Transradial access for thrombectomy is safe and effective to transfemoral access for Stroke: AHA

A recent study found transradial access for mechanical thrombectomy to be non-inferior to transfemoral access in terms of final recanalization. The key highlights of this study were published in the Stroke Journal.

Transfemoral access has been the standard method for accessing blocked arteries in stroke patients with large vessel occlusions. And so, a new investigation by David Hernandez and team introduced transradial access as a reliable alternative. This investigator-initiated, single-center clinical trial compared the efficacy and safety of transradial and transfemoral access in stroke patients undergoing mechanical thrombectomy.

The major findings of this study were;

The outcomes associated with transradial access was non-inferior to its traditional method which revealed achieving a successful recanalization for stroke intervention. Out of the 120 patients enrolled in the trial, the participants who were assigned to transradial access demonstrated a 96.6% achieving successful recanalization. This finding suggests that transradial access is a reliable method for restoring blood flow to the brain in stroke patients.

The procedural delays were noticed in the transradial access group, with longer median times recorded from angiosuite arrival to both first pass and recanalization when compared to the transfemoral approach. Despite this, both methods presented similar rates of severe complications and access conversions.

These pivotal findings offer clinicians an alternative approach for delivering life-saving treatment to stroke patients. However, maximum caution and further research is much imperative to fully elucidate the optimal approach in considering the procedural delays associated with the transradial access.

Source:

Hernandez, D., Requena, M., Olivé Gadea, M., De Dios Lascuevas, M., Gramegna, L. L., Muchada, M., García-Tornel, Á., Diana, F., Rizzo, F., Rivera, E., Rubiera, M., Piñana, C., Rodrigo-Gisbert, M., Rodriguez-Luna, D., PAGOLA, J., Carmona, T., Juega, J., Rodriguez-Villatoro, N., Molina, C. A., … Tomasello, A. (2024). Radial Versus Femoral Access for Mechanical Thrombectomy in Stroke Patients: A Non-Inferiority Randomized Clinical Trial. In Stroke. Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.1161/strokeaha.124.046360

Powered by WPeMatico

VEGF inhibitors may reduce all-cause mortality in nAMD patients

A recent study published in the Ophthalmology Science, assessed the safety concerns surrounding intravitreal VEGF inhibitors in the treatment of neovascular age-related macular degeneration (nAMD). This nationwide register-based cohort analysis spanned for 16 years to assess the impact of VEGF inhibitor treatment on the risk of all-cause mortality and cardiovascular disease (CVD) among the patients with nAMD.

The findings of the study involved over 37,000 patients with nAMD exposed to VEGF inhibitors and nearly 1.9 million unexposed individuals without nAMD. On the positive side, the patients with nAMD undergoing VEGF inhibitor treatment showed a reduced risk of all-cause mortality when compared to their counterparts without nAMD. This finding suggests that VEGF inhibitor treatment may not just be effective in nAMD management but could also contribute to improved overall survival rates in these patients.

Also, the study uncovered an increased risk of CVD in patients with nAMD who were receiving VEGF inhibitors. While the exact mechanism behind this relationship remains unclear, it raises major queries about the systemic effects of VEGF inhibitors beyond their intended ocular benefits.

Additional analyses into the dosing patterns and timing of VEGF inhibitor exposure revealed precise results. While the decreased risk of all-cause mortality persisted across different dosing regimens, there was no significant association between VEGF inhibitor treatment and CVD when considering shorter exposure periods after injection.

The study provides crucial insights into the safety profile of VEGF inhibitors for nAMD patients with decreased risk of mortality that is mostly influenced by the factors beyond the direct physiological effects of VEGF inhibitors, such as the overall health status and resilience of patients undergoing this treatment.

Source:

Thinggaard, B. S., Frederiksen, K., Subhi, Y., Möller, S., Sørensen, T. L., Kawasaki, R., Grauslund, J., & Stokholm, L. (2024). VEGF Inhibition Associates With Decreased Risk of Mortality in Patients With Neovascular Age-related Macular Degeneration. In Ophthalmology Science (Vol. 4, Issue 3, p. 100446). Elsevier BV. https://doi.org/10.1016/j.xops.2023.100446

Powered by WPeMatico

Faculty shortage in India is twofold- Genuine shortage and lack of inclination to teach at college level: Parliamentary Panel

New Delhi: The shortage of faculty across the medical colleges in India is not only due to the genuine shortage of qualified faculty, but it is also because even the available faculty often lacks the inclination to teach at the college level, a Parliamentary Health Panel recently opined in its report.

In order to deal with the issue of faculty shortage and ghost faculty, the panel has recommended that the Government strictly enforce the regulations already in place to curb the problem of ghost faculty and zero attendance.

Further, the panel has suggested that the National Medical Commission (NMC) should conduct regular inspections of medical colleges and take action against the colleges that are found to be violating the regulations.

The panel also took note of the NMC’s rules of limiting the appointment of non-medical teachers at medical colleges and opined that the authorities should introduce a transitional period allowing the non-MBBS faculties to continue teaching until enough MBBS-qualified educators become available.

Further, the panel advised the authorities to streamline and implement an efficient recruitment process to expedite faculty appointments and fill the vacant positions without any delays.

These observations have been mentioned in the One Hundred Fifty-Seventh report of the Department-related Parliamentary Standing Committee on Health and Family Welfare. The panel, chaired by Shri Bhubaneswar Kalita, presented its report before the Parliament on 9th February 2024. Several issues related to medical education such as infrastructure, faculty issues, and quality control of medical education were discussed in the report.

Indian Medical Colleges have been reeling under shortage of adequate faculty for a long time. Medical Dialogues had last year reported that 349 out of the total 654 medical colleges across the country got a show cause notice from the Apex Medical regulator NMC for violations of the Minimum Standard Requirements 2020 including a deficiency in having the required faculty numbers.

Also Read: Faculty Shortage, Violation of MSR: 349 out of 654 medical colleges get NMC Show Cause Notice

Noting that faculty is central to the quality of medical education, the panel highlighted that experienced, knowledgeable and qualified teachers play a crucial role in providing quality medical education, and to the development of competent and ethical healthcare professionals.

However, the panel observed that due to the Government’s efforts to increase the number of medical colleges and UG and PG medical seats, the medical colleges in India are facing an alarming shortage of faculty members. In this regard, the Director Professor of Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi informed the committee that there is a severe shortage of faculty positions in various medical colleges spread all over India.

While discussing the issue, the panel referred to the reply of the Union Health Minister in Rajya Sabha in August 2023, as per which about 5,527 faculty positions in all AIIMS have been sanctioned and around 2,161 seats were lying vacant. AIIMS, New Delhi which is a premier institute also faces severe faculty crunch with almost 347 faculty positions lying vacant and this accounts for almost 28% of the total sanctioned strength, noted the Panel.

Further, the panel pointed out that a recent assessment of 246 medical colleges in 2022-2023 by the UG Medical Education Board (UGMEB) of NMC revealed that no medical college had adequate faculty members or senior residents, and all failed to meet the 50% attendance requirement.

The assessment brought to light that most of the colleges had either ghost faculty or senior residents or had yet to employ the required faculty at all. While none of the institutes met the minimum 50% attendance requirement, zero attendance of faculty was common in most of the medical colleges.

In its report, the panel also referred to NITI Aayog’s “Barriers to Recruitment, Onboarding, and Retention of Faculty in Government Medical Colleges of India” report, where the primary reasons for severe shortage of faculty in medical colleges included- significant delays in the recruitment process, well-compensated positions in the private sector attracting professionals, preference for job postings in major urban centers or near one’s hometown, and restriction on recruiting faculty with PG qualifications in basic sciences due to the modified NMC guidelines in 2019.

Taking note of all these factors, the panel observed that “…establishing additional medical colleges is undoubtedly a positive stride in addressing the chronic shortage of healthcare professionals. However, in this effort, it is crucial to ensure the production of genuinely qualified doctors which is incumbent upon the presence of well-qualified and experienced faculty members. Teachers in medical colleges are the cornerstone of a robust medical education system, shaping not only the knowledge and skills but also the ethical foundations of future medical practitioners.”

“The Committee believes that whether it is the expansion of medical colleges or the implementation of progressive initiatives like NMC’s Competency-Based Medical Education (CBME) module, the efficacy of these reforms hinges on the availability of a dedicated, skilled teaching force. The shortage of qualified teachers is a common thread in both scenarios and addressing this issue is paramount. In this regard, the Committee has taken note of the findings of NMC for 246 medical colleges. The Committee views that NMC’s efforts, like AEBAS based attendance CCTVs in colleges, have yet to deliver much as issues like ghost faculty and zero faculty attendance have only escalated as per the NMC’s assessment,” it further noted.

Recommendations by the Panel: 

The panel agreed that the faculty shortage in the Indian medical colleges is not only because of genuine shortage, but also because the available faculty often lacks the urge to teach at medical colleges.

“Therefore, the Committee is of the consensus that the faculty shortage issue in India is twofold: first, there is a genuine shortage of qualified faculty members, and second, even the available faculty often lacks the inclination to teach at the college level,” observed the panel.

To deal with the issue, the panel has recommended the Government to strictly enforce the existing regulations. It mentioned in the report, “To address the issue of ghost faculty and ensure that the available faculty comes to the college to teach, the Committee recommends the Government to strictly enforce the regulations already in place to curb the problem of ghost faculty and zero attendance. NMC should conduct regular inspections of medical colleges and take action against colleges that are found to be violating the regulations.”

It also opined that the recruitment process should be streamlined and advised to implement an efficient recruitment process to expedite faculty appointments and fill the vacant positions without any delays.

“Additionally, streamlining the recruitment process is imperative. The significant delays in the recruitment process must be reduced through the simplification of bureaucratic procedures and the incorporation of technology for quicker application processing and interview scheduling. An efficient recruitment process is necessary to expedite faculty appointments and fill vacant positions without unnecessary delays,” it advised.

“NMC should make it easier for students and parents to report ghost faculty and zero attendance. Furthermore, the Committee feels that the Government should undertake some essential steps for retaining faculty viz. improved working conditions for faculty members, transparent career progression paths, etc. Clear criteria and milestones for promotions by recognising and rewarding excellence in teaching, research, and clinical work need to be chalked out. Regular performance evaluations are crucial in identifying and addressing concerns promptly,” the panel further mentioned in its report.

Faculty Qualifications and Competence: 

Further discussing the issue of faculty shortage, the panel referred to the NMC guidelines dating back to 2022 titled “Teacher’s Eligibility Qualifications in Medical Institutions Regulations, 2022”, which was put in place with the goal of elevating the standards of medical education and healthcare across the nation. As per the new guidelines, all medical teachers are required to have a postgraduate degree or equivalent qualification in the subject they are teaching. Furthermore, these regulations require all medical teachers to complete basic training in medical education technology and biomedical research. The new rules have more rigorous criteria for promotions of medical teachers.

At this outset, the panel noted, “The Committee notes that the NMC’s “Teacher’s Eligibility Qualifications in Medical Institutions Regulations, 2022″, are a significant step forward in improving the quality of medical education in India. By requiring higher qualifications for teachers, mandating training in medical education technology and biomedical research, and having more rigorous promotion criteria, the new regulations will help to ensure that medical teachers in India are highly skilled and qualified. The Committee, however, opines that along with the rigorous promotion criteria, NMC should focus more on Teacher-Learning Programmes than on manpower and infrastructure.”

“The Commission should also formulate norms to incentivize and encourage faculty to take up training for skills improvement and devise policies creating an ambience to kindle interest in research in the faculties. Furthermore, the Committee recommends the NMC design and strictly implement exhaustive training programs for faculties to enhance their understanding of the principles, functioning, and practices of CBME,” the panel further advised to the Commission.

Non-Medical Teachers: 

The issue of limited appointment of non-medical teachers as faculties in medical colleges has also been discussed by the Parliamentary Committee. The panel observed that in order to reform the quality of medical education and effectively implement the CBME module, NMC limited the appointment of Non-medical teachers in the Department of Anatomy, Physiology, and Biochemistry to the extent of 15% of the total number of posts and zero percent in microbiology and pharmacology subject to non-availability of medical teachers. It also observed that the erstwhile Medical Council of India, allowed allowed up to 30% appointment of nonmedical faculty in these courses.

Medical MSc degree is included in the first schedule of the Indian Medical Council Act, 1956. Medical MSc courses were opened for non-doctors in the 1960s to counter faculty shortage, observed the panel.

Referring to the issue, although the panel recognized NMC’s aspiration to introduce competency-based learning for MBBS students and foster clinical exposure from the early stages of their education, it also noted that “…the sudden cessation of non-MBBS candidates teaching non & non-para-clinical subjects, such as anatomy, pharmacology, and microbiology, presents a complex situation. While upholding high educational standards is paramount, there is a need for a balanced and gradual approach that accommodates the interests and expertise of non-MBBS candidates.”

Therefore, the panel recommended the authorities to take a “thoughtful and phased strategy” and further mentioned, “It is advisable to introduce a transitional period that allows non-MBBS faculty members to continue teaching these subjects until enough MBBS-qualified educators become available. This gradual shift will ensure that students continue to receive a comprehensive education as the transition toward competency-based learning takes place. Furthermore, it is crucial to emphasize faculty development for non-MBBS educators, offering them opportunities to enhance their teaching skills and align their curriculum with evolving standards in medical education. This will help them remain effective contributors to medical education. Non-MBBS educators often bring unique perspectives and expertise to the field. Rather than limiting their involvement, their expertise can be integrated into the education system through collaborative efforts, interdisciplinary research, and innovative teaching methodologies.”

Faculty Development: 

Further emphasizing the importance of faculty development to ensure that all faculty members have the required skills and knowledge, the panel has recommended NMC to release the guidelines on the Faculty Development Programme without any delay.

“The policies should be formulated to support the achievement of the goal to enhance the quality and relevance of education for future healthcare professionals. These guidelines should encompass critical areas such as clinical instruction, small group facilitation, large group presentations, feedback and assessment, personal and organizational growth, leadership, and scholarly activities. The strategies and formats for faculty development should exhibit flexibility, ensuring they are tailored to the specific healthcare requirements of our nation, institution, and learners. Faculty development programs (FDPs) can encompass a range of activities, including continuing education, on-the-job training, traditional classroom settings, in-person, online, or via tele/videoconferences, self-paced learning, mentorship, involvement in communities of practice, or a combination of these approaches,” opined the panel.

Taking note of the fact that conducting faculty training through regional bodies and nodal centers has limited availability and capacity, the panel has recommended “establishing a National Institute for Training of Medical Teachers. A dedicated institute would provide year-round access to training for medical college faculty, effectively expanding the capacity for teacher development and establishing standardized quality benchmarks. This may also lead to the institutionalization of training procedures and best practices.”

Also Read: Churachandpur Medical College in Manipur Struggles to Fill Unoccupied MBBS Seats Amidst Faculty Shortage

Powered by WPeMatico

3 Rajasthan nurses with PhDs cannot use ‘Dr’ before their names

Jaipur: Three nurses who have recently completed their PhD have been denied permission to use ‘Dr’ title with their names by the Rajasthan medical and health department.

The nurses posted in the health department had sent a proposal to it to allow them to use ‘Dr’ with their names after completing their PhD.

Suresh Nawal, director (non-gazetted) medical and health department, issued a letter on February 9 stating that three nurses have sent proposal to the directorate seeking permission to use ‘Dr’ title ahead of their names but the permission to use the title has not been granted by the administrative department.  

Also Read:Cancer patient dies after disruption in oxygen supply; Doctor, Nurses Suspended

Rajasthan Nurses Association state president Narendra Singh Shekhawat said that the order has discouraged nursing staff, who go for research in their field which ultimately benefits the patients.   

“The department has denied permission to nurses, who have done PhD, to use ‘Dr’ title. We will go to higher authorities in the government. Those with PhD want to use the ‘Dr’ title in their name. For this, changes in documents are required and to follow that procedure, permission of the government is necessary which has been denied,” Shekhawat said.     

“Allowing those with PhD to use ‘Dr’ title will only encourage the nurses to go for research and higher studies, which will benefit the patients,” he added.     

While the reason or ground to not allow the nurses to use the title is not mentioned in the letter, an official of the health department said that granting permission for this will create confusion among the people, who will not be able to differentiate a medical doctor or PhD holder nurse.  

As per a media report in TOI, Jogendra Sharma, principal of govt college of nursing in Jaipur, said,” Nurses are using ‘Dr’ as a title after completing PhD in nursing, but in govt sector, it is not easy. It is like changing the entire name for which a process is followed, and it is changed only through gazette norms.

Powered by WPeMatico

Blocking artery feeding dura during surgical drainage may reduce risk of repeat surgery in subdural hematoma

Injection of a substance to block an artery feeding the dura (protective sack around the brain) along with surgery to remove pooled blood reduced the risk that patients will require repeat surgery compared to surgical drainage alone, according to preliminary late-breaking science presented today at the American Stroke Association’s International Stroke Conference 2024. The meeting, held in person in Phoenix Feb. 7 – 9, 2024, is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

A subdural hematoma occurs when there is a tear in one of the thin blood vessels that stretch between the surface of the brain and the overlying membranes that protect the brain. A subdural hematoma can occur because of physical trauma such as a car accident, however, it may also develop slowly in the days or weeks after the injury. This study explored treatment for subacute or chronic subdural hematoma. Subacute subdural hematoma occurs following less severe trauma, such as a concussion-with symptoms such as weakness, numbness, tingling, seizure, headache, confusion or dizziness that develops over hours or days after the event. Chronic subdural hematoma can result from slow bleeding after minimal trauma that the patient may not even remember-American Heart Associationsymptoms may be subtle and/or may take weeks to be noticeable enough to seek treatment.

“Chronic subdural hematoma is one of the most common neurosurgical conditions and is likely to increase in the future since we have a sizeable aging population, with many taking blood thinners to manage various medical conditions,” said study co-author Jason Davies, M.D., Ph.D., an associate professor in the departments of neurosurgery and biomedical informatics at the State University of New York, Buffalo. “These hematomas often form in the elderly because as we age, the brain shrinks and pulls away from the inside of the skull, stretching the veins that form a bridge between the dura and the brain, which makes them more likely to tear after a small trauma and leak blood into the protective space between the brain and skull, the dura.”

Treatment for subacute or chronic subdural hematoma may involve a surgical procedure to drain pooled blood from the area or closely monitoring symptoms to determine if and when intervention may be necessary. The challenge is that even with surgery, repeat surgery may be needed in up to 20% of cases of subdural hematomas.

The EMBOLISE clinical trial tested whether a subacute or chronic subdural hematoma is less likely to require additional surgery if, in addition to surgical drainage, a substance is injected to block, or embolize, one of the arteries supplying blood to the dura. The OnyxTM liquid embolic system, tested in this trial, is already used prior to surgery to reduce bleeding in people having an operation to correct an abnormal connection between arteries and veins in the brain.

Between December 2020 and August 2023, researchers enrolled 400 adults (average age of 72; 27% women) at 39 centers (including both community and academic hospitals). All were about to undergo surgery for subacute or chronic subdural hematoma and were considered able to care for themselves and likely to survive at least one year. Patients were randomly assigned to receive either surgery alone or surgery plus embolization using the liquid embolic system to help reduce the progression or recurrence of subdural hematoma.

The primary outcome was how frequently there was reaccumulation of blood (a recurrence) that required surgical drainage within 90 days.

The analysis found:

  • Subsequent subdural hematoma within 90 days and need for surgical drainage occurred in 4.1% of patients who had surgery plus embolization and 11.3% of those who had surgery alone.
  • At 90 days after surgery, increasing disability and neurological dysfunction was found to be comparable (statistically the same) in both groups, with 11.9% of patients who had surgery plus embolization and 9.8% of patients who had surgery alone.
  • Serious adverse events attributed to embolization occurred in 2% of patients who received it.

“The EMBOLISE trial showed that there was a nearly 3-fold reduction in re-operation for patients that were treated with surgery plus embolization,” Davies said. “Fewer trips to the operating room mean less potential for pain, complications, recovery and expense for the patient. Furthermore, we see that the complications related to the embolization procedure were low and that there was no increase in neurological problems.”

Study details and background:

  • The EMBOLISE (Embolization of the Middle Meningeal Artery With OnyxTM Liquid Embolic System in the Treatment of Subacute and Chronic Subdural Hematoma) study was conducted at multiple hospitals and health centers in the United States.
  • The liquid embolic system treatment starts as an injectable soft solid, flows as a liquid when force is applied, and then returns to a soft solid state to stop the leaking blood vessel.
  • Other arms of the EMBOLISE study, which included patients not undergoing surgery and randomized to either receive the liquid embolic system or not, are ongoing and not being presented at ISC 2024.
  • Additional measures to gauge success of the liquid embolic system treatment included the number of hospital readmissions; change in hematoma (pooling of blood) volume or thickness; and change in midline shift (when a hematoma pushes brain tissue out of alignment), all assessed at 90 days after treatment.
  • Safety endpoints included the incidence of neurological death or serious adverse events occurring within 30, 90 and 180 days after treatment.

The main limitation was a relatively high loss to follow up. “One of the challenges of conducting this trial was dealing with a frail elderly population, especially in the middle of the pandemic. Tracking patients down for follow up is always a challenge, and these were compounded by the various COVID-era restrictions that many of our sites faced,” Davies said.

Powered by WPeMatico

Submit Safety Data From Phase I CT : CDSCO Panel Tells Novo Nordisk on CagriSema

New Delhi: Reviewing the Phase II clinical study protocol of CagriSema, a combination medication that includes semaglutide and Cagrilintide, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major NovoNordisk to submit detailed safety data from Phase I study and to include the Nephrologists as principal investigator/ Co-Principal Investigator (PI /Co –PI) from the same site/institute where the study is planned.

This came after NovoNordisk presented Phase II clinical study protocol No. NN9388-7700.

CagriSema is a combination medication that includes semaglutide and a drug called Cagrilintide. It mimics the action of amylin, a hormone produced by the pancreas that makes people feel “satiety,” or “fullness,” after eating a meal.

Cagrilintide is an amylin-analog, now being developed in combination with the GLP-1 agonist semaglutide to achieve sustained weight loss in persons with overweight and obesity.

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. It mimics the GLP-1 hormone, released in the gut in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood sugar (glucose).

At the recent SEC meeting for Endocrinology and Metabolism held on 24th January 2023, the expert panel reviewed the Phase II clinical study protocol for the FDC Cagrisema presented by the drug major Novo Nordisk.

After detailed deliberation, the committee recommended that the firm should submit detailed safety data from Phase I study for further review by the committee. Furthermore, the expert panel suggested that the firm should include the Nephrologists as PI /Co –PI from the same site/institute where the study is planned.

Also Read:Modify Clinical Study Protocol: CDSCO Panel Tells Roche On Multiple Sclerosis Drug Ocrelizumab

Powered by WPeMatico

1 st year MBBS student accuses seniors of ragging at MKCG medical college

A first year MBBS student has levelled allegations of ragging against his seniors at the MKCG Medical College and Hospital in Berhampur in Odisha’s Ganjam district.

The matter came to light after the father of the MBBS student complained before the anti-ragging cell accusing two of his son’s seniors of beating him up inside the campus late Friday evening, reports PTI.

For the full story, check out the link given below:

Alleged Ragging At MKCG Medical College: MBBS Student Accuses Seniors Of Assault

Powered by WPeMatico

CDSCO approves Jardiance for treatment of adults with chronic kidney disease in India

Mumbai: The national regulatory authority of India, the Central Drugs Standard Control Organisation (CDSCO), has approved Jardiance (empagliflozin) 10mg tablets to reduce the risk of sustained decline in eGFR (only for patients with eGFR 30-90 ml/min/1.73m2), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) at risk of progression.

This indication approval allows the nephrologists and cardiologists to use Jardiance 10mg tablets for the treatment of CKD in eligible patients. It should be noted that Jardiance is not recommended for the treatment of CKD in patients with polycystic kidney disease, or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease.

The approval has the potential to advance the standard of care for an estimated >33 million adults in India living with CKD and help relieve the burden on healthcare systems by reducing the risk of hospitalizations, as well as delaying progression to kidney failure, for people with CKD.

“Chronic kidney disease is an important health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Gagandeep Singh Bedi, Managing Director, Boehringer Ingelheim India. “We are very excited about the approval and the potential for empagliflozin to play an essential role in helping people living with kidney disease and their physicians. It also underscores our commitment to bringing innovative solutions that address the unmet medical needs in India.”

Dr. Shraddha Bhure, Medical Director, Boehringer Ingelheim India, emphasized the significance of this development. “CKD is a major health problem in India, arising from common risk factors like diabetes, hypertension, or cardiovascular disease, to name a few. Patients with CKD progression are at increased risk of hospital admissions, cardiac events, kidney failure, and death. Apart from the impact on health, a large proportion of patients with CKD also need to face catastrophic health expenditures. The prognosis of CKD may vary according to different underlying causes and/or stages of CKD; this may necessitate proven treatment options for different patients with CKD. The scientific evidence with empagliflozin, on providing clinically meaningful improvement in CKD outcomes across a broad range of eligible patients, provides compelling reasons to improve the current treatment landscape of CKD. Optimum management of CKD can foster substantial improvements in the health and economic outcomes, for not only the patients and their families but also the society and the country’s healthcare system at large.”

Padma Shri Dr. (Prof.) Kamlakar Tripathi has quoted, “Chronic kidney disease has been recognized as a priority in our country’s national program for non-communicable diseases. In the early stages, chronic kidney disease often progresses without overt clinical symptoms, which often leads to a delay in the diagnosis. Patients who are diagnosed with advanced chronic kidney disease, are at much greater risk of major events like hospitalizations, kidney failure, and cardiovascular death. A key aspect of optimum kidney care is early detection and slowing the progression of chronic kidney disease. An early intervention can retard the progression towards end-stage kidney disease.”

“People with diabetes, high blood pressure, cardiovascular disease, and family history of kidney disease, are some individuals who have a high risk for developing chronic kidney disease. It is essential that these individuals get regularly tested for chronic kidney disease and receive appropriate treatment for optimum kidney protection. It is heartening that good scientific research, like the EMPA-KIDNEY study, is yielding promising treatment options that can serve more diverse groups of eligible patients with chronic kidney disease,” added Dr. Tripathi.

Read also: Eli Lilly-Boehringer Ingelheim Jardiance gets USFDA approval for adults with chronic kidney disease

Powered by WPeMatico

NEET aspirant arrested for posing as doctor at Ram Manohar Lohia hospital, FIR lodged

New Delhi: A 24-year-old man was arrested for allegedly posing as a doctor at Ram Manohar Lohia Hospital in central Delhi, police said on Wednesday.

When Ashutosh Tripathi, a resident of Burari, was caught from the emergency department on Tuesday he was wearing a stethoscope and carrying a doctor’s coat in his bag, an official said.

A police officer said an FIR under section 170 (impersonating a public servant) of the Indian Penal Code has been registered at the North Avenue police station on the basis of a complaint filed by senior resident (department of surgery) Rahul Dhamija.

Also Read:Fake Doctor found prescribing medicines at Odisha Hospital, held

The officer said that when hospital authorities questioned Tripathi, he first introduced himself as a doctor and later as a medical student. Suspecting his credentials, the hospital informed the police.

During interrogation, he told the police he was preparing for the medical entrance examination NEET and wrote the exam last year but could not succeed.

“He would love to wear the doctor’s apron and stethoscope. But he failed to reveal the source of these articles,” the officer said, adding it appears that entered in the hospital with the intention of theft.

He also told the police that he was called by a friend to meet him in the hospital but his claims are yet to be verified, the officer said.

Powered by WPeMatico

Breakthrough Treatment with Mitapivat Mitigates Iron Overload in Rare Hereditary Anemia: Study

In a groundbreaking development, a
recent study has unveiled promising results for the treatment of pyruvate
kinase (PK) deficiency, a rare hereditary disease causing chronic hemolytic
anemia. They found that Mitapivat
is highlighted as the first disease-modifying pharmacotherapy to have
beneficial effects on iron overload in patients with PK deficiency as stimulation
of mutant PK enzyme (PKR) through mitapivat exhibited
substantial and enduring enhancements in both iron homeostasis and overload
over an extended period.


The
study results were published in the journal 
Blood Advances.

Patients with PK deficiency often
experience iron overload, a condition associated with severe complications such
as liver cirrhosis, cardiomyopathy, arrhythmia, sudden cardiac death, and
endocrine dysfunction.

The study, which combines data from
the ACTIVATE trial and its subsequent long-term extension (LTE) study, focuses
on the efficacy of mitapivat, an oral allosteric activator of the red blood
cell wildtype and mutant pyruvate kinase enzyme (PKR).

Mitapivat has gained
approval from the US Food and Drug Administration for treating hemolytic anemia
in adults with PK deficiency.

The ACTIVATE trial employed a
double-blind, placebo-controlled design, where patients with PK deficiency and not regularly
receiving transfusions were randomly assigned to receive either mitapivat or a
placebo. Those demonstrating clinical benefit from mitapivat or initially
assigned to the placebo arm were eligible to continue in the LTE study. The LTE
study included patients categorized into the mitapivat-to-mitapivat arm (M/M)
or placebo-to-mitapivat arm (P/M).
The ACTIVATE/LTE
analysis tracked changes over 96 weeks in iron-related markers, including
erythroferrone, soluble transferrin receptor, hepcidin, and liver iron
concentration. Patients with baseline iron overload were assessed for liver iron concentration (LIC) changes.


Findings:


  • Results from the combined analysis of
    both studies, involving 80 patients (M/M=40; P/M=40), underscore the profound
    impact of mitapivat on iron homeostasis and overload.
  • Meaningful improvements were observed
    in markers related to iron regulation, including hepcidin, erythroferrone,
    soluble transferrin receptor (sTfR), and liver iron concentration (LIC).

  • Notably, these improvements were
    sustained over an impressive period of up to 96 weeks of mitapivat treatment.


  • The study revealed that patients in
    the M/M arm experienced early-on improvements within 24 weeks of starting
    mitapivat, whereas minimal changes were observed in the P/M arm during the
    placebo phase.
  • Encouragingly, the P/M arm
    demonstrated similar improvements to the M/M arm after switching to mitapivat
    in the LTE.


  • Furthermore, among patients treated
    with mitapivat, over half (55.1%) initially met the criteria for iron overload
    at baseline.
  • These individuals exhibited clinically
    meaningful and continued improvements in iron overload over time, as evidenced
    by a significant decrease in LIC.

  • This reduction in iron overload is a
    critical finding, as excessive iron accumulation can lead to serious and
    potentially life-threatening complications.


In conclusion, the activation of PKR
with mitapivat emerges as a transformative therapeutic approach, showcasing
meaningful and sustained improvements in iron homeostasis and overload in
patients with PK deficiency. This breakthrough marks mitapivat as the first
disease-modifying pharmacotherapy with proven efficacy against iron overload in
individuals grappling with the challenges of PK deficiency. The results of this
study hold significant promise for enhancing the overall quality of life for
those affected by this rare genetic disorder.

Further reading: van Beers EJ, Al-Samkari H, Grace RF, et al. Mitapivat improves ineffective erythropoiesis and iron overload in adult patients with pyruvate kinase deficiency. Blood Adv. Published online February 8, 2024. doi:10.1182/bloodadvances.2023011743

Powered by WPeMatico