RG Kar Case: New Junior Doctors’ Association Calls for Audit of WBJDF Funds

Kolkata: A recent controversy has erupted between two doctors’ associations, making headlines as the West Bengal Junior Doctor Association (WBJDA) accuses the West Bengal Junior Doctors’ Front (WBJDF) of collecting funds under the pretence of seeking justice for Abhaya, the PG trainee doctor who was allegedly raped and murdered at R G Kar Medical College and Hospital in Kolkata.

On one hand, representatives in the WBJDA, a newly-formed association reportedly having the backing of the ruling Trinamool Congress, have accused the WBJDF members of exploiting the rape and murder issues to serve self-interest, which includes mobilisation of funds from the public in the name of the protests. According to recent media reports, the WBJDF has been accused of raising huge funds around Rs 4.75 crore into different accounts in the past two months. 

On the other hand, West Bengal Junior Doctors’ Front (WBJDF), the original umbrella body spearheading the protests over the rape and murder, has accused the newly-formed West Bengal Junior Doctors’ Association (WBJDA) of being a group of those junior doctors who had been accused of “threat culture” within the premises of medical colleges and hospitals. They have been accused of enjoying the patronage of erstwhile influential persons from the medical fraternity like the former principal of R G Kar Sandip Ghosh, PTI reports. 

Also read- CM Banerjee Criticizes Government Medical College Principals, Urges Fair Handling of Junior Doctors’ Concerns

As per an Indian Express news report, a section of junior doctors in which many of them were expelled on October 5 over an allegation that they were part of a “threat culture” at the RG Kar Medical College and Hospital announced the formation of a new association called West Bengal Junior Doctor Association (WBJDA) which is reported to be the rival group of WBJDF. 

Demanding to probe the activists of the WBJDF, including the source of funds mobilised by the front, WBJDA wrote a letter to the chief secretary stating, “The alleged financial irregularities of WBJDF, including fundraising in the name of Abhaya which has come into the public domain has to be addressed immediately. We demand a proper audit of that huge collection of funds and a proper investigation of the sources and motive of such alleged financial irregularities by a competent authority of the government.”

“No one in any medical college should be punished according to baseless perspectives or recommendations of one side, which has been going on in recent days… to fulfil political and personal agendas of some personnel. If such incidents are reported again in the future, then all govt officials including the principal and MSVP of that medical college or institute involved in such biased, vindictive decision-making processes have to undertake investigations accordingly…” added the letter. 

However, the WBJDF rubbished such allegations and claimed that the new association had been formed with the active backing of the ruling party to malign the agitation which has received massive mass support since the beginning.

“We had withdrawn our fast-unto-death considering the larger public interest and because of the request from the parents of the victim junior doctor. But that does not mean that we will be withdrawing the agitation in support of our demands on this issue. Rather we will be extending the ambit of our protest beyond metros, urban, suburban and district headquarters to rural West Bengal,” a WBJDF representative said.

Medical Dialogues had earlier reported that the WBJDF already announced that it will be organising a protest march to the office of the Central Bureau of Investigation (CBI) at Salt Lake on the northern outskirts of Kolkata on Wednesday, a day before the Kali Puja, demanding a speedy and logical conclusion of the central agency’s probe in the rape and murder case.

Also read- RG Kar Protest: Junior Doctors Plan Rally on October 30 to Demand Justice for Victim

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Eli Lilly Kisunla bags marketing authorization in Great Britain to treat mild cognitive impairment, mild dementia due to Alzheimer’s Disease

Indianapolis: Eli Lilly and Company has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer’s disease in eligible adults in Great Britain. Eligible patients are limited to apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers, which is a requirement for the class of currently approved amyloid-targeting therapies in Great Britain. Donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. Great Britain is the third major market to approve donanemab, marketed as Kisunla.

“People around the world want and deserve access to treatment options for this disease. This approval in Great Britain is another significant step to ensure patients with Alzheimer’s disease can receive treatment with this new class of amyloid targeting therapies, which could give them more time in the early symptomatic stage of the disease to do what matters most to them,” said Ilya Yuffa, executive vice president and president of Lilly International, Eli Lilly and Company. “Donanemab demonstrated meaningful results for people with early symptomatic Alzheimer’s disease by significantly slowing cognitive and functional decline in our TRAILBLAZER-ALZ 2 study.”

Currently, there are 982,000 people estimated to be living with dementia in the United Kingdom (UK), with 50-75% of cases attributable to Alzheimer’s disease. It is the leading cause of death in the UK and an economic cost to society. The total cost of dementia on patients, families and the public sector is estimated to be £42 billion in 2024. Unpaid care is the largest component, with costs per person increasing threefold from mild to severe dementia.

Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease. Donanemab can help the body remove the excessive buildup of amyloid plaques and slow the cognitive and functional decline that may diminish people’s ability to remember information, make meals, manage finances, and maintain independence.

“I believe we can improve the standard of care for people living with Alzheimer’s disease. Despite years of medical research, until recently, there has been little progress in treatment options for this disease. The authorisation of donanemab for eligible adults is welcome news. Great Britain now needs to rapidly increase National Health Service (NHS) capacity and expertise in diagnostics and treatment facilities to enhance the management of Alzheimer’s disease for the benefit of people today and tomorrow,” said Professor Cath Mummery, Consultant Neurologist at University College London Hospitals NHS Foundation Trust and Chair of the NIHR Dementia Translational Research Collaboration.

Read also: Eli Lilly appoints Thomas J Fuchs as Chief AI officer

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Verification of incentive marks: TN Health to close grievance portal for in-service candidates today

Tamil Nadu: Through a recent notice, TN Health has informed regarding the greivance portal for in-service candidates who intend to submit any discrepancy over the verification of their incentive marks.

In its notice, the DME informed the Candidates who have applied as in service for admission to Post Graduate Degree/Diploma Courses 2024-2025 session for Government Medical Colleges and Government Quota seats in Self Financing Medical Colleges that they instructed to verify their service incentive percentage as mentioned below and and if there is any discrepancy, they need send grievances through the grievance portal which is going to close today 30.10.2024 12 Noon . Any grievance can be submitted through the portal by using your login credentials (Already used during the application Process).  

The grievances submitted after the above date and time will not be considered. The Marks uploaded in the website will only be taken in to consideration if the grievances are not uploaded in the portal.

The following guidelines are practiced for awarding incentive marks to Service PG candidates for this academic year 2024-2025 and 50% reservation of PG seats as per the Hon’ble Supreme Court Judgment inW.P.No.196/2018 TNMOA Vs. UOI.

 Incentive Marks will be awarded for completed years as on 31.03.2024.

 Incentive Marks will be awarded for every completed years. In completed years, fractionalization of marks based on the number of months worked in particular stations [i.e., Difficult Hill (10%)/Difficult Plain(9%)/ Remote(8%)/ Rural(5%)].

 Incentive Marks will not be awarded for fractioned service month periods.

 Maximum of 30% of Incentive marks will be awarded as per MCI Regulations – 2000 amended till May 2018 and added to eligible PG NEET 2023 Score (Kindly note eligibility is determined prior to adding incentive marks) 

Illustration – I:

 When a Medical Officer has worked in 2 years 8 months 23 days in Difficult Hill area, Incentive Marks will be awarded for 2 years only.

Illustration- II:

 If a medical officer works in different areas for different periods (Incentive marks allotted areas) with completed year and fractionalized months, the following methodology is applied for calculating incentive marks:

“X” works in difficult hill area for 5 months, 20 days, in his next postings he works in difficult plain for a period of 1 year, 5months, 5 days and in another postings he works for 7 months, 3 days respectively as on 31.03.2022.  

tn health

Total incentive years = 1 completed year in difficult plain plus 17 months (5 months in Difficult Hill+ 5 months in Difficult plain+ 7 months in Rural). 12 months = 1 year. Rest of the 5 months(Least incentive mark area) will be left, since fractionalized months will not be accounted for calculating marks.

Illustration III:

 From service rendered in incentive work station, when there is shortage for a completed year in incentive places and days are more than 30 days, marks will be awarded as follows: 

YEAR

CALCULATION

MARKS

AWARDED (%) 

Difficult Hill

(10%) 

 5

10

=(5/12 X 10)

4.167%

Remote (8%) 

 1 2 8

=1 X 8 + (2/12 X 8) 

9.33% 

Rural (5%) 

 4

20

=(5/12 X 5)

2.08%

Total 

 1 11 38 15.58%

In 38 days, 30 days is added to 4 months, since the Medical Officer worked more number of days in rural area i.e. 20 days.

To view the official Notice, Click here :  https://medicaldialogues.in/pdf_upload/28102024105235-258714.pdf

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GLP-1 receptor agonists linked to substantial muscle loss as part of weight loss process: Lancet

A recent commentary published in The Lancet journal highlights the critical importance of skeletal muscle mass in the context of medically induced weight loss, particularly with the widespread use of GLP-1 receptor agonists. These medications, celebrated for their effectiveness in treating obesity, have raised concerns regarding the potential for substantial muscle loss as part of the weight loss process.

Dr. Steven Heymsfield, professor of metabolism and body composition, and Dr. M. Cristina Gonzalez, adjunct and visiting professor in metabolism-body composition, both of Pennington Biomedical Research Center, joined colleagues Dr. Carla Prado of the University of Alberta, and Dr. Stuart Phillips of McMaster University on authoring The Lancet commentary, titled “Muscle Matters: The Effects of Medically Induced Weight Loss on Skeletal Muscle.”

The authors emphasize that muscle loss, as measured by decreases in fat-free mass, can account for 25 to 39 percent of total weight lost over a period of 36 to 72 weeks. This rate of muscle decline is significantly higher than what is typically observed with non-pharmacological caloric restriction or normal aging and could lead to unintended negative health consequences.

Despite the promising metabolic benefits associated with GLP-1 receptor agonists, including improvements in fat-to-fat-free tissue ratios, the potential adverse effects of muscle loss are gaining attention. Skeletal muscle plays critical roles not only in physical strength and function but also in metabolic health and immune system regulation.

A decline in muscle mass has been linked to decreased immunity, increased risk of infections, poor glucose regulation, and other health risks. The authors suggest that muscle loss due to weight reduction may exacerbate conditions like sarcopenic obesity, which is prevalent among individuals with obesity and contributes to poorer health outcomes, including cardiovascular disease and higher mortality rates.

While the short-term effects of muscle loss on physical strength and function remain unclear, the commentary calls for future research to explore how reductions in muscle mass might improve muscle composition and quality. The authors stress the need for a multimodal approach to weight loss treatment, combining GLP-1 receptor agonists with exercise and nutritional interventions to preserve muscle mass.

“We have to be mindful of the side effects that we are seeing with the new weight loss medications, such as a person eating less while on the medications and not getting the appropriate amount of dietary vitamins and minerals,” Dr. Heymsfield said. “Also, when a person loses weight, they are not only losing fat, they also lose muscle. We are looking at how that muscle loss can be better managed with consumption of an adequate amount of protein along with an optimum amount of exercise.”

This evolving conversation underscores the importance of ensuring that weight loss interventions promote overall health, including muscle preservation, as part of a comprehensive strategy for treating obesity.

Reference:

Prado, Carla M et al., Muscle matters: the effects of medically induced weight loss on skeletal muscle, The Lancet, DOI:10.1016/S2213-8587(24)00272-9

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Microaxial Flow Pump Lowers Medication Needs and Improves Stability in Cardiogenic Shock Patients: DanGer Shock Substudy

Denmark: In a pivotal sub-study of the DanGer Shock randomized clinical trial, researchers have unveiled significant findings regarding the use of Microaxial Flow Pumps (MAFP) in patients suffering from infarct-related cardiogenic shock (CS) due to ST-elevation myocardial infarction (STEMI).

The study, published in JAMA Cardiology, revealed that using MAFP decreases the need for vasopressors and inotropic medications while ensuring hemodynamic stability and promoting quicker normalization of lactate levels in this critically ill patient population.

Cardiogenic shock, characterized by the heart’s inability to pump sufficient blood, often results from a severe heart attack and poses a high risk of mortality. Traditional management strategies include aggressive fluid resuscitation and the use of vasopressors and inotropic agents to support heart function. However, these methods can be limited and often result in variable patient responses.

Mechanical circulatory support using an MAFP has demonstrated improved survival rates in patients experiencing cardiogenic shock due to STEMI-CS. Understanding its effects on hemodynamic stability over time is essential for optimizing treatment strategies for these patients. Considering this, Nanna Louise Junker Udesen, Department of Cardiology, Odense University Hospital, Odense, Denmark, and colleagues assessed whether an MAFP decreases the reliance on pharmacological circulatory support while maintaining hemodynamic stability compared to standard care in patients with STEMI-related cardiogenic shock.

For this purpose, the researchers conducted a substudy of the Danish-German (DanGer) Shock trial, an international, multicenter, open-label randomized clinical trial involving patients from 14 heart centers across Denmark, Germany, and the UK. Participants included those with STEMI, systolic blood pressure below 100 mm Hg or receiving vasopressor treatment, left ventricular ejection fraction under 45%, and arterial lactate levels exceeding 2.5 mmol/L. After excluding patients who died in the catheterization lab or upon ICU admission, the remaining participants had serial hemodynamic, arterial lactate, and vasoactive drug use recordings. Those in comas post-cardiac arrest and those with mechanical complications or right ventricular failure were also excluded.

Patients received either an MAFP combined with standard care or standard care alone. The main outcomes assessed included hemodynamic status (heart rate and blood pressure), metabolic status (arterial lactate concentration), and vasoactive-inotropic score (VIS). Clinical events monitored during the first 72 hours included overall mortality, escalation of mechanical circulatory support, and discharge alive from the ICU.

The following were the key findings of the study:

  • Among the 355 enrolled patients, 324 underwent ICU treatment, with 52% in the MAFP group and 48% in the standard care group.
  • The mean age of patients was 68 years, with 80% being male.
  • Baseline characteristics were similar between the two groups.
  • No significant difference in heart rate was observed between groups.
  • Mean arterial pressure exceeded the treatment target of 65 mm Hg in both groups, achieved with a lower VIS in the MAFP group.
  • At randomization, no difference in arterial lactate levels was found; however, upon ICU arrival, the MAFP group had significantly lower lactate levels than the standard-care group (mean difference of 1.3 mmol/L).
  • This difference in lactate levels persisted throughout the first 24 hours.
  • The MAFP group achieved lactate normalization (<2 mmol/L) 12 hours earlier than the standard care group.

The findings from the substudy of the DanGer Shock randomized clinical trial indicate that the use of a Microaxial Flow Pump (MAFP) effectively reduced the reliance on vasopressors and inotropes, all while maintaining hemodynamic stability and facilitating quicker normalization of lactate levels.

“These results highlight the device’s capability to support circulation with a reduced need for pharmacological intervention,” the researchers concluded.

Reference:

Udesen NLJ, Beske RP, Hassager C, et al. Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock: A Substudy of the DanGer Shock Randomized Clinical Trial. JAMA Cardiol. Published online October 27, 2024. doi:10.1001/jamacardio.2024.4197

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Older Adults with Diabetes: Relaxed Glycemic Control Shows Unexpectedly Low Infection Risks, Study Reveals

USA: Recent findings shed light on the relationship between glycemic control and infection risks in older adults with type 2 diabetes (T2D).

A study published in Diabetes Care has indicated that older patients who maintain relaxed glycemic control levels, as outlined by clinical guidelines, do not face a significantly increased risk of hospitalization for most infections. However, those with an HbA1c level between 8% and 9% may be at a heightened risk for specific infections, particularly affecting the skin, soft tissue, and bones.

The management of diabetes in older adults often requires a careful balance between controlling blood sugar levels and avoiding the potential complications associated with strict glycemic targets. Relaxed glycemic control, characterized by higher HbA1c levels, can lead to concerns about an increased risk of infections, as hyperglycemia is known to impair the immune response. In light of this, Kasia J. Lipska, Section of Endocrinology, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, and colleagues aimed to compare the risk of hospitalization for infection between patients who maintain intensive glycemic control and those who achieve relaxed glycemic control.

For this purpose, the researchers conducted a retrospective cohort study involving adults aged 65 and older with type 2 diabetes from an integrated healthcare delivery system. They utilized negative binomial models to estimate incidence rates and relative risks (RR) of hospitalization for various infections—including respiratory, genitourinary, skin, soft tissue, bone infections, and sepsis.

The study compared two levels of relaxed glycemic control (hemoglobin A1c [HbA1c] 7% to <8% and 8% to <9%) against intensive control (HbA1c 6% to <7%) over the period from January 1, 2019, to March 1, 2020.

The study revealed the following findings:

  • Among 103,242 older patients:
    • 48.5% had HbA1c levels between 6% to <7%.
    • 35.3% had HbA1c levels between 7% to <8%.
    • 16.1% had HbA1c levels between 8% to <9%.
  • The overall rate of hospitalization for infections was 51.3 per 1,000 person-years.
  • Compared to patients with HbA1c 6% to <7%:
    • The unadjusted risk of hospitalization for infections was significantly higher in those with HbA1c 8% to <9%.
    • No significant increase in risk was observed for patients with HbA1c 7% to <8% (RR 0.99), and this difference became nonsignificant after adjustment.
  • In terms of specific infection categories:
    • The adjusted relative risk of hospitalization was significantly higher for skin, soft tissue, and bone infections in patients with HbA1c 8% to <9% (RR 1.33).

“The findings showed that older patients with type 2 diabetes who maintain relaxed glycemic control levels, as recommended by clinical guidelines, do not face a significantly higher risk of hospitalization for most infections. However, those with HbA1c levels between 8% and <9% are associated with an increased risk of hospitalization specifically for skin, soft tissue, and bone infections,” the researchers concluded.

Reference:

Kasia J. Lipska, Lisa K. Gilliam, Catherine Lee, Jennifer Y. Liu, Vincent X. Liu, Howard H. Moffet, Melissa M. Parker, Heidi Zapata, Andrew J. Karter; Risk of Infection in Older Adults With Type 2 Diabetes With Relaxed Glycemic Control. Diabetes Care 2024; dc241612. https://doi.org/10.2337/dc24-1612

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People with type 2 diabetes who eat low-carb may be able to discontinue medication, finds research

Adults with type 2 diabetes on a low-carbohydrate diet may see benefits to their beta-cell function allowing them to better manage their disease and possibly discontinue medication, according to new research published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.

Beta-cells are endocrine cells in the pancreas that produce and release insulin, the hormone that controls blood sugar levels.

More than 38 million Americans have diabetes, and over 90% of them have type 2 diabetes. Type 2 diabetes most often develops in people 45 or older, but more and more children, teens and young adults are also developing the disease.

People with type 2 diabetes have a compromised beta-cell response to blood sugar, possibly due in part to eating too many carbohydrates. Beta-cell failure or insufficiency on top of insulin resistance is responsible for the development and progression of type 2 diabetes.

“This study shows people with type 2 diabetes on a low-carbohydrate diet can recover their beta-cells, an outcome that cannot be achieved with medication,” said lead study author Barbara Gower, Ph.D., of the University of Alabama at Birmingham in Birmingham, Ala. “People with mild type 2 diabetes who reduce their carbohydrate intake may be able to discontinue medication and enjoy eating meals and snacks that are higher in protein and meet their energy needs.”

The researchers gathered data from 57 white and Black adults with type 2 diabetes, half on a low-carbohydrate diet and the other half on a high-carbohydrate diet and examined their beta-cell function and insulin secretion at baseline and after 12 weeks.

All of the participants’ meals were provided. People on the carbohydrate-restricted diet ate 9% carbohydrates and 65% fat, and participants on the high-carbohydrate diet ate 55% carbohydrates and 20% fat.

The researchers found those on a low-carbohydrate versus a high-carbohydrate diet saw improvements in the acute and maximal beta-cell responses that were 2-fold and 22% greater, respectively. Within each race group, Black adults on a low-carbohydrate diet saw 110% greater improvements in the acute beta-cell response and White adults had improvements in the maximal beta-cell response that were 48% greater than their respective counterparts on the high-carbohydrate diet.

“Further research is needed to determine if a low-carbohydrate diet can restore beta-cell function and lead to remission in people with type 2 diabetes,” Gower said.

Reference:

Barbara A Gower, Amy M Goss, Marian L Yurchishin, Sarah E Deemer, Bhuvana Sunil, William T Garvey. Effects of a Carbohydrate-Restricted Diet on β-Cell Response in Adults With Type 2 Diabetes. The Journal of Clinical Endocrinology & Metabolism, 2024; DOI: 10.1210/clinem/dgae670.

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Magnesium sulfate given according to Zuspan regimen safe in Women with Preeclampsia: Study

Preeclampsia is a hypertensive disease affecting 2-8% of all
pregnancies with associated edema, placental insufficiency, kidney and liver
dysfunction, hemolysis, coagulopathy, and seizures—referred to as eclampsia.
Eclampsia is a rare, but potentially fatal complication of preeclampsia.

Diagnostic criteria for preeclampsia have changed from
elevated blood pressure and proteinuria to a less strict definition of
hypertonia and any of several organ dysfunctions, such as anaemia or
thrombocytopenia, elevated liver enzymes, central nervous symptoms, proteinuria
or elevated creatinine, or foetal growth restriction. Magnesium sulfate
treatment is described as early as 1933. In the last decades of the 20th
century, magnesium sulfate treatment became less common, due to concerns of
magnesium toxicity, and the belief that anticonvulsant drugs were equally
efficacious in preventing eclampsia. The mechanism behind neuroprotection in
magnesium treatment is not fully understood but is believed to stem from
calcium antagonism, blocking overactivationof NMDA receptors and inhibiting
inflammatory cytokine response—both factors in a second phase of brain insults.

During the 1950s, Zuspan in Ohio, USA, and Pritchard in
Texas, USA, introduced standardised magnesium sulfate treatments. Zuspan
advocated a regime of intravenous bolus and maintenance treatment, whilst
Pritchard favoured intramuscular bolus and repeat injections. These regimens
persist today—Zuspan in high-resource settings and Pritchard in low-resource
settings. The tentative therapeutic range of serum magnesium (2.0–3.0 mM) stems
from measurements in successful cases of this era, whilst the threshold of
toxicity as measured by loss of patellar reflex (3.5 mM) was established in
1940. In the 2002 Magpie trial (MAGnesium sulfate for Prevention of Eclampsia),
designed to evaluate the effects of magnesium sulfate on pregnant women with
preeclampsia and their babies, there was a marked reduction in seizures for
mothers given magnesium sulfate rather than placebo, regardless of whether
treatment is started before or after delivery and irrespective of any previous
anticonvulsant therapy.

Since 2002, obesity rates have soared worldwide and are
expected to continue to increase. Increased weight increases distribution
volume, and thus time to achieve steady state concentration. Obesity is a
pronounced risk factor for developing preeclampsia, making it imperative to
ascertain that obese women receive adequate magnesium treatment.

The body mass index among women giving birth in authors’
health care region is lower than the population used in developing the
pharmacokinetic model. Thus, they hypothesised that body weight is lower among
women treated with magnesium sulfate in their region and therefore sought to
perform an external validation of the PK model. Since preeclampsia is a major
cause of preterm delivery and they do not treat extremely preterm neonates, there
might also be a difference in patient selection causing gestational age at
treatment to start to be higher in our population. The rationale for validating
this particular model is that it used a mixed model—decreasing the risk of
overfitting model to data, and that the population is well-characterised. A
secondary aim of the study was to evaluate the proportion of women in
historical cohort reaching the target serum magnesium of >2 mM.

Women with preeclampsia undergoing magnesium sulfate
treatment. Subjects initially received Zuspan treatment (4 g bolus and 1 g/h
maintenance dose), commonly increased by individual titration. Main Outcome measures
included difference in mean between measured and predicted magnesium
concentration and proportion of women reaching target concentration (>2 mM)
in 25 h.

56 women were included, with 356 magnesium measurements
available. Mean magnesium concentration was 1.82 mM. The prediction model
overestimated magnesium concentration by 0.10 mM (CI 0.04–0.16) but exhibited
no bias for weight, creatinine, or treatment duration. Weighted mean infusion
rate was 1.22 g/h during 30 hours. Overall success rate in reaching target
concentration was 54%, decreasing to 40% in women > 95 kg. Overall success
rate at 8 hours was 11%. No toxic concentrations were found.

This study found a good predictive capability of the
pharmacokinetic model. There was a statistically significant difference in
prediction vs outcome of +0.10 mM; however, the study was not designed nor
powered to evaluate its clinical impact. In a clinical setting, when using a
potentially very toxic drug. Overestimation is preferable to underestimation.
The model performed well at all concentrations, and without any bias
identified.

In this historical cohort, magnesium sulfate treatment with
using a 4 g bolus and a minimum maintenance dose of 1 g/h produced no toxic
concentration and thus did not necessitate additional monitoring with respect
to magnesium sulfate treatment. On the contrary, only 54% of treated women
reached target concentration > 2 0 mM within 25 hours, falling even lower
among women with high body weight or low creatinine. Calculating individual
bolus and maintenance doses could be used to improve treatment outcomes and
simultaneously decrease blood sampling. Further, the cohort of 56 cases with
356 magnesium measurements validated an external pharmacokinetic model for
magnesium sulfate treatment, proving that individualised treatment is
feasible—only requiring body weight and serum creatinine level.

Source: Erik Holmström Thalme 1 and Magnus Frödin-Bolling; Hindawi
Journal of Pregnancy Volume 2024, Article ID 1178220, 8 pages

https://doi.org/10.1155/2024/1178220

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Certolizumab Pegol Effective in Rheumatoid Arthritis Patients with high RA factor: Study

A recent post hoc analysis of the EXXELERATE study revealed that certolizumab pegol (CZP) sustained drug concentration and efficacy in rheumatoid arthritis (RA) patients with varying baseline rheumatoid factor (RF) levels compared to adalimumab (ADA). The findings were published in the Rheumatology journal.

Rheumatoid arthritis is a chronic autoimmune condition that often features elevated levels of RF, an antibody that targets the body’s own tissues and can exacerbate disease severity. RF levels are frequently used to gauge the aggressiveness of RA and predict treatment outcomes. In this study, baseline RF levels were divided into quartiles, with patients grouped into either ≤204 IU/ml (≤Q3) or >204 IU/ml (>Q3) RF categories. A total of 907 patients were included in the analysis, split almost evenly between those treated with CZP and ADA.

The finding suggest that, while CZP maintained stable drug concentration levels regardless of the RF baseline, ADA demonstrated a decrease in drug concentration for patients with RF levels above 204 IU/ml. The area under the curve (AUC), which measured overall drug exposure over time was lower in ADA-treated patients with high RF when compared to the ones with lower RF levels. This contrast highlights a potentially significant difference in drug pharmacokinetics between the two TNF inhibitors, especially in patients with high RF levels, which may impact drug efficacy.

When examining efficacy outcomes, the study used the disease activity score (DAS28)-CRP to measure changes in disease activity. For patients with RF levels ≤204 IU/ml, both CZP and ADA provided similar improvements in DAS28-CRP scores over the 104-week period. However, in the higher RF group (>204 IU/ml), CZP outperformed ADA, leading to a notably lower mean DAS28-CRP score by week 104. Also, a higher percentage of patients with high RF levels treated with CZP achieved low disease activity status by the end of the study when compared to the individuals on ADA.

These findings suggest that for RA patients with elevated RF levels, CZP may offer superior long-term efficacy and drug stability when compared to ADA. Overall, the EXXELERATE study results reinforce the need for tailored therapeutic strategies based on individual patient factors, such as RF levels, when selecting TNF inhibitors for RA management.

Source:

Smolen, J. S., Taylor, P. C., Tanaka, Y., Takeuchi, T., Hashimoto, M., Cara, C., Lauwerys, B., Tilt, N., Ufuktepe, B., Xavier, R. M., Balsa, A., Curtis, J. R., Mikuls, T. R., & Weinblatt, M. (2024). Impact of high rheumatoid factor levels on treatment outcomes with certolizumab pegol and adalimumab in patients with rheumatoid arthritis. In Rheumatology. Oxford University Press (OUP). https://doi.org/10.1093/rheumatology/keae435

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High emergency care use during pregnancy associated with increased risk of Severe Maternal Morbidity ,finds study

Pregnant women who frequently seek emergency care during pregnancy may be at a higher risk of experiencing severe maternal morbidity and other negative outcomes. Recent cohort study explored the association between frequent unscheduled care visits during pregnancy Data Source and the risk of severe maternal morbidity (SMM) at the time of birth. The study used data from the Massachusetts Pregnancy to Early Life Longitudinal (PELL) Data System, which links birth and fetal death records to corresponding maternal hospital encounters. The study population included 774,092 pregnant individuals in Massachusetts between October 1, 2002 and March 31, 2020. The key exposure was 4 or more emergency care visits, defined as either an emergency department (ED) visit or observational stay (OS) during pregnancy not resulting in hospital admission. The main outcome was the odds ratio for SMM at the time of birth. Study Results – ContinuedThe results showed that 31.3% of the sample had at least 1 unscheduled visit during pregnancy, and 3.3% had 4 or more visits. High emergency care use was more common among younger individuals, those with Hispanic or non-Hispanic Black race/ethnicity, those with public insurance, and those with a comorbidity or opioid use in the year prior to pregnancy. Study Results – ContinuedIn the multivariable analysis, those with 4 or more unscheduled visits had an adjusted odds ratio of 1.46 (95% CI, 1.29-1.66) for SMM compared to those with 0 visits. Additionally, 43.8% of those with 4 or more unscheduled visits used multiple hospitals during pregnancy. The study concludes that high emergency care use during pregnancy is associated with an increased risk of SMM. Given the fragmentation in care for those with frequent unscheduled visits, the authors suggest that community-based and integrated solutions across health systems may be most beneficial for this high-risk population.

Key Points –

1. The study explored the association between frequent unscheduled care visits during pregnancy and the risk of severe maternal morbidity (SMM) at the time of birth.

2. The study used data from the Massachusetts Pregnancy to Early Life Longitudinal (PELL) Data System, which links birth and fetal death records to corresponding maternal hospital encounters. The study population included 774,092 pregnant individuals in Massachusetts between October 1, 2002 and March 31, 2020.

3. The key exposure was 4 or more emergency care visits, defined as either an emergency department (ED) visit or observational stay (OS) during pregnancy not resulting in hospital admission. The main outcome was the odds ratio for SMM at the time of birth.

4. The results showed that 31.3% of the sample had at least 1 unscheduled visit during pregnancy, and 3.3% had 4 or more visits. High emergency care use was more common among younger individuals, those with Hispanic or non-Hispanic Black race/ethnicity, those with public insurance, and those with a comorbidity or opioid use in the year prior to pregnancy.

5. In the multivariable analysis, those with 4 or more unscheduled visits had an adjusted odds ratio of 1.46 (95% CI, 1.29-1.66) for SMM compared to those with 0 visits. Additionally, 43.8% of those with 4 or more unscheduled visits used multiple hospitals during pregnancy.

6. The study concludes that high emergency care use during pregnancy is associated with an increased risk of SMM, and suggests that community-based and integrated solutions across health systems may be most beneficial for this high-risk population.

Reference –Declercq ER, Liu CL, Cabral HJ, Amutah-Onukagha N, Diop H, Mehta PK. Emergency Care Use During Pregnancy and Severe Maternal Morbidity. JAMA Netw Open. 2024 Oct 1;7(10):e2439939. doi: 10.1001/jamanetworkopen.2024.39939. PMID: 39412800.

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