Bombay HC directs Navy to reconsider doctor’s disability pension within 6 weeks

Mumbai: The Bombay High Court has given the Navy six weeks to
reconsider its decision to revoke the disability pension of retired naval
doctor Dr Anan Jaiswal. The court warned that contempt proceedings may follow
if the Navy does not respond within the specified timeframe.

Dr Jaiswal, who served at INS Jeevanti in Goa and the
Andaman and Nicobar Islands, was discharged from service in 2012 after being
classified with a disability. The disability was due to his service. He was supposed to receive the disability pension of a retired naval doctor.

However, he has been engaged
in a legal battle to secure his pension. Although the Navy had assured the
Armed Forces Tribunal (AFT), Mumbai, that his pension would be reinstated, the
Navy unexpectedly revoked Jaiswal’s pension payment order (PPO).

According to the Times of India, the Navy began disbursing Dr Jaiswal’s disability pension in
March 2023, following the AFT’s 2019 ruling. However, the Navy has since ceased
these payments, despite the absence of a stay on the AFT’s decision. The court
has scheduled the next hearing for June 28, after its summer recess. “The Navy asked for time to reconsider, and the high court has given the Navy six weeks to respond. If they don’t respond, then our contempt petition will be accepted,” said Jaiswal’s lawyer Satendra Kumar.

Dr Jaiswal stated that a simple notice had been misinterpreted as a stay order. “What the Navy has done is it has misrepresented a notice as a stay order by the high court. They have deliberately made the stay order letter to stop the pension to harass me,” said Jaiswal. 
Armed Forces personnel who are retired or discharged from service with a disability sustained under circumstances accepted as Category ‘D’ and assessed not less than 20% are awarded a monthly disability compensation called Liberalized Impairment Relief. This is not a pension and ceases upon the recipient’s death.

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AstraZeneca says it will withdraw COVID-19 vaccine globally

New Delhi: The vaccine most consumed in India, will soon disappear from the drug shelves of the country as AstraZeneca on Tuesday announced it had initiated the worldwide withdrawal of its COVID 19 vaccine due to a ”surplus of available updated vaccines” since the pandemic.

The UK-based pharmaceutical company in collaboration with the Serum Institute of India (SII), the world’s largest vaccine manufacturer, had made available the Covishield vaccine to the Indian population .

AstraZeneca, which partnered with the University of Oxford to develop the vaccine, is now facing a lawsuit alleging that the vaccine resulted in deaths and serious injuries to recipients.

Also Read:AstraZeneca admits ‘very rare’ side effect of COVID vaccine in UK court

However, the company has cited commercial reasons for the withdrawal as “surplus of available updated vaccines”

The company also said it would proceed to withdraw the vaccine Vaxzevria’s marketing authorizations within Europe.

“As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines,” the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.

The Anglo-Swedish drugmaker has previously admitted in court documents that the vaccine causes side-effects such as blood clots and low blood platelet counts.

The firm’s application to withdraw the vaccine was made on March 5 and came into effect on May 7, according to the Telegraph, which first reported the development.

Medical Dialogues had earlier reported that the pharmaceutical giant is being sued in a class action in UK over claims that its vaccine against Covid-19, developed with the University of Oxford, caused death and serious injury, including TTS — Thrombosis with Thrombocytopenia Syndrome — which causes people to have blood clots and a low blood platelet count. In India as well, a plea was submitted to the Supreme Court last week , urging the establishment of a medical expert panel overseen by a retired apex court judge. This panel would be tasked with assessing potential side effects and risk factors associated with the Covishield vaccine.

London-listed AstraZeneca began moving into respiratory syncytial virus vaccines and obesity drugs through several deals last year after a slowdown in growth as COVID-19 medicine sales declined.

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Twice-weekly energy-restricted diet tops exercise to lower blood sugar in type 2 diabetes: Study

China: In a significant advancement in the realm of diabetes management, a pioneering three-arm randomized controlled trial has examined the effects of two distinct 5:2 regimens—energy-restricted diet and low-volume high-intensity interval training combined with resistance exercise—on glycemic control and cardiometabolic health in adults grappling with overweight/obesity and type 2 diabetes. The findings, published in Diabetes Care, provide valuable insights into tailored interventions for this high-risk population.

The study revealed that the medically supervised 5:2 energy-restricted diet could be an alternative strategy for improving glycemic control, and the exercise regimen could improve body composition, although it inadequately improved glycemic control.

Type 2 diabetes, a chronic metabolic disorder characterized by insulin resistance and hyperglycemia, poses a formidable public health challenge worldwide, with obesity emerging as a major predisposing factor. While lifestyle modifications, including diet and exercise, are cornerstone strategies in diabetes management, the optimal regimen for achieving glycemic control and reducing cardiovascular risk remains a subject of ongoing debate.

Mian Li, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues aimed to investigate the effects of a 5:2 regimen diet (2 days per week of energy restriction by formula diet) or an exercise (2 days per week of high-intensity interval training and resistance training) intervention versus routine lifestyle education (control) on cardiometabolic health and glycemic control among adults with overweight/obesity and type 2 diabetes.

For this purpose, the researchers conducted a two-center, open-label, three-arm, parallel-group, randomized controlled trial that recruited 326 participants with obesity/overweight and type 2 diabetes. They were randomized into 12 weeks of diet intervention (n = 109), exercise intervention (n = 108), or lifestyle education (control) (n = 109).

The study’s primary outcome was the glycemic control change measured as glycated hemoglobin (HbA1c) between the diet or exercise intervention groups and the control group after the 12-week intervention.

Based on the study, the researchers reported the following findings:

  • The diet intervention significantly reduced HbA1c level (%) after the 12-week intervention (−0.72) compared with the control group (−0.37) (diet versus control −0.34).
  • The reduction in HbA1c level in the exercise intervention group (−0.46) did not significantly differ from the control group (exercise vs. control −0.09).
  • The exercise intervention group was superior in maintaining lean body mass.
  • Both diet and exercise interventions induced improvements in adiposity and hepatic steatosis.

The findings showed that two days a week of a medically supervised energy-restricted diet may lower blood glucose levels in adults with overweight or obesity and type 2 diabetes.

“The diet intervention group experienced a greater energy deficit with a more pronounced metabolic benefit,” the researchers wrote. “Our study indicates that a medically supervised 5:2 energy-restricted diet could be an alternative strategy for improving glycemic control.”

Reference:

Mian Li, Jie Li, Yu Xu, Jinli Gao, Qiuyu Cao, Yi Ding, Zhuojun Xin, Ming Lu, Xiaoting Li, Haihong Song, Jue Shen, Tianzhichao Hou, Ruixin He, Ling Li, Zhiyun Zhao, Min Xu, Jieli Lu, Tiange Wang, Shuangyuan Wang, Hong Lin, Ruizhi Zheng, Jie Zheng, Callum John Baker, Shenghan Lai, Nathan Anthony Johnson, Guang Ning, Stephen Morris Twigg, Weiqing Wang, Yan Liu, Yufang Bi; Effect of 5:2 Regimens: Energy-Restricted Diet or Low-Volume High-Intensity Interval Training Combined With Resistance Exercise on Glycemic Control and Cardiometabolic Health in Adults With Overweight/Obesity and Type 2 Diabetes—A Three-Arm Randomized Controlled Trial. Diabetes Care 2024; dc240241. https://doi.org/10.2337/dc24-0241

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No benefit of aspirin as adjuvant therapy in breast cancer patients: shows trial

USA: In a groundbreaking development in breast cancer treatment, the Alliance A011502 Randomized Trial has provided compelling evidence regarding the potential benefits of aspirin as adjuvant therapy. The trial, which investigated the efficacy of aspirin compared to a placebo in preventing cancer recurrence and improving survival rates among breast cancer survivors, has garnered significant attention from the medical community worldwide.

The study, published in the Journal of the American Medical Association (JAMA), revealed that there was no benefit of aspirin at 300 mg/d on breast cancer recurrence and survival.

The randomized, placebo-controlled clinical trial comprised 3020 patients with high-risk nonmetastatic breast cancer. The trial was terminated early because of the lack of benefit from aspirin (hazard ratio for invasive disease-free survival for aspirin versus placebo, 1.27 [not statistically significant]).

Despite its wide availability and promise, aspirin should not be recommended as an adjuvant breast cancer treatment, the researchers suggested.

Breast cancer remains one of the most prevalent malignancies affecting women globally, with a pressing need for innovative therapeutic strategies to enhance outcomes and reduce the risk of disease recurrence. Adjuvant therapies, administered post-primary treatment, play an important role in achieving these objectives by targeting residual cancer cells and preventing metastatic spread.

Observational studies of breast cancer survivors and prospective trials of aspirin for cardiovascular disease suggest improved breast cancer survival among aspirin users, however, there is a lack of prospective studies of aspirin to prevent breast cancer recurrence. To fill this knowledge gap, Wendy Y. Chen, Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts, and colleagues aimed to determine whether aspirin decreases the risk of invasive cancer events among breast cancer survivors.

For this purpose, the research team conducted a phase 3, randomized, placebo-controlled, double-blind trial (A011502) in Canada and the United States comprising 3020 participants with high-risk nonmetastatic breast cancer, participants were enrolled from 534 sites from 2017 through 2020, with follow-up to March 4, 2023.

Participants were randomized to receive 300 mg of aspirin (n = 1510) or placebo once daily (n = 1510) for five years (stratified for hormone receptor status [positive versus negative], body mass index [≤30 versus >30], stage II versus III, and time since diagnosis [<18 versus ≥18 months]). 3020 participants were randomized when the data and safety monitoring committee recommended study suspension at the first interim analysis because the hazard ratio had crossed the prespecified futility bound.

The primary outcome was invasive disease-free survival. The key secondary outcome was overall survival.

The following were the key findings of the study:

  • By median follow-up of 33.8 months, 253 invasive disease-free survival events were observed (141 in the aspirin group and 112 in the placebo group), yielding a hazard ratio of 1.27.
  • All invasive disease-free survival events, including death, invasive progression (both distant and locoregional), and new primary events, were numerically higher in the aspirin group, however, the differences were not statistically significant.
  • There was no difference in overall survival (hazard ratio, 1.19).
  • Rates of grades 3 and 4 adverse events were similar in both groups.

The findings showed that among participants with high-risk nonmetastatic breast cancer, daily aspirin therapy failed to improve the risk of breast cancer recurrence or survival in early follow-up.

“Patients with a history of early breast cancer should not be encouraged to take aspirin routinely to improve their breast cancer outcomes,” the researchers wrote.

Reference:

Chen WY, Ballman KV, Partridge AH, et al. Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer: The Alliance A011502 Randomized Trial. JAMA. Published online April 29, 2024. doi:10.1001/jama.2024.4840

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Reduction in inflammation does not improve coronary microvascular dysfunction in rheumatoid arthritis: LiiRA Study

USA: Rheumatoid arthritis (RA) is not just a disease of the joints; it affects multiple systems in the body, including the cardiovascular system. In a groundbreaking development, the LiiRA study has uncovered the intricate interplay between systemic inflammation, myocardial injury, and coronary microvascular dysfunction in individuals with rheumatoid arthritis. These findings offer crucial insights into the cardiovascular complications associated with RA and may pave the way for targeted interventions to improve patient outcomes.

Researchers found that in RA patients on anti‐inflammatory therapy, despite a reduction in inflammatory markers like high‐sensitivity CRP (hs-CRP) & interleukin‐1b, there was no significant improvement in myocardial flow reserve (MFR). Nearly half had coronary microvascular dysfunction at baseline, yet neither high‐sensitivity cardiac troponin T (hs‐cTnT) nor MFR levels changed significantly.

The study findings were published online in the Journal of the American Heart Association on April 30, 2024.

Coronary microvascular dysfunction, measured by myocardial flow reserve, is associated with increased cardiovascular risk in rheumatoid arthritis. Brittany Weber, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, and colleagues aimed to determine the association between reducing inflammation with MFR and other measures of cardiovascular risk.

For this purpose, the researchers enrolled patients with RA with active disease about to initiate a tumor necrosis factor inhibitor. All participants underwent a cardiac perfusion PET scan to quantify MFR at baseline before tumor necrosis factor (TNF) inhibitor initiation and after the initiation of TNF inhibitor at 24 weeks. MFR <2.5 in the absence of obstructive coronary artery disease was defined as coronary microvascular dysfunction. Blood samples were measured at baseline and 24 weeks for inflammatory markers (eg, hs-CRP, interleukin‐1b, and hs‐cTnT).

The primary outcome was mean MFR before and after TNF inhibitor initiation, with Δhs‐cTnT as the secondary outcome. Secondary and exploratory analyses included the correlation between ΔhsCRP and other inflammatory markers with MFR and hs‐cTnT. 66 subjects were studied; 82% were women, and the mean RA duration was 7.4 years.

The following were the study’s key findings:

  • The median atherosclerotic cardiovascular disease risk was 2.5%; 47% had coronary microvascular dysfunction, and 23% had detectable hs‐cTnT.
  • There was no change in mean MFR before (2.65) and after treatment (2.64) or hs‐cTnT.
  • A correlation was observed between a reduction in hs-CRP and interleukin‐1b with a decrease in hs‐cTnT.

The findings showed that nearly 50% of subjects had coronary microvascular dysfunction at baseline in the RA cohort with a low prevalence of cardiovascular risk factors. A reduction in inflammation was not associated with improved myocardial flow reserve. However, a modest reduction in interleukin‐1b and no other inflammatory pathways correlated with a decrease in subclinical myocardial injury.

Reference:

Weber B, Weisenfeld D, Massarotti E, Seyok T, Cremone G, Lam E, Golnik C, Brownmiller S, Liu F, Huang S, Todd DJ, Coblyn JS, Weinblatt ME, Cai T, Dahal K, Kohler M, Yinh J, Barrett L, Solomon DH, Plutzky J, Schelbert HR, Campisi R, Bolster MB, Di Carli M, Liao KP. Interplay Between Systemic Inflammation, Myocardial Injury, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis: Results From the LiiRA Study. J Am Heart Assoc. 2024 Apr 30:e030387. doi: 10.1161/JAHA.123.030387. Epub ahead of print. PMID: 38686879.

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Monoclonal Antibody Shows Promise in Preventing Malaria in Children, reports study

Researchers have found that a single subcutaneous injection of an investigational monoclonal antibody called L9LS significantly reduces the risk of malaria in children. This phase II trial in Mali demonstrated that the antibody was both safe and effective in preventing Plasmodium falciparum infections among children aged 6 to 10 years. This study was published in The New England Journal Of Medicine by Kayentao and colleagues.

Malaria, a life-threatening disease caused by Plasmodium parasites, continues to pose a significant health burden worldwide, particularly in sub-Saharan Africa. In 2022, the World Health Organization (WHO) reported over 600,000 deaths due to malaria, the majority among young children. The development of long-acting drugs for malaria prevention could be a major step forward in controlling the disease.

The Mali Malaria mAB trial included 225 children aged 6 to 10 years and evaluated the safety and efficacy of L9LS in preventing malaria. Children were randomized to receive either a 150-mg dose, a 300-mg dose, or a placebo injection. Before the trial, participants were treated with antimalarial medication to clear any existing infections.

The key findings of the study were as follows:

  • Infection rates were significantly lower in both L9LS dose groups compared to the placebo group.

  • Specifically, 48% of children in the 150-mg dose group and 40% in the 300-mg dose group became infected, compared to 81% in the placebo group.

  • The antibody provided 67% efficacy with the 150-mg dose and 77% efficacy with the 300-mg dose against clinical malaria, compared to the placebo group.

  • No safety concerns were identified in either phase of the study.

  • Adverse events were rare, mild to moderate in severity, and resolved without intervention.

The study indicates that the L9LS monoclonal antibody offers substantial protection against malaria, providing a potentially transformative approach to malaria prevention in high-risk populations. The long-acting nature of the antibody, with its single-dose delivery, could enhance accessibility and adherence.

The trial’s findings support the use of L9LS as a promising new tool in the fight against malaria. The antibody demonstrated a high level of efficacy and safety in preventing Plasmodium falciparum infection in children. As the global malaria community seeks new strategies to combat the disease, monoclonal antibodies like L9LS may play a critical role in achieving malaria eradication.

Reference:

Kayentao, K., Ongoiba, A., Preston, A. C., Healy, S. A., Hu, Z., Skinner, J., Doumbo, S., Wang, J., Cisse, H., Doumtabe, D., Traore, A., Traore, H., Djiguiba, A., Li, S., Peterson, M. E., Telscher, S., Idris, A. H., Adams, W. C., McDermott, A. B., … Crompton, P. D. (2024). Subcutaneous administration of a monoclonal antibody to prevent malaria. The New England Journal of Medicine, 390(17), 1549–1559. https://doi.org/10.1056/nejmoa2312775

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Validation of capnodynamic approach for evaluating critically sick patients’ end-expiratory lung volume: Study

Recently published research paper discusses the significance of reduced end-expiratory lung volume (EELV) in mechanically ventilated patients and its association with increased risk for ventilation-induced lung injury. It also explores the challenges associated with clinical measurement of EELV in this patient population. The study aimed to validate a novel continuous capnodynamic method based on expired carbon dioxide (CO2) kinetics for measuring EELV in mechanically ventilated critically ill patients. The study included 46 patients, 25 of whom had a diagnosis of acute respiratory distress syndrome (ARDS), most of which were COVID-19-related. The findings demonstrated that both EELVCT and EELVCO2 were significantly reduced compared to theoretical values of functional residual capacity, indicating a decrease in lung volume among the studied patients.

The capnodynamic method provided good estimates of both total and functional EELV, with bias improving after correcting EELVCO2 for extra-alveolar CO2 content when compared with CT estimated volume. The study concluded that the capnodynamic method presented reasonable estimates of EELV in critically ill patients on mechanical ventilation, with potential implications in clinical monitoring by quantifying the size of the baby lung, monitoring dynamic lung strain, adjusting tidal volume, and assessing the response to PEEP or lung recruitment.

However, the method exhibited a small bias but large limits of agreement, reducing its precision in measuring EELV. The study also highlighted certain methodological aspects, limitations, and potential biases, acknowledging the need for further evaluations to confirm the findings in a larger population and different ICU patient populations. The authors suggested that with further validations, the capnodynamic method may become a promising bedside tool for continuous monitoring of EELV in critically ill mechanically ventilated patients.

The paper provides a detailed overview of the development, validation, and potential applications of the novel capnodynamic method, highlighting its implications for improving clinical assessments and management of mechanically ventilated patients with reduced EELV. The methodology of the study, including the use of CT scans as a reference method and the analysis of benefits and limitations of the capnodynamic method, contributes to the understanding of the challenges and opportunities in monitoring and managing EELV in critically ill patients.

Key Points

– The study focuses on the significance of reduced end-expiratory lung volume (EELV) in mechanically ventilated patients and its association with increased risk for ventilation-induced lung injury, particularly in patients with acute respiratory distress syndrome (ARDS).

– The research validates a novel continuous capnodynamic method based on expired carbon dioxide (CO2) kinetics for measuring EELV in mechanically ventilated critically ill patients. The findings demonstrate that the capnodynamic method provides good estimates of both total and functional EELV, with potential implications in clinical monitoring, adjusting tidal volume, and assessing the response to PEEP or lung recruitment.

– While the capnodynamic method presents reasonable estimates of EELV, it exhibits a small bias and large limits of agreement, reducing its precision in measuring EELV. Further evaluations are required to confirm the findings in a larger population and different ICU patient populations, but the method shows promise as a bedside tool for continuous monitoring of EELV in critically ill mechanically ventilated patients.

Reference –

Sanchez Giralt, J.A., Tusman, G., Wallin, M. et al. Clinical validation of a capnodynamic method for measuring end-expiratory lung volume in critically ill patients. Crit Care 28, 142 (2024). https://doi.org/10.1186/s13054-024-04928-w

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Ghrelin shows promise for neuroprotection in post-cardiac arrest coma: reveals Groundbreaking trial

Netherlands: In a groundbreaking development in critical care medicine, a recent randomized clinical trial has shed light on the potential neuroprotective effects of Ghrelin in patients experiencing post-cardiac arrest coma. The findings, published in the prestigious journal JAMA Neurology, offer new hope for improving outcomes in this vulnerable patient population.

Acyl-ghrelin demonstrated potential efficacy and safety in enhancing neurological outcomes. There is a need for Phase 3 trials for conclusive evidence.

“In phase 2, a placebo-controlled, multicenter, randomized clinical trial (RCT) that comprised 160 patients in a coma within 12 hours of cardiac arrest, treatment with IV (intravenous) acyl-ghrelin for one week was safe,” the researchers reported.

“Neurological outcome by the categories of cerebral performance was nonsignificantly better, and neuron-specific enolase levels were significantly lower in the intervention group.”

Post-cardiac arrest coma, a devastating consequence of cardiac arrest, is characterized by profound neurological dysfunction and impaired consciousness, often resulting from global cerebral ischemia-reperfusion injury. Despite advancements in resuscitation techniques, neurological recovery remains a significant challenge, prompting researchers to explore novel therapeutic strategies aimed at mitigating brain injury and enhancing neuronal survival.

Despite research on more than 20 neuroprotective strategies involving patients in comas after cardiac arrest, none have shown unequivocal evidence of efficacy; however, acyl-ghrelin treatment has demonstrated improved functional and histological brain recovery in experimental models of cardiac arrest and was safe in a wide variety of human study populations.

Against the above background, Sjoukje Nutma, University of Twente, Enschede, the Netherlands, and colleagues aimed to determine the safety and efficacy of IV acyl-ghrelin to improve neurological outcomes in patients in a coma after cardiac arrest.

For this purpose, the researchers conducted the GRECO trial between 2019 and 2022. The researchers assessed adult patients 18 years or older who were in a comatose state after cardiac arrest for eligibility; patients were from 3 intensive care units (ICUs) in the Netherlands. Expected death within 48 hours or unfeasibility of treatment initiation within 12 hours were exclusion criteria.

Patients were randomized to receive IV acyl-ghrelin, 600 μg (intervention group), or placebo (control group) within 12 hours after cardiac arrest, continued for seven days, twice daily, in addition to standard care.

The study’s primary outcome was the Cerebral Performance Categories (CPC) scale score at six months. Safety outcomes included any severe adverse events. Secondary outcomes were neuron-specific enolase (NSE) levels and mortality on days 1 and 3.

Seven hundred eighty-three adult patients in a coma after cardiac arrest were assessed for eligibility, and 160 patients (median age, 68 years; 75% were males) were enrolled. Eighty-one patients were assigned to the intervention group, and 79 were assigned to the control group.

The study revealed the following findings:

  • The common odds ratio (OR) for any CPC improvement in the intervention group was 1.78. This was consistent over all CPC categories.
  • Mean NSE levels on day one after cardiac arrest were significantly lower in the intervention group (34 μg/L versus 56 μg/L) and on day 3 (28 μg/L versus 52 μg/L).
  • Serious adverse events were comparable in incidence and type between the groups.
  • Mortality was 37% in the intervention group vs 51% in the control group (absolute risk reduction, 14%).

“In phase 2, placebo-controlled, RCT, IV treatment with acyl-ghrelin for 1 week was safe and potentially effective to improve neurological and brain recovery in patients in a coma after cardiac arrest,” the researchers wrote. “There is a need for phase 3 trials for conclusive evidence of efficacy.”

Reference:

Nutma S, Beishuizen A, van den Bergh WM, et al. Ghrelin for Neuroprotection in Post–Cardiac Arrest Coma: A Randomized Clinical Trial. JAMA Neurol. Published online May 06, 2024. doi:10.1001/jamaneurol.2024.1088

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Personalized screening early in pregnancy may improve preeclampsia detection, reports study

A new screening algorithm for preeclampsia combining maternal history, ultrasound data and several tests for blood markers may better predict the majority of preeclampsia cases in the first trimester of pregnancy, when it may still be preventable, according to new research published today in Hypertension, an American Heart Association journal.

Preeclampsia is the most dangerous form of high blood pressure during pregnancy (blood pressure measures ≥140/90 mm Hg), and it is a leading cause of maternal death worldwide. Preeclampsia is potentially life-threatening when untreated. It affects 1 in 25 pregnancies in the U.S. and is more common in first-time pregnancies. Symptoms include headaches, vision changes and swelling of the mother’s hands, feet, face or eyes; or a change in the well-being of the baby. Recent research has found that preeclampsia can be linked to an increased risk of developing cardiovascular complications for women later in life.

“Preeclampsia is one of the most severe illnesses of pregnancy and may lead to preterm birth and/or maternal death,” said senior study author Emmanuel Bujold, M.D., M.Sc., professor in the department of obstetrics and gynecology at the Université Laval in Québec City, Canada.

The biological mechanisms that lead preeclampsia usually start in the first trimester of pregnancy (weeks 1 through 12), however, the initial symptoms of preeclampsia most often do not appear before week 20, Bujold noted.

The current risk factor-based guidelines from the American College of Obstetricians and Gynecologists (ACOG) recommend pregnant women take aspirin if they have a major risk factor such as chronic high blood pressure, Type 2 diabetes, chronic kidney disease, lupus or preeclampsia in a prior pregnancy. Aspirin is also recommended by ACOG for pregnant women with two moderate risk factors such as being a Black woman, having a sister or mother with history of preeclampsia, having a first pregnancy, obesity or an IVF pregnancy.

“Following those guidelines, almost all Black women should take aspirin during pregnancy, as should about one-third of all women of other races and ethnicities,” Bujold said.

Previous studies from the Fetal Medicine Foundation have found that preterm preeclampsia, defined as developing preeclampsia before 37 weeks of gestation, can be predicted in the first trimester using a combination of ultrasound and blood biomarker tests. In this study, researchers recruited over 7,000 women with first-time pregnancies across Canada who were between 11 and 14 weeks pregnant to evaluate the Fetal Medicine Foundation’s screening model. The model consisted of maternal history, ultrasound data and several tests for blood markers.

The study found:

  • Using the Fetal Medicine Foundation’s screening model for participants between 11 and 13 weeks of pregnancy, the preeclampsia detection rate was 63.1% for preterm preeclampsia (before 37 weeks of gestation) and 77.3% for early preeclampsia (before 34 weeks of gestation). The false positive rate was 15.8%.
  • Using the risk factor-based guidelines from the American College of Obstetricians and Gynecologists, the detection rate for preterm preeclampsia would be 61.5% and 59.1% for early preeclampsia, with a false-positive rate of 34.3%. This would be more than twice the false-positive rate of the Fetal Medicine Foundation’s screening model.

The only way to resolve preeclampsia once it has developed is to deliver the baby. by the study  previous meta-analysis found that taking one low-dose aspirin daily may reduce the risk of developing preeclampsia by up to 53%.

“Using this new screening model, treatment decisions were based on each individual’s personal risk,” Bujold said. “With their personal risk calculated, it’s much easier for a woman to make the right decision, for example, if she chooses to take daily low-dose aspirin, she is much more likely to follow through because it’s based on personalized screening test.”

Study background and details:

  • The study was conducted between 2014 and 2020 at five health centers across Canada. Of note: Canada has a national health care service, and coverage is universal for all Canadian citizens and permanent residents.
  • 7,554 women who were pregnant for the first time were recruited between 11 and 14 weeks of pregnancy. 7,325 delivered after 20 weeks and remained eligible for the final analysis; 229 had pregnancies with fetal anomalies and were excluded from the analyses for the study.
  • At time of enrollment in the study, participants underwent screening for preeclampsia. The data collected included age, weight, ethnicity, smoking status and chronic health conditions (chronic hypertension, Type 1 diabetes or Type 2 diabetes and antiphospholipid syndrome, an autoimmune disease that may be associated with pregnancy complications).
  • The study participants had an average age of 29 years. 92% of participants self-identified as white; 4% as Black; 2.6% as South Asian; 0.9% as East Asian; 0.3% as First Nations; and 0.2% as mixed race or undetermined.
  • The study excluded women who were taking antihypertensive medication for chronic hypertension, low-dose aspirin or low-molecular-weight-heparin (a blood thinner) on a daily basis were excluded from the study.
  • Participants were followed until delivery. The primary outcome was preterm preeclampsia. The secondary outcome was early preeclampsia.
  • Of the 7,325 women included in the analysis, 65 (0.9%) developed preterm preeclampsia, and 22 (0.3%) developed early preeclampsia.

Among the study’s limitations, several women with risk factors for preeclampsia, such as high blood pressure and Type 2 diabetes before pregnancy, were not included in the study if they were already taking aspirin for preeclampsia prevention. This would make it difficult to determine whether this population would rely solely on the Fetal Medicine Foundation’s screening model to decide whether or not to take daily, low-dose aspirin, Bujold noted. Additionally, only one lab was used to analyze blood samples, and blood samples collected at other centers across Canada were frozen and shipped for analysis, meaning that biomarkers were measured several weeks after the blood was drawn, which may have affected the results.

“It’s reasonable to believe that the inclusion of the entire population and immediate analysis of blood samples may both have improved the screening process. If we implemented a screening program in big cities across North America, the screening would be expected to be even better and more accurate,” Bujold said. “The good news is that we now have a more precise screening approach using existing tests that can predict preeclampsia early in pregnancy. The next step is to make this screening available to all pregnant women so that more women could receive a diagnosis early in pregnancy and begin preventative aspirin treatment, potentially preventing complications of severe preeclampsia.”

According to Sadiya S. Khan, M.D., M.Sc., FAHA, chair of the writing group for the Association’s 2023 scientific statement on Optimizing Prepregnancy Cardiovascular Health to Improve Outcomes in Pregnant and Postpartum Individuals and Offspring, predicting risk for term and preterm preeclampsia remains an important goal and priority to improve maternal health and mitigate disparities. Khan is the Magerstadt Professor of Cardiovascular Epidemiology and an associate professor of medicine and preventive medicine at the Northwestern University Feinberg School of Medicine in Chicago and a preventive cardiologist at Northwestern Medicine.

“Since the risks for preeclampsia may be largely influenced by health before pregnancy, the ability of a screening model to be applied in early pregnancy is very helpful and can initiate conversations between the clinician and patient about strategies to optimize heart health,” Khan said. “However, challenges remain with implementation of models such as this one that integrate biomarkers that are not routinely assessed and may not be widely available, especially among people in vulnerable populations who are most likely to have the highest risk for preterm preeclampsia.”

Reference:

Paul Guerby, Francois Audibert, Jo-Ann Johnson, Nanette Okun, Yves Giguère, Jean-Claude Forest, Nils Chaillet, Benoit Mâsse, David Wright, Louise Ghesquiere and Emmanuel Bujold, Prospective Validation of First-Trimester Screening for Preterm Preeclampsia in Nulliparous Women (PREDICTION Study), Hypertension, https://doi.org/10.1161/HYPERTENSIONAHA.123.22584.

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Botulinum Toxin A emerges as promising treatment for female pattern hair loss: Study

China: In a breakthrough discovery in dermatology, a recent study has illuminated the potential of botulinum toxin A as a novel therapeutic option for female pattern hair loss (FPHL). The findings, published in Skin Research and Technology, offer new hope for individuals grappling with this distressing condition and signify a paradigm shift in hair loss management.

The study suggested the effectiveness of Botulinum Toxin Type A (BTA) for female pattern hair loss is limited to three months. However, it can be considered for tentative use after effective communication with patients. Further observation and study are needed for BTA’s long-term safety and efficacy in treating FPHL.

Female pattern hair loss, characterized by progressive hair thinning primarily over the crown and frontal scalp regions, affects a significant proportion of women worldwide, exerting profound psychological and emotional impact. Despite its prevalence, treatment options have traditionally been limited, with topical minoxidil and oral medications like spironolactone comprising the mainstay of therapy.

However, the emergence of botulinum toxin A, commonly known for its cosmetic applications in wrinkle reduction, heralds a promising alternative for FPHL sufferers. Xiuzu Song, The Department of Dermatology, Hangzhou Third People’s Hospital, Hangzhou City, China, and colleagues aimed to assess the safety and efficacy of subcutaneous injections of Botulinum Toxin Type A in FPHL treatment.

The study included outpatients with FPHL who exhibited an allergic reaction to minoxidil solution. FPHL diagnosis was established through trichoscopy and clinical examination. Inclusion criteria involved patients with no prior treatment within the last year and without comorbidities.

BTA, specifically 100 units, was mixed with 2 mL of 0.9% normal saline. Twenty injection target sites, spaced 2–3 cm apart, were symmetrically marked on the scalp’s hairless area. At each target site, a dosage of five units was injected intradermally. Scalp’s representative photographs and dermoscopic images were captured before and after three months of treatment.

The study included ten women with FPHL, aged between 26 and 40 years. The average age was 30.3 ± 4.64 years, and all patients had a positive family history of Androgenetic Alopecia. The average disease duration was 3.70 ± 1.42 years.

The study led to the following findings:

  • According to patients’ self-assessment, after one month of treatment, 10 FPHL patients reported experiencing moderate to marked improvement in symptoms related to scalp oil secretion.
  • Three months later, dermatological assessments showed that three had mild improvement, six had no change, and one had a worsening condition.
  • No adverse effects were observed.

The study showed that the effectiveness of Botulinum Toxin Type A for treating Female Pattern Hair Loss treatment is limited to 3 months. However, it can be considered for tentative use after effective communication with patients.

The study limitations were the small sample size of this experiment, FPHL patients of different severity have not been grouped and stratified compared, and for a short follow-up period.

“The long-term safety and efficacy of BTA in treating FPHL require further observation and study,” the researchers concluded.

Reference:

Hu, L., Dai, Y., Zhang, H., Wu, Y., Wang, T., & Song, X. (2024). Efficacy and safety of botulinum toxin A in the treatment of female pattern hair loss. Skin Research and Technology, 30(4), e13696. https://doi.org/10.1111/srt.13696

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