Empagliflozin cardiovascular and renal effectiveness and safety compared to dipeptidyl peptidase-4 inhibitors across 11 countries in Europe and Asia : Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study

Background: Continued expansion of indications for sodium-glucose cotransporter-2 inhibitors increases importance of evaluating cardiovascular and kidney efficacy and safety of empagliflozin in patients with type 2 diabetes compared to similar therapies. Methods: The EMPRISE Europe and Asia study is a non-interventional cohort study using data from 2014 -2019 in seven European (Denmark, Finland, Germany, Norway, Spain, Sweden, United Kingdom) and four Asian (Israel, Japan, South Korea, Taiwan) countries. Patients with type 2 diabetes initiating empagliflozin were 1:1 propensity score matched to patients initiating dipeptidyl peptidase-4 inhibitors. Primary end-points included hospitalization for heart failure, all-cause mortality, myocardial infarction and stroke. Other cardiovascular, renal, and safety outcomes were examined.Findings: Among 83,946 matched patient pairs, (0.7 years overall mean follow-up time), initiation of empagli-flozin was associated with lower risk of hospitalization for heart failure compared to dipeptidyl peptidase-4 inhibitors (Hazard Ratio 0.70; 95% CI 0.60 to 0.83). Risks of all-cause mortality (0.55; 0.48 to 0.63), stroke (0. 82; 0.71 to 0.96), and end-stage renal disease (0.43; 0.30 to 0.63) were lower and risk for myocardial infarc-tion, bone fracture, severe hypoglycemia, and lower-limb amputation were similar between initiators of empagliflozin and dipeptidyl peptidase-4 inhibitors. Initiation of empagliflozin was associated with higher risk for diabetic ketoacidosis (1.97; 1.28 to 3.03) compared to dipeptidyl peptidase-4 inhibitors. Results were consistent across continents and regions.Interpretation: Results from this EMPRISE Europe and Asia study complements previous clinical trials and real-world studies by providing further evidence of the beneficial cardiorenal effects and overall safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors.(c) 2023 The Authors. Published by Elsevier Masson SAS. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)Peer reviewe

Second victim: Malpractice disputes and quality of life among primary care physicians

Purpose: The health of physicians can have a strong impact on the quality and safety of the health care they provide. Studies have shown a link between work stress, burnout, and depression. The aim of this study was to examine the association between malpractice dispute experiences and the well-being of physicians. Methods: We conducted a cross-sectional survey to collect information about the malpractice experiences of primary care physicians in 2004. Data on sociodemographic and clinical characteristics and SF-36 measures were also collected. We used propensity score matching to estimate the association of medical malpractice experience with the general health, mental health, and vitality of physicians. Results: Among the 1206 primary care physicians who completed the survey (response rate of 13.4%), 25.2% reported having ever experienced a malpractice dispute. After adjustment for baseline variables, physicians who had experienced a malpractice dispute had significantly worse health-related quality of life with regard to general health [−4.85; 95% confidence interval (CI), −7.61 to −1.80; P = 0.0016], mental health (−2.68; 95% CI, −5.03 to −0.34; P = 0.0252), and vitality (−3.28; 95% CI, −6.10 to −0.47; P = 0.0224). The effects were particularly strong among physicians specializing in surgery or obstetrics and gynecology. Conclusion: The results reveal that a malpractice dispute can have a long-term negative effect on the health of physicians. Harm reduction programs for physicians involved in malpractice disputes should be implemented. Keywords: Health-related quality of life, Medical malpractice, Physician, Propensity score matchin

Cost-effectiveness analysis of quadrivalent versus trivalent influenza vaccine in Taiwan: A lifetime multi-cohort model

A government-funded trivalent influenza vaccine (TIV) program to prevent seasonal influenza was implemented in Taiwan since 1998. However, mismatch between the vaccine and circulating strains may occur. Alternatively, a quadrivalent influenza vaccine (QIV) includes all 4 influenza lineages could minimize the risk of mismatches. Therefore, QIV could be considered as an alternative strategy to enhance protection against seasonal influenza. The objective of the study was to analyze, from a governmental perspective, the cost-effectiveness of using QIV vs. TIV as a vaccination strategy in Taiwan. A lifetime multi-cohort, static Markov model was constructed with 9 age groups to assess the costs and effectiveness of QIV vs. TIV. Direct costs were obtained from a database released by the Ministry of Health and Welfare. Outcomes included life-years gained, quality-adjusted life years (QALYs) gained, influenza cases avoided and incremental cost-effectiveness ratios (ICERs). The discount rate of costs and effectiveness was set at 3.5% and the time horizon used in the model was 100 y. Results show that a vaccination strategy utilizing QIV instead of TIV would bring an additional 10,557 QALYs at an extra cost of US$39.4 million, yielding an ICER of US$3,015.07 per QALY gained. When setting the willingness-to-pay threshold at US$10,000, compared to TIV, the probability that QIV would be cost-effective was 98%. Sensitivity analyses show that ICER was sensitive to the changes of circulation of influenza virus subtypes and vaccine mismatch. From a governmental perspective, the QIV vaccination could be considered as a cost-effective strategy within the context of public health in Taiwan

Is normal-tension glaucoma a risk factor for stroke?-A 10-year follow-up study.

To investigate whether patients with normal-tension glaucoma (NTG) have a higher incidence of stroke.A population-based retrospective cohort study based on data from the Taiwan National Health Insurance Research Database (NHIRD) from January 1, 2001, to December 31, 2010.Data were retrospectively collected from the NHIRD. A total of 245 (20.1%) patients with a history of stroke at the time of glaucoma diagnosis were excluded, and 1,218 patients with NTG who were 20 years of age and older were identified. Patients' age, gender and pre-existing comorbidities, including hypertension, diabetes, congestive heart failure, ischemic heart disease, atrial fibrillation and disorders of lipid metabolism, were recorded. The propensity score method with a 1:5 matching ratio was used to minimize selection bias. Cox regression with robust variance estimation was used to estimate the hazard ratio (HR) of developing stroke between the NTG and control groups.After adjusting for patient age, gender, and pre-existing comorbidities, the HR was 6.34, indicating that the incidence of stroke was significantly higher in patients with NTG than in controls. Furthermore, a higher risk of stroke was also found in most subgroups with the above-mentioned comorbidities.NTG is a significant risk factor for subsequent stroke in most of the described comorbidity subgroups. Early interventions for stroke prevention should be provided to newly diagnosed patients with NTG

Effects of laparoscopic surgery on survival, quality of care and utilization in patients with colon cancer: a population-based study

<p><b>Objective:</b> Laparoscopy is a safe and effective treatment for colon cancer. However, its effects on short- and long-term health outcomes and medical utilization are not fully elucidated. This study aimed to compare short- and long-term utilization and health outcomes of colon cancer patients who underwent either laparoscopic or open surgery in a population-based cohort.</p> <p><b>Methods:</b> This study was conducted by linking data from Taiwan Cancer Registry, National Health Insurance claims and Death Registry. Patients aged 18 and older with colon cancer between 2009 and 2012 were included in the study. Propensity score matching was used to minimize selection bias between laparoscopic and open surgery groups. Cox proportional hazard regression and generalized linear mixed logistic regression were used to test hypotheses.</p> <p><b>Results:</b> Among the 11,269 colon cancer patients who underwent colectomy, 3236 (28.72%) received laparoscopy and 8033 (71.28%) underwent open surgery. Patients who received laparoscopic surgery had better overall survival (HR = 0.82; 95% CI: 0.70–0.97). These patients also had lower 30 day mortality (0.44% vs. 0.91%), lower 1 year mortality (2.83% vs. 4.68%), lower overall occurrence of complications (6.16% vs. 8.77%), shorter mean length of stay (12.53 vs. 14.93 days) and lower cost for index hospitalization (US$4325.34 vs. US$4453.90). No significant differences were observed in medical utilization over a period of 365 days after the surgery.</p> <p><b>Conclusions:</b> Our results demonstrate that, in both the short- and long-term post-operation periods, laparoscopic surgery reduced the likelihood of postoperative complications, 30 day, and 1 year mortality while being no more expensive than open surgery for colon cancer.</p

Development and validation of nomograms for predicting survival probability of patients with advanced adenocarcinoma in different EGFR mutation status.

IntroductionMolecular markers are important variables in the selection of treatment for cancer patients and highly associated with their survival. Therefore, a nomogram that can predict survival probability by incorporating epidermal growth factor receptor mutation status and treatments for patients with advanced adenocarcinoma would be highly valuable. The aim of the study is to develop and validate a novel nomogram, incorporating epidermal growth factor receptor mutation status and treatments, for predicting 1-year and 2-year survival probability of patients with advanced adenocarcinoma.Material and methodsData on 13,043 patients between June 1, 2011, and December 31, 2014 were collected. Seventy percent of them were randomly assigned to the training cohort for nomogram development, and the remaining 30% assigned to the validation cohort. The most important factors for constructing the nomogram were identified using multivariable Cox regression analysis. The discriminative ability and calibration of the nomograms were tested using C-statistics, calibration plots, and Kaplan-Meier curves.ResultsIn the training cohort, 1-year and 2-year OS were 52.8% and 28.5% in EGFR(-) patients, and 73.9% and 44.1% in EGFR(+) patients, respectively. In EGFR(+) group, factors selected were age, gender, congestive heart failure, renal disease, number of lymph node examined, tumor stage, surgical intervention, radiotherapy, first-line chemotherapy, ECOG performance status, malignant pleural effusion, and smoking. In EGFR(-) group, factors selected were age, gender, myocardial infarction, cerebrovascular disease, chronic pulmonary disease, number of lymph node examined, tumor stage, surgical intervention, radiotherapy, ECOG performance status, malignant pleural effusion, and a history of smoking. Two nomograms show good accuracy in predicting OS, with a concordance index of 0.83 in EGFR(+) and of 0.88 in EGFR(-).ConclusionsThe survival prediction models can be used to make individualized predictions with different EGFR mutation status and a useful tool for selecting regimens for treating advanced adenocarcinoma

Demographic characteristics and comorbid medical disorders for patients with NTG and patients in a comparison group in Taiwan, 2001–2010 (N = 5,658).

<p>Demographic characteristics and comorbid medical disorders for patients with NTG and patients in a comparison group in Taiwan, 2001–2010 (N = 5,658).</p

Adjusted HR for stroke during the follow-up period for patients with NTG as compared with patients in the comparison group, stratified by different comorbidities.

<p>Adjusted HR for stroke during the follow-up period for patients with NTG as compared with patients in the comparison group, stratified by different comorbidities.</p

Table_1_Clinical outcomes and cumulative healthcare costs of TAVR vs. SAVR in Asia.PDF

ObjectivesThis study compared transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in terms of short- and long-term effectiveness.MethodsThis retrospective cohort study based on nationwide National Health Insurance claims data and Cause of Death data focused on adult patients (n = 3,643) who received SAVR (79%) or TAVR (21%) between 2015 and 2019. Propensity score overlap weighting was applied to account for selection bias. Primary outcomes included all-cause mortality (ACM), hospitalization for heart failure, and a composite endpoint of major adverse cardiac events (MACE). Secondary outcomes included medical utilization, hospital stay, and total medical costs at index admission for the procedure and in various post-procedure periods. The Cox proportional-hazard model with competing risk was used to investigate survival and incidental health outcomes. Generalized estimation equation (GEE) models were used to estimate differences in the utilization of medical resources and overall costs.ResultsAfter weighting, the mean age of the patients was 77.98 ± 5.86 years in the TAVR group and 77.98 ± 2.55 years in the SAVR group. More than half of the patients were female (53.94%). The incidence of negative outcomes was lower in the TAVR group than in the SAVR group, including 1-year ACM (11.39 vs. 17.98%) and 3-year ACM (15.77 vs. 23.85%). The risk of ACM was lower in the TAVR group (HR [95% CI]: 0.61 [0.44–0.84]; P = 0.002) as was the risk of CV death (HR [95% CI]: 0.47 [0.30–0.74]; P = 0.001) or MACE (HR [95% CI]: 0.66 [0.46–0.96]; P = 0.0274). Total medical costs were significantly higher in the TAVR group than in the SAVR in the first year after the procedure ($1,271.89 ± 4,048.36 vs.$887.20 ± 978.51; P = 0.0266); however, costs were similar in the second and third years after the procedure. The cumulative total medical costs after the procedure were significantly higher in the TAVR group than in the SAVR group (adjusted difference: $420.49 ± 176.48; P = 0.0172).ConclusionIn this real-world cohort of patients with aortic stenosis, TAVR proved superior to SAVR in terms of clinical outcomes and survival with comparable medical utilization after the procedure.</p