Aspirin use may significantly delay progression of Abdominal Aortic Aneurysm with favorable safety profile.

The preclinical research indicates that aspirin may play a role in slowing the progression of abdominal aortic aneurysms (AAAs) and averting their rupture. However, human studies are scarce to demonstrate the clinical advantages of aspirin in treating AAA.

In a recent retrospective study of a clinical cohort of 3435 patients with objectively measured changes in aortic aneurysm progression, aspirin usage slowed the progression of abdominal aortic aneurysm (AAA) with a favorable safety profile.

This original Investigation on Cardiology was published in JAMA Network Open.

This retrospective study included adult patients with at least two vascular ultrasounds available at the Cleveland Clinic. Patients with a history of aneurysm repair, dissection, or rupture were excluded. All patients were followed for ten years, and clinical outcomes were analyzed from May 2022 to July 2023. The primary outcomes were the time-to-first occurrence of all-cause mortality, major bleeding, or a composite of dissection, rupture, and repair. Multivariable-adjusted Cox proportional-hazard regression and Fine and Gray proportional subhazard regression were used.

Key summary points of this investigation are:

  • There were 2672 male patients with a mean age of 73 years.
  • The median follow-up duration was 4.9 years.
  • Two thousand one hundred fifty patients were verified to be taking aspirin by prescription.
  • Patients taking aspirin had a slower mean annualized change in aneurysm diameter (2.8 vs 3.8 mm per year ) and lower odds of having rapid aneurysm progression compared to patients who were not taking aspirin.
  • The adjusted odds ratio was 0.64.
  • There was no association between aspirin use and risk of all-cause mortality, major bleeding and composite outcome with aHR of 0.92, 0.88 and 1.16, respectively.

They said that in this study, aspirin use slowed the progression of abdominal aortic aneurysms, especially in men and nonsmokers. Aspirin use was not associated with all-cause mortality, major bleeding, or the risk of aneurysm dissection, rupture, or repair after ten years.

Reference:

Hariri E, Matta M, Layoun H, et al. Antiplatelet Therapy, Abdominal Aortic Aneurysm Progression, and Clinical Outcomes. JAMA Netw Open. 2023;6(12):e2347296

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High resting heart rate may be risk factor for end-stage renal disease

High resting heart rate may independent risk factor for end-stage renal disease suggests a new study published in the Journal of the American Heart Association. 

The relationship between resting heart rate (RHR) and the risk of end‐stage renal disease (ESRD) among those without cardiovascular disease remains unclear. We aim to establish temporal consistency and elucidate the independent relationship between RHR and the risk of ESRD.

This cohort enrolled participants from 476 347 individuals who had taken part in a screening program from 1996 to 2017. We identified 2504 participants who had ESRD, and the median follow‐up was 13 years. RHR was extracted from electrocardiography results, and the study assessed the relationship between RHR and the risk of ESRD using the Cox proportional hazards model. Of the participants, 32.6% had an RHR of 60 to 69 beats per minute (bpm), and 22.2% had an RHR of ≥80 bpm. Participants with an RHR of ≥80 bpm had a higher stage of chronic kidney disease, lower estimated glomerular filtration rate, and more proteinuria than those with an RHR of 60 to 69 bpm. Participants with an RHR of 80 to 89 and ≥90 bpm had a 24% (hazard ratio [HR], 1.24 [95% CI, 1.09–1.42]) and 64% (HR, 1.64 [95% CI, 1.42–1.90]) higher risk of ESRD, respectively. The risk of ESRD remained significantly elevated (HR, 1.32 [95% CI, 1.10–1.58] per 10‐beat increase from 60 bpm) after excluding participants who smoked; had hypertension, diabetes, or hyperlipidemia; or were overweight.

An RHR of ≥80 bpm is significantly associated with an increased risk of ESRD. These results suggest that RHR may serve as a risk factor for kidney disease in individuals without established cardiovascular disease risk factors.

Reference:

Resting Heart Rate Independent of Cardiovascular Disease Risk Factors Is Associated With End‐Stage Renal Disease: A Cohort Study Based on 476 347 Adults

Min‐Kuang Tsai, Wayne Gao, Kuo‐Liong Chien, Thu Win Kyaw, Chin‐Kun Baw, Chih‐Cheng Hsu and Chi‐Pang Wen. Originally published1 Dec 2023https://doi.org/10.1161/JAHA.123.030559Journal of the American Heart Association. 2023;12:e030559

Keywords:

High, resting, heart, rate, may, independent, risk, factor, for, end-stage, renal, disease, Journal of the American Heart Association, Min‐Kuang Tsai, Wayne Gao, Kuo‐Liong Chien, Thu Win Kyaw, Chin‐Kun Baw, Chih‐Cheng Hsu and Chi‐Pang We

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Elagolix monotherapy Safe Against Heavy Menstrual Bleeding associated with Uterine Leiomyomas

A new phase 4 study published in The Journal of Obstetrics and Gynecology found elagolix 150 mg monotherapy taken once-daily to solve heavy menstrual bleeding associated with uterine leiomyomas were the safe and effective. This offers promise to premenopausal patients aged 18–51 years.

This randomized, double-blind, placebo-controlled study assessed  a total of 82 patients, with 54 receiving elagolix 150 mg and 28 receiving a placebo. The primary endpoint was a reduction in menstrual blood loss volume to less than 80 mL at the final month, coupled with at least a 50% reduction from baseline to the final month.

The results found 49.4% of patients in the elagolix group who met the primary endpoint, compared with 23.3% in the placebo group (P=.035). The differences in mean reduction of menstrual blood loss were significant as early as month 1 (P<.05 for months 1–3 and 5).

Moreover, elagolix demonstrated its effectiveness in suppressing bleeding (P=.036). The patients on elagolix experienced greater improvements in the proportion of those with amenorrhea, hemoglobin concentrations, and health-related quality of life.

Elagolix treatment was well-tolerated. There were no serious or severe adverse events reported, in stark contrast to the 7.1% of participants in the placebo group facing serious adverse events, including coronavirus disease 2019 (COVID-19) and an enlarged uvula. Only 5.6% of patients discontinued elagolix due to adverse events.

This study brings out a significant improvement in addressing heavy menstrual bleeding associated with uterine leiomyomas in premenopausal patients. The positive outcomes of elagolix 150 mg once-daily monotherapy, coupled with its favorable safety profile, underscore its potential as a transformative treatment option.

Source:

Brown, E., Kroll, R., Li, H., Ng, J., Pinsky, B., Rodriguez, J. W., Thomas, J., & Snabes, M. C. (2023). Low-dose elagolix for the treatment of heavy menstrual bleeding in patients with uterine leiomyomas: A randomized controlled trial. Obstetrics and Gynecology, 142(5), 1068–1076. https://doi.org/10.1097/aog.0000000000005380

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Delay in treatment of cancer patient leading to death: GTB Hospital, doctors held negligent, slapped Rs 5 lakh compensation

New Delhi: Noting that the apathetic approach of the hospital and its doctors towards the gravity of the ailment raises a presumption as regards to the failure of treating doctors in clinical judgment and choosing the right course of action in time, the Delhi State Consumer Disputes Redressal Commission has upheld the District Forum’s order that found GTB Hospital and its two doctors guilty of negligence and delay in treating a cancer patient who eventually succumbed to the disease.

The District Commission had directed the facility and the doctors to jointly pay a lump sum compensation of Rs 5 lakhs to the heirs (complainants) of the deceased patient.

The State Commission’s bench comprising of Justice Sangita Dhingra Sehgal, President, and Pinki, Member (judicial) dismissed the appeal filed by GTB Hospital and its doctors challenging the District Commission’s order, and crucially remarked that courts are not experts in the field of medical science and are required to be assisted by experts to form opinion, in order to decide as to whether negligence was committed or not.

The case concerns a man named Singh, who held the role of a senior Mali in the PWD Department under the Government of NCT of Delhi. His work was stationed at G.T.B Hospital in Dilshad Garden, Shahdra. Singh was enrolled in the Delhi Govt. Employees Health Scheme (DGEHS), an initiative for the healthcare of Delhi Government employees. A nominal deduction of Rs 30 per month from his salary was regularly allocated for his subscription to this scheme. Consequently, he was identified as a consumer, a status inherited by his heirs following his death.

In April 2005, Singh noticed an unusual growth in his mouth, reminiscent in size and shape of a pea. Concerned, he sought assistance at GTB Hospital, where he was officially registered for medical treatment. Here, a Central ID No. was assigned to him, guiding him to the ENT Department of the Hospital.

A tissue sample was procured from his mouth for a biopsy by the Hospital. However, despite this step, an accurate diagnosis was delayed by an entire month, ultimately confirming that he was grappling with “Squamous Cell Carcinoma (Oral Cavity Cancer)” on the left side of his mouth. The initial tumor size was a mere square centimeter, but alleged negligent and careless treatment by the hospital led to a worrying increase to 3 square centimeters by July 2005.

In the following months, the patient made multiple visits to the hospital, seeking treatment. However, he alleged to receive no medicine or proper treatment during these visits. The situation escalated to the point where a surgical intervention was planned for the tumor in May 2005. He underwent a pre-operative P.A.C. test, a prerequisite for anesthesia preparation, at the Anesthesia Department of the hospital and was instructed to arrange a unit of blood for the operation, which he promptly organized. However, the operation did not proceed as scheduled, leaving the much-needed treatment elusive.

Amidst this medical uncertainty, the patient revisited, this time guided to a doctor in the Dental Department of the hospital. Despite this referral, the operation failed to materialize. Subsequently, in July 2005, he was referred to L.N.J.P Hospital, Delhi by GTB Hospital for further treatment. Despite subsequent visits to LNJP and other hospitals, the negligence and lack of proper treatment persisted, eventually leading to the death of the patient in February 2007.

In the aftermath, the deceased’s legal heirs (the complainants), filed a consumer complaint with the District Commission alleging negligence and delays in treatment by various medical practitioners, ultimately leading to the patient’s death; and sought a claim amount of Rs. 13 lakhs, Rs 40,000 as compensation for the mental and physical distress, along with litigation costs of Rs. 11,000.

The District Commission reviewed the evidence and passed an order. They considered whether the deceased, a government employee and member of DGEHS, qualified as a consumer under section 2(1)(d) of the Act. They affirmed the deceased’s consumer status based on previous legal interpretations.

The Commission further addressed another critical issue if the deceased’s death resulted from doctors’ negligence. It went through the medical experts’ reports from R.M.L hospital and evidence that indicated that GTB Hospital and the doctor did not provide adequate care and precaution during the deceased’s treatment. Despite the detection of cancer, they pursued tests and treatments for tuberculosis instead of addressing the actual disease. The delay in surgery allowed the tumor to grow, ultimately contributing to the patient’s death. Subsequently, the hospital and the doctor were found negligent.

The Commission awarded a lump sum compensation of Rs 5 lakhs to the complainants, along with additional amounts for mental pain, agony, and litigation costs. The compensation was to be paid by the hospital and the doctors jointly and severally within one month of receiving the order. Failure to comply would incur 6% p.a. interest from the complaint filing date till realization.

Displeased with the District Commission’s verdict, GTB Hospital and the doctors lodged an appeal with the State Commission asserting that the District Commission overlooked the patient’s lackadaisical attitude towards his condition and his disinclination for surgery. They argue that there was no undue delay or any negligence or deficiency on their part. Moreover, they emphasize that the patient was advised to schedule surgery, but he did not. Finally, they contend that the District Commission erred in dismissing the report from the medical expert committee of Safdarjung Hospital and relying solely on the report from RML Hospital, which they claim did not encompass the complete medical history of the deceased.

In response, the complainants asserted that the deceased patient eagerly anticipated his surgery and meticulously adhered to every directive, prescription, and advice provided by the doctors from the hospital. They argue that the doctors at the hospital never advised the patient to ‘schedule’ the surgery; instead, it was the responsibility of the treating doctors at GTB hospital to ‘arrange’ the surgery date for the deceased. Additionally, they claim that the hospital and the doctors unnecessarily prolonged the surgery date without valid justification, allowing the disease to advance to an incurable stage. They further argued that during the 106-day period the patient spent at the Hospital, no cancer-specific treatment was administered, and the patient only developed purulent discharge in his mouth after the hospital’s treating doctors took a biopsy sample (muscle piece) from the patient’s mouth, causing a wound.

After hearing the arguments, the State Commission remarked that the discussion and available records demonstrate the patient’s full compliance with the hospital and the doctor’s instructions. The patient efficiently completed all necessary steps, from PAC to dental extraction and arranging blood, indicating a clear willingness to undergo the operation. There is no doubt about the patient’s readiness for the surgery. It further observed;

“In our opinion, it is highly improbable that any patient suffering from a life-usurping disease like cancer shall assume a casual attitude towards his own treatment. Therefore, the contention of the Appellants (GTB Hospital and the doctors) that the patient was reluctant to undergo surgery and didn’t take his treatment seriously holds no water in light of the material on record.”

The Commission found it baffling why the doctor continuously delayed the surgery without valid reasons. Over the 2-month period, the tumor size increased significantly from 1 sq.cm to 3 sq.cm. Notably, the hospital and the doctors did not administer any cancer-specific treatment, despite knowing cancer is a progressive disease. The prolonged wait for surgery is perplexing, especially when the patient needed radiotherapy, indicating a lack of urgency and clinical judgment. Additionally, the failure to refer the patient to LNJP, if the hospital lacked the necessary resources or expertise, raises questions about appropriate action. It observed;

“We fail to understand as to why the patient was made to wait for an extended period of time for performing surgery in the first place when ultimately the patient was to be referred to another hospital for a completely different modality of treatment i.e. radiotherapy. Such conduct clearly indicates the Appellant’s’ apathetic approach towards the gravity of the ailment and raises a presumption as regards to the failure of treating doctors in clinical judgment and choosing the right course of action in time. We fail to understand that if the Appellant-hospital didn’t have the required facilities or specialized doctors to treat the patient, then why was the patient not referred to LNJP in the first instance.”

The Commission further strengthened its opinion based on the expert medical report of RML Hospital, which concluded as:

“The Committee Members have concluded that the patient was advised surgery and was fit from anaesthesia department on 27/05/05. However, he was not operated upon and referred to LNJP Hospital for Radiotherapy on 18/07/2005. There was definite delay in referring him and crucial time was lost in his repeated visits to oncology clinic GTB Hospital.”

The Commission noted;

“In the present case, the expert medical board constituted at RML hospital clearly opines that the patient was not operated upon in time and there was definite delay in referring, thereby crucial time was wasted in his repeated visits to the Oncology Clinic at the Appellant No.1-hospital. The patient was PAC fit and surgery was planned on 13.05.2005 which means he was fit for surgery, yet inexplicable delays were caused and he was not operated upon. Therefore, it is established beyond doubt that the Appellants have clearly failed to act in a case where time was the essence and made delays which rendered the disease incurable, ultimately resulting in the patient’s death.”

The consumer body also emphasized that the medical record does not indicate any consultation with an Oncologist or Cancer Specialist. This observation is reinforced by reviewing the Directory of officers and employees of GTB Hospital, which confirms the absence of an Oncologist or Cancer Specialist in the hospital.

The Commission focused on the final aspect to consider, whether the District Commission erred in disregarding the Safdarjung Hospital Medical Board’s opinion. The board, led by Dr. J.S. Bhatia, stated that from April 6, 2005, to June 16, 2005, the patient underwent diagnosis, staging, and obtained PAC clearance after ruling out co-morbid conditions. However, from June 20, 2005, to July 15, 2005 (25 days), the patient did not report to doctors. Cancer being a progressive disease, by July 18, 2005, the disease had progressed, leading to a change in the treatment approach from surgery to radiotherapy. The board affirmed that there was no negligence at any stage in the management of the case.

However, the State Commission disagreed with the same, and observed that;

“On a combined analysis of the abovementioned shortcomings during the treatment and the negligence culled out by the District Commission through the impugned judgment, we are of the opinion that such recurrent negligent conduct is against medical ethics and is intolerable in light of the casual attitude of the treating doctors towards the patient. Also, the members of the Expert Panel of Safdarjung Hospital have ostensibly turned a blind eye towards such conduct of the Appellants (GTB Hospital and its doctors) and have remarked “no medical negligence” in their report, which is not tenable in the eyes of law. Such opinion prima facie appears to be baseless and biased in as much as no details pertaining to the aforementioned misconduct have been taken into consideration nor any thoughtful deliberations have been recorded in this regard. As such, we find no reason as to why would the District Commission not be perturbed by such glaring irregularity that reeks of connivance on part of the expert panel and treating doctors, at the time when the District Commission required medical expertise in the form of valuable inputs for deciding the present case.”

“It is pertinent to remark that Courts are not experts in the field of medical science and are required to be assisted by experts to form opinion, in order to decide as to whether negligence was committed or not. Therefore, expert opinion is crucial for the adjudicating court to decide the matter, but in the present case, the opinion of the experts was an attempt to mislead the court and therefore, reliance upon the same could have resulted into gross injustice towards the Respondents (the heirs/complainants).”

Subsequently, the State Commission affirmed the District Commission’s decision and found no fault in the impugned order. Therefore, dismissing the appeal filed by GTB Hospital and its doctors with no costs awarded.

To view the original order, click on the link below:

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PFAS exposure tied to reduced bone health in adolescents and young adults

USA: Exposure to per- and polyfluoroalkyl substances (PFAS) is associated with lower bone mineral density (BMD) in adolescence and young adulthood, critical periods for bone development, which may have implications on future bone health and osteoporosis risk in adulthood, a recent study has found. 

PFAS manufactured chemicals used in products such as food packaging and cosmetics, can lead to reproductive problems, increased cancer risk and other health issues. A growing body of research has also linked the chemicals to lower bone mineral density, which can lead to osteoporosis and other bone diseases. But most of those studies have focused on older, non-Hispanic white participants and only collected data at a single point in time.

Now, researchers from the Keck School of Medicine of USC have replicated those results in a longitudinal study of two groups of young participants, primarily Hispanics, a group that faces a heightened risk of bone disease in adulthood.

“This is a population completely understudied in this area of research, despite having an increased risk for bone disease and osteoporosis,” said Vaia Lida Chatzi, MD, PhD, a professor of population and public health sciences at the Keck School of Medicine and the study’s senior author.

In a group of 304 adolescents, exposure to PFAS was linked to a decrease in bone mineral density over time. In a group of 137 young adults, PFAS exposure was also linked to lower baseline bone density, but no differences were observed over time. The results were just published in the journal Environmental Research.

“Many existing studies haven’t included participants this young, but we’re now able to see that this association is already happening at a time when bones are supposed to be developing,” said Emily Beglarian, MPH, a doctoral student in the Keck School of Medicine’s Department of Population and Public Health Sciences and lead author of the study.

The researchers say the findings highlight the need for stricter regulation of PFAS, which have contaminated public drinking water, food and soil across the United States.

“PFAS are ubiquitous-we are all exposed to them,” Chatzi said. “We need to eliminate that exposure to allow our youth to reach their full potential in terms of bone development to help them avoid osteoporosis later in life.”

Implications across the lifespan

Bone mineral density increases during adolescence, peaks between the ages of 20 and 30, then slowly decreases throughout adulthood. Peak bone mineral density helps predict whether a person will get osteoporosis later in life, prompting the researchers to investigate how PFAS can affect young people.

“We want to make sure we’re not exposing ourselves to things that harm our bone development, because it has implications over the rest of our lives,” Beglarian said.

The researchers studied 304 Hispanic adolescents, with an average age of 11 years, from the Study of Latino Adolescents at Risk of Type 2 Diabetes. They collected blood samples to measure PFAS levels and a special kind of x-ray known as a dual x-ray absorptiometry (DXA) scan to measure bone density, then followed up after about one and a half years to check for a change over time. For each doubling of baseline perfluorooctanesulfonic acid (PFOS), one type of PFAS, participants had an average decrease in bone mineral density of .003 g/cm2 per year at follow-up.

They also studied 137 young adults, who were 58.4% Hispanic and had an average age of 19 years, from the Southern California Children’s Health Study. They collected blood samples and DXA scans at baseline, then followed up about four years later. When baseline levels of PFOS doubled, participants had an average of .032 g/cm2 lower baseline bone mineral density, though no significant change was observed over time.

Limiting exposure to PFAS

The researchers say stricter regulations are needed for PFAS, especially to protect high-risk communities such as Hispanics who also face increased exposures to other types of pollutants.

“It’s important to regulate PFAS as a class because we are not just exposed to one chemical, we are exposed to thousands of chemicals,” Chatzi said.

While the burden of reducing PFAS should not fall to individuals, the researchers are planning outreach efforts to help people learn how to limit their exposure. Tips include avoiding nonstick pans and personal care products known to include PFAS.

Chatzi, Beglarian and their colleagues are also expanding their research to confirm the findings across the lifespan and in other communities throughout the U.S., with a continued focus on Hispanics. They also plan to study the biological mechanisms behind the effects of PFAS on bone health, including looking for biomarkers that could indicate bone health is at risk before osteoporosis sets in.

Reference:

Emily Beglarian, Elizabeth Costello, Douglas I. Walker, Hongxu Wang, Tanya L. Alderete, Zhanghua Chen, Damaskini Valvi, Brittney O. Baumert, Sarah Rock, Bruna Rubbo, Max T. Aung, Frank D. Gilliland, Michael I. Goran, Dean P. Jones, Rob McConnell, Sandrah P. Eckel, David V. Conti, Jesse A. Goodrich, Lida Chatzi, Exposure to perfluoroalkyl substances and longitudinal changes in bone mineral density in adolescents and young adults: A multi-cohort study, Environmental Research, 2023, https://doi.org/10.1016/j.envres.2023.117611.

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Glucocorticoid effective option for preventing delirium after major surgeries

Glucocorticoid effective option for preventing Postoperative delirium among patients undergoing major non-cardiac surgery suggests a new study published in the BMC Anesthesiology.

The effects of intravenous glucocorticoids on postoperative delirium (POD) in adult patients undergoing major surgery remain controversial. Therefore, we conducted this meta-analysis to assess whether intravenous glucocorticoids can decrease POD incidence in the entire adult population undergoing major surgery and its association with patients age, type of surgery, and type of glucocorticoid.

They searched the relevant literature published before November 3, 2023, through Cochrane Library, PubMed, Embase, and Web of Science. The primary outcome was POD incidence. The risk ratio for the primary outcome was calculated using the Mantel–Haenszel method. The secondary outcomes included 30-day mortality, length of hospital stay, ICU duration, mechanical ventilation duration, and occurrence of glucocorticoid-related adverse effects (e.g., infection and hyperglycemia). This meta-analysis was registered in PROSPERO: CRD42022345997.

Results

They included eight randomized controlled studies involving 8972 patients. For the entire adult population undergoing major surgery, intravenous glucocorticoids reduced the POD incidence (risk ratio = 0.704, 95% confidence interval, 0.519–0.955; P = 0.024). However, subgroups defined by type of surgery showed differential effects of glucocorticoids on POD. Intravenous glucocorticoids can not reduce POD incidence in adult patients undergoing cardiac surgery (risk ratio = 0.961, 95% confidence interval, 0.769–1.202; P = 0.728), with firm evidence from trial sequential analysis. However, in major non-cardiac surgery, perioperative intravenous glucocorticoid reduced the incidence of POD (risk ratio = 0.491, 95% confidence interval, 0.338–0.714; P < 0.001), which warrants further studies due to inconclusive evidence by trial sequence analysis. In addition, the use of glucocorticoids may reduce the mechanical ventilation time (weighted mean difference, -1.350; 95% confidence interval, -1.846 to -0.854; P < 0.001) and ICU duration (weighted mean difference = -7.866; 95% confidence interval, -15.620 to -0.112; P = 0.047).

For the entire adult population undergoing major surgery, glucocorticoids reduced the POD incidence. However, the effects of glucocorticoids on POD appear to vary according to the type of surgery. In patients receiving major non-cardiac surgery, glucocorticoid may be an attractive drug in the prevention of POD, and further studies are needed to draw a definitive conclusion. In cardiac surgery, intravenous glucocorticoids have no such effect.

Reference:

Li, C., Zhang, Z., Xu, L. et al. Effects of intravenous glucocorticoids on postoperative delirium in adult patients undergoing major surgery: a systematic review and meta-analysis with trial sequential analysis. BMC Anesthesiol 23, 399 (2023). https://doi.org/10.1186/s12871-023-02359-8

Keywords:

Glucocorticoid, effective, option, preventing, Postoperative, delirium, among, patients, undergoing, major, non-cardiac surgery, BMC Anesthesiology, Li, C., Zhang, Z., Xu, L

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How much money is being spent on doctor in conferences? Pharma companies, associations may soon have make those declarations

The pharma companies and medical associations might need to disclose in the future the money they spend per doctor in conferences, a recent media report by The Print has stated.

Recommendations in this regard were made by a high-level government panel set up to review the Uniform Code of Pharmaceutical Marketing Practices (UCPMP).

Apart from this, the panel has also suggested that the doctors cannot be given brand reminders, in case the value exceeds Rs 1,000 per item. Brand reminders refer to products that are offered for free to doctors by marketing representatives of pharma companies with the names of popular medicinal brands.

For more details, check out the link given below:

How Much Money Is Being Spent On Doctor In Conferences? Pharma Companies, Associations May Soon Have Make Those Declarations

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Add on Metformin to insulin in pregnant women with diabetes fails to reduce neonatal complications: JAMA

USA: Metformin plus insulin treatment for preexisting type 2 or gestational diabetes diagnosed early in pregnancy failed to reduce a composite neonatal adverse outcome, a recent study published in the Journal of the American Medical Association (JAMA) has revealed.

In a randomized clinical trial of 794 pregnant women (18-45 years), metformin added to insulin for treating preexisting diabetes or diabetes identified in early pregnancy did not reduce a composite adverse neonatal outcome (71% vs 74%) compared with placebo but resulted in fewer large-for-gestational-age infants.

For pregnant women with preexisting type 2 diabetes (T2D) or diabetes diagnosed early in pregnancy, insulin is recommended. Previous studies have shown that metformin addition to insulin improves neonatal outcomes. Kim A. Boggess, University of North Carolina at Chapel Hill School of Medicine, and colleagues aimed to estimate the effect of metformin added to insulin for preexisting type 2 or diabetes diagnosed early in pregnancy on a composite adverse neonatal outcome.

The randomized clinical trial conducted in 17 US centres enrolled pregnant adults (18 to 45 years) with pre-existing T2D or diabetes diagnosed before 23 weeks gestation between 2019 and 2021. Each participant was given insulin treatment and was assigned to either metformin 1000 mg (n=397) or placebo (n=397) orally twice per day from enrollment (11 weeks -<23 weeks) through delivery.

The primary outcome of the study was a composite of neonatal complications including preterm birth, perinatal death, hyperbilirubinemia, and large or small for gestational age requiring phototherapy.

Prespecified secondary outcomes were neonatal fat mass at birth and maternal hypoglycemia, and prespecified subgroup analyses by maternal BMI less than 30 vs 30 or greater and those with preexisting vs diabetes early in pregnancy.

The study revealed the following findings:

  • The composite adverse neonatal outcome occurred in 71% of the metformin group and 74% of the placebo group (adjusted odds ratio, 0.86).
  • The most commonly occurring events in the primary outcome in both groups were neonatal hypoglycemia, preterm birth, and delivery of a large-for-gestational-age infant.
  • The study was halted at 75% accrual for futility in detecting a significant difference in the primary outcome.
  • Prespecified secondary outcomes and subgroup analyses were similar between groups.
  • Of individual components of the composite adverse neonatal outcome, metformin-exposed neonates had lower odds of being large for gestational age (adjusted odds ratio, 0.63) when compared with the placebo group.

“Using insulin plus metformin to treat preexisting type 2 or gestational diabetes diagnosed early in pregnancy failed to reduce a composite neonatal adverse outcome,” the researchers wrote.

“The effect of reduction in odds of a large-for-gestational-age infant seen after metformin addition to insulin warrants further investigation.”

Reference:

Boggess KA, Valint A, Refuerzo JS, et al. Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial. JAMA. 2023;330(22):2182–2190. doi:10.1001/jama.2023.22949

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NBE tells 326 Diploma, DNB, FNB doctors to either complete registration process or get PG, SS admission cancelled

Noting that around 326 doctors have not completed their registration formalities with the National Board of Examinations (NBE) for the year 2021 and 2022, the NBE has now given them a last warning to either complete the process by December 15th or get their admissions cancelled.

Through a recent notice, National Board of Examinations (NBE) has informed regarding the Cancellation of candidature of 2021 and 2022 Admission Session trainees to pursue NBEMS courses.

For more details, check out the link given below:

Either Complete Registration Process Or Get Your PG, SS Admission Cancelled: NBE Tells 326 Diploma, DNB, FNB Doctors

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Marstacimab Therapy for Hemophilia Shows Long-term Efficacy and Safety

A recent study demonstrated significant efficacy and safety of monoclonal antibody Marstacimab in the long-term management of severe hemophilia A (HA) or hemophilia B (HB) without inhibitors. This outcomes from the pivotal Phase 3 BASIS study could revolutionize the approach to treat bleeding disorders. The findings were published in American Society of Hematology.

Marstacimab enhances hemostasis through the extrinsic pathway of blood coagulation and already has shown promise in previous studies. Early Phase 1/2 trials indicated its effectiveness and safety in reducing bleeding episodes in adults with severe hemophilia A or B.

The study enrolled male participants aged 12 to 75 with severe HA or moderately severe to severe HB, with or without inhibitors. After a 6-month observational phase, participants were grouped into on-demand (OD) or routine prophylaxis (RP). The active treatment phase involved a subcutaneous loading dose of 300 mg followed by once-weekly 150 mg marstacimab.

The results involved 128 participants who showed impressive outcomes. The annualized bleeding rate (ABR) for treated bleeds significantly reduced for both OD and RP groups, with marstacimab demonstrating superiority over OD and RP therapy. Safety analyses revealed a favorable profile with less incidence of adverse events and no treatment-related serious adverse events recorded.

As a step forward, this study found that subcutaneous marstacimab given once-weekly is not only safe but also highly effective to reduce bleeding events for participants with severe HA or moderately severe to severe HB without inhibitors. The positive results persisted beyond the 12-month active treatment phase, providing hope for a paradigm shift in hemophilia management.

This highlights marstacimab as a potential game-changer for hemophilia treatment, offering hope to those suffering from challenging bleeding disorders. As the study participants move into the long-term extension (LTE) phase, the expectation is high for continued positive outcomes that could redefine hemophilia care.

Source:

Matino, D., Acharya, S., Palladino, A., Hwang, E., McDonald, R., Taylor, C. T., & Teeter, J. (2023). Efficacy and Safety of the Anti-Tissue Factor Pathway Inhibitor Marstacimab in Participants with Severe Hemophilia without Inhibitors: Results from the Phase 3 Basis Trial. In Blood (Vol. 142, Issue Supplement 1, pp. 285–285). American Society of Hematology. https://doi.org/10.1182/blood-2023-181263

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