Nevin Manimala

Circulation. 2025 Sep 10. doi: 10.1161/CIRCULATIONAHA.125.075080. Online ahead of print.

ABSTRACT

BACKGROUND: Limited treatment options exist for infrapopliteal disease in patients with chronic limb-threatening ischemia (CLTI), a condition associated with a high risk of limb loss. Interventional management of diseased infrapopliteal vessels with percutaneous transluminal angioplasty (PTA) is associated with high rates of restenosis and reintervention. In the LIFE-BTK trial, the drug-eluting resorbable scaffold (DRS) demonstrated superior 12-month efficacy compared with PTA in a selected CLTI population with predominantly noncomplex, mildly to moderately calcified lesions. This report presents the 2-year safety and efficacy outcomes of the Esprit below-the-knee (BTK) DRS system in the LIFE-BTK randomized trial comparing DRS with PTA for treatment of infrapopliteal vessels and CLTI.

METHODS: The LIFE-BTK trial was a multicenter, subject-blinded, randomized controlled trial enrolling 261 patients with CLTI who were randomized 2:1 to receive either DRS or PTA. The revised primary efficacy end point was freedom from target limb amputation, target vessel occlusion, clinically driven target lesion revascularization, or binary restenosis. The primary safety end point was freedom from major adverse limb events and perioperative death. Predictors of efficacy and clinically driven target lesion revascularization were analyzed along with subgroup assessments.

RESULTS: At 2 years, the primary efficacy end point was observed in 68.8% of the DRS group versus 45.4% of the PTA group (P=0.0004). Limb salvage rates were 94.7% for DRS and 97.3% for PTA (P=0.34). Binary restenosis occurred in 28.5% of DRS patients versus 48.2% of PTA patients (P=0.005), and clinically driven target lesion revascularization rates were 9.7% versus 18.6%, respectively (P=0.034). The primary safety end point was observed in 91.6% of the DRS group versus 95.6% of the PTA group (P=0.16). Scaffold treatment was an independent predictor of efficacy (odds ratio, 0.27; P=0.0003) and showed a trend toward reduced risk of clinically driven target lesion revascularization, though this did not reach statistical significance. Other predictors included lesion length, Rutherford-Becker class 5, total occlusion, previous amputation, preintervention stenosis, and number of wounds. Subgroup analyses demonstrated consistent efficacy across various patient populations.

CONCLUSIONS: At 2 years, the Esprit BTK DRS demonstrated improved efficacy compared with PTA in maintaining arterial patency, preventing restenosis, and reducing revascularization rates while maintaining a comparable safety profile. These findings support the Esprit BTK scaffold as a promising treatment option for appropriately selected patients with infrapopliteal artery disease and CLTI.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04227899.

PMID:40927852 | DOI:10.1161/CIRCULATIONAHA.125.075080

Int J Dermatol. 2025 Sep 10. doi: 10.1111/ijd.70059. Online ahead of print.

ABSTRACT

INTRODUCTION: Cutaneous scalp metastases from breast carcinoma (CMBC) represent an uncommon manifestation of metastatic disease, with heterogeneous clinical presentations, including nodular or infiltrative lesions and scarring alopecia (alopecia neoplastica). The absence of standardized diagnostic criteria, particularly for alopecic phenotypes, poses challenges to early recognition of CMBC, which may represent either the first indication of neoplastic progression or a late recurrence.

MATERIALS AND METHODS: We retrospectively analyzed a multicenter cohort of 15 patients with histologically confirmed CMBC. Demographic, clinical, molecular, and trichoscopic data were collected and correlated with the main clinical phenotypes: patchy alopecia (alopecia neoplastica) versus nodules/plaques. The statistical analyses we performed were the Mann-Whitney test for group comparisons and Fisher’s exact test for categorical variables.

RESULTS: The median age at CMBC diagnosis was 64 years. Alopecia neoplastica was the most frequent phenotype (53.3%). Patients with alopecia neoplastica showed a longer median interval between primary tumor diagnosis and metastasis onset compared to those with nodules/plaques (73.5 months vs. 59.5 months; p = 0.11). Trichoscopic analysis revealed significant differences in the distribution of features between the alopecia neoplastica group and the nodular/plaque group. Statistically significant differences were found among the two groups, including linear-irregular vessels (87.5% vs. 28.6%, p = 0.041), polymorphic vessels (87.5% vs. 28.6%, p = 0.041), pili torti (75% vs. 14.3%, p = 0.041), follicular hyperkeratosis and follicular plugging (87.5% vs. 14.3%, p = 0.01). Overall, the trichoscopic pattern in alopecia neoplastica appeared more variable and heterogeneous compared to that observed in the nodular/plaque phenotype.

CONCLUSION: Alopecia neoplastica, often underestimated in clinical practice, emerges as the predominant CMBC phenotype in our cohort and is associated with a distinct trichoscopic profile. The complexity of the alopecic phenotype may reflect intrinsic biological differences compared to nodular lesions. Larger prospective studies are needed to validate these findings and incorporate trichoscopic profiles into standard diagnostic pathways.

PMID:40927845 | DOI:10.1111/ijd.70059

Dan Med J. 2025 Aug 22;72(9):A01250002. doi: 10.61409/A01250002.

ABSTRACT

INTRODUCTION: In various countries, an increasing proportion of general practitioner (GP) referrals is returned by hospitals. We aimed to uncover the causes and consequences of referral returns from the perspective of GP liaisons.

METHODS: Individual interviews with 20 GP liaison officers from various departments in Southern Denmark, serving 1.2 million citizens, were analysed using systematic text condensation.

RESULTS: The collaboration between general practice and hospital departments was generally viewed as both effective and constructive. Well-argued returns include relevant advice on how to manage the patient and enhance the capabilities of general practice. In contrast, poorly motivated returns harm collaboration and lead to mistrust between GPs, hospitals and patients. Patients with an unclear diagnosis, multimorbidity or social problems do not fit into standard patient pathways, and their referrals are returned more frequently. They may face prolonged diagnostic processes and receive a lower quality of treatment, contributing to health inequalities and the risk of delayed diagnosis or treatment. Furthermore, the return of referrals transfers tasks to general practice.

CONCLUSIONS: Facilitating dialogue-based collaboration between primary and secondary care may improve patient care. However, referral returns may pose risks, particularly for frail or complex patients, and could potentially complicate the collaboration between GPs and hospitals. The underlying reasons and consequences of referral returns are diverse.

FUNDING: Funded by the Quality Improvement Committee Southern Denmark. RIO/SDU 12.228.

TRIAL REGISTRATION: Not relevant.

PMID:40927834 | DOI:10.61409/A01250002

Dan Med J. 2025 Aug 7;72(9):A02250077. doi: 10.61409/A02250077.

ABSTRACT

INTRODUCTION: Erysipelas is a common disease in the emergency department, whereas necrotising soft tissue infections (NSTIs) are rare but more severe. The study aimed to investigate the prevalence, incidence, population-based incidence rate, one-year mortality and clinical presentation of erysipelas and NSTIs, and the aetiology, treatment and recurrence of erysipelas.

METHODS: This was a population-based cohort study including acute non-trauma patients ≥ 18 years old with erysipelas or NSTIs from the Region of Southern Denmark in the period from 1 January 2016 to 19 March 2018.

RESULTS: Among 223,618 acute non-trauma visits, 2,136 had erysipelas (prevalence 1%), and 20 had NSTIs (prevalence 0.01%), 96.7 and 0.89 per 10,000 visits, respectively. The population-based incidence rates were 72.10 per 100,000 person-years for incident cases of erysipelas and 0.94 for NSTIs. One-year mortality was 15% for erysipelas and 25% for NSTIs. Erysipelas and NSTI patients had similar demographics and vital signs. For erysipelas, the predominant pathogen in blood cultures was Streptococcus dysgalactiae, with two-thirds of patients treated with narrow-spectrum penicillin. One-third of the erysipelas patients had a prior hospitalisation for the condition, and 7.7% of incident cases had recurrence within one year. Obesity and liver disease were risk factors for recurrence.

CONCLUSIONS: Erysipelas is a common infection in the emergency department, whereas NSTIs are much rarer but also more severe and, at presentation, not distinctive in clinical parameters, which underlines the importance of clinical judgement.

FUNDING: None.

TRIAL REGISTRATION: Not relevant.

PMID:40927829 | DOI:10.61409/A02250077

Cutan Ocul Toxicol. 2025 Sep 10:1-33. doi: 10.1080/15569527.2025.2554799. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to assess the potential risk of Bullous pemphigoid (BP) associated with antidiabetic agents, antimicrobials, diuretics, immune checkpoint inhibitors, and biological agents.

RESEARCH DESIGN AND METHODS: A retrospective pharmacovigilance data analysis was conducted using the FDA Adverse Event Reporting System (FAERS) between Q1/2004 and Q3/2024. Disproportionality analyses, viz. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) were performed to identify signals of BP. Additionally, a literature review of case reports of BP was conducted in PubMed, Google Scholar, and Scopus.

RESULTS: Disproportionality analysis identified 61 signals, and the following drugs exhibited the highest number of BP case associations: metformin (596 cases), vildagliptin (406 cases), nivolumab (376 cases), and furosemide (301 cases). Strong statistical correlation for signals was observed for vildagliptin [PRR = 295.8, LB (lower bound) ROR = 287.2, IC₀₂₅ = 7.5], dapsone [PRR = 20.7, LBROR = 14.4, IC₀₂₅ = 3.4], furosemide [PRR = 7.2, LBROR = 6.4, IC₀₂₅ = 2.6], and nivolumab [PRR = 31.5, LBROR = 28.5, IC₀₂₅ = 4.6]. These findings were supported by 106 identified case reports of BP.

CONCLUSION: This study suggests a strong statistical correlation between vildagliptin, dapsone, furosemide, nivolumab, and the development of BP.

PMID:40927818 | DOI:10.1080/15569527.2025.2554799

Health Sci Rep. 2025 Sep 7;8(9):e71207. doi: 10.1002/hsr2.71207. eCollection 2025 Sep.

ABSTRACT

BACKGROUND AND AIMS: Dental caries in children remains a global health challenge. Fissure sealant therapy (FST) is an effective preventive measure, yet parental acceptance remains low. This study aimed to identify predictors of parental FST behavior for children aged 6-12 years in Bandar Abbas, Iran, using the health belief model (HBM).

METHODS: The present cross-sectional descriptive-analytical study was conducted in Bandar Abbas in 2023. A total number of 449 parents to children aged 6-12 years were included. A multi-stage cluster sampling method was used. The data were collected using a researcher-made questionnaire to explore demographic information, knowledge questions, and HBM model constructs. Descriptive statistics, correlation matrix, and logistic regression were used to analyze the data.

RESULTS: The findings showed that the mean scores of perceived susceptibility, perceived severity, cues to action, and self-efficacy in the group that performed preventive behavior were significantly higher than the group that did not show the behavior of interest. There was also a significant and positive correlation between the constructs of perceived susceptibility, perceived severity, perceived benefits, self-efficacy, and cues to action with FST behavior (p < 0.001). In urban areas, with an increase in perceived susceptibility (95% CI (1.26,1.96):OR = 1.56), perceived severity (95% CI (1.03,1.27):OR = 1.17), cues to action (95% CI (1.01,1.34):OR = 1.16), and self-efficacy (95% CI (1.21,1.91):OR = 1.50), the odds of the preventive behavior increase significantly. In rural areas, with an increase in perceived susceptibility (95% CI (1.01,1.28):OR = 1.13) and self-efficacy (95% CI (1.05,1.28):OR = 1.18), the odds of preventive behavior increase significantly.

CONCLUSION: As the findings showed, the HBM can be an appropriate model to predict the adoption of FST in parents. These findings can improve and advance knowledge about the predictors of FST adoption. These findings can be used to develop effective educational and promotional interventions to increase FST adoption among parents and improve children’s oral health.

PMID:40927814 | PMC:PMC12415267 | DOI:10.1002/hsr2.71207

Health Sci Rep. 2025 Sep 7;8(9):e71040. doi: 10.1002/hsr2.71040. eCollection 2025 Sep.

ABSTRACT

BACKGROUND AND AIMS: Several observational studies have reported inconsistent associations between dyslipidaemia, stains use and atopic dermatitis (AD). Nevertheless, the available data on the effects of -C-lowering as well as TG-lowering drugs remain inconclusive and limited. The aim of this study was to evaluate the causal association of lipid traits and long-term use of lipid-lowering drugs on AD risk.

METHODS: Drug-targeted Mendelian randomization analyses were performed in European ancestry. Pooled statistics on low-density lipoprotein cholesterol, triglyceride and AD were extracted from large genome-wide association studies datasets. Instrumental variables located in and around lipid-lowering target genes were used as proxies for therapeutic inhibition of these target genes. Inverse-variance-weighted approach was applied as the primary analysis.

RESULTS: We explored the role of seven lipid-lowering target genes in AD, among which genetically proxied Niemann-Pick C1-like 1 inhibition, a target of LDL-C-lowering drugs, was associated with an increased risk of AD (odds ratio, 3.03; 95% CI, 1.36-6.75; p = 0.007). This association was replicated in FinnGen cohort (odds ratio, 1.72; 95% CI, 1.09-2.72; p = 0.020). A series of sensitivity analyses confirmed the robustness of the estimates.

CONCLUSION: We found no genetic support for the repurposing of seven lipid-lowering drug targets for the prevention of AD. However, pharmacovigilance of AD risk in Niemann-Pick C1-like 1 inhibitor users may be warranted.

PMID:40927812 | PMC:PMC12415263 | DOI:10.1002/hsr2.71040

Int J Gen Med. 2025 Sep 3;18:5073-5083. doi: 10.2147/IJGM.S531095. eCollection 2025.

ABSTRACT

BACKGROUND: Mycoplasma pneumoniae pneumonia (MPP) is a common respiratory infection in children, current treatments are limited by resistance and side effects. This study aims to evaluate the clinical efficacy and safety of combining Qingke Mixture with azithromycin for treating MPP in children.

METHODS: This prospective, randomized, double-blind, controlled trial included 92 children diagnosed with MPP. The treatment group received Qingke Mixture and azithromycin, while the control group received azithromycin alone. Outcomes assessed included clinical symptoms, inflammatory markers, immune response, pulmonary function, and adverse events.

RESULTS: The treatment group showed significantly higher clinical efficacy (95.65% vs 80.43%, P < 0.05). The treatment group showed faster resolution of pulmonary symptoms, shorter hospital stays, and greater improvements in pulmonary function and TCM symptom scores (P < 0.05). Inflammatory markers (WBC, CRP, IL-6, IL-8) were significantly lower, while immunoglobulin levels (IgA, IgG, IgM) and T lymphocyte subsets (CD3+, CD4+/CD8+ ratio) were higher in the treatment group compared to the control group (P < 0.05). The incidence of adverse events was low in both groups, with no statistically significant difference.

CONCLUSION: Qingke Mixture combined with azithromycin significantly improves clinical outcomes in children with MPP, enhancing efficacy while maintaining safety.

PMID:40927775 | PMC:PMC12415112 | DOI:10.2147/IJGM.S531095

Int J Gen Med. 2025 Sep 4;18:5183-5193. doi: 10.2147/IJGM.S537848. eCollection 2025.

ABSTRACT

OBJECTIVE: This study aims to investigate the association between the dynamics of routine metabolic markers and endometriosis severity.

METHODS: A retrospective analysis was conducted on patients diagnosed with endometriosis at Zhongshan Hospital, Xiamen, affiliated with Fudan University. The collected data encompassed demographic details and biochemical indicators related to lipid, hepatobiliary, renal metabolism, and electrolyte balance. Independent influencing factors were screened by univariate logistic regression and statistically significant variables were included in the model for adjustment. Restricted cubic spline (RCS) models were also plotted to analyze the nonlinear relationship between factors and endometriosis severity. The receiver operating characteristic (ROC) curve was used to validate the discriminative ability of independent influencing factors.

RESULTS: Ninety-four patients were enrolled in the study, including 32 at stage IV as classified by the American Society for Reproductive Medicine (ASRM) staging. Univariate analysis identified fasting blood glucose (FBG), total protein, direct bilirubin, total bilirubin (TBil) and glutamic-pyruvic transaminase (ALT) as significant metabolic indicators. Additionally, carbohydrate antigen 125 (CA125) and human epididymal protein 4 (HE4) emerged as significant covariates. The RCS analysis revealed a nonlinear association between most metabolic indicators and outcome measures. ROC curve analysis showed that the area under the curve (AUC) of the alanine transaminase (ALT) was above 0.6.

CONCLUSION: ALT had a negative correlation with the severity of endometriosis and was an independent influencing factor with statistical significance. This finding could offer clinicians non-invasive biomarkers for early detection and precise monitoring of disease progression.

PMID:40927773 | PMC:PMC12416391 | DOI:10.2147/IJGM.S537848

Curr Dev Nutr. 2025 Aug 6;9(9):107518. doi: 10.1016/j.cdnut.2025.107518. eCollection 2025 Sep.

ABSTRACT

BACKGROUND: The objective of this study was to compare the effects of daily consumption of white potatoes compared with white rice on cardiometabolic health in individuals with type-2 diabetes (T2D).

OBJECTIVE: To determine the effects of white potato consumption compared to white rice (a commonly consumed refined grain) on indices of glycemic control and cardiovascular health in individuals with overweight or obesity and T2D.

METHODS: In this randomized crossover study, comparative control trial, 24 adults with T2D [45-80 y, body mass index (kg/m²) 25-40] consumed baked white potatoes (100 g) or calorie-matched white rice (75 g) daily for 12 wk, separated by a 2-wk washout, with assessments of glycemic control, lipids, inflammation, blood pressure, endothelial function, and body composition at baseline (only 1 baseline visit included as a covariate in statistical analyses), 6 wk, and 12 wk. A linear mixed model was used to assess treatment (potato or rice), time (6 wk or 12 wk), and the treatment-by-time interaction for all outcome variables.

RESULTS: There were no significant (P ≤ 0.05) treatment-by-time interactions for any outcome. There was a main effect of treatment (i.e., independent of time) with the potato regimen resulting in lower waist circumference (P < 0.0001; 4.5 ± 1.0 cm), percent fat mass (P = 0.01; 1.7 ± 0.7%), waist-to-hip ratio (P = 0.002; 0.025 ± 0.013), heart rate (P = 0.01; 3.1 ± 1.2 bpm), as well as higher percent fat-free mass (P = 0.05; 1.4 ± 0.7%) and maximum brachial artery dilation (P = 0.05; 0.074 ± 0.037 mm) when compared to the rice regimen. There were significant timepoint effects (i.e., independent of treatment) for increased homeostatic model assessment of β-cell function (P = 0.02; 34.3 ± 14.5) and decreased high sensitivity C-reactive protein (P = 0.02; 0.08 ± 0.05 μg/mL) and flow-mediated dilation/shear (P = 0.03; 4.3 × 10^-5 ± 3.79 × 10^-5) during the study.

CONCLUSIONS: White potatoes did not negatively affect glycemic indices, vascular health, lipids, or blood pressure compared to white rice and modestly improved body composition and vascular measures. In both groups, over time, there were reductions in flow-mediated dilation/shear stress, β cell function, and high-sensitivity C-reactive protein. Our preliminary results support white potatoes as a substitute for white rice in T2D.

PMID:40927748 | PMC:PMC12414893 | DOI:10.1016/j.cdnut.2025.107518