Categories
Nevin Manimala Statistics

Overall Survival with Apalutamide Versus Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer

Adv Ther. 2025 May 29. doi: 10.1007/s12325-025-03207-6. Online ahead of print.

ABSTRACT

INTRODUCTION: Survival outcomes associated with different androgen receptor pathway inhibitors (ARPIs) prescribed for the treatment of metastatic castration (hormone)-sensitive prostate cancer (mCSPC) have not been directly compared. The objective of this study was to compare overall survival (OS) by 24 months among ARPI-naïve patients with mCSPC initiating apalutamide or enzalutamide.

METHODS: A retrospective, causal longitudinal inverse probability of treatment weighted analysis was conducted to compare OS between patients initiating apalutamide or enzalutamide between December 2019 and December 2023 using de-identified linked US clinical and insurance claims data. Patients were excluded if they had prior exposure to ARPIs, had evidence of castration resistance, had < 12 months of database activity prior to ARPI initiation, were diagnosed with other primary cancers, or were treated with other advanced prostate cancer (PC)-related treatment (except docetaxel). Using an intention-to-treat approach, weighted Cox proportional hazards models were used to compare OS by 24 months between patients treated with apalutamide or enzalutamide (primary analyses; exploratory analyses used all available follow-up).

RESULTS: Overall, 1810 and 1909 ARPI-naïve patients who initiated apalutamide or enzalutamide, respectively, were included. Measured baseline characteristics between cohorts were well balanced after weighting (for both: mean age 73.0 years, ~ 60% white, ~ 23% black or African American, ~ 78% Medicare-insured, mean Quan-CCI 8.6, ~ 20% with visceral metastasis, 56.2% with de novo PC). At 24 months post index, there was a statistically significant 23% reduction in the risk of mortality among patients who initiated apalutamide compared with enzalutamide (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.62, 0.96; p = 0.019). Results remained consistent when using all available follow-up metrics (HR 0.77; 95% CI 0.64, 0.93; nominal p = 0.008).

CONCLUSION: In this head-to-head causal analysis among ARPI-naïve patients with mCSPC, treatment with apalutamide resulted in better survival outcomes at 24 months compared with enzalutamide. Longer follow-up studies are required to fully determine the therapeutic comparator impact of these agents.

PMID:40439959 | DOI:10.1007/s12325-025-03207-6

Categories
Nevin Manimala Statistics

Matching-Adjusted Indirect Comparison of Osilodrostat Versus Metyrapone for the Treatment of Cushing’s Syndrome

Adv Ther. 2025 May 29. doi: 10.1007/s12325-025-03229-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Cushing’s syndrome (CS) is a rare, chronic condition caused by prolonged exposure to elevated levels of circulating cortisol, and characterized by high morbidity and mortality. The primary treatment option for CS is surgery; however, medical therapy may be useful when surgery is unsuitable, refused, or has not been curative, or a rapid control of hypercortisolism is required. While osilodrostat and metyrapone are two treatments for controlling cortisol levels, they have not been compared directly in a clinical trial. This study evaluated the comparative efficacy and tolerability of osilodrostat versus metyrapone for the treatment of CS using indirect treatment comparison methods.

METHODS: Unanchored matching-adjusted indirect comparison was used to synthesize relative treatment effects by reweighting patient-level data from two clinical trials for osilodrostat to published aggregate data for metyrapone. Efficacy endpoints included complete response (CR), defined as mean urinary free cortisol ≤ 1.0 × the upper limit of normal, at Weeks 12, 24, and 36. Tolerability endpoints included all-cause treatment discontinuation and treatment discontinuation due to lack of efficacy (LoE) or adverse events (AEs).

RESULTS: The base case analysis demonstrated that osilodrostat provides increased odds of CR versus metyrapone at Week 12 [odds ratio (OR) 2.75; 95% confidence interval (CI) 1.29, 5.88], Week 24 (OR 3.28; 95% CI 1.58, 6.84) and Week 36 (OR 10.50; 95% CI 1.84, 59.96), implying a greater proportion of patients experience normalized cortisol levels at these time-points. Although the base case analysis showed that the odds of all-cause discontinuation and discontinuation due to LoE or AEs were numerically lower for osilodrostat, the evidence was insufficient to show a statistically significant difference.

CONCLUSION: These analyses show that osilodrostat increases the odds of achieving CR at Weeks 12, 24, and 36 versus metyrapone, demonstrating that osilodrostat is a more efficacious treatment option for normalizing cortisol levels in CS patients.

PMID:40439958 | DOI:10.1007/s12325-025-03229-0

Categories
Nevin Manimala Statistics

Dietary Intake of Major Minerals and Trace Elements in Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease: Implications for Dietary Intervention

Adv Ther. 2025 May 29. doi: 10.1007/s12325-025-03238-z. Online ahead of print.

ABSTRACT

INTRODUCTION: An imbalanced diet is one of the leading causes of metabolic dysfunction-associated steatotic liver disease (MASLD) development. Diet modification remains the leading approach in the disease management. However, the role of minerals in MASLD development and treatment is poorly understood. In this retrospective study we compared minerals intake in patients with MASLD and age- and sex-matched controls, based on the data of a food frequency questionnaire.

METHODS: A retrospective database search was performed to identify eligible data of the nutritional assessment with software based on a food frequency questionnaire. The institutional medical records of the obtained cohort were then searched for medical conditions in accordance with the inclusion/exclusion criteria. On the basis of the presence of MASLD, the subjects were allocated to either MASLD or the control group. Sex- and age-matched pairs were formed for the analysis. Consumption of major minerals and trace elements was compared using non-parametric statistics.

RESULTS: Records of 15,862 subjects were screened, and the data of 226 sex- and age-matched pairs of patients with MASLD and controls were selected for the analysis. The absolute average daily intake of most of the minerals, except silicon, cobalt, molybdenum, nickel, and chromium, was greater in the MASLD group than in the control group. However, relative value (per 1000 kcal) analysis revealed that only boron intake was greater in the MASLD group (28.3 ± 38.5 vs 19.5 ± 24.7 μg/day, p = 0.013). Subjects with MASLD exceeded the recommended daily allowance (RDA) for sodium (241% of RDA), phosphorus (211%), vanadium (1576%), manganese (410%), and selenium (197%) intake, but consumed less than the recommended amounts of silicon (5% of the RDA), molybdenum (28%), fluorine (3%), zinc (91%), and chromium (37%).

CONCLUSION: Patients with MASLD consumed greater amounts of most minerals than did the control group due to overeating. When diet modification for patients with MASLD is planned, the intake of calcium, zinc, and boron needs to be controlled, and the diet may be modified with food supplements or specific foods rich in these minerals.

PMID:40439957 | DOI:10.1007/s12325-025-03238-z

Categories
Nevin Manimala Statistics

Mendelian randomization reveals limited causal effects of genetic variants on cervical cancer risk: insights from immune cell populations

Discov Oncol. 2025 May 29;16(1):944. doi: 10.1007/s12672-025-02819-2.

ABSTRACT

BACKGROUND: Cervical cancer remains a significant global health concern, with immune system regulation potentially playing a crucial role in disease development. This study investigates potential causal relationships between genetic variants associated with immune cell populations and cervical cancer risk.

METHODS: We employed multiple Mendelian randomization (MR) approaches inverse-variance weighted, MR-Egger, simple median, and weighted median methods to evaluate genetic instrumental variables linked to various T-cell and B-cell subtypes. Differential gene expression was analyzed using single-cell RNA sequencing, while forest plots, scatter plots, and funnel plots facilitated comprehensive MR analysis.

RESULTS: Forest plots consistently demonstrated odds ratios clustered tightly around 1.000 (range: 0.998-1.001), despite some variants reaching statistical significance (p < 0.05). MR analysis of CD69 + LGALS3A + regulatory T-cells, CD8 + T-cell populations, and CD20 + B-cells revealed only weak associations with cervical cancer susceptibility. Comparative analysis across different MR methodologies produced consistent results with minimal horizontal pleiotropy bias.

CONCLUSION: While immune cell genetic factors may contribute to cervical cancer development, their causal effects appear modest. These findings suggest that genetic predisposition through immune cell regulation likely plays a supplementary rather than primary role in cervical cancer pathogenesis.

PMID:40439950 | DOI:10.1007/s12672-025-02819-2

Categories
Nevin Manimala Statistics

Energetic compounds and heavy metals in surface soil of training ranges on southeast coast of China: pollution characteristics and source analysis

Environ Monit Assess. 2025 May 29;197(6):693. doi: 10.1007/s10661-025-14130-2.

ABSTRACT

To assess the environmental impact of training activities, surface soil was systematically collected at 3 training ranges (designated as A, B1, B2) located along the southeast coast of Guangdong, China. Analytical results of energetic compounds (ECs) in soil revealed that 2,4,6-trinitrotoluene (TNT) was the predominant ECs, with a mean concentration of 234 ng/g. The detection rate for Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) was over 50%, peaking at 710 ng/g. Heavy metal analysis demonstrated significant enrichment of cadmium (Cd), mercury (Hg), lead (Pb), copper (Cu), and arsenic (As) in soil. Particularly noteworthy were the Cu and Pb concentrations in range B2, reaching maximum levels of 259 mg/kg and 801 mg/kg, respectively. Metal enrichment was predominantly attributed to metallic components and shrapnel fragments originating from explosive materials. Field investigations indicated that metallic fragments dispersed in surface soils exhibited limited weathering, with iron (Fe) constituting the primary metallic element, accompanied by trace amounts of chromium (Cr). The quantitative analysis of ECs and heavy metals concentrations suggests a clear trend of environmental accumulation. These findings underscore the necessity for implementing long-term environmental monitoring programs and conducting comprehensive risk assessments to evaluate potential ecological risks related to military training activities.

PMID:40439947 | DOI:10.1007/s10661-025-14130-2

Categories
Nevin Manimala Statistics

Evaluation of glymphatic system function in patients with thalassemia: a study based on DTI-ALPS technology

Neuroradiology. 2025 May 29. doi: 10.1007/s00234-025-03654-6. Online ahead of print.

ABSTRACT

BACKGROUND: Thalassemia is an inherited hematological disorder characterized by chronic anemia and multisystem involvement, including potential impacts on the central nervous system. Research has suggested a relationship between thalassemia and glymphatic system dysfunction, which may contribute to neurocognitive impairments. However, the exact mechanisms linking thalassemia to changes in glymphatic function remain unclear.

OBJECTIVE: To investigate the relationship between glymphatic system function and thalassemia severity, particularly in patients with transfusion-dependent and non-transfusion-dependent thalassemia.

METHODS: The study included a population of 40 thalassemia patients (TM, n = 40) confirmed through genetic testing, consisting of 19 patients who were transfusion-dependent (TDT, n = 19) and 21 patients who were non-transfusion-dependent (NTDT, n = 21), along with 39 healthy controls (HC, n = 39) matched for age and sex. Glymphatic function was assessed using the index for diffusivity along the perivascular space (ALPS-index), with regions of interest selected from the medullary veins and crossing fibers in the lateral ventricles. Statistical analyses were performed using Analysis of Variance (ANOVA) for intergroup comparisons, supplemented by Bonferroni correction for multiple comparisons. Pearson correlation was utilized to explore the relationships between the diffusion tensor image analysis along the perivascular space (DTI-ALPS) index and demographic factors, while multiple linear regression was employed to adjust for confounding variables. A significance threshold of P less than 0.05 was established for all statistical tests.

RESULTS: The mean DTI-ALPS Index for thalassemia patients were significantly lower than those of healthy controls, indicating impaired glymphatic function. No significant differences in DTI-ALPS Index were found between transfusion-dependent and non-transfusion-dependent groups. Correlation analysis showed minimal influence of age and education on glymphatic function in the study population.

CONCLUSION: This study demonstrates significant impairment in glymphatic system function in thalassemia patients, potentially related to chronic anemia and iron overload. These findings contribute to understanding the mechanisms underlying cognitive dysfunction in thalassemia.

PMID:40439942 | DOI:10.1007/s00234-025-03654-6

Categories
Nevin Manimala Statistics

Artificial intelligence in neurosurgery: a systematic review of applications, model comparisons, and ethical implications

Neurosurg Rev. 2025 May 29;48(1):455. doi: 10.1007/s10143-025-03597-9.

ABSTRACT

BACKGROUND: Artificial Intelligence (AI) has emerged as a transformative tool in medicine, particularly addressing neurosurgical challenges such as complex anatomical delineation and intraoperative decision-making. Despite advancements in diagnostic and prognostic algorithms, obstacles including algorithmic bias, data privacy, and model interpretability continue to limit its widespread clinical adoption.

OBJECTIVE: This systematic review aims to evaluate the current applications of AI in neurosurgery, compare the performance of various AI models, and examine the ethical challenges associated with their integration into clinical practice.

METHODS: A systematic literature search was conducted in PubMed, Scopus, and Web of Science databases, following PRISMA guidelines. Studies from 2015 to 2025 focusing on AI applications in diagnostic, prognostic, surgical, and intraoperative neurosurgical contexts were included. Statistical outcomes, model performance metrics, and ethical considerations were analyzed.

RESULTS: Thirteen studies met the inclusion criteria. AI models, particularly ML and DL, demonstrated superior diagnostic accuracy (AUC > 0.90) and improved prognostic predictions by up to 15%. AI-assisted surgical planning enhanced precision and reduced complication rates by 10-20%. However, algorithmic bias, limited transparency, and lack of external validation remain key barriers to clinical adoption.

CONCLUSION: AI improves diagnostic accuracy, prognostic predictions, and surgical precision while reducing complication rates. However, challenges such as bias, limited interpretability, and the need for external validation must be addressed for widespread clinical integration.

PMID:40439939 | DOI:10.1007/s10143-025-03597-9

Categories
Nevin Manimala Statistics

Opium addiction is associated with increased risk of ERCP-related complications: A matched case-control study

Indian J Gastroenterol. 2025 May 29. doi: 10.1007/s12664-025-01771-x. Online ahead of print.

ABSTRACT

OBJECTIVE: The potential impact of opium addiction on medical procedures has not been thoroughly investigated. In the present study, we aimed at investigating the potential association between opium addiction and the outcomes of endoscopic retrograde cholangiopancreatography (ERCP).

METHODS: In this retrospective case-control study, patients who underwent ERCP between July 2021 and October 2023 at a tertiary care center were screened and patients with opium addiction were matched with non-addict patients based on age, sex, ERCP indication and the cannulation approach at 1:1 ratio. The analysis compared the ERCP findings and post-ERCP complications between the two groups.

RESULTS: Overall, 276 patients with and without opium addiction were included (n = 138 for each group). The overall complication rate in the opium group was 10.1%, significantly higher than the control group (1.4%) (p = 0.003). Post-ERCP pancreatitis (5.8% vs. 1.4%, p = 0.046), bleeding (2.9% vs. 0%, p = 0.044) and perforation (1.4% vs. 0%, p = 0.156) were more common in the opium group. The procedural success rate of ERCP was 79.0% in opium group, while patients without opium addiction had a success rate of 85.5%, but it was not statistically significant (p = 0.207).

CONCLUSION: ERCP could be associated with higher rate of complications in opium-addict patients. Accurate procedural techniques and appropriate prophylaxis should be considered to reduce the risk of complications.

PMID:40439935 | DOI:10.1007/s12664-025-01771-x

Categories
Nevin Manimala Statistics

Prevalence of inflammatory skin disorders in patients with inflammatory bowel disease (IBD)

Arch Dermatol Res. 2025 May 29;317(1):786. doi: 10.1007/s00403-025-04282-z.

ABSTRACT

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder, which primarily affects the gut, but is not restricted to the intestinal tract. IBD is result of a complex interplay between a dysfunctional host immune response and environmental triggers. Extraintestinal manifestations (EIMs) are frequently observed in patients with IBD. The aim of this study was to evaluate the prevalence and features of the major cutaneous manifestations and associating factors in patients with IBD. This cross-sectional study was conducted on patients with IBD who were referred to gastroenterology and dermatology outpatient clinics in Imam Khomeini Hospital Complex, in Tehran, Iran, between March 2020 and March 2021. All patients underwent a body examination by a gastroenterologist and dermatologist. We used SPSS (version 25) to run appropriate statistical tests to analyze any relationship between skin diseases, and socio-demographic and disease-related characteristics of the patients, as well as medications used. A total of 226 patients were included in this study of which 59 (26.1%) were diagnosed with CD and 167 (73.9%) with UC. Eighty-six participants (38.1%) of all IBD patients (52.5% of CD patients and 32.9% of UC patients) had skin disease at the time of examination. Patients with CD were significantly more likely to have skin disease at the time of examination or while IBD was active (p = 0.008 and p = 0.019, respectively). Aphthous stomatitis and atopic dermatitis were the most frequent skin disease observed in all IBD patients (11.1% for both) as well as UC patients, whereas perianal fissure was the most frequent cutaneous manifestation in CD patients. Psoriasis and aphthous stomatitis were more common in female patients (p = 0.046 and p = 0.004, respectively). Skin diseases were generally more frequent in female (p = 0.001) and married patients (p = 0.015). Our research revealed that aphthous stomatitis and atopic dermatitis were the most common skin-related extraintestinal manifestations (EIMs) observed in all patients with inflammatory bowel disease (IBD). Furthermore, individuals with Crohn’s disease (CD) were more prone to developing skin manifestations. Women and married individuals are considered high-risk groups for skin lesions, and it is advisable for these patients to undergo regular skin examinations.

PMID:40439921 | DOI:10.1007/s00403-025-04282-z

Categories
Nevin Manimala Statistics

Hypoglycemia During Bowel Preparation for Colonoscopy in Outpatients: A Cross-Sectional Study

Gastroenterol Nurs. 2025 May-Jun 01;48(3):191-202. doi: 10.1097/SGA.0000000000000868. Epub 2025 May 28.

ABSTRACT

This study investigated the current occurrence of hypoglycemia during bowel preparation of outpatients undergoing colonoscopy in endoscopy centers. A total of 399 outpatients from an eastern province of China participated in the survey. Participants’ characteristics and health information, colonoscopy information questionnaire and the state-trait anxiety inventory (STAI) were used as the study tools. Terminal blood glucose was measured by trained nurses before and after colonoscopy. The results showed that the incidence of hypoglycemia during bowel preparation was 17%. Mildly coughing when eating food (odds ratio [OR] = 3.821, 95% confidence interval [CI] = 1.570-9.299, p = .003), drinking alcohol 4-6 times per week (OR = 5.776, 95% CI = 1.794-18.600, p = .003), a history of hypoglycemia (OR = 2.275, 95% CI = 1.135-4.557, p = .020), fasting time ≥ 10 h (OR = 2.933, 95% CI = 1.118-7.699, p = .029), waiting time ≥ 12 h (OR = 0.446, 95% CI = 0.226-0.879, p = .020), subjective hunger (OR = 4.742, 95% CI = 2.255-9.972, p < .001), and STAI score (OR = 1.051, 95% CI = 1.012-1.090, p < .001), were the influencing factors of hypoglycemia in outpatients. It is suggested that clinical staff in endoscopy centers should identify the above risk factors as soon as possible, and conduct timely intervention to prevent hypoglycemia and avoid more serious consequences.

PMID:40439905 | DOI:10.1097/SGA.0000000000000868