Difference In Rate Research Articles

Infertility treatment is associated with increased risk of postpartum hospitalization due to heart disease.

Cardiovascular disease is a major cause of maternal mortality, but the extent to which infertility treatment is implicated in heart disease remains unclear. To evaluate the association between infertility treatment and postpartum heart disease. We designed a retrospective cohort study of patients who delivered in the United States between 2010 and 2018. The primary outcome was hospitalization within 12-month post-delivery due to heart disease (including ischemic heart disease, atherosclerotic heart disease, cardiomyopathy, hypertensive disease, heart failure, and cardiac dysrhythmias). We estimated the rate difference (RD) of hospitalizations among patients who conceived with infertility treatment and those who conceived spontaneously. Associations were expressed as hazard ratios (HRs) and 95% confidence intervals (CIs), derived from Cox proportional hazards regression after adjustment for potential confounders. Infertility treatment was recorded in 0.9% (n=287,813) of 31,339,991 deliveries. Rates of heart disease hospitalizations with infertility treatment and with spontaneous conception were 550 and 355 per 100,000, respectively (RD 195, 95% CI: 143-247; adjusted HR 1.99, 95% CI: 1.80-2.20). The most important increase in risk was observed for hypertensive disease (adjusted HR 2.16, 95% CI: 1.92-2.42). This increased risk was apparent as early as 30-day post-delivery (HR 1.61, 95% CI: 1.39-1.86), with progressively increasing risk up to a year. Although the absolute risk of postpartum heart disease hospitalization is low, infertility treatment is associated with an increased risk, especially for hypertensive disease. These findings highlight the importance of timely postpartum follow-ups in patients who received infertility treatment.

Cardiorenal effectiveness of empagliflozin vs. glucagon-like peptide-1 receptor agonists: final-year results from the EMPRISE study

BackgroundNo randomized clinical trials have directly compared the cardiorenal effectiveness of empagliflozin and GLP-1RA agents with demonstrated cardioprotective effects in patients with a broad spectrum of cardiovascular risk. We reported the final-year results of the EMPRISE study, a monitoring program designed to evaluate the cardiorenal effectiveness of empagliflozin across broad patient subgroups.MethodsWe identified patients ≥ 18 years old with type 2 diabetes who initiated empagliflozin or GLP-1RA from 2014 to 2019 using US Medicare and commercial claims databases. After 1:1 propensity score matching using 143 baseline characteristics, we evaluated risks of outcomes including myocardial infarction (MI) or stroke, hospitalization for heart failure (HHF), major adverse cardiovascular events (MACE – MI, stroke, or cardiovascular mortality), a composite of HHF or cardiovascular mortality, and progression to end-stage kidney disease (ESKD) (in patients with chronic kidney disease stages 3–4). We estimated hazard ratios (HR) and rate differences (RD) per 1,000 person-years, overall and within subgroups of age, sex, baseline atherosclerotic cardiovascular disease (ASCVD), and heart failure (HF).ResultsWe identified 141,541 matched pairs. Compared with GLP-1RA, empagliflozin was associated with similar risks of MI or stroke [HR: 0.99 (0.92, 1.07); RD: -0.23 (-1.25, 0.79)], and lower risks of HHF [HR: 0.50 (0.44, 0.56); RD: -2.28 (-2.98, -1.59)], MACE [HR: 0.90 (0.82, 0.99); RD: -2.54 (-4.76, -0.32)], cardiovascular mortality or HHF [HR: 0.77 (0.69, 0.86); RD: -4.11 (-5.95, -2.29)], and ESKD [0.75 (0.60, 0.94); RD: -6.77 (-11.97, -1.61)]. Absolute risk reductions were larger in older patients and in those with baseline ASCVD/HF. They did not differ by sex.ConclusionsThe cardiovascular benefits of empagliflozin vs. cardioprotective GLP-1RA agents were larger in older patients and in patients with history of ASCVD or HF, while they did not differ by sex. In patients with advanced CKD, empagliflozin was associated with risk reductions of progression to ESKD.

Sodium-Glucose Cotransporter 2 Inhibitors and Nephrolithiasis Risk in Patients With Type 2 Diabetes

Type 2 diabetes (T2D) is associated with an increased risk of kidney stones. Sodium-glucose cotransporter 2 inhibitors (SGLT2is) might lower the risk of nephrolithiasis by altering urine composition. However, no studies have investigated the association between SGLT2i use and nephrolithiasis risk in patients receiving routine care in the US. To investigate the association between SGLT2i use and nephrolithiasis risk in clinical practice. This new-user, active comparator cohort study used data from commercially insured adults (aged ≥18 years) with T2D who initiated treatment with SGLT2is, glucagon-like peptide 1 receptor agonists (GLP-1RAs), or dipeptidyl peptidase 4 inhibitors (DPP4is) between April 1, 2013, and December 31, 2020. The data were analyzed from July 2021 through June 2023. New initiation of an SGLT2i, GLP-1RA, or DPP4i. The primary outcome was nephrolithiasis diagnosed by International Classification of Diseases codes in the inpatient or outpatient setting. New SGLT2i users were 1:1 propensity score matched to new users of a GLP-1RA or DPP4i in pairwise comparisons. Incidence rates, rate differences (RDs), and estimated hazard ratios (HRs) with 95% CIs were calculated. After 1:1 propensity score matching, a total of 716 406 adults with T2D (358 203 pairs) initiating an SGLT2i or a GLP-1RA (mean [SD] age, 61.4 [9.7] years for both groups; 51.4% vs 51.2% female; 48.6% vs 48.5% male) and 662 056 adults (331 028 pairs) initiating an SGLT2i or a DPP4i (mean [SD] age, 61.8 [9.3] vs 61.7 [10.1] years; 47.4% vs 47.3% female; 52.6% vs 52.7% male) were included. Over a median follow-up of 192 (IQR, 88-409) days, the risk of nephrolithiasis was lower in patients initiating an SGLT2i than among those initiating a GLP-1RA (14.9 vs 21.3 events per 1000 person-years; HR, 0.69 [95% CI, 0.67-0.72]; RD, -6.4 [95% CI, -7.1 to -5.7]) or a DPP4i (14.6 vs 19.9 events per 1000 person-years; HR, 0.74 [95% CI, 0.71-0.77]; RD, -5.3 [95% CI, -6.0 to -4.6]). The association between SGLT2i use and nephrolithiasis risk was similar by sex, race and ethnicity, history of chronic kidney disease, and obesity. The magnitude of the risk reduction with SGLT2i use was larger among adults aged younger than 70 years vs aged 70 years or older (HR, 0.85 [95% CI, 0.79-0.91]; RD, -3.46 [95% CI, -4.87 to -2.05] per 1000 person-years; P for interaction <.001). These findings suggest that in adults with T2D, SGLT2i use may lower the risk of nephrolithiasis compared with GLP-1RAs or DPP4is and could help to inform decision-making when prescribing glucose-lowering agents for patients who may be at risk for developing nephrolithiasis.

Evaluating the effects of the 2017 National Health Insurance coverage expansion on amenable mortality and its disparities between areas in South Korea using Bayesian structural time-series models

To improve the low coverage rate of the National Health Insurance (NHI), South Korea implemented the NHI coverage expansion plan in 2017 to cover medically essential non-covered services and reduce copayment rates. This study aimed to estimate the effects of the 2017 NHI coverage expansion on amenable mortality and its disparities between areas in South Korea under a controlled interrupted time-series design using Bayesian structural time-series models. Age-standardized amenable mortality rates and rate differences (RDs) and rate ratios (RRs) between areas for amenable mortality were calculated monthly between July 2012 and December 2021 and used as the response series. The non-equivalent control series were monthly non-avoidable mortality rates and their regional disparities. After the coverage expansion, amenable mortality rates decreased for both males (−8.8%, 95% credible interval [CrI] −13.4% to −3.9%) and females (−8.3%, 95% CrI −13.4% to −2.4%), with the largest decline in the non-Seoul-Capital metropolitan area (−11.6%, 95% CrI −16.5% to −6.3%) rather than the Seoul Capital Area (−7.5%, 95% CrI −11.9% to −2.5%) and a non-significant reduction in the non-Seoul-Capital non-metropolitan area in females. RDs and RRs between areas for amenable mortality decreased non-significantly (−16.2%, 95% CrI −31.3% to 2.6% for RD and −1.2%, 95% CrI −3.7% to 1.5% for RR), except for a significant decrease in RD in males (−21.8%, 95% CrI −38.0% to −1.5%), and decreased less in females than in males. The coverage expansion was generally effective in reducing amenable mortality rates by area, but had limited effects in closing amenable mortality disparities between areas, favoring males and the non-Seoul-Capital metropolitan area. These results implied that additional measures are necessary to improve access to quality health care for females and underserved areas to enhance the effectiveness of the coverage expansion.

Antipsychotic Medications and Mortality in Children and Young Adults

Dose-related effects of antipsychotic medications may increase mortality in children and young adults. To compare mortality for patients aged 5 to 24 years beginning treatment with antipsychotic vs control psychiatric medications. This was a US national retrospective cohort study of Medicaid patients with no severe somatic illness or schizophrenia or related psychoses who initiated study medication treatment. Study data were analyzed from November 2022 to September 2023. Current use of second-generation antipsychotic agents in daily doses of less than or equal to 100-mg chlorpromazine equivalents or greater than 100-mg chlorpromazine equivalents vs that for control medications (α agonists, atomoxetine, antidepressants, and mood stabilizers). Total mortality, classified by underlying cause of death. Rate differences (RDs) and hazard ratios (HRs) adjusted for potential confounders with propensity score-based overlap weights. The 2 067 507 patients (mean [SD] age, 13.1 [5.3] years; 1 060 194 male [51.3%]) beginning study medication treatment filled 21 749 825 prescriptions during follow-up with 5 415 054 for antipsychotic doses of 100 mg or less, 2 813 796 for doses greater than 100 mg, and 13 520 975 for control medications. Mortality was not associated with antipsychotic doses of 100 mg or less (RD, 3.3; 95% CI, -5.1 to 11.7 per 100 000 person-years; HR, 1.08; 95% CI, 0.89-1.32) but was associated with doses greater than 100 mg (RD, 22.4; 95% CI, 6.6-38.2; HR, 1.37; 95% CI, 1.11-1.70). For higher doses, antipsychotic treatment was significantly associated with overdose deaths (RD, 8.3; 95% CI, 0-16.6; HR, 1.57; 95% CI, 1.02-2.42) and other unintentional injury deaths (RD, 12.3; 95% CI, 2.4-22.2; HR, 1.57; 95% CI, 1.12-2.22) but was not associated with nonoverdose suicide deaths or cardiovascular/metabolic deaths. Mortality for children aged 5 to 17 years was not significantly associated with either antipsychotic dose, whereas young adults aged 18 to 24 years had increased risk for doses greater than 100 mg (RD, 127.5; 95% CI, 44.8-210.2; HR, 1.68; 95% CI, 1.23-2.29). In this cohort study of more than 2 million children and young adults without severe somatic disease or diagnosed psychosis, antipsychotic treatment in doses of 100 mg or less of chlorpromazine equivalents or in children aged 5 to 17 years was not associated with increased risk of death. For doses greater than 100 mg, young adults aged 18 to 24 years had significantly increased risk of death, with 127.5 additional deaths per 100 000 person-years.

Abstract 11600: Association Between Obesity and Risk of Total and Obesity-Related Cancer in Persons With Incident Cardiovascular Disease

Introduction: Cardiovascular disease (CVD) and cancer often occur in the same people, in part due to shared risk factors. In a Global Burden of Disease analysis of cohorts from &gt;180 countries, obesity was a top 3 modifiable risk factor for CVD and cancer. Beyond shared risk factors, CVD pathophysiologies may synergize with obesity to influence carcinogenesis. If so, an excess cancer risk in obese persons with CVD has implications for clinical management. Hypothesis: Obesity is positively associated with obesity-related cancer (ObCa) risk in persons with incident CVD independent of shared risk factors. Methods: We used data from the Atherosclerosis Risk in Communities (ARIC) study, a cohort with 28 years of cancer follow-up. The analytic cohort was 5127 participants with incident CVD among whom 1511 were diagnosed with a first primary cancer. Follow up began at incident CVD diagnosis date after visit 1. Obesity was classified by BMI, waist circumference (WC), and waist-to-hip ratio (WHR) measured by trained technicians. We calculated incidence rate differences (RD) between obesity groups adjusted for age, sex, and center. The obesity-cancer association was estimated using Fine-Gray regression adjusted for shared risk factors, including smoking. Results: In people with CVD, cancer incidence was higher in the obese (BMI: RD=226.6/100,000 person-years) than normal weight group. In people with CVD, obesity was suggestively positively associated with ObCa (Table 1). In females with CVD, obesity was associated with increased ObCa risk. Associations were null in males, including after excluding prostate cancer. Conclusion: In this prospective study, obesity is positively associated with ObCa risk in women with incident CVD independent of shared risk factors. More work is needed to investigate why the association appeared in women only, and to identify possible mechanisms by which CVD pathophysiologies may interact with obesity to produce cancer risk.

Red blood cell distribution width and mortality risk in critically ill cardiovascular patients

BackgroundThe association between red blood cell distribution width (RDW) and mortality risk in critically ill cardiovascular patients has not been well studied. ObjectiveTo examine the association between RDW and 30-day all-cause and cause-specific mortality in critically ill cardiovascular patients. MethodsThis cohort study included 47,266 patients from the eICU database. RDW was categorized as <13.0 %, 13.0–13.4 %, 13.5–13.9 %, 14.0–14.4 %, 14.5–14.9 %, ≥15.0 %. Logistic regression model was used to estimate adjusted odds ratios (ORs), and log-linear regression model was used to examine absolute rate differences (RDs) in mortality risk. Cubic spline curve was used to explore the nonlinear association between changes in RDW and mortality. ResultsA graded association between higher RDW and incremental risk of death was observed. Compared with RDW of <13.0 %, the adjusted odds ratios for all-cause mortality were 1.29 (95 % CI, 1.10 to 1.53) for RDW of 13.5–13.9 %, 1.57 (95 % CI, 1.33 to 1.85) for RDW of 14.0–14.4 %, 1.94 (95 % CI, 1.64 to 2.29) for RDW of 14.5–15.0 %, and 3.15 (95 % CI, 2.74 to 3.63) for RDW of ≥15.0 %. The absolute rate differences for RDW of 13.5–13.9 %, 14.0–14.4 %, 14.5–14.9 %, and ≥15.0 % indicated an additional 6, 13, 14, and 40 deaths per 1000 patients, respectively. RDW was associated with most, but not all, cause-specific deaths. ConclusionRDW was strongly associated with all-cause mortality and most cause-specific mortality in critically ill cardiovascular patients. These findings underscore the importance of this readily available hematologic indicator in mortality risk stratification.

Stratified analysis in comparative effectiveness studies that emulate randomized trials.

For observational cohort studies that employ matching by propensity scores (PS), preliminary stratification by consequential predictors of outcome better emulates stratified randomization and potentially reduces variance and bias through relaxed dependence on modeling assumptions. We assessed the impact of pre-stratification in two real-life examples. For both, prior evidence from placebo-controlled randomized clinical trials (RCTs) suggested small or no risk reduction, but observational analysis suggested protection, presumably the result of confounding bias. The study populations consisted of Medicare beneficiaries (2014-18) with type 2 diabetes initiating either (i) empagliflozin versus dipeptidyl peptidase-4 inhibitors (DPP-4i) or (ii) empagliflozin versus glucagon-like peptide-1 receptor agonists (GLP-1RA). The outcome was myocardial infarction or stroke. We estimated hazard ratios (HR) and rate differences (RD) after controlling for 143 pre-exposure covariates via 1:1 PS matching after (1) PS estimation in the total cohort (total-cohort PS-matching) and (2) PS estimation separately by baseline cardiovascular disease (stratified PS matching). Stratified PS matching resulted in HRs that exceeded those from total-cohort PS-matching by 13% and 9%, respectively, for the comparisons of empagliflozin to DPP-4i and GLP-1RA. Against both comparators, HRs and RDs after stratified PS matching were closer to the null, with slightly higher variances (2%-3%) than those after total-cohort PS matching. Stratified PS matching produced effect estimates closer to the expected trial findings than total-cohort PS matching. The price paid in increased variance was minimal.

Statin use and risk of colorectal cancer in patients with inflammatory bowel disease

Statin use has been linked to a reduced risk of advanced colorectal adenomas, but its association with colorectal cancer (CRC) in patients with inflammatory bowel disease (IBD) - a high risk population for CRC - remains inconclusive. From a nationwide IBD cohort in Sweden, we identified 5273 statin users and 5273 non-statin users (1:1 propensity score matching) from July 2006 to December 2018. Statin use was defined as the first filled prescription for ≥30 cumulative defined daily doses and followed until December 2019. Primary outcome was incident CRC. Secondary outcomes were CRC-related mortality and all-cause mortality. Cox regression estimated adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs). During a median follow-up of 5.6 years, 70 statin users (incidence rate (IR): 21.2 per 10,000 person-years) versus 90 non-statin users (IR: 29.2) were diagnosed with incident CRC (rate difference (RD),-8.0 (95% CIs:-15.8 to-0.2 per 10,000 person-years); aHR=0.76 (95% CIs: 0.61 to 0.96)). The benefit for incident CRC was duration-dependent in a nested case-control design: as compared to short-term use (30 days to <1 year), the adjusted odd ratios were 0.59 (0.25 to 1.43) for 1 to <2 years of use, 0.46 (0.21 to 0.98) for 2 to <5 years of use, and 0.38 (0.16 to 0.86) for ≥5 years of use (Pfor tread=0.016). Compared with non-statin users, statin users also had a decreased risk for CRC-related mortality (IR: 6.0 vs. 11.9; RD,-5.9 (-10.5 to-1.2); aHR, 0.56 (0.37 to 0.83)) and all-cause mortality (IR: 156.4 vs. 231.4; RD,-75.0 (-96.6 to-53.4); aHR, 0.63 (0.57 to 0.69)). Statin use was associated with a lower risk of incident CRC, CRC-related mortality, and all-cause mortality. The benefit for incident CRC was duration-dependent, with a significantly lower risk after ≥2 years of statin use. This research was supported by Forte (i.e., the Swedish Research Council for Health, Working Life and Welfare).

Racial, Ethnic, Sex, and Age Differences in COVID-19 Cases, Hospitalizations, and Deaths Among Incarcerated People and Staff in Correctional Facilities in Six Jurisdictions, United States, March-July 2020.

To examine disparities by sex, age group, and race and ethnicity in COVID-19 confirmed cases, hospitalizations, and deaths among incarcerated people and staff in correctional facilities. Six U.S. jurisdictions reported data on COVID-19 confirmed cases, hospitalizations, and deaths stratified by sex, age group, and race and ethnicity for incarcerated people and staff in correctional facilities during March 1- July 31, 2020. We calculated incidence rates and rate ratios (RR) and absolute rate differences (RD) by sex, age group, and race and ethnicity, and made comparisons to the U.S. general population. Compared with the U.S. general population, incarcerated people and staff had higher COVID-19 case incidence (RR = 14.1, 95% CI = 13.9-14.3; RD = 6,692.2, CI = 6,598.8-6,785.5; RR = 6.0, CI = 5.7-6.3; RD = 2523.0, CI = 2368.1-2677.9, respectively); incarcerated people also had higher rates of COVID-19-related deaths (RR = 1.6, CI = 1.4-1.9; RD = 23.6, CI = 14.9-32.2). Rates of COVID-19 cases, hospitalizations, and deaths among incarcerated people and corrections staff differed by sex, age group, and race and ethnicity. The COVID-19 hospitalization (RR = 0.9, CI = 0.8-1.0; RD = -48.0, CI = -79.1- -16.8) and death rates (RR = 0.8, CI = 0.6-1.0; RD = -11.8, CI = -23.5- -0.1) for Black incarcerated people were lower than those for Black people in the general population. COVID-19 case incidence, hospitalizations, and deaths were higher among older incarcerated people, but not among staff. With a few exceptions, living or working in a correctional setting was associated with higher risk of COVID-19 infection and resulted in worse health outcomes compared with the general population; however, Black incarcerated people fared better than their U.S. general population counterparts.

The first meta-analysis research on the effects of endovenous laser ablation combined with sapheno-femoral junction high ligation of the great saphenous vein.

Endovenous laser ablation (EVLA) is a common minimally invasive technique used to treat varicose veins. The most commonly used laser wavelengths for EVLA/EVLT of varicose veins are 810 nm and 1470 nm. The laser pulse frequency is typically set to continuous wave (CW) mode, with a pulse duration of a few milliseconds (ms) delivered in a radial mode. The energy delivered per pulse is typically set between 40 and 120 Joules, with a power setting of 10 to 30 watts and an intensity setting of 40 to 120 J/cm2. The controversy exists regarding the benefits of performing saphenofemoral junction (SFJ) ligation prior to EVLA to decrease the recurrence rate of varicose veins. This meta-analysis aims to investigate the effectiveness of combining EVLA with high ligation versus using EVLA alone in treating lower extremity varicose veins. We conducted a systematic search of four databases from their inception until July 1, 2022, for randomized controlled trials and prospective controlled trials evaluating the advantages and disadvantages of EVLA with or without high ligation for the treatment of lower extremity varicose veins. In analyzing binary data, rate difference (RD) is used, while odds ratio (OR) is used for evaluating the confidence interval (CI) of binary data. A P value of less than 0.05 is deemed statistically significant. Heterogeneity is assessed using the chi-square test. If the I2 statistic, which reflects statistical heterogeneity, is greater than 50%, a random-effects model should be used. In the absence of significant statistical heterogeneity, a fixed-effects model should be used if I2 is less than 50%. We used the Cochrane risk-of-bias tool to assess the quality of the studies and Review Manager 5.4 for the primary and secondary outcome analysis. The meta-analysis was conducted in accordance with the Cochrane Handbook. There were no significant differences in the rate of major complications (RR = 1.63; 95% CI, 0.40-6.69; P = 0.50) or in the frequency of minor complications (RR = 1.07, 95% CI, 0.87-1.31; P = 0.52) between the EVLA with high ligation (EVLA/HL) group and the EVLA group. However, the rate of vein occlusion was significantly lower in the EVLA group than in the EVLA/HL group (RR = 1.06; 95% CI, 1.03-1.09; P = 0.0004). Our meta-analysis indicates that combining EVLA with high ligation provides stable long-term clinical efficacy in treating varicose veins of the lower extremities, although it increases the invasiveness of the surgery. The use of EVLA alone may be less effective in preventing vein occlusion.

Comparison of the effects and safety of dydrogesterone and medroxyprogesterone acetate on endometrial hyperplasia without atypia: a randomized controlled non-inferior phase Ⅲ clinical study

Objective: To compare the effects and safety of dydrogesterone (DG) and medroxyprogesterone acetate (MPA) on the treatment in patients with endometrial hyperplasia without atypia (EH). Methods: This was a single-center, open-label, prospective non-inferior randomized controlled phase Ⅲ trial. From February 2019 to November 2021, patients with EH admitted to the Obstetrics and Gynecology Hospital of Fudan University were recruited. Enrolled patients were stratified according to the pathological types of simple hyperplasia (SH) or complex hyperplasia (CH), and were randomised to receive MPA or DG. Untill May 14, 2022, the median follow-up time after complete response (CR) was 9.3 months (1.1-17.2 months). The primary endpoint was the 6-month CR rate (6m-CR rate). The secondary endpoints included the 3-month CR rate (3m-CR rate), adverse events rate, recurrence rate, and pregnancy rate in one year after CR. Results: (1) A total of 292 patients with EH were enrolled in the study with the median age of 39 years (31-45 years). A total of 135 SH patients were randomly assigned to MPA group (n=67) and DG group (n=68), and 157 CH patients were randomly assigned to MPA group (n=79) and DG group (n=78). (2) Among 292 patients, 205 patients enrolled into the primary endpoint analysis, including 92 SH patients and 113 CH patients, with 100 patients in MPA group and 105 in DG group, respectively. The 6m-CR rate of MPA group and DG group were 90.0% (90/100) and 88.6% (93/105) respectively, and there were no statistical significance (χ2=0.11, P=0.741), with the rate difference (RD) was -1.4% (95%CI:-9.9%-7.0%). Stratified by the pathology types, the 6m-CR rate of SH patients was 93.5% (86/92), and MPA group and DG group were respectively 91.1% (41/45) and 95.7% (45/47); and the 6m-CR rate of CH patients was 85.8% (97/113), and MPA group and DG group were 89.1% (49/55) and 82.8% (48/58) respectively. The 6m-CR rates of the two treatments had no statistical significance either (all P>0.05). A total of 194 EH patients enrolled into the secondary endpoint analysis, including 88 SH patients and 106 CH patients, and 96 patients in MPA group and 98 in DG group, respectively. The 3m-CR rate of SH patients were 87.5% (77/88), while the 3m-CR rates of MPA group and DG group were 90.7% (39/43) and 84.4% (38/45), respectively; the 3m-CR rate of CH patients was 66.0% (70/106), and MPA group and DG group had the same 3m-CR rate of 66.0% (35/53). No statistical significance was found between the two treatments both in SH and CH patients (all P>0.05). (3) The incidence of adverse events between MPA group and DG group had no statistical significance (P>0.05). (4) A total of 93 SH patients achieved CR, and the cumulative recurrence rate in one year after CR were 5.9% and 0 in MPA group and DG group, respectively. While 112 CH patients achieved CR, and the cumulative recurrence rate in one year after CR were 8.8% and 6.5% in MPA group and DG group, respectively. There were no statistical significance between two treatment groups (all P>0.05). Among the 93 SH patients, 10 patients had family planning but no pregnancy happened during the follow-up period. Among the 112 CH patients, 21 were actively preparing for pregnancy, and the pregnancy rate and live-birth rate in one year after CR in MPA group were 7/9 and 2/7, while in DG group were respectively 4/12 and 2/4, and there were no statistical significance in pregnancy rate and live-birth rate between the two treatment groups (all P>0.05). Conclusions: Compared with MPA, DG is of good efficacy and safety in treating EH. DG is a favorable alternative treatment for EH patients.

COVID-19 burden differed by city districts and ethnicities during the pre-vaccination era in Amsterdam, the Netherlands.

During the first wave of COVID-19 in Amsterdam, the Netherlands, a disproportional number of COVID-19 hospitalizations occurred in individuals with an ethnic minority background and in individuals living in city districts with a lower socioeconomic status (SES). In this study, we assessed whether these disparities continued throughout the second wave, when SARS-CoV-2 testing was available to anyone with symptoms but prior to the availability of COVID-19 vaccination. Surveillance data on all notified SARS-CoV-2 cases in Amsterdam between 15 June 2020 and 20 January 2021 were matched to municipal registration data to obtain the migration background of cases. Crude and directly age- and sex-standardized rates (DSR) of confirmed cases, hospitalizations, and deaths per 100,000 population were calculated overall, and by city districts, and migration backgrounds. Rate differences (RD) and rate ratios (RR) were calculated to compare DSR between city districts and migration backgrounds. We used multivariable Poisson regression to assess the association of city districts, migration backgrounds, age, and sex with rates of hospitalization. A total of 53,584 SARS-CoV-2 cases (median age 35 years [IQR = 25-74]) were notified, of whom 1,113 (2.1%) were hospitalized and 297 (0.6%) deceased. DSR of notified infections, hospitalization, and deaths per 100,000 population were higher in lower SES peripheral city districts (South-East/North/New-West) than higher SES central districts (Central/West/South/East), with almost a 2-fold higher hospitalization DSR in peripheral compared to central districts (RR = 1.86, 95%CI = 1.74-1.97). Individuals with a non-European migration background also had a higher COVID-19 burden, particularly with respect to hospitalization rates, with a 4.5-fold higher DSR for individuals with a non-European background compared to ethnic-Dutch (RR 4.51, 95%CI = 4.37-4.65). City districts, migration backgrounds, male gender, and older age were independently associated with COVID-19 hospitalization rates. Individuals with a non-European background and individuals living in city districts with lower SES continued to independently have the highest COVID-19 burden in the second wave of COVID-19 in Amsterdam, the Netherlands.

Comparison of inequality in utilization of postnatal care services between Bangladesh and Pakistan: Evidence from the Demographic and Health Survey 2017–2018

BackgroundInequality in postnatal care (PNC) has remained a challenge in many low- and middle-income countries, like Bangladesh and Pakistan. The study examines within-country and between-country inequality in utilizing PNC services for Bangladesh and Pakistan.MethodsThe study used the latest Demographic and Health Survey (DHS, 2017–2018) datasets of Bangladesh and Pakistan for women aged 15–49 years who had given at least one live birth in the three years preceding the survey. As outcome variables, three PNC service indicators were considered: PNC check of women, PNC check of newborns, and adequate PNC content of newborns. Concentration curves and equiplots were constructed to visually demonstrate inequality in PNC services. For ordered equity strata with more than two categories, the relative concentration index (RCI), absolute concentration index (ACI), and slope index of inequality (SII) were calculated to measure inequalities in the utilization of PNC services. For two categories equity strata, rate ratio (RR) and rate difference (RD) were calculated.ResultsIn Bangladesh, the level of inequality was high and almost the same for the PNC check of women and newborns based on women’s education (PNC women- RCI: 0.404, ACI: 0.403, SII: 0.624; and PNC newborn- RCI: 0.402, ACI: 0.402, SII: 0.622), wealth (PNC women- RCI: 0.448, ACI: 0.448, SII: 0.643; and PNC newborn- 0.441, ACI: 0.441, SII: 0.633), and number of ANC visits (PNC women- RCI: 0.329, ACI: 0.329, SII: 0.595; and PNC newborn- RCI: 0.329, ACI: 0.329, SII: 0.594). In Pakistan, the level of inequality was higher for the PNC check of women among all PNC services based on women’s education (ACI: 0.388 and SII: 0.676) and wealth (ACI: 0.397 and SII: 0.598). For Bangladesh and Pakistan, RR values (2.114 and 3.873, respectively) indicated greater media exposure-related inequality in adequate PNC content of newborns. Inequality in facility delivery was highest for PNC checks of women and newborns in Bangladesh (PNC women- RD: 0.905, PNC newborn- RD: 0.900) and Pakistan (PNC women- RD: 0.726, PNC newborn-RD: 0.743).ConclusionInequality was higher in Bangladesh than in Pakistan for PNC checks of women and newborns based on wealth, media exposure, and mode of delivery. For adequate PNC content of newborns, inequality was greater in Pakistan than in Bangladesh. Country-specific customized policies would better minimize the gap between the privileged and underprivileged groups and reduce inequality.

270-OR: Health Care Utilization and Cost Associated with Empagliflozin in Older Adults with Type 2 Diabetes—Results from the EMPRISE study

Within the EMPRISE study program, we compared the cost and healthcare utilization of empagliflozin (EMPA) vs. dipeptidyl peptidase-4 inhibitors (DPP-4i) using Medicare data (2014-18). We identified 23,335 pairs of 1:1 propensity score-matched patients aged ≥65 years with type 2 diabetes (T2D) initiating EMPA or a DPP-4i, overall and stratified by baseline cardiovascular disease (CVD). We estimated ratios and differences in rates of healthcare utilization per 1,000 person-years, and costs per member per year (PMPY) for EMPA vs. DPP-4i using zero-inflated negative binomial or gamma models. Compared to DPP-4i, EMPA was associated with lower rates of hospital days [rate ratio (RR) (95% CI) 0.89 (0.82, 0.97); rate difference (RD) -557 (-587, -528)], number of hospitalizations [RR 0.86 (0.79, 0.93); RD -73 (-84, -61)], and number of emergency visits [RR 0.86 (0.82, 0.91); RD -128 (-145, -111)]. Estimates were similar when stratified by baseline CVD. Relative to DPP-4i, EMPA was associated with lower total costs in USD [RR 0.94 (0.92, 0.96); PMPY -1109 (-1478, -739)], and inpatient costs [RR 0.84 (0.81, 0.87); PMPY -713 (-847, -579)], and nearly-similar pharmacy costs [RR 1.04 (1.02, 1.06); PMPY 355 (177, 532)]. RRs in baseline CVD subgroups were similar, but absolute RDs were larger in those with CVD. Relative to DPP-4i, EMPA reduced healthcare utilization and costs in routine care. Disclosure P.T.Htoo: Employee; Johnson &amp; Johnson. E.Patorno: Research Support; Boehringer Ingelheim Inc., National Institutes of Health, Patient-Centered Outcomes Research Institute, US Food and Drug Administration. H.Tesfaye: None. S.Schneeweiss: Consultant; Aetion, Inc., Research Support; UCB, Inc., Boehringer Ingelheim International GmbH, Stock/Shareholder; Aetion, Inc. D.J.Wexler: Other Relationship; Novo Nordisk A/S. R.Glynn: Research Support; Amarin Corporation, AstraZeneca, Kowa Pharmaceuticals America, Inc., Novartis, Pfizer Inc. N.Schmedt: Employee; Boehringer Ingelheim International GmbH. A.Deruaz-luyet: Employee; Boehringer Ingelheim International GmbH. L.Koeneman: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. J.M.Paik: None. Funding Boehringer Ingelheim (116283)

1227-P: Cardiorenal Effectiveness of Empagliflozin vs. GLP-1 Receptor Agonists in Patients with Advanced Chronic Kidney Disease—Results from the EMPRISE Study

Patients with chronic kidney disease (CKD) are at an increased risk of cardiovascular disease, heart failure, and mortality. We reported the final year results of the EMPRISE study program in patients with type 2 diabetes (T2D) and advanced CKD. Using Medicare, Optum, and Marketscan data (2014-19), we identified 10,930 pairs of 1:1 propensity score-matched patients aged &amp;gt;18 years with T2D and CKD stage 3-4 who initiated empagliflozin (EMPA) or a glucagon-like peptide-1 receptor agonist (GLP-1RA). Primary outcomes were hospitalization for heart failure (HHF), a composite of myocardial infarction (MI) or stroke, and end-stage renal disease (ESRD). Secondary outcomes were MI, stroke, and all-cause mortality. We estimated hazard ratios (HR) and rate differences (RD), adjusting for 143 baseline covariates. Compared to GLP-1RA, EMPA was associated with a reduced risk of HHF [HR 0.68 (0.55-0.85); RD -9.44 (-14.78, -4.10)], and ESRD [HR 0.70 (0.56-0.87); RD -9.01 (-14.30, -3.72)], and a trend towards reduced risk for the composite outcome [HR 0.88 (0.72-1.07); RD -3.84 (-9.60, 1.93)]. Estimates for the secondary outcomes were: MI [HR 0.78 (0.61-1.00)], stroke [HR 1.16 (0.83-1.62)], and all-cause mortality [HR 1.08 (0.86-1.36)]. In patients with T2D and advanced CKD in routine care, we observed risk reductions for cardiorenal outcomes with EMPA vs. GLP-1RA. Disclosure P.T.Htoo: Employee; Johnson &amp; Johnson. E.Patorno: Research Support; Boehringer Ingelheim Inc., National Institutes of Health, Patient-Centered Outcomes Research Institute, US Food and Drug Administration. H.Tesfaye: None. D.J.Wexler: Other Relationship; Novo Nordisk A/S. R.Glynn: Research Support; Amarin Corporation, AstraZeneca, Kowa Pharmaceuticals America, Inc., Novartis, Pfizer Inc. N.Schmedt: Employee; Boehringer Ingelheim International GmbH. L.Koeneman: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. S.Schneeweiss: Consultant; Aetion, Inc., Research Support; UCB, Inc., Boehringer Ingelheim International GmbH, Stock/Shareholder; Aetion, Inc. J.M.Paik: None. Funding Boehringer Ingelheim (116283)

Burden of disease in patients hospitalised with COVID-19 during the first and second pandemic wave in Switzerland: a nationwide cohort study

The first and second waves of the COVID-19 pandemic led to a tremendous burden of disease and influenced several policy directives, prevention and treatment strategies as well as lifestyle and social behaviours. We aimed to describe trends of hospitalisations with COVID-19 and hospital-associated outcomes in these patients during the first two pandemic waves in Switzerland. In this nationwide retrospective cohort study, we used in-hospital claims data of patients hospitalised with COVID-19 in Switzerland between January 1st and December 31st, 2020. First, stratified by wave (first wave: January to May, second wave: June to December), we estimated incidence rates (IR) and rate differences (RD) per 10,000 person-years of COVID-19-related hospitalisations across different age groups (0-9, 10-19, 20-49, 50-69, and ≥70 years). IR was calculated by counting the number of COVID-19 hospitalisations for each patient age stratum paired with the number of persons living in Switzerland during the specific wave period. Second, adjusted odds ratios (aOR) of outcomes among COVID-19 hospitalisations were calculated to assess the association between COVID-19 wave and outcomes, adjusted for potential confounders. Of 36,517 hospitalisations with COVID-19, 8,862 (24.3%) were identified during the first and 27,655 (75.7%) during the second wave. IR for hospitalisations with COVID-19 was highest during the second wave and among patients above 50 years (50-69 years: first wave: 31.49 per 10,000 person-years; second wave: 62.81 per 10,000 person-years; RD 31.32 [95% confidence interval [CI]: 29.56 to 33.08] per 10,000 person-years; IRR 1.99 [95% CI: 1.91 to 2.08]; ≥70 years: first wave: 88.59 per 10,000 person-years; second wave: 228.41 per 10,000 person-years; RD 139.83 [95% CI: 135.42 to 144.23] per 10,000 person-years; IRR 2.58 [95% CI: 2.49 to 2.67]). While there was no difference in hospital readmission, when compared with the first wave, patients hospitalised during the second wave had a lower probability of death (aOR 0.88 [95% CI: 0.81 to 0.95], ARDS (aOR 0.56 [95% CI: 0.51 to 0.61]), ICU admission (aOR 0.66 [95% CI: 0.61 to 0.70]), and need for ECMO (aOR 0.60 [95% CI: 0.38 to 0.92]). LOS was -16.1 % (95% CI: -17.8 to -14.2) shorter during the second wave. In this nationwide cohort study, rates of hospitalisations with COVID-19 were highest among adults older than 50 years and during the second wave. Except for hospital readmission, the likelihood of adverse outcomes was lower during the second pandemic wave, which may be explained by advances in the understanding of the disease and improved treatment options.

Association of Minimal Residual Disease Negativity Rates With Progression Free Survival in Frontline Therapy Trials for Newly Diagnosed Multiple Myeloma: A Meta-analysis.

Current frontline therapies for newly diagnosed multiple myeloma patients have significantly prolonged progression-free survival (PFS). This has led to interest in minimal residual disease negativity (MRDng) as an efficacy-response biomarker and possible surrogate endpoint. A meta-analysis was conducted to explore the surrogacy of MRD for PFS and quantify the relationship between MRDng rates and PFS at the trial level. A systematic search was conducted on phase II and III trials reporting MRDng rates along with median PFS (mPFS) or PFS hazard ratios (HR). Weighted linear regressions were conducted relating mPFS to MRDng rates, and relating PFS HRs to either odds ratios (OR) or rate differences (RD) for MRDng in comparative trials. A total of 14 trials were available for the mPFS analysis. log(MRDng rate) was moderately associated with log (mPFS), with a slope of β=0.37 (95% CI, 0.26 to 0.48) and R2=0.62. A total of 13 trials were available for the PFS HR analysis. Treatment effects on MRDng rates were correlated with the corresponding effects on PFS: log (PFS HR) and log (MRDng OR) had a moderate association with β=-0.36 (95% CI, -0.56 to -0.17) and R2=0.53 (95% CI, 0.21 to 0.77); log (PFS HR) and the MRDng RD had a stronger association with slope β=-0.03 (95% CI, -0.04 to -0.02) and R2=0.67 (95% CI, 0.31 to 0.86). MRDng rates moderately associate with PFS outcomes. MRDng RDs are more strongly associated with HRs than MRDng ORs, with evidence suggestive of potential surrogacy.

Comparing a novel Catfish flow restoration device and the Solitaire stent retriever for thrombectomy revascularisation in emergent largevessel occlusion stroke: a prospective randomised controlled study

BackgroundThe Catfish stent retriever is a newly developed mechanical thrombectomy device for rapid recanalisation in emergent large vessel occlusion (ELVO) stroke. The current trial aimed to assess whether the Catfish...

Small bowel cleansing for capsule endoscopy, systematic review and meta- analysis: Timing is the real issue.

The optimal small bowel preparation modality before capsule endoscopy (SBCE) is still uncertain, regarding preparation type, dose and timing of administration. The aim of the study is to evaluate the small bowel cleansing in patients undergoing small bowel capsule endoscopy after fasting alone or active treatment with purgative solutions. We searched 4 major scientific databases from inception to December 2021 for studies evaluating small bowel preparation before SBCE. Different preparation efficacy was compared using fasting as reference. Main variables evaluated in the current study were: preparation type, administration schedule and timing. 17 studies (27 treatment arms) with 2372 patients (male 47,4%) were included, mean age 54 years. Fasting alone VS overall purgative preparations pooled rate difference (RD) was 0.15 I2=81.5% p: 0.000. Sub-analysis for preparation schedule (day-before, split and same-day) and the time lapse showed that administration of PEG after the ingestion of capsule had the highest rate of adequate small bowel cleansing with a RD 0.33, administration between 1 and 6h before SBCE had a RD 0.28, 6 to 12h had a RD 0.21 and ≥12h had a RD 0.05. Timing of ingestion was found to be critical for bowel cleansing; the shorter time laps between the ingestion last dose of laxative and SBCE, the better was the mucosal visualization.