Pentraxin 3 accurately predicts advanced fibrosis and CIMT in patients with MAFLD: Study

Background and objectives

Metabolic-associated fatty liver disease (MAFLD) may increase the risk of cardiovascular events. In this study, we assessed the predictive value of pentraxin 3 (PTX3) for severe fibrosis and carotid intima-media thickness (CIMT) in patients with MAFLD.

Methods

188 patients (114 with MAFLD, 74 with dual etiology MAFLD and chronic hepatitis C) were included. All participants underwent clinical history and examination, metabolic parameter assessment, serum level evaluation of PTX3, Fibrosis-4 index and nafld fibrosis score scores, abdominal ultrasound, and CIMT assessment.

Results

The serum PTX3 was significantly elevated in patients with advanced fibrosis compared to those with mild/moderate fibrosis (1.8 vs 1.4, p = 0.006). The PTX3 level was independently associated with advanced fibrosis (odds ratio = 1.26, 95% confidence interval 1.008–1.040). In MAFLD patients, the PTX3 levels in patients with low fibrosis compared to those with advanced fibrosis were 1.4 (1–2.1) and 1.9 (1.3–3.8), respectively (p = 0.027). A significantly greater CIMT was noted in patients with elevated PTX3 levels (3.85 (3.42–4) vs 4.05 (3.7–4.67), p = 0.0001) compared to those with low PTX3 levels.

Conclusions

In this study, we demonstrated that PTX3 accurately predicts the presence of advanced fibrosis and CIMT in a population with MAFLD. Thus, it could be useful for risk stratification and management. Further independent studies will be required to confirm these findings in larger cohorts and in the general population, which has diverse representations of individuals of other races and ethnicities.

References: Alshymaa A. Hassnine1,* , Yasser Fouad1, Zienab M. Saad1, Alaa M. Mostafa1, Hend M. Moness2, Nehal I. Abbas2, Nasr M. Osman3 and Wafaa Abdelghany1

Author information Gene Expression 2024doi: 10.14218/GE.2023.00047

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Daily sauna time might help prevent menopause-related weight gain, suggests study

New research performed with mice suggests that daily time in a warm environment such as a sauna might help older adults, especially women, combat age-related obesity and insulin resistance. The study shows the potential of heat treatments as a simple way to promote healthier aging.

The researchers found that older female mice receiving a daily 30-minute whole-body heat treatment gained less weight and showed improved use of insulin, which helps control blood sugar. The investigators also identified the biological processes responsible for these beneficial effects.

“Compared to men, women have a higher likelihood of being obese or overweight,” said research team leader Soonkyu Chung, PhD, associate professor in the Department of Nutrition at the University of Massachusetts Amherst. “This is especially true after menopause, due to the loss of estrogen in the body. Our study suggests that whole-body heat therapy could serve as an effective, non-invasive solution for managing weight gain and insulin resistance associated with menopause.”

Rong Fan, a doctoral candidate advised by Chung, will present the findings at NUTRITION 2024, the flagship annual meeting of the American Society for Nutrition held June 29–July 2 in Chicago.

“Heat therapy could be a practical option for those with increased abdominal fat and a higher risk of metabolic diseases triggered by menopausal hormonal changes,” said Fan. “It could be easily integrated into routine healthcare practices through regular sessions in saunas, heated baths or with specialized heat wraps.”

For the study, the ovaries of older female mice were removed to model post-menopausal conditions. To induce weight gain, the mice received a Western diet that contained 45% calories from fat. One group of mice received 30 minutes of daily heat therapy in a heat chamber set to 40℃ (104°F) for 12 weeks while the other group did not receive heat treatment.

The mice receiving the heat treatment showed no tissue damage and exhibited significantly reduced lactate dehydrogenase levels, indicating less aging-related tissue damage. The therapy also effectively mitigated weight gain induced by a high fat diet.

Compared to the mice not receiving the treatment, those that underwent heat therapy showed significant improvements in insulin sensitivity and insulin signaling as well as reduced fat accumulation in key areas such as the liver and in brown fat. While adipose tissue stores energy, brown fat is a metabolically active type of fat that helps the body burn more energy. Research has shown that people tend to lose brown fat as they age and when entering menopause, which contributes to a slower metabolism.

The researchers also explored the molecular mechanisms involved in the beneficial effects of heat therapy. They found that the heat triggers several molecular processes that help the body use energy more efficiently and burn fat. A key player is a protein known as TRPV1, which functions as a calcium ion channel in the cell membrane. When activated by heat, TRPV1 kicks off a process known as futile calcium cycling where the body uses up energy (in the form of ATP) to pump calcium ions across cell membranes. This process helps increase the amount of energy the body burns.

TRPV1 activation and the subsequent calcium cycling also stimulate the breakdown and burning of fats. This reduces fat accumulation in tissues like the liver and helps improve the body’s insulin sensitivity, which is crucial for overall metabolic health. “This series of events suggests that regular application of heat can mimic the effects of calorie burning and fat loss,” said Fan. “It could be particularly advantageous for individuals who find physical activities challenging, providing a relaxing way to improve metabolic health.”

The researchers note that more research needs to be done to determine the optimal duration and intensity of heat exposure in people for health benefits and confirm its safety and effectiveness across diverse populations.

Reference:

Daily sauna time might help prevent menopause-related weight gain, American Society for Nutrition, Meeting: NUTRITION 2024.

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FDA approves another drug for treatment of adults with early symptomatic Alzheimer’s disease

The US Food and Drug Administration has approved aother drug donanemab (Kisunla) for treatment of adults with early symptomatic Alzheimer’s disease with confirmed amyloid pathology and Alzheimer’s patients with mild cognitive impairment and mild dementia.

The U.S. Food and Drug Administration has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in the clinical trials.

Kisunla is administered as an intravenous infusion every four weeks. The recommended dosage is detailed in the prescribing information.

Disease or Condition

Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer’s are not fully known, it is characterized by changes in the brain—including amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections. These changes affect a person’s ability to remember, think and speak.

Effectiveness

The efficacy of Kisunla was evaluated in a double-blind, placebo-controlled, parallel-group study (Study 1, NCT04437511) in patients with Alzheimer’s disease. The patients had confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease. 1736 patients were randomized 1:1 to receive700 mg Kisunla every 4 weeks for the first 3 doses, and then 1400 mg every 4 weeks (N = 860) or placebo (N = 876) for a total of up to 72 weeks. The treatment was switched to placebo based on a prespecified reduction in amyloid levels measured by positron emission tomography (PET) at Week 24, Week 52, and Week 76.

Patients treated with Kisunla demonstrated a statistically significant reduction in clinical decline on the Integrated Alzheimer’s Disease Rating Scale (iADRS) compared to placebo at Week 76 in the overall population (2.92, p<0.0001), as well as on the iADRS component scales, the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog13) (-1.33, p=0.0006) and the Alzheimer’s Disease Cooperative Study – instrumental Activities of Daily Living (ADCS-iADL) scale (1.70, p=0.0001). Patients treated with Kisunla also demonstrated a statistically significant reduction in clinical decline on the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) compared to placebo at Week 76 in the overall population (-0.70, p<0.0001).

At baseline, the study population had a mean age of 73 years, with a range of 59 to 86 years. Fifty-seven percent of patients were female, 91% were White, 6% were Asian, 4% were Hispanic or Latino, and 2% were Black or African American.

Safety Information

The prescribing information includes a boxed warning for amyloid-related imaging abnormalities (ARIA). ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain. ARIA usually does not have symptoms, although serious and life-threatening events rarely can occur.

Patients who are ApoE ε4 homozygotes have a higher incidence of ARIA, including symptomatic and serious ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ε4 status should be performed prior to beginning treatment to inform the risk of developing ARIA.

There is risk of infusion-related reactions, with symptoms such as flu-like symptoms, nausea, vomiting and changes in blood pressure, and hypersensitivity reactions, including anaphylaxis (severe, life-threatening allergic reaction) and angioedema (swelling).

The most common side effects of Kisunla were ARIA and headache.

See full prescribing information for additional information on risks associated with Kisunla.

Designations

The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations.

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AI shows high accuracy, sensitivity, and specificity in diagnosing skin cancer, suggests study

AI shows high accuracy, sensitivity, and specificity in diagnosing skin cancer, suggests a study published in the Dermatologic Surgery.

Limited access to dermatologic care may pose an obstacle to the early detection and intervention of cutaneous malignancies. The role of artificial intelligence (AI) in skin cancer diagnosis may alleviate potential care gaps. The aim of this systematic review was to offer an in-depth exploration of published AI algorithms trained on dermoscopic and macroscopic clinical images for the diagnosis of melanoma, basal cell carcinoma, and cutaneous squamous cell carcinoma (cSCC). Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, a systematic review was conducted on peer-reviewed articles published between January 1, 2000, and January 26, 2023. Among the 232 studies in this review, the overall accuracy, sensitivity, and specificity of AI for tumor detection averaged 90%, 87%, and 91%, respectively. Model performance improved with time. Despite seemingly impressive performance, the paucity of external validation and limited representation of cSCC and skin of color in the data sets limits the generalizability of the current models. In addition, dermatologists coauthored only 12.9% of all studies included in the review. Moving forward, it is imperative to prioritize robustness in data reporting, inclusivity in data collection, and interdisciplinary collaboration to ensure the development of equitable and effective AI tools.

Reference:

Jairath, Neil MD*; Pahalyants, Vartan MD, MBA*; Shah, Rohan BS†; Weed, Jason MD*; Carucci, John A. MD, PhD*; Criscito, Maressa C. MD*. Artificial Intelligence in Dermatology: A Systematic Review of Its Applications in Melanoma and Keratinocyte Carcinoma Diagnosis. Dermatologic Surgery ():10.1097/DSS.0000000000004223, May 9, 2024. | DOI: 10.1097/DSS.0000000000004223

Keywords:

AI, high, accuracy, sensitivity, specificity, diagnosing, skin cancer, suggests, study, Dermatologic Surgery, Jairath, Neil, Pahalyants, Vartan, Shah, Rohan, Weed, Jason, Carucci, John A, Criscito, Maressa C.

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Routine Intracameral Antibiotics May Not Be Necessary After Cataract Surgery: Study

Researchers have found that routine use of intracameral antibiotics may not be essential for preventing endophthalmitis after cataract surgery. A retrospective cohort study conducted at the Rotterdam Ophthalmic Institute revealed that using prophylactic antibiotics only for complicated cases did not lead to a higher incidence of this severe infection. This study was published in JAMA Ophthalmology.

Endophthalmitis, a rare but devastating infection following intraocular surgery, can result in significant and permanent vision loss in the affected eye. Preventive measures traditionally include the application of intracameral antibiotics. However, the necessity and efficacy of routine antibiotic prophylaxis remain controversial, with concerns about cost, side effects, and antibiotic resistance.

This study reviewed data from cataract surgeries performed between 2016 and 2022 at a specialized hospital in Rotterdam. The incidence of postoperative endophthalmitis was compared across different periods and surgical practices, including times when routine antibiotic prophylaxis was standard. The study also analyzed cases where a lower concentration of povidone iodine (1%) was used instead of the more common 5% to 10%.

The study included all cataract surgeries performed from 1993 to 2022 at the Rotterdam Eye Hospital. For the period from 2016 to 2022, prophylactic intracameral antibiotics were used only in complicated surgeries, specifically when a tear occurred in the posterior lens capsule. The incidence of postoperative endophthalmitis was calculated and compared to historical data.

  • Current Study Period (2016-2022): 17 cases of postoperative endophthalmitis were recorded out of 56,598 procedures (incidence rate 0.000, 95% CI 0.000-0.000).

  • Historical Comparisons: From 1993 to 1999, 36 cases occurred in 27,114 procedures (incidence rate 0.001), and from 2000 to 2010, 62 cases occurred in 68,335 procedures (incidence rate 0.001).

  • Pathogen Analysis: Of the 17 cases from 2016 to 2022, cultures yielded coagulase-negative staphylococci (n=8), Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus mitis, and Enterococcus faecalis. Five cases had no growth in cultures.

  • Antibiotic Prophylaxis: The application of intracameral antibiotics in only complicated cases did not increase the incidence of endophthalmitis.

The study’s findings suggest that routine intracameral antibiotics may not be necessary for preventing endophthalmitis in cataract surgeries. The practice of using 1% povidone iodine for disinfection, instead of the more common higher concentrations, may have contributed to the low infection rates observed. The study also highlights the potential benefits of reducing antibiotic use, including lower costs, fewer side effects, and decreased risk of antibiotic resistance.

Vincent Daien, MD, PhD, and colleagues, in an accompanying commentary, noted the controversy surrounding this issue. They pointed out previous studies that demonstrated a significant reduction in endophthalmitis risk with the routine use of intracameral antibiotics. However, they acknowledged that selective use of antibiotics, as shown in this study, warrants further investigation.

The authors noted several limitations, including the retrospective nature of the study and the specific setting of the Rotterdam Eye Hospital, which may not be fully comparable to general hospitals or academic centers. The findings are based on a specialized environment with potentially different patient demographics and surgical protocols.

This study provides evidence that routine intracameral antibiotics may not be necessary for preventing endophthalmitis after cataract surgery. Selective use of antibiotics in complicated cases, along with effective antiseptic protocols, can maintain low infection rates. These findings may influence future surgical practices and guidelines, emphasizing the importance of tailored prophylactic strategies.

Reference:

van Rooij, J., Nolte, K., van de Vondervoort, F., Lekkerkerk, S., Bourgonje, V., & Wubbels, R. (2024). Prophylactic intracameral antibiotics and endophthalmitis after cataract surgery. JAMA Ophthalmology. https://doi.org/10.1001/jamaophthalmol.2024.1716

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Bubble CPAP may improve respiratory outcomes in labour room and NICU: Study

A recent study published in the Pediatrics journal found improved respiratory outcomes for very preterm infants by utilizing bubble continuous positive airway pressure (bCPAP) as the primary respiratory support in the delivery room (DR) and neonatal intensive care unit (NICU).

This comprehensive study from January 2012 to June 2020 assessed the impact of a multidisciplinary bCPAP protocol on infants with a gestational age of less than 32 weeks and a birth weight below 1250 grams. The study categorized the infants into four distinct periods as, pre-implementation (P0: 2012–2014) and three post-implementation phases (P1: 2014–2016, P2: 2016–2018, P3: 2018–2020).

The primary focus of the study was to evaluate the rates of death and severe bronchopulmonary dysplasia (BPD), while secondary outcomes included the need for intubation in the DR and NICU within the first seven days of life, the necessity of surfactant administration and incidences of pneumothorax. Multivariate logistic regression models were employed to adjust for relevant risk factors and calculate adjusted odds ratios (ORs).

The study encompassed a total of 440 infants who were distributed as, 90 in P0, 91 in P1, 128 in P2 and 131 in P3. Over time, significant improvements were observed:

  • The rates of death and severe BPD dropped markedly post-implementation. By the third post-implementation period (P3), the odds ratio for death and severe BPD decreased to 0.37 (95% confidence interval [CI] 0.15–0.84) from the pre-implementation period by indicating a substantial reduction.
  • The requirement for intubation in the delivery room saw a dramatic decline, from 66% in P0 to 24% in P3 for the entire cohort and from 96% to 40% in infants under 26 weeks of gestational age.
  • While the necessity for NICU intubation remained similar across the periods, the need for surfactant decreased, albeit at higher oxygen levels (FiO2) by suggesting that infants could maintain better oxygenation with less invasive support.
  • The rates of pneumothorax remained unchanged which indicated that the new protocol did not increase the risk of this particular adverse outcome.

The implementation of the bCPAP protocol has led to a significant and sustained improvement in respiratory practices and outcomes for very preterm infants. This protocol has reduced the rates of severe respiratory complications and the need for invasive procedures which marks a significant advancement in neonatal care. The success of this protocol highlights the importance of multidisciplinary approaches in improving the survival and health of vulnerable infants in NICU settings.

Source:

de Carvalho Nunes, G., Barbosa de Oliveira, C., Zeid, M., Leone, M., Mardakis, S., Remmer, E., Boyer, J., Hailu, E., Altit, G., Beltempo, M., Shalish, W., & Sant’Anna, G. (2024). Early Bubble CPAP Protocol Implementation and Rates of Death or Severe BPD. In Pediatrics. American Academy of Pediatrics (AAP). https://doi.org/10.1542/peds.2023-065373

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Website unlawfully selling versions of Novo Nordisk weight loss drugs gets USFDA warning

The U.S. Food and Drug Administration (USFDA) said on tuesday it had issued a warning against a website called ozempen.com for illegally selling versions of  weight-loss drugs of Novo Nordisk.

Increasing demand for Novo’s Ozempic, Eli Lilly’s Mounjaro, and other GLP-1 drugs that aid in weight loss has led to a burgeoning global market for counterfeit versions.

The FDA said the website was offering unapproved versions of obesity and diabetes drugs Ozempic and Wegovy.
“These products are only available pursuant to a prescription from a licensed practitioner,” as per Reuters report , the health regulator said.
Last month, the World Health Organization issued warnings on fake drugs claiming to contain the active ingredient found in Ozempic and Wegovy.
Read also: WHO, Eli Lilly warn against fake versions of popular weight loss, diabetes drugs
Lilly and Novo have sued several entities to stop them from selling products claiming to contain the active ingredients tirzepatide and semaglutide that are used in their respective popular diabetes and weight-loss drugs.

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Medical Negligence Complaint Cannot be Entertained Without Another Doctor’s opinion: HC relief to Doctor, criminal proceedings under IPC 304A quashed

Ranchi: In a recent judgment, the Jharkhand High Court has stated that a private complaint accusing a doctor of medical negligence cannot be entertained unless prima facie evidence is being produced in the form of credible opinion of another doctor to support the negligence of the accused doctor.

Reiterating the legal precedence set by the Supreme Court in this regard in the cases of Jacob Mathew v. State of Punjab, and Martin F. D’ Souza v. Md. Ishfaq, the Jharkhand High Court observed, “In view of the above two judgments of the Hon’ble Supreme Court, it is crystal clear that a private complaint may not be entertained unless the complainant has produced prima facie evidence in the form of credible opinion given by another doctor to support the charge of rashness or negligence on the part of the accused doctor. It appears that to allow the proceeding to continue, will amount to an abuse of the process of law.”

This observation was made by the High Court bench while considering a petition by a doctor seeking quashing of the criminal proceedings against him including the order taking cognizance of the offence under Section 304-A of the Indian Penal Code (IPC) against him.

As per the complainant, his mother died due to gross medical negligence committed by the accused doctors while she was admitted to the Dwaraka Das Jalan Memorial Hospital. The history of the case goes back to 2011 when the patient was admitted to the treating hospital for her weakness and trouble passing urine. At the hospital, the petitioner (the accused doctor) treated the patient and the other accused junior doctors attended her. 

It was alleged that based on the advice given by the petitioner doctor, the patient was admitted to the CCU as she was suffering from an Urinary tract infection. The petitioner asked the family of the patient to purchase some medicine and also informed them that since she was suffering from high blood sugar, insulin was required to be administered.

However, the hospital allegedly did not provide proper care to the patient instead they were prescribing medicines that the complainant had to buy from the shop affiliated with the hospital. Further, the hospital allegedly also collected some amount even after the patient’s death and the complainant was completely unaware of the reason for her death. 

It was further alleged that one day the patient’s elder son applied for a copy of the documents for a medical claim, and after scrutinizing the medical record, the complainant realised that due to heavy administration of Insulin, the patient died. Also, the instrument used for testing glucose was allegedly faulty which led to an erroneous reading of the blood sugar level. Therefore, accusing the petitioner doctor of medical negligence, the complainant registered a case against him. 

On the other hand, the treating doctor refuted these allegations and submitted that there was no medical negligence in the treatment. The doctor submitted that he, along with other doctors put their best efforts into taking care of the patient. However, despite this, they could not save the patient’s life.

While considering the matter, the HC bench relied on the Supreme Court order in the case of Jacob Mathew v. State of Punjab and Martin F. D’ Souza v. Md. Ishfaq and observed that a private complaint may not be entertained unless the complainant has produced prima facie evidence in the form of a credible opinion given by another doctor to support the charge of rashness or negligence on the part of the accused doctor.

With this observation, the HC bench noted, 

“It appears that to allow the proceeding to continue, will amount to an abuse of the process of law.”

Accordingly, granting relief to the petitioner doctor, the High Court dismissed the proceedings against him and noted, 

“Accordingly, the entire criminal proceeding including the order taking cognizance dated 14.01.2016, by which, cognizance for the offence under Section 304-A of the Indian Penal Code has been taken against the petitioner, in connection with Complaint Case no. 1201 of 2012, pending in the court of learned Judicial Magistrate, Dhanbad, are hereby, quashed.”

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/jharkhand-hc-order-242953.pdf

Also Read: Medical Negligence: SC to decide whether State Human Rights Commission can consider Complaint dismissed by NHRC

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A potential game-changer for emergency medicine: Synthetic platelets

Imagine being a paramedic treating a trauma patient who’s bleeding severely. You know your patient’s life is in danger, but there’s not much you can do because the patient needs an infusion of blood containing platelets. Platelets encourage clotting, help stop bleeding, and are critical in emergencies like this. Yet on board your ambulance, none are on hand.

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Study reveals new factor associated with the risk of severe COVID-19 in people with obesity

At the beginning of the COVID-19 pandemic, a group of Brazilian researchers showed why SARS-CoV-2 infection tends to be more severe in diabetic patients. Now, the same team based at the Institute of Biology of the State University of Campinas (IB-UNICAMP) has discovered one of the reasons why obese people who do not have diabetes or even insulin resistance also have an increased risk of developing the severe form of the disease.

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