Arunkumar Krishnan, MD, MS’ Post

✳️ Risks of Placebo in IBD Maintenance Trials Recent findings from a meta-analysis shared an important aspect of clinical trials in inflammatory bowel disease (IBD).  While the efficacy of licensed biologics and small molecules in maintaining remission is well-established, the potential harms associated with placebo treatment during these trials deserve closer observation.⚡  🧠 Key Findings: 💠 This systematic review included 45 trials with 16,562 patients and emphasized that receiving a placebo in maintenance trials is not without risks. 💠 Notably, patients receiving active drugs experienced lower rates of any worsening of IBD activity (12.8% vs. 22.8%), withdrawals due to adverse events (5.9% vs. 9.0%), and serious adverse events (10.4% vs. 12.0%) compared to those on placebo. 💠 Conversely, the risks of any infections and drug-related adverse events were found to be higher in the active drug group.   👉 My View: It's important to balance aiming for effectiveness and considering the ethical aspects of trial design. ↗️ The study's results highlight the importance of transparently communicating with patients about the possible adverse effects of receiving a placebo in clinical trials. ↗️ This also highlights the need for meaningful discussions about creating innovative trial structures that reduce risks while generating reliable data on new treatments. ↗️ By providing that patients receive comprehensive information and support, we can promote a more ethical approach to clinical research that prioritizes patient well-being.⚡ #IBD #ClinicalTrials #InflammatoryBowelDisease #Placebo #PatientSafety #ResearchEthics #HealthcareInnovation

I am thrilled to announce the publication of my latest research article, "Molecular Mechanisms and Therapeutic Potential of Natural Flavonoids in Diabetic Nephropathy: Modulation of Intracellular Developmental Signaling Pathways," in the Q1-ranked *Current Research in Pharmacology and Drug Discovery* journal by Elsevier. This study discusses the intricate subcellular mechanisms underlying the pathogenesis of diabetic nephropathy (DN) and highlights the molecular targets of flavonoids in combating this disease. Our findings underscore the critical need for innovative drug discovery approaches, increased clinical trials, and the therapeutic significance of natural compounds in treating DN. I invite you to explore the open-access article here: https://lnkd.in/dSgXiMYR

https://lnkd.in/d68sgi9A PRECAME Study: Preventing cardiovascular effects with metformin in obese patients ( Corpori Sano Biotechnology & Walter LAB, Brasil 🇧🇷 2002 ): " Specific therapy, to live healthily " " Creating a scientific basis for an infinite possibility of future studies and research " " The era of insulin resistance modulators, ability to alter the cellular regulatory circuit " " Drug that modulates mitochondrial, endothelial and DNA-telomere function " " A new therapeutic approach in cardiovascular, metabolic and oncological prevention " " Insulin resistance sensitiizers or modulators: Therapeutic link between human metabolism, cardiovascular system and cancer " " Scientific research that studies the basis of the iceberg of cardiovascular disease " " Through innovative medicines for public health and commited to bringing better health and a better future for patients, translating science and regenerative medicine into medicines that change human lives, as the main objective " " PRECAME Study and Walter's Metabolic Theory, improving the perspective and quality of life of patients " #science #ciencia #health #cardiovascular #insulinresistance #cancer #obesity

👇 𝐓𝐡𝐞𝐬𝐞 𝐀𝐫𝐞 𝐘𝐨𝐮𝐫 𝐓𝐨𝐩 𝟓 𝐍𝐞𝐰𝐬 𝐒𝐭𝐨𝐫𝐢𝐞𝐬 𝐀𝐫𝐨𝐮𝐧𝐝 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐀𝐜𝐭𝐢𝐨𝐧𝐬 𝐚𝐧𝐝 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥𝐬 𝐘𝐨𝐮 𝐍𝐞𝐞𝐝 𝐭𝐨 𝐑𝐞𝐚𝐝 𝐓𝐡𝐢𝐬 𝐖𝐞𝐞𝐤 👇 1️⃣ The FDA has granted breakthrough therapy status to Arrowhead Pharmaceuticals’ plozasiran, an RNA interference drug aimed at reducing triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder. 📰 https://lnkd.in/eM4kGsWX 2️⃣ BIOCAPTIVA has secured its first US patent for a liquid biopsy technology that captures cell-free DNA (cfDNA) from bodily fluids, aimed at improving early disease detection, treatment monitoring, and personalised medicine. 📰 https://lnkd.in/evuPEzBF 3️⃣ Johnson & Johnson’s TREMFYA (guselkumab) has been approved by the FDA for the treatment of moderately to severely active ulcerative colitis (UC). This marks the drug's third FDA approval, following earlier approvals for plaque psoriasis and psoriatic arthritis. 📰 https://lnkd.in/ek8KjTVY 4️⃣ The FDA has granted breakthrough therapy designation to Neuraptive Therapeutics' NTX-001 for treating peripheral nerve injury requiring repair. This designation was awarded following promising results from the Phase II NEUROFUSE study. 📰 https://lnkd.in/deFA4Hvb 5️⃣ Scotland has become the first UK nation to approve Tecvayli (teclistamab) for patients with relapsed and refractory multiple myeloma (RRMM). This approval by the Scottish Medicines Consortium offers new hope for patients who have exhausted other treatment options. 📰 https://lnkd.in/eCEg98tw #RegulatoryActionsAndApprovals | #LifeSciences | #NewsRoundUp

📃Scientific paper: Pathophysiological Mechanisms Involved in Overactive Bladder/Detrusor Overactivity Abstract: Purpose of Review To examine the latest published findings on the pathophysiological mechanisms involved in the development of overactive bladder (OAB) and detrusor overactivity (DO), and to identify common pathways linked to the risk factors associated with these conditions. Recent Findings Evidence is accumulating, both clinical and experimental, that many of the factors linked to the development of OAB/DO, including ageing, bladder outlet obstruction, psychological stress, and obesity are associated with reduced bladder blood flow. This induces local tissue inflammation with cytokine release and enhanced oxidative stress, ultimately resulting in altered detrusor sensitivity, detrusor hypertrophy and fibrosis, together with afferent hypersensitivity. These mechanisms would explain the symptoms of urgency and frequency observed in OAB patients. Although not a characteristic of OAB, undetected low level bacterial infections of the bladder have been proposed to explain the OAB symptoms in patients resistant to standard treatments. In this condition, inflammatory responses without reductions in perfusion activate the inflammatory pathways. Summary Evidence is mounting that poor bladder perfusion and local inflammatory responses are central mechanisms involved in the development of OAB/DO. As our understanding of these pathophysiological mechanisms advances, new avenues for drug development will be identified and ultimately treatment may become more individualized depen... Continued on ES/IODE ➡️ https://etcse.fr/8Qjul ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.

https://lnkd.in/dhUmBZcN PRECAME Study: Preventing cardiovascular effects with metformin in obese patients ( Corpori Sano Biotechnology & Walter LAB, Brazil 🇧🇷 2002 ): " Creating a scientific basis for an infinite possibility of future studies and research " " Specific therapy, to live healthily " " The era of insulin resistance modulators, ability to alter the cellular regulatory circuit " " Drug that modulates mitochondrial, endothelial and DNA-telomere function " " Scientific research that studies the basis of the iceberg of cardiovascular disease " " A new therapeutic approach in cardiovascular, metabolic and oncological prevention " " Insulin resistance sensitiizers or modulators: Therapeutic link between human metabolism, cardiovascular system and cancer " " Through innovative medicines for public health and commited to bringing better health and a better future for patients, translating science and regenerative medicine into medicines that change human lives, as the main objective " " PRECAME Study and Walter's Metabolic Theory, improving the perspective and quality of life of patients " #science #research #medicine #innovation #clinicalresearch #healthcare #genetherapy #populationhealth #digitalhealth #hypertension #diabetescare #obesity #cancer #heartattack #cardiovascularhealth #lifescience #diabetes #cardiovascular #industry #industriafarmaceutica #immunology #atherosclerosis #immunology #pharmaceutical #clinicaltrials #endocrinology #clinicalresearch #healthcare

# MyastheniaGravis (MG) is a B-cell mediated autoimmune disease that destroys the neuromuscular junction where muscles and nerves meet. It is characterized by profound muscle weakness throughout the body, resulting in motor impairment, disabling fatigue, shortness of breath due to respiratory muscle weakness and episodes of respiratory failure. Approximately 65,000 to 70,000 patients in the United States are affected by this disease. GD3 provides a full spectrum of preclinical and clinical services to support the development of therapies for immune-mediated diseases, including Myasthenia Gravis (MG). Leveraging our extensive expertise and state-of-the-art facilities, we are committed to advancing new treatments for MG by offering comprehensive service and support for chemistry, non-GLP discovery and efficacy, IND enabling, and NDA enabling studies. 👉🏼 Supporting capabilities and areas of expertise include chemistry, lead optimization, in vitro ADME assays, analysis of biomarkers, custom in vitro assay development, bioanalytical studies, rapid screening methods, bioavailability/bioequivalence, large and small animal PK/PD, disease modeling, toxicology, histopathology, and clinical study support. Innovative end-to-end support for your clinical trial needs include study design, regulatory, project management, data management, clinical monitoring, medical monitoring, safety review / pharmacovigilance, biostatistical expertise, and medical writing. 🌎 Extensive worldwide clinical trial experience with >100 neurology studies, >100 studies on autoimmune disorders, 65 ophthalmology studies to name a few. 🏟 Extensive global network of academic & community-based ophthalmology sites with available performance metrics. 🔑 DISC Gold Member: SDTM/ADaM expertise 👋 Connect with one of GD3's experts to learn more about how we can provide innovative support to advance the success of your program. https://lnkd.in/ezTBzjzk

# MyastheniaGravis (MG) is a B-cell mediated autoimmune disease that destroys the neuromuscular junction where muscles and nerves meet. It is characterized by profound muscle weakness throughout the body, resulting in motor impairment, disabling fatigue, shortness of breath due to respiratory muscle weakness and episodes of respiratory failure. Approximately 65,000 to 70,000 patients in the United States are affected by this disease. GD3 provides a full spectrum of preclinical and clinical services to support the development of therapies for immune-mediated diseases, including Myasthenia Gravis (MG). Leveraging our extensive expertise and state-of-the-art facilities, we are committed to advancing new treatments for MG by offering comprehensive service and support for chemistry, non-GLP discovery and efficacy, IND enabling, and NDA enabling studies. 👉🏼 Supporting capabilities and areas of expertise include chemistry, lead optimization, in vitro ADME assays, analysis of biomarkers, custom in vitro assay development, bioanalytical studies, rapid screening methods, bioavailability/bioequivalence, large and small animal PK/PD, disease modeling, toxicology, histopathology, and clinical study support. Innovative end-to-end support for your clinical trial needs include study design, regulatory, project management, data management, clinical monitoring, medical monitoring, safety review / pharmacovigilance, biostatistical expertise, and medical writing. 🌎 Extensive worldwide clinical trial experience with >100 neurology studies, >100 studies on autoimmune disorders, 65 ophthalmology studies to name a few. 🏟 Extensive global network of academic & community-based ophthalmology sites with available performance metrics. 🔑 DISC Gold Member: SDTM/ADaM expertise 👋 Connect with one of GD3's experts to learn more about how we can provide innovative support to advance the success of your program. https://lnkd.in/ezTBzjzk

Eli Lilly and Company's recent data on its Alzheimer's drug Kisunla highlights how modifying the dosing regimen can significantly reduce brain swelling (ARIA-E) events, showing a 41% reduction in patients on an altered schedule. This important finding may lead to a label change, potentially easing concerns for prescribers and patients alike. The phase 3 TRAILBLAZER-ALZ study underscores the impact of personalized dosing, especially for patients with the APOE4 genetic variant, who saw a remarkable 67% reduction in ARIA-E risk with the modified regimen. Such insights are crucial as we work toward safer, more effective Alzheimer’s treatments. • Points to consider:   - Could dosing personalization become standard practice for Alzheimer’s treatments, and how might it impact prescribing?   - What additional steps should be taken to ensure patient safety in trials for neurodegenerative therapies?   - How can transparency about genetic risks in clinical trials improve patient trust and outcomes? These results mark a promising direction in balancing efficacy and safety in Alzheimer’s care, opening doors to a more refined approach in disease-modifying therapies. #AlzheimersResearch #NeurodegenerativeDiseases #EliLilly #ClinicalTrials #PatientSafety #PrecisionMedicine #FDAApproval #DrugDevelopment #HealthcareInnovation #BrainHealth

Your DNA and MS treatment: New personalized medicine options Multiple Sclerosis (MS) is a complex autoimmune condition with various treatment options available. This article reviews the current medications for MS and discusses the roles of genetic testing and clinical pharmacy services in optimizing treatment for each individual. https://lnkd.in/ghnUGncD