Real-world Retrospective Study Research Articles

Efficacy and safety of ixekizumab in psoriatic patients: a long-term real-world retrospective multicenter study from Southern Italy.

This is a long-term retrospective multicenter study on adult patients with moderate to severe psoriasis in order to assess long-term efficacy and safety of ixekizumab in a real-world setting. Our observation took into account all patients who started treatment between July 1, 2017 and December 31, 2019 maintaining the treatment for at least 4 years. The majority of our cohort (52 patients; 74.3%) was between 260 and 312 weeks (6 years) under continuous treatment with ixekizumab. Our data confirm that ixekizumab may be considered a long-term effective and safe therapeutic option of moderate to severe plaque psoriasis.

One-Year Outcomes of Aflibercept in Treat-and-Extend Versus Pro Re Nata Regimens for Bevacizumab-Resistant Diabetic Macular Edema: A Real-World Study.

The aim of this study was to compare the efficacy of the treat-and-extend (TAE) regimen versus the pro re nata (PRN) regimen in patients with bevacizumab-resistant diabetic macular edema (DME) treated with aflibercept, with or without adjunctive laser therapy. Ninety-one eyes from 91 patients who were switched to aflibercept after three consecutive intravitreal bevacizumab injections for the treatment of DME were included in this retrospective real-world study. The patients were categorized into three groups: TAE (n = 30), TAE + laser (n = 31), and PRN (n = 30). Changes in best-corrected visual acuity and central macular subfield thickness (CMST) at 12, 24, and 52weeks were defined as the primary functional and anatomical outcomes. A total of 91 eyes from 91 patients (49.5% female) with a mean age of 63.9 ± 7.1years were included in the analysis. At 52weeks, the mean letter gains were 8.03, 8.90, and 10.23 in the TAE, TAE + laser, and PRN groups, respectively. Anatomical improvements, as measured by CMST reduction, were 55.33µm, 33.35µm, and 48.96µm in the TAE, TAE + laser, and PRN groups, respectively. The average number of injections administered was 7.7, 8.1, and 8.1, respectively. The final extension interval for the TAE group was 8.7weeks, compared to 9.5weeks in the TAE + laser group. The PRN group demonstrated the highest functional improvement while the TAE group showed the greatest anatomical improvement. Overall, both anatomical and functional outcomes in the TAE regimen were comparable to the PRN regimen in patients with bevacizumab-resistant diabetic macular edema.

Correlation between thyroid dysfunction and efficacy of immune checkpoint inhibitors in patients with advanced solid tumors

BackgroundImmune checkpoint inhibitors (ICIs) are currently the first line of tumor immunotherapy for the treatment of a wide range of tumors. However, the main side effect of immune checkpoint inhibitors is that they cause immune-related adverse events (irAEs) in patients. The relationship between the occurrence of immune side effects in patients and efficacy is controversial. The objective of this study was to confirm the relationship between patients who develop thyroid dysfunction after immune checkpoint inhibitors and efficacy.MethodsThis study was a retrospective real-world clinical study, and a total of 50 patients with advanced tumors treated with immune checkpoint inhibitors at Anqing People's Hospital from 2020.8 to 2022.5 were retrospectively collected. Among them, 30 patients with hypothyroidism and 20 patients with normal or hyperthyroidism occurred, and the treatment effects and prognostic differences between the two groups were compared.FindingAfter PD1 treatment in all patients, there were 10 cases of partial remission(PR), 18 cases of stable disease(SD) and 2 cases of progressive disease(PD) in patients who developed hypothyroidism, with a disease control rate(DCR) of 93.3% and objective remission rate(ORR) of 33.3%. There were 0 complete remission (CR) patient, 3 PR patients, 11 SD patients, 6 PD patients, 70.0% DCR and 15.0% ORR in patients who did not develop hypothyroidism. The DCR and ORR of patients who developed hypothyroidism were better than those of non-hypothyroid patients, and the difference was statistically significant (P < 0.05). Kaplan–Meier survival analysis showed that progression-free survival (PFS) reached 9.2 months (95% CI 7.726–10.779) in patients who developed hypothyroidism and did not hypothyroidism patients have a PFS of 7.3 months (95% CI 5.604–8.505), with a statistically significant difference (P = 0.0341 < 0.05). Further subgroup analysis revealed that among patients who developed hypothyroidism, PFS was 3.3 months (95% CI 0.630–5.440) in patients with cholangiocarcinoma, 6.89 months (95% CI 5.604–8.505) in patients with non-small cell lung cancer, > 12 months in patients with hepatocellular carcinoma, and 11.05 months (95% CI 9.308–12.792) in patients with esophageal cancer months and PFS for patients with gastric cancer was 9.74 months (95% CI 6.979–12.502).InterpretationWhen patients with advanced tumors were treated with immune checkpoint inhibitors, DCR and ORR were higher in patients who developed hypothyroidism, and patients had better PFS. The benefits were greater in patients with gastric, esophageal, and hepatocellular carcinomas.

Depigmented, polymerized cat epithelium extract is safe and improves rhinitis and asthma symptoms in cat allergic patients: A real-world retrospective study.

Cat allergy is often difficult to avoid. Here, we evaluated the safety and effectiveness of a depigmented, polymerized cat epithelium extract (Dpg-pol-cat) for the treatment of allergic rhinoconjunctivitis and asthma. Real-world, retrospective study of patients ≥12 years with cat allergy and moderate to severe allergic rhinitis/rhinoconjunctivitis, with or without asthma, who started allergen immunotherapy (AIT) with Dpg-pol-cat extract during routine visits to the Allergy Department. Safety and effectiveness (improvement in FEV1) of AIT were evaluated. The use of rescue medication and patient perceptions were also assessed. A total of 62 patients were included, of which 34 (54.8%) received at least 12 months of AIT. There were 15 adverse reactions, 8 local and 7 systemic, of which 3 led to AIT discontinuation. Patients with moderate to severe rhinitis decreased from 88.2% at baseline to 29.4% at 12 months (p <0.0001), and patients with moderate asthma decreased from 76.5% to 38.2% (p = 0.0004). FEV1 improved from a mean (SD) of 3188.9 (771.4) ml to 3419.6 (878.4) ml (p = 0.0023). The use of rescue medications for rhinitis decreased from 94.1% to 23.5% (p <0.0001), all patients requiring rescue medications for conjunctivitis (20.6%) were medication free at 12 months, and 97.1% and 92.6% of patients reported improvement in rhinitis and asthma symptoms, respectively. AIT with Dpg-pol-cat extract shows a favorable safety and effectiveness profile in patients with allergic rhinitis/rhinoconjunctivitis, with or without allergic asthma, due to cat allergy, representing a valuable treatment option for these patients.

Abstract 4138813: The Use of Direct Oral Anticoagulants for Valvular Atrial Fibrillation in Central Australia

Background: In developed countries, valvular atrial fibrillation (vAF) in the setting of rheumatic heart disease (RHD) disproportionately impacts minority groups. In Australia, Indigenous Australians account for 92% of cases despite only representing 3.8% of the population. Studies to date, such as the INVICTUS trial, support the use of Vitamin K antagonists (VKAs) over direct oral anticoagulants (DOACs) in vAF. However, this assumes consistent adherence and regular clinic follow up. Reduced access to monitoring and dispensing clinics in Central Australia remains a challenge in the provision of VKAs and the use of DOACs may address this. Hypothesis: DOACs may be comparably effective with VKAs in preventing major adverse cardiac and cerebrovascular events (MACCE) in a real-world vAF population. Aim: To conduct a real-world retrospective observational study examining rates of MACCE for patients on VKAs or DOACs for vAF in Central Australia over a five-year period. Methods: The Northern Territory RHD Register was accessed to identify patients with RHD and vAF in January 2019. Demographic and five-year outcome data (until January 2024) were collected. The primary outcome was MACCE, a composite of ischaemic stroke, systemic embolism, non-fatal myocardial infarction, cardiovascular death and all-cause mortality. The primary safety endpoint was major bleeding. Statistical analyses were conducted as both intention-to-treat (ITT) based on initial anticoagulation and as-treated (AT) based on anticoagulation prior to MACCE or trial endpoint, each excluding patients without anticoagulation. Results: 61 patients were included. The mean age was 61.9 ± 13.9 years and 68.9% were female. At baseline, 65.6% received VKA, 14.8% DOAC and 19.7% were not anticoagulated. 30.6% of patients crossed over from the ITT analysis, with a non-significant trend favouring switch to DOAC (11 vs 0, p=0.09). In the ITT analysis (n=49), there was no significant difference in MACCE (25.0% vs 22.2%, p=0.86) or major bleeding (20.0% vs 11.1%, p=0.53) between VKA and DOAC groups. In the AT analysis (n=51), there was no significant difference in MACCE (27.3% vs 16.7%, p=0.39) or major bleeding (18.2% vs 22.2%, p=0.73) between VKA and DOAC groups. Conclusion: Over a five-year period, there was a trend towards use of DOACs over VKAs in vAF. This study demonstrates that DOACs may be as effective as VKAs for reducing MACCE in a real-world vAF population however further investigation is required.

Real-World Performance of Excimer Laser Ablation Combined with Drug-Coated Balloon Versus Drug-Coated Balloon for the Treatment of Femoropopliteal In-Stent Restenosis Disease.

This study aims to assess the effectiveness and identify the risk factors associated with postoperative restenosis in patients with femoropopliteal in-stent restenosis (FP-ISR) disease treated with excimer laser ablation (ELA) combined with drug-coated balloon (DCB) versus DCB alone. This retrospective real-world study compares patients with FP-ISR treated with ELA + DCB versus DCB alone. Additionally, subgroup analysis was conducted for long-segment lesions (lesion length ≥200 mm) and Tosaka III lesions. Then Cox regression analysis was used to examine 24-month outcomes of target lesion revascularization and restenosis. We found no significant differences in primary patency and freedom from clinically driven target lesion revascularization (CD-TLR) at 24 months between the ELA + DCB group (49 patients) and the DCB group (82 patients). In the subgroup analysis of long-segment lesions (target lesion length ≥200 mm), the results showed that ELA + DCB was superior to DCB at 24 months in terms of both primary patency (55.0% vs 35.3%; P = 0.048) and freedom from CD-TLR (77.8% vs 50.8%; P = 0.033). The 2 treatment methods did not show statistical significance in the subgroup analysis of Tosaka III patients. Target lesion length of ≥200 mm was found to have a significant association with restenosis (hazard ratio = 5.28; 95% CI, 2.48-11.23; P < 0.001) and freedom from CD-TLR (hazard ratio = 3.02; 95% CI, 1.02-9.30; P = 0.044) in the multivariate analysis. We do not have sufficient evidence to show a significant difference between ELA + DCB and DCB alone for FP-ISR. However, for patients with long-segment FP-ISR lesions, ELA + DCB may provide better long-term patency. Our results suggest that for patients with long-segment (≥200 mm) FP-ISR, the efficacy of ELA combined with DCB may be superior to that of DCB alone. For patients with FP-ISR <200 mm, DCB alone may achieve satisfactory efficacy, thus reducing the medical burden on patients and allowing for the selection of more appropriate treatment options for different types of lesions.

Efficacy of disitamab vedotin in non-small cell lung cancer with HER2 alterations: a multicenter, retrospective real-world study.

Non-small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) alterations poses a substantial treatment challenge. Current HER2-targeted therapies offer limited efficacy. Antibody-drug conjugates (ADCs) targeting HER2 have emerged as a promising therapeutic strategy. This study aimed to evaluate the clinical response to a novel ADC drug Disitamab vedotin (RC48) in advanced NSCLC with HER2 alterations. This study conducted a retrospective review of patients harboring HER2 alterations treated with RC48 in the real world. Clinical outcomes were evaluated in terms of objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Out of 22 patients, 21 (95.5%) received RC48 combination therapy, while one received RC48 monotherapy. The ORR of all patients reached 45.5%, and the DCR stood at 90.9%. The median PFS (mPFS) was 7.5 months. Among patients receiving RC48 combination therapy, the ORR was 47.7%, and the mPFS of 8.1 months. The combination of RC48 with platinum+/- bevacizumab resulted in the highest ORR of 71.4% (5 out of 7 patients), with HER2 TKI following at a 50.0% ORR (4 out of 8 patients). First-line (1L) treatment with RC48 showed an ORR of 62.5% (5 out of 8 patients), second-line (2L) treatments had a 57.1% ORR (4 out of 7 patients), and beyond second-line (>2L) treatments exhibited a 14.3% ORR (1 out of 7 patients). Patients with 1L, 2L, or >2L treatment had a mPFS of 8.1 months, 7.2 months, and 7.4 months, respectively. Patients with HER2 mutations or amplifications, and those with concurrent mutations and amplifications at baseline, showed mPFS of 8.1 months, 9.4 months, and 7.4 months, respectively. The mPFS was significantly longer in patients with HER2 amplification. The most common adverse events included hand-foot syndrome (54.5%), asthenia (50.0%), decreased white blood cell count (45.5%), and liver impairment (45.5%). Grade 3 adverse events occurred in one (4.5%) patient. RC48, particularly in combination regimens, demonstrates promising efficacy in advanced NSCLC with HER2 alterations. These findings underscore the need for further research to validate RC48's application in clinical practice.

Efficacy of rechallenge after first-line immunotherapy for advanced gastric cancer: A retrospective real-world study

ABSTRACT We aimed to explore the efficacy of rechallenge after first-line immunotherapy in advanced gastric cancer (AGC) and to analyze the factors affecting prognosis based on clinical characteristics. Eighty-five AGC patients who underwent rechallenged after the failure of first-line treatment with immune checkpoint inhibitors (ICIs) were retrospectively collected from July 2019 to December 2022 in Jiangsu Cancer Hospital. Potential factors affecting prognosis were analyzed by univariate and multivariate Cox analysis. Survival analysis was performed by Kaplan–Meier method and Log rank test. Stratified factors included human epidermal growth factor receptor 2 (HER-2) and programmed cell death-ligand 1 combined positive score (PD-L1 CPS). The objective response rate (ORR) was 15.3%, and the disease control rate (DCR) was 74.1%. The median progression-free survival (PFS) was 4.8 months. Results showed that patients in the I + C group had the best response. The ORR was 20.0% VS 8.7% in the I + C group and I + C + AAD group. The DCR was 78.0% VS 65.2%, and the median PFS was 6.7 VS 4.7 months [hazard ratio (HR): 0.55, 95% confidence interval (CI): 0.30–1.00, p = .022]. The ORR was 20.0% VS 8.3% in the I + C group and I + C + ADC group. The DCR was 78.0% VS 75.0%, and the median PFS was 6.7 VS 4.4 months (HR: 0.59, 95%CI: 0.26–1.30, p = .112). The median PFS was 4.7 VS 4.4 months in the I + C + AAD group and I + C + ADC group (HR: 1.21, 95%CI: 0.60–2.47, p = .580). Adverse events (AEs) were found in 34 patients, mainly including leukopenia 9 (10.6%), and neutropenia 8 (9.4%). The incidence of grade 3–4 AEs was 8.2%. There were no drug-related deaths and all AEs were manageable. Rechallenge after first-line immunotherapy showed good survival benefit and acceptable safety in the therapy of AGC. Especially for patients with HER-2-positive and PD-L1 CPS ≥ 1%, rechallenge may be an effective treatment modality.

Effectiveness of a Combination of Nasturtium Herb and Horseradish Root (Angocin®Anti-Infekt N) Compared to Antibiotics in Managing Acute and Recurrent Urinary Tract Infections: A Retrospective Real-world Cohort Study.

The goal of this study was to evaluate whether the medical recommendation of Angocin®Anti-Infekt N, compared to standard antibiotic treatment shortly after the diagnosis of a urinary tract infection (UTI) or cystitis, is negatively associated with an early, sporadic, or recurrent UTI, subsequent antibiotic prescriptions, pyelonephritis as a renal complication, or UTI-associated sick leave. This retrospective cohort study was based on data from the IQVIATM Disease Analyzer database and included patients diagnosed with acute UTI or cystitis by physicians in Germany between 2005 and 2021, who were prescribed either Angocin® or standard antibiotics within 4 days after diagnosis. Patients prescribed antibiotics were matched to those prescribed Angocin® (5:1) using propensity scores. Univariable logistic and Cox regression models were used to investigate the association between Angocin® prescription and the defined study outcomes. The effects of Angocin® were adjusted for age, sex, insurance status, index diagnosis, and physician specialty. A total of 2277 Angocin® patients and 11,385 antibiotic patients were available for analysis. Compared to antibiotic prescriptions, Angocin® prescription was associated with significantly lower odds of an early relapse within 1-30 days after the index date (odds ratio (OR): 0.74; 95% confidence interval (CI): 0.62-0.87; p < 0.001), further sporadic UTI within 31-365 days after the index date (OR: 0.68; 95% CI: 0.58-0.78; p < 0.001), and recurrent UTI (OR: 0.63; 95% CI: 0.48-0.82; p < 0.001). This was also accompanied by reduced antibiotic prescriptions (1-30 days: OR: 0.63; 95% CI: 0.53-0.74, p < 0.001; 31-365 days: OR: 0.56; 95% CI: 0.49-0.64, p < 0.001). A strong, but due to the low incidence, not significant, negative association was observed between Angocin® prescription and the occurrence of pyelonephritis (hazard ratio (HR): 0.67; 95% CI: 0.43-1.06; p = 0.073). The results of this real-world data study demonstrate that Angocin® can be an effective therapeutic option for managing acute and recurrent UTIs and serves as an alternative therapy to antibiotics.

Clinical Features, Management, and Recurrence of Acute Ischemic Stroke Occurring in Patients on Oral Anticoagulant Treatment for Nonvalvular Atrial Fibrillation: A Real-World Retrospective Study.

The optimal management of acute ischemic stroke (AIS) in patients with oral anticoagulation (OA) is challenging. Our study aimed to analyze the clinical characteristics and outcome of AIS in patients with OA for nonvalvular atrial fibrillation (NVAF). We retrospectively analyzed data on NVAF patients with AIS on direct oral anticoagulants (DOAC) or vitamin K antagonists (VKA) admitted to our Stroke Unit from 2017 to 2022. Ninety-day modified Rankin Scale (mRS), 90-day, and 12-month stroke recurrences were recorded. A total of 169 patients (53.2% female, mean age 82.8±6.7 y), 117 (69.2%) on DOAC, and 52 on VKA (30.8%), were enrolled. Mean age, in-hospital mortality, and 90-day mRS ≥4 were significantly higher in VKA patients. 63.4% of VKA patients had subtherapeutic INR, whereas 47.1% of DOAC patients were on low-dose (14.2% off-label). Large vessel occlusion and embolic etiology were more frequent in VKA patients (34.6% vs. 26.4%, P =0.358; 92.3% vs. 74.3%, P =0.007, respectively), whereas lacunar strokes were more frequent in DOAC patients (19.8% vs. 12.2%, P =0.366). Among patients on VKA before AIS 86.4% were switched to DOAC, whereas a DOAC-to-VKA and a DOAC-to-DOAC switch were done in 25.4% and 11.7%, respectively. Stroke recurrence occurred in 6.4% of patients at 90 days and 10.7% at 12 months. Anticoagulant switching was not associated with stroke recurrences. In our study, nonembolic etiology was more frequent in DOAC patients and anticoagulant switching did not reduce the risk of stroke recurrence. Prospective multicentric studies are warranted.

Real-world use of immune checkpoint inhibitors in advanced or recurrent endometrial cancer

ObjectiveThe aim of this study was to describe real-world use of immune checkpoint inhibitors for women with advanced or recurrent endometrial cancer.MethodsAdult women with advanced or recurrent endometrial cancer who...

P128 ArtemisR: Final analysis of a European real-world retrospective study of mHSPC patients treated with apalutamide

P128 ArtemisR: Final analysis of a European real-world retrospective study of mHSPC patients treated with apalutamide

Thyroid-stimulating hormone suppression in low-risk papillary thyroid cancer: a large-scale retrospective analysis of real-world data

Over 500,000 new cases are diagnosed with papillary thyroid cancer (PTC) globally per year, of whom the vast majority are in the low-risk stratification. Although thyroid-stimulating hormone (TSH) suppression is traditionally recommended for all postoperative PTCs in current guidelines, its necessity remains highly controversial in low-risk patients. Since relevant recommendations in current guidelines are still empirical, we aim to provide a direct, large-scale, real-world evidence. This large-scale real-world retrospective study included 11,140 low-risk PTC patients from two Chinese large-volume centers (Fudan University Shanghai Cancer Center [FUSCC] and Cancer Hospital of Chinese Academy of Medical Sciences [CH-CAMS]) treated from January 1, 2000 to June 30, 2022. The mean TSH level was calculated based on postoperative serum TSH values during follow-up. The primary outcome was the association between postoperative TSH level and structural recurrence assessed by Kaplan-Meier, log-rank, multivariate Cox regression analyses and equivalence testing by Two One-Sided Tests (TOST) procedure. Propensity score matching (PSM) was used to adjust for confounders among groups. A total of 11,140 patients with low-risk PTC were included with a median follow-up of 70 months. Based on the mean TSH level, we classified these patients into ≤0.5 (n=1,504, 13.5%), (0.5-1] (n=4,336, 38.9%), (1-2] (n=4,285, 38.5%), (2-3] (n=704, 6.3%) and >3 (n=311, 2.8%) mU/L groups. After PSM adjusting for age, sex, T and N stage, 8991 patients were included in further analysis, for whom the log-rank analyses showed no significant differences between any two groups (all P>0.05) in recurrence-free survival (RFS), locoregional recurrence-free survival (LRRFS) and distant metastasis-free survival (DMFS), and suppressed TSH was not associated with tumor recurrence in the multivariate Cox analysis (TSH > 2 group vs TSH ≤ 2 group: HR=1.30, 95% CI=0.85-2.01, P=0.23). Furthermore, the TOST equivalence tests showed that tumor recurrence status of any two TSH groups were statistically comparable (all Bonferroni-corrected P values<0.005). Subgroup multivariate analyses showed that TSH level did not impact tumor recurrence regardless of age, tumor size, lymph node metastasis, multifocality, surgical extent, biochemical evidence. Our results suggested that postoperative TSH level was not associated with tumor recurrence in patients with low-risk PTC, for whom deliberate TSH suppression may be exempted to avoid potential secondary complications. Maintaining a TSH level within the normal range may be safe for these patients. The study was supported by the National Natural Science Foundation of China (82072951 to Y.W.; 82373008 to X.S.), Shanghai Hospital Development Center (SHDC2020CR6003-001 to Y.W., SHDC2024CRI087 to Y.-J.W.), the Science and Technology Commission of Shanghai Municipality (22Y21900100/23DZ2305600 to Y.W.; 23ZR1412000 to X.S.), the Shanghai Anticancer Association Foundation (SACA-AX202213 to Yu Wang), Shanghai Municipal Health Commission and Shanghai Medicine and Health Development Foundation (WJWRC202302 to X.S.).

Using machine learning approaches to develop a fast and easy-to-perform diagnostic tool for patients with light chain amyloidosis: a retrospective real-world study.

Immunoglobulin light chain (AL) amyloidosis is a severe disorder caused by the accumulation of amyloid fibrils, leading to organ failure. Early diagnosis is crucial to prevent irreversible damage, yet it remains a challenge due to nonspecific symptoms that often appear later in the disease progression. A retrospective study analyzed data collected from 133 AL amyloidosis patients and 271 non-AL patients with similar symptoms but different diagnoses between January 1st, 2017, and September 30th, 2022. Demographic data and laboratory test results were collected. Subsequently, significant features were identified by both logistic regression and independent expert clinical ability. Eventually, logistic regression and four machine learning (ML) algorithms were employed to construct a diagnostic model, utilizing fivefold cross-validation and blind set testing to identify the optimal model. The study successfully identified nine independent predictors of AL amyloidosis patients with kidney or cardiac involvement, respectively. Two models were developed to identify key features that distinguish AL amyloidosis from nephrotic syndrome and hypertrophic cardiomyopathy, respectively. The light gradient boosting machine (LightGBM) model emerged as the most effective, demonstrating superior performance with the area under curve (AUC) of 0.90 in both models, alongside high sensitivity, specificity, and F1-score. This research highlights the potential of using a machine learning-based LightGBM model to facilitate early and accurate diagnosis of AL amyloidosis. The model's effectiveness suggests it could be a valuable tool in clinical settings, aiding in the timely identification of AL amyloidosis among patients with non-specific symptoms. Further validation in diverse populations is recommended to establish its universal applicability.

Disparities in SGLT2i utilization among heart failure patients with different ejection fraction in China: findings from chinese cardiovascular association database-heart failure center registry

Abstract Background Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are recommended for heart failure (HF) patients regardless of left ventricular ejection fraction (LVEF). Although Chinese HF guidelines still recommend traditional renin–angiotensin–aldosterone system inhibitors, beta blockers, mineralocorticoid receptor antagonists, the Chinese Cardiovascular Association (CCA) HF Center Registry has launched a project to promote the guideline-directed medical therapy (GDMT) for HF patients in China. However, data on the utilization of GDMT in Chinese HF patients is scarce, especially SGLT2i. Purpose We aimed to investigate the usage status of SGLT2i in HF patients with different LVEFs and explore associated factors with SGLT2i adoption in hospitalized HF Chinese patients. Methods This is a retrospective real world study using data from the CCA Database-HF Center Registry. The study included HF patients hospitalized in 52 secondary or tertiary hospitals, including 26 accredited heart failure centers (HFC) and 26 non-accredited heart failure centers (NHFC). Centers that meet the 25 quality control standards established by CCA can be accredited as HFC. We evaluated the use rate of SGLT2i overall and by HF type, as well as the change of SGLT2i usage rate at discharge during the study period from 1st July 2022 to 31st March 2023. LASSO and multivariable logistic regression were also used to explore associated factors of SGLT2i adoption at discharge. Result We included 8,843 hospitalized HF patients: 5,326 (60.2%) were male, 2,980 (33.7%) HFrEF, 1,624 (18.4%) HFmrEF, 3,653 (41.3%) HFpEF and 586 (6.6%) lacked EF data. Overall, SGLT2i were adopted in 3,666 (41.5%) HF patients at discharge (58.1% in HFrEF, 45.3% in HFmrEF, 28.8% in HFpEF). Overall, the usage rate of SGLT2i at discharge rose from 35.2% to 50.2%. Specifically, for HFrEF patients, there was a rise from 56.2% to 64.4%. For HFmrEF and HFpEF patients, the usage rate increased from 37.5% to 54.4% and from 22.2% to 35.7%, respectively (Figure 1). The usage rate of SGLT2i was higher in HFC compared with NHFC (47.1% vs. 35.8%, p&amp;lt;0.001). In multivariable logistic regression, older age, new-onset heart failure, hospital location, etc. were associated with a lower usage rate of SGLT2i at discharge. In contrast, HFC, dilated cardiomyopathy, obesity, etc. were associated with a higher utilization rate of SGLT2i (Figure 2). HF classification by LVEF was also an independent influencing factor even after adjusting other factors; when HFrEF was used as a reference, the use rate of SGLT2i was lower in HFmrEF (OR 0.79, 95% CI 0.69 - 0.91) and HFpEF (OR 0.44, 95% CI 0.39 - 0.49). Conclusion In clinical practice in China, the usage rate of SGLT2i for HF treatment is increasing but needs to be further improved. Disparities exist in usage rates among HF patients with different LVEFs. Addressing this disparity necessitates a targeted approach, emphasizing increased utilization in HF patients regardless of LVEF.SGLT2i usage rate in HFFactors affecting SGLT2i adoption in HF

Effects of Concurrent Administration of Spironolactone in Veterans with Metastatic Prostate Cancer Receiving Abiraterone: A Real-World Retrospective Study.

Prostate cancer is the most common cancer in men in the United States with low survival rates once metastasized. Abiraterone is approved for use in castrate-sensitive and castrate-resistant prostate cancer and is used extensively in the Veterans Affairs (VA) healthcare system. Spironolactone, a diuretic used to treat heart failure, edema, ascites, and hypertension, may increase androgen levels and reduce effectiveness of abiraterone when used concurrently to treat prostate cancer patients. While previous case studies support this, no large epidemiology studies have been conducted. The current study utilizes the large, VA prostate cancer data core and evaluates the effect of concomitant spironolactone on efficacy of abiraterone treatment in metastatic prostate cancer patients. The study selected 18,943 veterans with metastatic prostate cancer on abiraterone treatment. Of these, 581 patients (3.1%) were also on concomitant spironolactone. The concomitant treatment group, abiraterone + spironolactone, significantly differed from the abiraterone-only group in body mass index, prevalence rates of heart failure and liver disease, and being previously treated with docetaxel. A 1:1 propensity score matching method was used to balance sample sizes and baseline traits between the two treatment groups, abiraterone versus abiraterone + spironolactone. Kaplan-Meier curves and Cox proportional hazard model were used to compare 5-year overall survival and all-cause mortality outcomes, respectively, between the two groups. After propensity score matched, the abiraterone + spironolactone group was treated with abiraterone significantly longer than the abiraterone-only group (mean ± standard deviation days 549.0 ± 552.3 vs. 435.5 ± 474.1; p = 0.0002) and had a higher 5-year overall survival rate (44% vs. 37%; p = 0.0116). Veterans with metastatic prostate cancer treated with abiraterone + spironolactone also had a lower 5-year all-cause mortality compared to those only on abiraterone (hazard ratio 0.80, 95% confidence intervals 0.61-0.96; p = 0.012). This large VA observational study suggests that concomitant use of spironolactone does not compromise cancer control or survival of metastatic prostate cancer patients treated with abiraterone.

Timing of inopressor initiation in patients with acute myocardial infarction complicated by cardiogenic shock

Abstract Introduction Inotropes and vasopressors (inopressors) are commonly used in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS). The characteristics of patients subjected to early or late initiation of inopressors are not yet described, and the impact of timing on outcomes remains uncertain. Purpose This retrospective real-world data study aims to identify patient-, treatment-, and outcome characteristics of AMICS patients treated with early- or late initiated inopressors. Methods The Netherlands Heart Registration (NHR) prospectively records baseline, procedural, and outcome data for PCI patients. Between 2017-2021, additional retrospective data on CS patients were collected by fourteen Dutch hospitals. Patients were categorized based on the timing of inopressor initiation, either early (pre PCI) or solely late (at the cathlab or within 24 hours after PCI). Patients presenting with an out of hospital cardiac arrest were excluded. Missing data were imputed through multiple imputation (30x). Multivariable logistic regression analysis was performed to evaluate the association between the timing of inopressor initiation and 30-day mortality, adjusting for univariate significant confounders among variables known at admission. Results A total of 956 consecutive CS patients were included of whom 418 (43.7%) and 538 (57.3%) patients were subjected to early and late initiation of inopressors respectively. The most frequently used drug in both groups was noradrenaline. At baseline, patients in the early initiation group were younger (67.4 vs. 70.0 years, p &amp;lt;0.001), presented with a lower mean arterial pressure (MAP) (72.5 vs. 76.3, p = 0.048) and higher lactate (4.2 vs. 3.6, p = 0.012), and presented with a NSTEMI more often (36.0% vs. 14.2%, p &amp;lt;0.001). They also had a higher prevalence of previous myocardial infarction (33.9% vs. 22.9%, p &amp;lt;0.001) and previous CABG (14.3% vs. 6.2%, p &amp;lt;0.001). Moreover, 30-day mortality rates were higher in the early initiated group (48.6% vs. 37.6%, pLogrank &amp;lt;0.001). After multivariate adjustment for age, admission MAP and lactate, early inopressor initiation remained independently associated with 30-day mortality (OR 1.44, 95%-CI 1.08-1.98) compared to late initiation. Conclusion In this Dutch cohort of CS patients undergoing PCI, baseline- treatment- and outcome characteristics differed between patient categories receiving either early or late initiated inopressors. Patients who were subjected to early initiated inopressors were younger, presented with worse hemodynamics, had a more extensive cardiovascular medical history and higher 30-day mortality rates. The results of this study reemphasize the importance of identifying patients who benefit from inopressors.30-day mortality late vs. earlyTable patient characteristics

One-year outcomes of a digital twin intervention for type 2 diabetes: a retrospective real-world study

This retrospective observational study, building on prior research that demonstrated the efficacy of the Digital Twin (DT) Precision Treatment Program over shorter follow-up periods​​, aimed to examine glycemic control and reduced anti-diabetic medication use after one-year in a DT commercial program. T2D patients enrolled had adequate hepatic and renal function and no recent cardiovascular events. DT intervention powered by artificial intelligence utilizes precision nutrition, activity, sleep, and deep breathing exercises. Outcome measures included HbA1c change, medication reduction, anthropometrics, insulin markers, and continuous glucose monitoring (CGM) metrics. Of 1985 enrollees, 132 (6.6%) were lost to follow-up, leaving 1853 participants who completed one-year. At one-year, participants exhibited significant reductions in HbA1c [mean change: -1.8% (SD 1.7%), p < 0.001], with 1650 (89.0%) achieving HbA1c below 7%. At baseline, participants were on mean 1.9 (SD 1.4) anti-diabetic medications, which decreased to 0.5 (SD 0.7) at one-year [change: -1.5 (SD 1.3), p < 0.001]. Significant reductions in weight [mean change: -4.8 kg (SD 6.0 kg), p < 0.001], insulin resistance [HOMA2-IR: -0.1 (SD 1.2), p < 0.001], and improvements in β-cell function [HOMA2-B: +21.6 (SD 47.7), p < 0.001] were observed, along with better CGM metrics. These findings suggest that DT intervention could play a vital role in the future of T2D care.

Effects of immunosuppressive therapy on renal prognosis in primary membranous nephropathy

BackgroundImmunosuppressive therapy plays a crucial role in treating membranous nephropathy, with previous studies highlighting its benefits for patients with primary membranous nephropathy (PMN). Guidelines suggest that the management of membranous nephropathy should be tailored to individual risk levels. However, there is a lack of real-world studies examining the effects of immunosuppressive therapy on renal outcomes in PMN patients. This study aimed to investigate the relationship between immunosuppressive therapy and renal prognosis in PMN patients.MethodsThis was a real-world retrospective study including patients diagnosed with PMN in Shenzhen Second People’s Hospital and Hechi People’s Hospital. Univariate and multivariate Cox regression analysis and Kaplan-Meier survival analysis were used.ResultsAfter propensity score-matching, 464 PMN patients were included and they were assigned to conservative and immunosuppressive group in a 1:1 ratio. Immunosuppressive therapy was the protective factor of renal composite outcome (HR = 0.65, p < 0.01). Separately, the effect was significant in moderate- and high-risk but not in low-risk patients. Key influencing factors including age, blood pressure, albumin and total cholesterol levels, with slight differences among patients at different risk.ConclusionsThis study demonstrates the efficacy of immunosuppressive therapy in non-low-risk PMN patients. The key factors affecting renal prognosis in patients with different risk levels are emphasized to help provide individualized treatment.

Risk of Surgical Site Infections after Tooth Extraction in Chronic Kidney Disease: A Retrospective Real-World Study in Japan.

Risk of Surgical Site Infections after Tooth Extraction in Chronic Kidney Disease: A Retrospective Real-World Study in Japan.