Add on E cigarettes to standard smoking-cessation counseling may lead to higher rates of tobacco abstinence: NEJM

Electronic nicotine-delivery systems, commonly known as e-cigarettes, have gained popularity as a potential aid for tobacco smokers attempting to quit. However, evidence on their efficacy and safety remains crucial. A recent study published in The New England Journal Of Medicine by Reto Auer and colleagues sheds light on this.

In an open-label, controlled trial, adults smoking at least five tobacco cigarettes per day were randomly assigned to either an intervention group, receiving free e-cigarettes, e-liquids, and smoking-cessation counseling, or a control group, receiving standard counseling and a voucher. The primary outcome was biochemically validated continuous abstinence from smoking at 6 months.

The key findings of the study were:

  • 1246 participants were randomized, with 622 in the intervention group and 624 in the control group.

  • Validated continuous abstinence from tobacco smoking at 6 months was 28.9% in the intervention group and 16.3% in the control group.

  • Abstinence from smoking in the 7 days before the 6-month visit was 59.6% in the intervention group and 38.5% in the control group.

  • Serious adverse events occurred in 4.0% of the intervention group and 5.0% of the control group.

The addition of e-cigarettes to standard smoking-cessation counseling led to higher rates of tobacco abstinence compared to counseling alone. This suggests that e-cigarettes may be a beneficial tool in smoking cessation efforts.

Reference:

Auer, R., Schoeni, A., Humair, J.-P., Jacot-Sadowski, I., Berlin, I., Stuber, M. J., Haller, M. L., Tango, R. C., Frei, A., Strassmann, A., Bruggmann, P., Baty, F., Brutsche, M., Tal, K., Baggio, S., Jakob, J., Sambiagio, N., Hopf, N. B., Feller, M., … Berthet, A. Electronic nicotine-delivery systems for smoking cessation. The New England Journal of Medicine,2024;390(7):601–610. https://doi.org/10.1056/nejmoa2308815

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Azelnidipine Demonstrates Efficacy in Lowering BP in Indian Patients with Hypertension: Study

Hypertension (HTN) is a prevalent cardiovascular condition with significant morbidity and mortality worldwide. Azelnidipine, a selective calcium channel blocker, has shown promise in lowering blood pressure (BP) in hypertensive patients. Azelnidipine is known for its potent antihypertensive effects and has been widely used in the management of mild to moderate hypertension. However, its effectiveness in Indian patients has not been extensively studied.

A recent retrospective real-world evidence (RWE) study conducted in Indian patients aimed to evaluate the efficacy of azelnidipine in this population.This study was published in the Journal Of Association Of Physicians Of India by Chetan Shah and colleagues. The retrospective cohort study included 882 Indian patients aged 18 years or older with mild to moderate hypertension who had been on azelnidipine treatment for the last 3 months.

Data were collected on changes in systolic and diastolic BP from baseline to subsequent visits (4 and 12 weeks), as well as the proportion of patients achieving target BP levels.The key findings of the study were:

  • Mean reduction in systolic/diastolic BP from baseline to 12 weeks: 13.92/7.91 mm Hg (p < 0.0001)

  • Mean reduction in systolic/diastolic BP in newly diagnosed HTN patients: 11.77/7.43 mm Hg (p < 0.0001)

  • Mean reduction in systolic/diastolic BP in known cases of HTN: 16.50/8.48 mm Hg (p < 0.0001)

  • Mean reduction in systolic/diastolic BP in diabetic patients: 15.35/8.69 mm Hg (p < 0.0001)

  • Proportion of patients achieving target BP of <130/80 mm Hg: 4.99%

  • Proportion of patients achieving target BP of <140/90 mm Hg: 46.26%

  • Mean change in heart rate (HR) from baseline: reduction of 5.22 beats/minute

The study findings suggest that azelnidipine is effective in lowering BP and HR in Indian patients with mild to moderate hypertension. With significant reductions observed in BP and HR, azelnidipine demonstrates potential as an effective antihypertensive drug in this population. These results highlight the importance of considering azelnidipine as a treatment option for hypertension management in Indian patients.

Reference:

Shah C, Tiwaskar M, Pakhale K, et al. A Retrospective Study to Evaluate Real-world Evidence of Azelnidipine in Indian Patients (REDEFINE Study). J Assoc Physicians India 2024;72(1):22–26. https://www.japi.org/y274a4a4/a-retrospective-study-to-evaluate-real-world-evidence-of-azelnidipine-in-indian-patients-redefine-study

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Crisaborole may improve signs and symptoms of Stasis Dermatitis,reveals study

Stasis Dermatitis (SD) is often associated with poor venous circulation and can lead to complications such as skin ulcers and infection. Treatment options for SD are limited, and there is a need for effective and well-tolerated therapies. Crisaborole’s anti-inflammatory properties make it a potential candidate for the management of SD.

Stasis dermatitis (SD) is a common inflammatory skin condition affecting individuals aged 45 years and older, characterized by itching, redness, and swelling. Crisaborole ointment, 2%, a nonsteroidal topical phosphodiesterase 4 inhibitor, has been approved for the treatment of mild-to-moderate atopic dermatitis.

A recent phase 2a study aimed to assess the efficacy and safety of crisaborole in patients with SD. This study was published in the Journal Of The American Academy Of Dermatology by Jonathan I. and colleagues. The randomized, double-blind, vehicle-controlled study enrolled 65 participants with SD without active ulceration. Patients received either crisaborole or vehicle ointment twice daily for 6 weeks. The primary endpoint was the percentage change from baseline in total sign score at week 6, assessed by in-person and central reader evaluations.

The key findings of the study were:

  • Crisaborole-treated participants showed a significant reduction in total sign score from baseline compared to the vehicle group.

  • In-person assessment by nondermatologists demonstrated a reduction of 32.4% in the crisaborole group versus 18.1% in the vehicle group (P = .0299).

  • Central reader assessment of photographs showed an even greater reduction of 52.5% versus 10.3% (P = .0004).

  • Efficacy outcomes, including success and improvement per Investigator’s Global Assessment score and lesional percentage body surface area, reached statistical significance based on central reader assessments but not in-person evaluations.

  • Skin and subcutaneous tissue disorders were the most common treatment-emergent adverse events with crisaborole, indicating that the treatment was generally well tolerated.

Crisaborole ointment, 2%, demonstrated efficacy in improving signs and symptoms of SD in patients aged 45 years and older. The study findings support the use of crisaborole as a potential treatment option for SD. Central reader assessment showed promise as a method for evaluating treatment efficacy in decentralized clinical research settings.

Reference:

Silverberg, J. I., Kirsner, R. S., Margolis, D. J., Tharp, M., Myers, D. E., Annis, K., Graham, D., Zang, C., Vlahos, B. L., & Sanders, P. Efficacy and safety of crisaborole ointment, 2%, in participants aged ≥45 years with stasis dermatitis: Results from a fully decentralized, randomized, proof-of-concept phase 2a study. Journal of the American Academy of Dermatology,2024. https://doi.org/10.1016/j.jaad.2023.12.048

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Silk fibroin wound dressing significantly reduces incidence of wound healing complications after surgery

Silk fibroin wound dressing significantly reduces the incidence of wound healing complications after surgery suggests a new study published in the Plastic Reconstructive Surgery.

Silk fibroin is an emerging biomaterial with enhanced properties of cellular regeneration, growth and proliferation. The use of a silk fibroin wound dressing has the potential to decrease the incidence of wound healing complications and to improve patient outcomes compared to synthetic dressing alternatives. A prospective, randomized, single-blinded clinical trial was conducted on 50 patients who were dressed with a silk fibroin dressing on one side of their body and on the contralateral side with 3M Steri-Strips® after undergoing abdominoplasty, reduction mammaplasty, or Brachioplasty procedures. Data was collected over 5 postoperative visits using photographs and an investigator-administered questionnaire to monitor erythema, skin irritation, skin discomfort, the need for pharmaceutical intervention, wound dehiscence and mechanical skin injury. A comprehensive 75-patient statistical analysis was conducted combining the results with a previously published study comparing Dermabond® Prineo® to the silk dressing. Results: 20.8% (10/48) of patients were assessed by surgeons as having skin erythema (7-10) on the Steri-Strip® control side and 0% (0/48) on the silk dressing side (p=0.002). The frequency of breast triple point separation in 43 cases was 30.2% (13/43) on the Steri-Strip® side and 9.3% (4/43) on the silk side (p=0.012). 75% (36/48) of patients had a partial or total detachment of Steri-Strips® while 0% (0/48) had a total detachment of the silk dressing and 18.8% (9/48) had a partial detachment of the silk dressing within the first two weeks (p<0.001). A silk fibroin wound dressing significantly reduces the incidence of wound healing complications throughout the postoperative period. Clinical Relevance Statement: The adoption of a silk fibroin wound dressing into clinical practice has the potential to improve patient outcomes, decrease medical adhesive-related skin injuries and reduce the rate of wound healing complications.

Reference:

Rouhani DS, Singh NK, Chao JJ, Almutairi A, Seradj MH, Badowski-Platz R, Toranto JD, Mofid MM. Superiority of a Silk Surgical Site Wound Closure Device Over Synthetic Dressings. Plast Reconstr Surg. 2024 Feb 7. doi: 10.1097/PRS.0000000000011316. Epub ahead of print. PMID: 38330504.

Keywords:

Silk fibroin, wound dressing, incidence, wound healing, complications, surgery, Rouhani DS, Singh NK, Chao JJ, Almutairi A, Seradj MH, Badowski-Platz R, Toranto JD, Mofid MM, Plastic Reconstructive Surgery

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Current strategies and forthcoming evidence for targeting the host response in sepsis

Immunomodulatory Treatments in Sepsis

Recently published research paper discusses the challenges and advancements in sepsis treatment, focusing on the varied immune responses of sepsis patients and the potential for precision immunotherapy to improve outcomes. It highlights the dysregulated host response to infection in sepsis and emphasizes the need to identify responders to specific immune interventions. The paper presents various immunomodulatory treatments, such as targeting tumor necrosis factor (TNF), interleukin-1 (IL-1) signaling, and IL-6, and discusses their effects on sepsis patients. It also covers the potential of targeting the complement system, glucocorticoids, antibiotics with anti-inflammatory properties, and other immunomodulatory agents in sepsis treatment. Additionally, the paper explores the role of immunostimulatory cytokines and growth factors, mesenchymal stem cells, immune checkpoint inhibitors, and extracorporeal strategies in modulating the host response to sepsis.

Precision Medicine Approaches in Sepsis

The paper emphasizes the complexity and heterogeneity of sepsis, underscoring the need for precision medicine approaches. It discusses the importance of identifying subphenotypes and endotypes in sepsis patients using biomarkers, immunophenotyping, transcriptomics, proteomics, and metabolomics, and highlights the potential for predictive enrichment to tailor targeted treatments. Furthermore, the paper addresses the role of the microbiome, host metabolism, organ dysfunction, and disease tolerance in shaping the response to infection in sepsis. It underscores the significance of understanding patients’ immunologic and metabolic status pre-sepsis to reveal risk factors and targets for immune modulation.

Future Perspectives in Precision Immunotherapy

The paper also outlines the future perspectives in the field of precision immunotherapy, the need for improved monitoring tools, and the potential for computational tools like artificial intelligence and machine learning to uncover new treatable traits. It further discusses the challenge of organizing clinical trials and emphasizes the importance of investigating organ dysfunction and finding better ways to understand host responses in sepsis patients. The overall focus is on personalizing and monitoring therapies to improve disease tolerance and modulate immunity in individual septic patients.

Refrence –

Bode, C., Weis, S., Sauer, A. et al. Targeting the host response in sepsis: current approaches and future evidence. Crit Care 27, 478 (2023). https://doi.org/10.1186/s13054-023-04762-6.

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Sun Pharma Gets CDSCO Panel Nod to Study Tildrakizumab Injection 100 mg/ ml

New Delhi: The drug major Sun Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of Tildrakizumab injection, a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders.

This came after the drug major Sun Pharma presented phase 3 clinical study protocol no. TILD-21.01, amendment 2 dated 9th November 2023.

Tildrakizumab is a high-affinity, humanized, IgG1 κ antibody targeting interleukin 23 p19 that shows promise in the evolution of treatment strategy in chronic plaque psoriasis.

This drug selectively binds interleukin (IL)-23 p19 subunit of cytokine IL-23 and neutralizes its function IL-23 regulates Th17 cells and is a powerful activator of keratinocyte proliferation. Targeting IL-23p19 alone is a promising treatment approach in patients with moderate-to-severe chronic plaque psoriasis. Upon administration, downregulation of Th17 and Th22 cell responses occurs.

IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.

At the recent SEC meeting for Analgesic and Rheumatology held on the 6th of February 2024, the expert panel reviewed the Phase III clinical study of the drug Tildtildrakizumab injection.

After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.

Also Read:Indiscreet prescribing of antibiotics is key contributor to microbial resistance nationwide: MoS Health

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Making mathematical models to study fentanyl and morphine pharmacokinetics

Pain is an unpleasant feeling that includes emotional and physical aspects. It may be connected to an injury or the risk of becoming hurt. On the other hand, analgesia is the relief of pain by a variety of pharmaceutical and non-pharmacological techniques, depending on the kind and degree of the pain. Pharmacokinetics is the study of how a drug moves through the body when it is administered and ends with excretion. Pharmacokinetics often uses compartmental modelling to describe how medications travel through the body and are eliminated. Recently published research examined many mathematical model types to comprehend medication pharmacokinetics. On the drug kinetics, the impact of starting concentration and rate constants was examined. The effectiveness and long-term effects of morphine and fentanyl on the human body were investigated using models specifically designed for these drugs.

Drug distribution, transition, and concentration in the bodily compartments were theoretically analysed using non-linear ordinary differential equations and numerical analytic approaches. A computer application called MATLAB, version 2023a from Math Works, Inc. was used to characterise how the drug’s kinetics were affected by beginning concentration and rate constants. Pharmacokinetic parameters were plotted to determine a specific therapeutic concentration of fentanyl and morphine in blood.

The study’s findings demonstrated how long it takes for morphine and fentanyl to accumulate to a point in the bloodstream where they may provide the desired therapeutic effects. The pharmacokinetics of fentanyl and morphine were compared mathematically, and the results indicated that fentanyl was metabolised and excreted from the body more quickly (44 minutes sooner than morphine) and reached the target therapeutic concentration 125 minutes earlier.

Several mathematical models were used in this work to describe the behaviour of drugs within the human body. The pharmacokinetics of morphine and fentanyl were plotted with the use of compartment modelling; it was discovered that fentanyl took less time to reach the goal therapeutic threshold established in the blood. Fentanyl exited the body sooner than morphine. In order to define medication interactions inside the human body, optimise dosage schedules, forecast drug effects, and plan clinical trials, pharmacokinetic models are essential. These mathematical models improve our knowledge of how medications affect various targets and pathways by predicting and quantifying drug-drug interactions caused by one drug changing the effects of another. Nevertheless, by dividing the human body into two compartments, these models are limited to the bolus administration of the medication.

Reference –

Shenoy, Prathvi; Rao, Mahadev1; Chokkadi, Shreesha2; Bhatnagar, Sushma3; Salins, Naveen4. Developing mathematical models to compare and analyse the pharmacokinetics of morphine and fentanyl. Indian Journal of Anaesthesia 68(1):p 111-117, January 2024. | DOI: 10.4103/ija.ija_1036_23

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Incorporate AETCOM in NEET, MBBS curriculum: Parliamentary Panel

New Delhi: Highlighting the role of the Attitudes, Ethics, and Communication (AETCOM) module in cultivating the right attitude, ethics and communication skills among medical students, a Parliamentary Health Committee has suggested that the module should be made part of the MBBS curriculum. Further, the panel has suggested incorporating these criteria in the National Eligibility-cum-Entrance Test (NEET) as well to assess the aptitude of aspiring medical students.

The panel opined that such aptitude tests at the entrance level not only assess the knowledge of the aspirants but also evaluate the genuine interest and passion of the candidate for the field of medicine.

“It will enable the system to identify candidates who have a sincere calling for the profession and distinguish them from those who may be under external pressure or legacy expectations. By doing so, we can ensure that medical work continues to attract individuals who are genuinely committed to delivering high-quality healthcare,” opined the Department-related Parliamentary Standing Committee on Health an d Family Welfare in its One Hundred Fifty-Seventh report.

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.

Referring to the new UG curriculum the panel observed that the new curriculum aims to help students transition from acquiring knowledge to acquiring practical skills. It further noted that achieving this shift depends on aligning and integrating various disciplines.

The committee observed in its report that the key elements of the revised curriculum include foundational courses (FC), early exposure to clinical practice (ECE), training in attitudes, ethics and communication (AETCOM), elective opportunities, and alignment and integration of different areas of study. Additionally, the curriculum promotes electives, self-directed learning, problem-based learning, structured feedback, and maintaining a logbook, the panel noted.

At this outset, the committee acknowledged the critical elements introduced in the new curriculum to help students acquire practical skills and strongly recommended implementing AETCOM module within the MBBS curriculum.

“The Committee strongly recommends the rigorous and comprehensive implementation of the AETCOM module within the MBBS curriculum. This module is paramount as it is pivotal in cultivating the right attitude, ethics, and communication skills among medical students. Patient care is not solely about clinical knowledge and technical skills; it hinges on empathy, compassion, and effective communication. By instilling these qualities in future healthcare professionals, we can significantly enhance the overall quality of patient care. Therefore, the Committee recommends the Government ensure that the AETCOM module is enforced consistently and effectively to empower medical students with the essential attributes needed to provide holistic and patient centered healthcare,” recommended the panel.

Apart from implementing AETCOM in the MBBS curriculum, the panel further advised incorporating these criteria in NEET as well to assess the aptitude of the aspiring medical students.

It mentioned in the report, “In addition to the implementation of AETCOM, the Committee recommends the incorporation of these criteria in NEET so that the aptitude of aspiring medical students can be assessed. Such aptitude tests at the entrance level go beyond mere knowledge assessment of aspirants, often obtained through rote learning and mastering MCQ-based exams, and evaluate the genuine interest and passion of the candidate for the field of medicine. It will enable the system to identify candidates who have a sincere calling for the profession and distinguish them from those who may be under external pressure or legacy expectations. By doing so, we can ensure that medical work continues to attract individuals who are genuinely committed to delivering high-quality healthcare.”

Also Read: Multiple registrations of doctors with various State Medical Councils makes tracking difficult, Parliamentary Panel gives recommendations

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Navi Mumbai doctor, associate cheat farmer of Rs 25000 with job promise

Thane: The Navi Mumbai doctor and his associate have been booked for allegedly a 32-year-old farmer of Rs 25,000 by making a false promise to get him a job in the Indian Railways.

The victim, hailing from Jalgaon in Maharashtra, allegedly paid Rs 25,000 to the doctor at his clinic in the Belapur area of Navi Mumbai on November 28, 2023, the official from CBD police station said on Thursday.

Also Read:Lucknow doctor alleges dowry harassment by husband, in-laws; FIR lodged

The farmer claimed he was promised the job of an announcer in the Railways and a fake appointment letter was provided to him after he paid the money.

He filed a complaint with the Government Railway Police at Igatpuri station.

The complaint was transferred to the CBD police station, where a case was registered against the doctor and his associate on Wednesday under Indian Penal Code sections 420 (cheating), 465 (forgery) and 34 (common intention), the official said.

Also Read:Navi Mumbai doctor allegedly demands 20 lakh dowry, FIR lodged

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PM Modi lays down foundation stone for AIIMS in Rewari

PM Modi to inaugurate six new All India Institutes of Medical Sciences (AIIMS) next week, complementing the initiation of AIIMS in Rewari, Haryana. Prime Minister Narendra Modi laid down the foundation stone for AIIMS Rewari today marking a significant development in healthcare infrastructure. The project, with an estimated cost of Rs 1650 crore, will feature a comprehensive hospital complex offering 720 beds, a medical college with 100 seats, a nursing college with 60 seats, and an AYUSH Block with 30 beds.

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