ConclusionThe software proved effective in extracting saccades and reducing noise in VVOR data, thereby enhancing the evaluation of vestibular function and potentially improving diagnostic accuracy for vestibular disorders.

Comparative effectiveness and cardiovascular safety of romosozumab versus teriparatide in patients with osteoporosis: a population-based cohort study.

This study aimed to determine the preventive effects of romosozumab versus teriparatide on fractures and the risk of cardiovascular events in patients initiating these drugs. We conducted an active comparator, a new user cohort design, with confounding controlled by inverse probability of treatment weighting using a Japanese administrative claims database (March 2019 to October 2022). This cohort study included 49,104 patients aged 50years or older who initiated romosozumab (n = 16,125) or teriparatide (n = 32,979) for osteoporosis. The study exposure was the initiation of romosozumab or teriparatide. Effectiveness outcomes were nonvertebral fracture and hip fracture. The safety outcome was major adverse cardiac events (MACE). Follow-up period was 365days. The weighted incidence rate difference (IRD) for nonvertebral fracture between romosozumab versus teriparatide was -0.08 (95% confidence interval [CI], -0.34 to 0.17) events per 100 person-years (weighted hazard ratio [HR], 0.95 [95% CI, 0.81 to 1.12]); weighted IRD for hip fracture was 0.00 (95% CI, -0.16 to 0.16) events per 100 person-years (weighted HR, 0.99 [95% CI, 0.76 to 1.29]); and weighted IRD for MACE was -0.06 (95% CI, -0.20 to 0.09) events per 100 person-years (weighted HR, 0.90 [95% CI, 0.68 to 1.19]). In patients with osteoporosis, there was no significant difference in the prevention of nonvertebral fracture and hip fracture between romosozumab and teriparatide. In addition, the risk of MACE was comparable between the two drugs.

Abstract A038: Uncovering the role of social determinants of health in racial disparities in cancer incidence in Alabama

Abstract Purpose Black-White racial disparities have long been recognized in cancer incidence. National estimates may not reflect racial disparities in individual states. In Alabama (AL), a primarily rural underserved state, Black Americans are more often diagnosed with breast, prostate and colorectal cancer (CRC), with Black men more often diagnosed with lung cancer. Although rurality and area-level deprivation, as social determinants of health (SDoH), have been associated with cancer, their role in explaining racial disparities in cancer incidence remains unknown. We assessed racial disparities in breast, prostate, CRC and lung cancer incidence in AL. Methods We used the Alabama Statewide Cancer Registry (ASCR) to collect data on incident cases of breast, prostate, CRC and lung cancers diagnosed between January 1, 2010 and December 31, 2019. We categorized cases according to age group (0-14, 15-19, 20-24, 25-34, 35-44, 45-64, 65-84, ≥85 years), racial/ethnic group (non-Hispanic Black/White), rural-urban status (defined by AL Rural Health Association), and national area deprivation index (ADI) quartile (Q1-Q4) of census tract at diagnosis. For each combination of these variables, we calculated age-adjusted incidence per 100,000. We conducted bivariate descriptive analysis of incidence rates by race, and rural-urban status and ADI quartile stratified by race. Results Incidence of breast, prostate and CRC cancer was higher in Black versus White individuals (breast 143 vs 127; prostate 206 vs100; CRC males 57.2 vs 45.4, CRC females 42.7 vs 32.6). Lung cancer incidence was higher in Black males and White females (Black vs White: males 82.7 vs 77.6; females 36.9 vs 49.9). In all cancers, racial differences in incidence existed by rural versus urban status (breast Black 142 vs 144, breast White 131 vs 124; prostate Black 204 vs 207, prostate White 101 vs 99.4; male CRC Black 60 vs 55.3, male CRC White 47.7 vs 43, female CRC Black 43.5 vs 42.3, female CRC White 35.2 vs 30.2; male lung Black 84.5 vs 81.7, male lung White 85.1 vs 70.2, female lung Black 31.4 vs 40.1, female lung White 54.4 vs 45.6). In all cancers, racial differences in incidence also existed by ADI status (reporting Q1 vs Q4) [breast Black 190 vs 130, breast White 144 vs 118; prostate Black 269 vs 189, prostate White 109 vs 101; CRC male Black 64.2 vs 56.7, CRC male White 41.2 vs 49.7, CRC female Black 43.4 vs 43.5, CRC female White 29.5 vs 36.6; lung male Black 73.7 vs 91, lung male White 57.9 vs 97.6, lung female Black 41 vs 37.7, lung female White 40.8 vs 60.7]. Conclusions In AL, racial differences in incidence rates for each of the most common cancers exist overall and by key SDoH. Generally, Black individuals have higher rates of cancer, particularly those in rural and low ADI areas. Next, we will perform a decomposition analysis to decompose the Black/White differences in incidence into a portion explained and unexplained by rural-urban status and ADI. Ultimately, these results may inform interventions in a rural underserved state with a large Black population at higher risk of cancer. Citation Format: Mackenzie E. Fowler, Hayden Reeves, Melissa J. Smith, Geetanjali Saini, Mahak Bhargava, Ritu Aneja. Uncovering the role of social determinants of health in racial disparities in cancer incidence in Alabama [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A038.

Emergency department discharges directly to hospice: Longitudinal assessment of a streamlined referral program

Introduction80 % of Americans wish to die somewhere other than a hospital, and hospice is an essential resource for providing such care. The emergency department (ED) is an important location for identifying patients with end-of-life care needs and providing access to hospice. The objective of this study was to analyze a quality improvement (QI) program designed to increase the number of patients referred directly to hospice from the ED, without the need for an observation stay and without access to in-hospital hospice. MethodsWe implemented a QI program in September 2021 consisting of three components: (1) clarification and streamlining of referral workflows, (2) staff/provider education on hospice and workflows, and (3) electronic medical record (EMR) tools to facilitate hospice transitions. The primary outcome was the change in monthly ED-to-hospice cases pre- and post-implementation. We also calculated the monthly incidence rate of ED-to-hospice transfers. The secondary outcome was ED length of stay (LOS). Results202 patients completed ED-to-hospice transfers from January 1, 2019 to February 29, 2024. 98 patients transitioned from the ED to hospice before QI implementation, and 104 patients transitioned after implementation. We observed a slight but insignificant increase in the mean monthly ED-to-hospice cases from 3.16 patients per month pre-implementation to 3.47 patients per month post-implementation (P = 0.46). We found no significant difference in the monthly incidence rate of ED-to-hospice cases before and after implementation (P = 0.78). ED LOS was unaffected (P = 0.21). ConclusionIn this largest study to date on direct ED-to-hospice discharges, a QI program focused on workflow optimization, education, and EMR modification was insufficient to significantly impact ED-to-hospice discharges. Future efforts to increase hospice transitions from the ED should investigate methods to improve patient identification, the impact of in-hospital hospice programs, and coordination with hospital and community teams to support home-based care for those desiring to remain there.

Efficacy and safety of choline alphoscerate for amnestic mild cognitive impairment: a randomized double-blind placebo-controlled trial

BackgroundEffective interventions for overall healthy subjects with mild cognitive impairment are currently limited. Choline alphoscerate (alpha glyceryl phosphorylcholine, αGPC) is a choline-containing phospholipid used to treat cognitive function impairments in specific neurological conditions. This study aimed to investigate the efficacy and safety of αGPC in individuals diagnosed with mild cognitive impairment.MethodsIn this multicenter, randomized, placebo-controlled trial, 100 study subjects with mild cognitive impairment underwent a double-blind SHCog™ soft capsule (600 mg αGPC) or placebo treatment for 12 weeks. The primary efficacy outcome included changes from baseline on the Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-cog). Safety assessments included regular monitoring of adverse events, and clinical laboratory tests were conducted at baseline and the end of the trial.ResultsAfter 12 weeks of αGPC treatment, the ADAS-cog score decreased by 2.34 points, which was significantly greater than the change observed in the placebo group. No serious AEs were reported, and no study subjects discontinued the intervention because of AEs. There was no significant difference in incidence rate of AEs between the αGPC group and the placebo group.ConclusionThis study suggests that αGPC is a safe and effective intervention for improving cognitive function in study subjects with mild cognitive impairment.Trial registrationClinical Research Information Service; Osong (Chungcheongbuk-do): Korea Centers for Disease Control and Prevention, Ministry of Health and Welfare (Republic of Korea); KCT0008797; A 12-week, multicenter, randomized, double-blind, placebo-controlled human application study to evaluate the efficacy and safety of SH_CAPK08 on cognitive function improvement in mild cognitive decline.