Finerenone Benefits in HF With Mildly Reduced or Preserved Ejection Fraction Regardless of Baseline Risk: JAMA

UK: A secondary analysis of the FINEARTS-HF randomized clinical trial evaluated the performance of the PREDICT-HFpEF model in estimating heart failure risk and its potential role in guiding finerenone therapy.

The study, published in JAMA Cardiology, demonstrated that patients with heart failure with mildly reduced (HFmrEF) or preserved ejection fraction (HFpEF) benefit from finerenone, regardless of baseline risk. The PREDICT-HFpEF models also performed well in calibration and discrimination, confirming their reliability.

For this purpose, the researchers conducted the FINEARTS-HF trial across 653 sites in 37 countries, enrolling adults aged 40 years and older with symptomatic heart failure and a left ventricular ejection fraction of 40% or greater. Participants were randomized between September 2020 and January 2023 to receive finerenone (titrated to 20 mg or 40 mg) or a placebo.

The study assessed the three PREDICT-HFpEF risk scores for cardiovascular death or heart failure hospitalization, cardiovascular death alone, and all-cause mortality. Predicted risk was compared with observed outcomes, and model performance was evaluated using the Harrell C statistic. The rates of predicted outcomes, including the composite of cardiovascular death and worsening heart failure events, were analyzed across risk quintiles, along with the effect of finerenone in different risk categories.

The study led to the following findings:

  • The FINEARTS-HF trial included 6001 patients with a mean age of 72 years, with 54.5% being male.
  • The PREDICT-HFpEF model performed well in predicting cardiovascular outcomes, with C statistics of 0.71 for cardiovascular death or heart failure hospitalization, 0.68 for cardiovascular death, and 0.69 for all-cause death at two years.
  • Patients in the highest risk quintile had an 8- to 10-fold greater risk of composite outcomes than those in the lowest quintile.
  • Finerenone consistently reduced risk across all patient groups, with no significant difference in effect based on baseline risk.

The researchers demonstrated that the PREDICT-HFpEF model effectively assessed risk in patients with HFmrEF or HFpEF, showing strong calibration and discrimination. Despite the wide range of risk levels among participants, the baseline risk did not alter the therapeutic benefits of finerenone. Those at the highest risk experienced the most significant absolute benefit when the drug was added to their treatment.

“These findings highlight the consistent efficacy of finerenone across risk groups and support the integration of predictive models like PREDICT-HFpEF to enhance individualized heart failure management,” the researchers concluded.

They noted limitations, including trial-specific patient selection, and limiting generalizability. One missing variable may have affected accuracy, and socioeconomic factors were not analyzed. Additionally, alternative HFpEF risk scores may provide different predictive insights.

Reference:

McDowell K, Docherty KF, Campbell RT, et al. Finerenone for Heart Failure and Risk Estimated by the PREDICT-HFpEF Model: A Secondary Analysis of FINEARTS-HF. JAMA Cardiol. Published online March 05, 2025. doi:10.1001/jamacardio.2025.0025

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METS-VF Score: A Promising Tool for Early Diabetes Detection, Indian Study Finds

India: A recent study based on data from the National Health and Nutrition Examination Survey (NHANES) 2011-2018 highlights the effectiveness of the Metabolic Score for Visceral Fat (METS-VF) in predicting diabetes mellitus. The study, published in PLoS ONE, found that METS-VF is a strong predictor of left ventricular hypertrophy (LVH) in individuals with type 2 diabetes (T2DM), outperforming conventional obesity markers.

The prevalence of LVH increased progressively across METS-VF quartiles, ranging from 7.9% to 31%. Higher METS-VF levels were associated with a nearly tenfold greater risk of developing LVH (OR: 9.79). These findings suggest that METS-VF could be a valuable tool for early cardiac risk assessment in T2DM patients.

The researchers note that visceral fat, which accumulates around internal organs, is a well-established risk factor for metabolic disorders, including diabetes. With obesity affecting 42.4% of the U.S. population, the prevalence of diabetes mellitus (DM) continues to rise, highlighting the need for effective assessment tools. Traditional methods for measuring visceral adipose tissue (VAT), such as imaging techniques, are often costly and impractical for routine use. The METS-VF offers a simple yet effective alternative by integrating metabolic parameters to estimate VAT levels.

Against the above background, Amandeep Singh, Affiliation Department of Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India, and colleagues investigated the association between METS-VF and the risk of developing DM, emphasizing its potential as a practical tool for early risk assessment.

For this purpose, the researchers analyzed data from the NHANES dataset, spanning the 2011–2018 cycles. They employed multivariate logistic regression and Receiver Operating Characteristic (ROC) analysis to evaluate the association between METS-VF and DM. Furthermore, they compared various VAT measurement indices with METS-VF to assess its predictive ability for DM.

The study led to the following findings:

  • Among 3,445 participants, METS-VF showed a strong positive association with diabetes (OR: 6.8) with an AUC of 0.791.
  • The association between METS-VF and diabetes increased across quartiles, with METS-VF >6.5 linked to significantly higher risk (OR: 53.8).
  • METS-VF demonstrated superior ability in identifying diabetes compared to other visceral adipose tissue (VAT) indices, including lipid accumulation product (LAP), visceral adiposity index (VAI), waist circumference, and waist-to-height ratio (WHtR).
  • Premenopausal females with a BMI >25 and METS-VF >6.5 had an elevated risk of developing diabetes.

The researchers found a strong association between METS-VF and the prevalence of diabetes, highlighting its effectiveness as a tool for visceral adipose tissue measurement. Compared to other surrogate markers, METS-VF demonstrated superior predictive ability, making it a valuable option for routine clinical assessments.

“Given its reliability across different demographic and lifestyle factors, integrating METS-VF into daily practice and large-scale epidemiological studies could aid in the early identification of individuals at risk of diabetes, enabling timely intervention and improved disease management,” they concluded.

Reference:

Tripathi, H., Singh, A., Prakash, B., Dubey, D. K., Sethi, P., Jadon, R. S., Ranjan, P., & Vikram, N. K. (2025). The Metabolic Score for Visceral Fat (METS-VF) as a predictor of diabetes mellitus: Evidence from the 2011–2018 NHANES study. PLOS ONE, 20(2), e0317913. https://doi.org/10.1371/journal.pone.0317913

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Improvement of Sleep Health may halt progression of gestational diabetes to type 2 diabetes: JAMA

Research indicates that improving sleep health plays a crucial role in preventing the progression from gestational diabetes (GD) to type 2 diabetes (T2D) in women. Researchers have found in a new study that by Improving Sleep health, the progression of gestational diabetes to type 2 diabetes may be prevented.

Women with a history of gestational diabetes (GD) are at high risk for developing type 2 diabetes (T2D). Sleep is a crucial lifestyle factor associated with cardiometabolic health, yet studies on its role in the progression from gestational diabetes to T2D are sparse.

A study was done to investigate the associations of sleep duration and quality with T2D risk and levels of glucose metabolism biomarkers in women with a history of GD. Design, Setting, and Participants This cohort study used data from the Nurses’ Health Study II, an ongoing longitudinal cohort that began in 1989 and initially included 116 429 female nurses with health status and lifestyle factors updated every 2 to 4 years.

A subset of participants with a history of gestational diabetes was followed up through June 2021. Sleep characteristics were assessed in the 2001 questionnaire (administered from June 2001 to June 2003), which served as the baseline for follow-up. Data were analyzed from November 2023 to August 2024. Physician-diagnosed incident T2D was ascertained biennially via questionnaires. Cox proportional hazards regression models were used to estimate the hazard ratios (HRs) and 95% CIs. Biomarkers (glycated hemoglobin [HbA1c], C-peptide, and insulin) were compared across sleep characteristic categories using multivariable-adjusted least-squares means (LSMs) and 95% CIs. Results During a total of 42 155 person-years of follow-up among 2891 women with a history of gestational diabetes (mean [SD] age, 45.3 [4.4] years), 563 women (19.5%) developed type 2 diabetes.

Compared with women who reported rarely snoring, those with occasional or regular snoring had significantly higher T2D risk, with adjusted HRs of 1.54 (95% CI, 1.18-2.02) and 1.61 (95% CI, 1.21-2.13), respectively. Compared with women who slept 7 to 8 hours per day, shorter sleep duration (≤6 hours per day) was significantly associated with a higher risk of type 2 diabetes (HR, 1.32; 95% CI, 1.06-1.64). Women who slept 6 or fewer hours per day and snored regularly had the highest risk of developing type 2 diabetes.

Additionally, more frequent snoring was associated with higher HbA1c, C-peptide, and insulin levels in the full adjusted models. In this cohort study of women with a history of gestational diabetes, shorter sleep duration and both occasional and regular snoring were significantly associated with an increased risk of type 2 diabetes. These findings suggest that improving sleep health may be important to reduce type 2 diabetes incidence in this high-risk population.

Reference:

Yin X, Bao W, Ley SH, et al. Sleep Characteristics and Long-Term Risk of Type 2 Diabetes Among Women With Gestational Diabetes. JAMA Netw Open. 2025;8(3):e250142. doi:10.1001/jamanetworkopen.2025.0142

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Omalizumab treats multi-food allergy better than oral immunotherapy, unravels study

A clinical trial has found that the medication omalizumab, marketed as Xolair, treated multi-food allergy more effectively than oral immunotherapy (OIT) in people with allergic reactions to very small amounts of common food allergens. OIT, the most common approach to treating food allergy in the United States, involves eating gradually increasing doses of a food allergen to reduce the allergic response to it. Thirty-six percent of study participants who received an extended course of omalizumab could tolerate 2 grams or more of peanut protein, or about eight peanuts, and two other food allergens by the end of the treatment period, but only 19% of participants who received multi-food OIT could do so. Researchers attributed this difference primarily to the high rate of allergic reactions and other intolerable side effects among the participants who received OIT, leading a quarter of them to discontinue treatment. When the participants who discontinued therapy were excluded from the analysis, however, the same proportion of each group could tolerate at least 2 grams of all three food allergens.

The findings were published in an online supplement to The Journal of Allergy and Clinical Immunology and presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress in San Diego on Sunday, March 2, 2025.

“People with highly sensitive multi-food allergy previously had only one treatment option-oral immunotherapy-for reducing their allergic response to moderate amounts of those foods,” said Jeanne Marrazzo, M.D., M.P.H., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), the study’s funder and regulatory sponsor. “This study shows that omalizumab is a good alternative because most people tolerate it very well. Oral immunotherapy remains an effective option if treatment-related adverse effects are not an issue.”

Omalizumab works by binding to the allergy-causing antibody called immunoglobulin E in the blood and preventing it from arming key immune cells responsible for allergic reactions. This renders these cells much less sensitive to stimulation by any allergen.

The current study is the second stage of a landmark clinical trial that found a 16-week course of omalizumab increased the amount of peanut, tree nuts, egg, milk and wheat that multi-food allergic children as young as 1 year could consume without an allergic reaction. This next stage of the trial was designed to directly compare omalizumab with OIT for the first time.

At 10 locations across the United States, the study team enrolled 177 children and adolescents ages 1 to 17 years and three adults ages 18 to 55 years, all with confirmed allergy to less than half a peanut and similarly small amounts of at least two other common foods among milk, egg, cashew, wheat, hazelnut or walnut. After completing the first stage of the trial, 117 individuals entered the second stage of the trial.

Upon beginning Stage 2, all participants received injections of omalizumab for eight weeks. Then the participants were randomly divided in half and placed into one of two groups. Group A received omalizumab injections and multi-allergen OIT for eight weeks, while group B received omalizumab injections and placebo OIT for eight weeks. Subsequently, group A received placebo injections and multi-allergen OIT for 44 weeks, while group B continued to receive omalizumab injections and placebo OIT for 44 weeks. Neither the participants nor the investigators knew who was in which treatment group.

Group A received omalizumab before and during their early months of OIT because data from prior studies suggested that pretreatment with the medication would significantly augment the safety of OIT, and continuing omalizumab during the early months of OIT would provide additional benefit.

During the study treatment period, 29 of 59 participants in group A discontinued therapy: 15 due to allergic reactions-some severe-or other intolerable symptoms of OIT, and 14 for other reasons, including aversion to the study foods or the burden of participating in the trial. No participants in group B had allergic reactions or other side effects from omalizumab that led them to discontinue therapy, but seven participants in group B left the study mainly due to the burden of participating in it. In all, 30 of the original 59 members of group A (51%) and 51 of the original 58 members of group B (88%) completed treatment.

After the study treatment period, the clinical trial team tested whether the participants who completed therapy could eat at least 2 grams of peanut protein and their two other study foods without an allergic reaction. Twenty-one of the original 58 participants in group B, or 36%, could tolerate at least 2 grams of all three foods, while only 11 of the original 59 participants in group A (the OIT-treated group), or 19%, could do so. When evaluating only the participants who completed therapy, however, the same proportion of each group could tolerate at least 2 grams of all three foods.

These results showed that omalizumab was more effective than OIT at treating multi-food allergy in people who originally had a very low tolerance to common food allergens. Investigators attributed this outcome mainly to the high rate of allergic reactions and other side effects leading to treatment discontinuation among the OIT-treated participants, despite receiving omalizumab before and during the early months of therapy.   

Reference:

RA Wood et al. Treatment of multi-food allergy with omalizumab compared to omalizumab-facilitated multi-allergen OIT. Journal of Allergy and Clinical Immunology DOI: 10.1016/j.jaci.2024.12.1022 (2025).

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Depression positively correlated with gynecologic cancers, suggests study

An NHANES-based study found that high depression scores correlated with an increased risk of ovarian and endometrial cancers. Among 11,574 participants, those with gyneoclogical cancers had significantly higher PHQ-9 scores. Depression was associated with ovarian and endometrial cancer but not cervical cancer. These findings highlight the importance of mental health screening in cancer risk assessment.

Depression is one of the leading sources of disease burden globally and plays a significant role in the occurrence and development of many cancers, representing an important health risk. However, the relationship between depression and the risk of gynecologic cancers has not been fully assessed. This study aims to explore the association between depression and the risk of gynecologic cancers. They selected 11,574 participants from the NHANES 2009–2018 cycles, among which 274 had gynecologic cancer (GC), 137 had cervical cancer (CC), 48 had ovarian cancer (OC), and 89 had endometrial cancer (EC). Box plots were used to assess the differences in PHQ-9 depression scores between cancer and non-cancer groups. Logistic regression models and restricted cubic spline (RCS) models were employed to evaluate the relationship between PHQ-9 scores and gynecologic cancers. Subgroup analyses and interaction tests examined the consistency of the association across different characteristics. Results: There was a significant difference in PHQ-9 scores between the cancer group and the non-cancer group. In the multivariable logistic regression analysis, PHQ-9 scores were positively correlated with gynecologic cancers, ovarian cancer, and endometrial cancer, while no significant association was found with cervical cancer risk. Additionally, the RCS model also indicated no nonlinear association between PHQ-9 scores and cervical cancer risk. Additionally, subgroup analyses suggested that the relationship between PHQ-9 scores and cervical cancer and ovarian cancer was consistent across groups, whereas the association between PHQ-9 scores and gynecologic cancers and endometrial cancer showed heterogeneity about race and marital status. Depression is positively correlated with gynecologic cancers. Specifically, higher levels of depression are associated with an increased risk of ovarian cancer and endometrial cancer, while no significant association was found with cervical cancer risk. Future attention should be given to the impact of depression on the incidence of gynecologic cancers, particularly ovarian cancer and endometrial cancer.

Reference:

Wang, C., Xu, J., Li, X., & Jiang, L. (2025). Depression as a Risk Factor for Gynecological Cancers: Evidence from NHANES Data. International Journal of Women’s Health, 17, 615–625. https://doi.org/10.2147/IJWH.S504049

Keywords:

Wang, C., Xu, J., Li, X., & Jiang, L., Depression, Risk Factor, Gynecological, Cancers: Evidence, NHANES Data, Wang, C., Xu, J., Li, X, Wang, C., Xu, J., Li, X

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Customized Zirconia Membranes effective for Alveolar Ridge Augmentation: A systematic review

Researchers have found in a systematic review of case series and reports that customized zirconia membranes have proven effective in alveolar ridge augmentation. This supports successful dental implant placement with minimal complications, particularly low membrane exposure rates. However, no studies establish zirconia’s superiority over other materials or determine the optimal design and bone grafting strategy for these membranes.

Since the inception of intraosseous implants, the significance of alveolar bone volume has become crucial in formulating treatment plans for dental implants. Various barrier membranes have been extensively employed in alveolar ridge reconstruction, highlighting their efficacy. Recent advancements include the fabrication of customized barrier membranes using multiple materials, with titanium and zirconia being prominent choices. The objective of this study was to conduct a comprehensive review of all clinical studies, case reports, and case series that utilized customized zirconia membranes for alveolar ridge augmentation. An electronic literature search was performed to find relevant clinical studies, case reports, and case series published in English up to August 2024. The following keywords used in the search were customized zirconia membrane, alveolar ridge augmentation, Guided bone regeneration, zirconia sheet, ceramic sheet, and Personalized membrane. The quality assessment was conducted using the Joanna Briggs Institute (JBI) critical appraisal checklist specific to each type of study. Results: The electronic search initially yielded 539 articles. Following deduplication, 263 unique articles remained. Subsequent manual screening of titles and abstracts led to the exclusion of 250 articles, resulting in 13 remaining articles. After conducting a thorough full-text assessment of these 13 articles to verify adherence to the inclusion/exclusion criteria, 6 articles were further excluded, leaving a total of 7 articles included in this review. While all studies included in this review were case series or case reports, customized zirconia membranes have demonstrated effectiveness in the literature for alveolar ridge augmentation, facilitating the placement of dental implants in all cases with relatively low complication rates, particularly membrane exposure. There is currently no literature evidence supporting the superiority of zirconia over other materials used in customized fabrication, nor is there evidence of superior design or preferred bone grafting under these membranes.

Reference:

Albash, Z., Khalil, A., & Kashkash, W. (2024). Alveolar Ridge Augmentation using Customized Zirconia Membranes: A Systematic Review. The Open Dentistry Journal, 9 December 2024. https://doi.org/10.2174/0118742106356292241122070017

Keywords:

Customized membrane, Alveolar ridge augmentation, Guided bone regeneration, Zirconia sheet, Ceramic sheet, Personalized membrane, Zirconia, Systematic review, Albash, Z., Khalil, A., & Kashkash, W

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Fluoride in drinking water associated with impaired childhood cognition, reveals research

Elevated concentrations of fluoride can occur in well water, and in some countries, it is added to drinking water to counteract caries in the population. A study from Karolinska Institutet in Sweden now supports a few previous studies indicating that exposure to fluoride during the fetal stage or early childhood may impair cognition in children. The study is published in the journal Environmental Health Perspectives.

Fluoride occurs naturally as fluoride ions in drinking water, but the concentrations are generally low in public water supplies. In some countries, such as the USA, Canada, Chile, Australia and Ireland, fluoride is commonly added to the municipal water supply at around 0.7 mg per litre to prevent caries.

“Given the concern about health risks, the addition of fluoride to drinking water is controversial and has been widely debated in the USA and Canada,” says Maria Kippler, associate professor at the Institute of Environmental Medicine, Karolinska Institutet. “Our results support the hypothesis that even relatively low concentrations of fluoride can impact children’s early development.”

500 mothers and children

The researchers followed 500 mothers and their children in rural Bangladesh, where fluoride occurs naturally in the drinking water, to investigate the association between early exposure to fluoride and children’s cognitive abilities. The concentrations are similar to those found in many other countries worldwide.

Trained psychologists evaluated the children’s cognitive abilities at five and ten years of age, using well-established tests. The exposure to fluoride in the mothers and children was determined by measuring the concentrations in urine samples, which reflects ongoing exposure to all sources, such as drinking water, food and dental care products.

“I’d like to stress that dental care products such as toothpaste are not normally a significant source of exposure since they are not intended for ingestion,” says Dr Kippler. “Fluoride in toothpaste is important for prevention of caries, but it’s important to encourage small children not to swallow the toothpaste during brushing.”

Decreased cognitive abilities

The median concentration of fluoride in urine of the pregnant Bangladeshi women was 0.63 mg/L. Increasing concentrations of fluoride in the pregnant women could be linked to decreasing cognitive abilities in their children at five and ten years of age.

Children that had more than 0.72 mg/L fluoride in their urine by the age of ten also had lower cognitive abilities than children with less fluoride in their urine, with most pronounced associations for verbal reasoning skills and the ability to interpret and process sensory input. The exposures that were associated with impaired cognitive development are lower than those obtained at the existing WHO and EU threshold for fluoride in drinking water, which is 1.5 mg/L.

The researchers found no statistically significant link between fluoride concentrations in the urine of the five-year-olds and their cognitive abilities.

“This may be due to the shorter exposure time,” Dr Kippler speculates, “but also to the fact that urinary fluoride concentrations aren’t as reliable in younger children owing to greater variations in how much fluoride is taken up and stored in the body, particularly in the bones.”

More studies needed

Since it was an observational study, no firm conclusions can be drawn about causalities. It is therefore important to assess the overall results of several similar longitudinal studies, according to the researchers. They will now investigate the associations in other populations and establish experimental models to determine the possible molecular mechanisms driving it.

“There is a need for more research to create a robust basis for reviewing fluoride health risks and thresholds for drinking water, foods, and dental care products, especially for children,” she continues. “Even small changes in cognition at a population level can have serious public health consequences.”

Reference:

 Taranbir Singh, Klara Gustin, Syed Moshfiqur Rahman, Shamima Shiraji, Fahmida Tofail, Marie Vahter, Mariza Kampouri, and Maria Kippler, Prenatal and childhood exposure to fluoride and cognitive development: findings from the longitudinal MINIMat cohort in rural Bangladesh, Environmental Health Perspectives, https://doi.org/10.1289/EHP14534. 

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Trabecular Bone Score Enhances Bone Health Assessment in Postmenopausal Women with Type 2 Diabetes: Study Finds

India: A recent cross-sectional study has highlighted the significance of the Trabecular Bone Score (TBS) in assessing bone health among Asian-Indian postmenopausal women across different stages of hyperglycaemia.

The study, published in the Indian Journal of Endocrinology and Metabolism, showed that postmenopausal women with type 2 diabetes had significantly lower trabecular bone scores despite having similar areal bone mineral density (aBMD) as non-diabetic and prediabetic individuals. TBS negatively correlated with HbA1c levels and diabetes duration, highlighting its relevance in fracture risk assessment. The researchers suggest that TBS incorporation alongside BMD may improve bone health evaluation in this population.

The researchers note that type 2 diabetes mellitus (T2DM) is associated with a higher risk of fragility fractures, even when the areal bone mineral density (aBMD) remains normal or elevated compared to non-diabetic individuals. This discrepancy has led to growing interest in the trabecular bone score as a potential alternative for assessing bone health in this population. To explore its clinical utility, Dr. Sanjay K. Bhadada, Department of Endocrinology, PGIMER, Chandigarh, India, and colleagues evaluated TBS in postmenopausal women with T2DM and compared it with non-diabetic individuals, aiming to provide deeper insights into bone quality and fracture risk assessment.

For this purpose, the researchers conducted a cross-sectional study involving 101 individuals with T2DM and 101 without overt diabetes, including 43 with prediabetes and 58 with normal glucose levels. All participants underwent a detailed medical history assessment, physical examination, biochemical testing, and a dual-energy X-ray absorptiometry (DXA) scan with TBS measurement to evaluate bone health.

Key Findings:

  • Postmenopausal women with T2DM showed no significant difference in aBMD levels compared to those with prediabetes or normoglycaemia.
  • Despite similar aBMD across groups, the mean TBS value was significantly lower in the T2DM group.
  • Higher glycated haemoglobin (HbA1c) levels and longer diabetes duration were significantly associated with lower TBS values.

The researchers highlighted the importance of incorporating the Trabecular Bone Score alongside aBMD assessments for a more comprehensive evaluation of bone health in individuals with T2DM. Their findings suggest that TBS could be a valuable marker of bone quality, particularly when aBMD alone does not accurately reflect fracture risk.

“Both glycaemic control and diabetes duration significantly influence TBS values, further emphasizing the need for tailored bone health assessments in this population. Future studies with larger cohorts are needed to validate these findings and explore the clinical utility of TBS in fracture risk prediction for individuals with T2DM,” the researchers concluded.

Reference:

Aggarwal, Tanushi; Shah, Ravi1; Pal, Rimesh1; Rastogi, Ashu1; Singla, Veenu2; Bhadada, Sanjay K.1. Trabecular Bone Score in Asian-Indian Post-menopausal Women Across the Spectrum of Hyperglycaemia: Insights from a Cross-Sectional Study. Indian Journal of Endocrinology and Metabolism 29(1):p 43-48, Jan–Feb 2025. | DOI: 10.4103/ijem.ijem_310_24

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HPV Vaccination Promising in Reducing Actinic Keratosis Burden: VAXAK Trial Findings

Denmark: A recent randomized clinical trial, VAXAK, has highlighted the potential benefits of human papillomavirus (HPV) vaccination in managing actinic keratosis (AK), a prevalent precancerous skin condition. The study findings, published in JAMA Dermatology, suggest that standard alphapapillomavirus vaccination could reduce the burden of AK among immunocompetent individuals with multiple lesions.

Actinic keratosis, commonly seen in fair-skinned populations, is a chronic and recurrent condition primarily caused by prolonged exposure to ultraviolet (UV) radiation. The researchers note that while current treatment options include topical medications, cryotherapy, and photodynamic therapy, recurrence remains a significant challenge.

Observations indicate that HPV vaccination may have potential therapeutic and preventive benefits against AK and keratinocyte carcinomas (KCs). Considering this, Emily Wenande, Department of Dermatology, Copenhagen University Hospital–Bispebjerg and Frederiksberg, Copenhagen, Denmark, and colleagues aimed to examine the impact of HPV vaccination on disease burden in immunocompetent patients with multiple AK lesions.

For this purpose, the researchers conducted the VAXAK trial, a parallel-design, double-blind, randomized sham-controlled clinical study at Bispebjerg University Hospital, Copenhagen, from May 2021 to June 2024. Immunocompetent adults with 15 or more AK lesions in a defined test area were enrolled and randomized 1:1 to receive either a 9-valent alphapapillomavirus vaccine or a sham vaccine at 0, 2, and 6 months. Thick AK lesions underwent cryotherapy at months 6 and 9, with no other treatments administered.

The primary outcome was the percentage reduction in baseline AKs, while secondary measures included total lesion count, new AKs, thick lesions, and incident keratinocyte carcinomas over 12 months.

The following were the key findings of the study:

  • Out of 163 screened patients, 70 participants were enrolled, with 69 completing the study.
  • The median age of participants was 75.5 years, and 67% were male.
  • The HPV-vaccinated group showed a consistently higher reduction in AK burden than the sham group over time:
    • Month 2: 35% vs 25%
    • Month 6: 47% vs 29%
    • Month 9: 58% vs 42%
    • Month 12: 58% vs 47%
  • Total AK numbers were lower in the HPV-vaccinated group at:
    • Month 6: 14 vs 17
    • Month 12: 10 vs 16
  • There were fewer thick AKs in the HPV-vaccinated group:
    • Month 6: 5 vs 6.5
    • Month 12: 3 vs 5
  • No significant differences were noted in new AK development (1-2 per month) or keratinocyte carcinoma incidence over 12 months.

The researchers demonstrated that standard HPV vaccination effectively reduced AK burden in immunocompetent individuals with multiple lesions.

“While its impact on skin cancer development remains uncertain, their findings suggest that HPV-targeted vaccines could be valuable in managing AK, a chronic and relapsing condition, that represents the most common precancer in fair-skinned populations,” they concluded.

Reference:

Wenande E, Hastrup A, Wiegell S, et al. Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial. JAMA Dermatol. Published online March 06, 2025. doi:10.1001/jamadermatol.2025.0531

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Intraoperative unfractionated heparin may prevent thrombotic complications and enhance flap viability in reconstructive surgery: Study

In reconstructive surgery, specifically free flap reconstructive surgery, concerns persist regarding the risk of failures due to thrombosis and bleeding complications, leading to flap loss. Even with advancements in surgical techniques and perioperative care, standardized protocols for anticoagulation management remain lacking. Recent study aimed to investigate the role of anticoagulation and perioperative practices in free flap reconstructive surgery and their impact on surgical outcomes.

The retrospective single-center study included 489 free flap surgeries from 2009 to 2020, with most flaps taken from the upper extremity for tumor-related reconstructions. Flap loss occurred in 14.5% of cases, with intraoperative unfractionated heparin (UFH) significantly predicting flap survival. Prothrombin time (PTT) values on day 1 post-surgery were also significantly related to flap survival, with each unit increase reducing the relative probability of flap loss by 5.2%. There was no significant difference in flap survival between patients treated with heparin alone and those treated with both heparin and aspirin. However, the aspirin-only group was limited in size. The study highlighted the importance of intraoperative UFH and PTT-guided postoperative management in enhancing free flap survival. The findings emphasized the need for standardized anticoagulation protocols to optimize outcomes in free flap reconstructive surgery. Moreover, the study noted that factors such as the location of the defect, flap origin, and duration of surgery significantly influenced perioperative flap survival rates.

Recommendations for Anticoagulation Strategies

The study recommended intraoperative UFH administration and continued postoperative therapy with PTT-controlled UFH to minimize bleeding risk. It suggested targeting a PTT range of 40–60 seconds for an effective balance between thrombosis and bleeding risks. There was no significant benefit observed from combining UFH with aspirin postoperatively. The research emphasized the importance of a standardized perioperative anticoagulation protocol to improve flap survival rates and surgical success in free flap surgery. Although the study had limitations like its retrospective nature and diverse patient cohort, it concluded that anticoagulation is crucial for free flap preservation. The authors called for future research, suggesting a prospective multicenter study to address the lack of consensus in perioperative anticoagulation therapy. Ultimately, the study underlined the significance of optimized anticoagulation practices in achieving successful outcomes in free flap reconstructive surgery.

Key Points

– Anticoagulation management in free flap reconstructive surgery is crucial to prevent complications such as thrombosis and bleeding, which can lead to flap loss.

– A retrospective single-center study of 489 free flap surgeries revealed that intraoperative unfractionated heparin (UFH) significantly predicted flap survival, and higher prothrombin time (PTT) values on day 1 post-surgery were associated with reduced relative probability of flap loss.

– Patients treated with UFH alone showed no significant difference in flap survival compared to those receiving both UFH and aspirin, although the aspirin-only group was small. – Intraoperative UFH administration and postoperative therapy with PTT-controlled UFH were recommended to minimize bleeding risk, with a target PTT range of 40–60 seconds proposed for balancing thrombosis and bleeding risks effectively.

– The study emphasized the necessity for standardized anticoagulation protocols in free flap surgery to enhance flap survival rates and ensure surgical success.

– Despite limitations of the study, such as its retrospective design and diverse patient population, the importance of anticoagulation for free flap preservation was underscored, urging the need for future prospective multicenter studies to establish consensus on perioperative anticoagulation therapy.

Reference –

Saeed Torabi et al. (2025). Impact Of Perioperative Anticoagulation Management On Free Flap Survival In Reconstructive Surgery: A Retrospective Analysis. *BMC Anesthesiology*, 25. https://doi.org/10.1186/s12871-025-02975-6

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