Internal Medicine in the Era of the Fourth Industrial Revolution 4IR

On October 28, 2022, American College of Physicians celebrates the #NationalInternalMedicineDay.

As an internist, I would like to celebrate this day through the 14th Newsletter of?@Healthcare Present & Future.

National Internal Medicine Day was established in 2019 by the National Day Calendar and the?American College of Physicians?(ACP) to recognize the contributions of internal medicine physicians who are united by a commitment to excellence around the globe. Representing approximately 160,000 Internal Medicine Physicians, the ACP consists of internal medicine specialists, subspecialists, and medical students. In fact, the organization is the largest medical-specialty society in the world, and its mission is to enhance the quality and effectiveness of health care by fostering excellence and professionalism in the practice of Medicine.

Internal Medicine Physicians, also known as internists, are the cornerstone of comprehensive health care. They are experts in complexity who see every connection in the adult human body. They serve and lead in a variety of settings. Their expertise is vital to patients, medical professionals, and health care.

Innovations in Internal Medicine:

1.?????AI for Early Detection of Sepsis

·??????Sepsis is a severe inflammatory response to infection and a leading cause of hospitalization and death worldwide.

·??????Because of its very high mortality rate, early diagnosis of sepsis is critical.

·??????Diagnosis can be complicated because early symptoms are common across other conditions, and the current standard for diagnosis is non-specific.

·??????#Artificial intelligence (#AI) has surfaced as a new tool that can help rapidly detect sepsis.

·??????Using AI algorithms, the tool detects several key risk factors in real time by monitoring patients' electronic medical records as physicians input information.

·??????Flagging high-risk patients can help facilitate early intervention, which can improve outcomes, lower healthcare costs and save lives.

2.?????Implantable for Severe Paralysis:

·???????Recently, a team has offered new hope for these patients by leveraging implanted brain-computer interface technology to recover lost motor control and enable patients to control digital devices.

·???????The technology uses implanted electrodes to collect movement signals from the brain and decode them into movement commands. It has been shown to restore voluntary motor impulses in patients with severe paralysis due to brain, spinal cord, peripheral nerve or muscle dysfunction.

·???????While the interface technology is in its infancy, the FDA has designated the implantable a "breakthrough device," reinforcing the need to move this technology to the bedside of patients who need it most.

3.?????Non-Hormonal Alternatives for Menopause

·???????While effective and safe when used appropriately, hormone therapy involves some risk and not all patients are appropriate candidates or ready to try this treatment option.

·???????Fortunately, a new group of non-hormonal drugs, called NK3R antagonists, have emerged as a viable alternative to hormone therapy.

·???????These drugs disrupt a signaling pathway in the brain that has been linked to the development of hot flashes and have shown promise in clinical trials for relieving moderate to severe menopausal hot flashes as effectively as hormones.

·???????While additional studies are needed to fully understand the effectiveness and safety of these new drugs, it is clear that the next generation of non-hormonal treatments for menopausal hot flashes is on the horizon.

4.?????New Treatment for the Reduction of LDL

·???????High levels of blood cholesterol, particularly low-density lipoproteins (LDL-C), are known to be a significant contributor to cardiovascular disease.

·???????In 2019, the FDA reviewed the application for inclisiran in treating primary hyperlipidemia in adults who have elevated LDL-C while on a maximally tolerated dose of statin therapy. Inclisiran is an injectable small interfering RNA that targets the PCSK9 protein.

·???????In contrast to statins, it requires infrequent dosing (twice per year) and provides effective and sustained LDL-C reduction in conjunction along with statins. Its prolonged effect may help alleviate medication non-compliance, one of the leading causes of failure to lower cholesterol levels.

·???????Inclisiran was FDA-approved in December 2021 and is widely considered a game-changer for heart disease patients

Inclisiran (Leqvio?; Novartis) is?a first-in-class, cholesterol-lowering small interfering RNA (siRNA) conjugated to triantennary N-acetylgalactosamine carbohydrates (GalNAc)

5.?????Novel Drug for Treatment of Type 2 Diabetes

·???????One potential therapy is a once-weekly injectable dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide receptor agonist (GLP-1) that aims to control blood sugar. Injected under the skin, GLP-1 and GIP receptors cause the pancreas to release insulin and block the hormone glucagon, limiting blood sugar spikes after a meal. Additionally, it slows digestion, resulting in individuals remaining full longer and eating less. Thus far, late phase III clinical trials reveal that the treatment significantly reduces hemoglobin A1C in type 2 diabetes and supports weight loss, making it potentially the most effective therapy for diabetes and obesity yet developed.

·???????Imeglimin (IMEG) is the first drug of the "glimin" group. Glimin is a new group of hypoglycaemic drugs for the treatment of patients with type 2 diabetes mellitus (T2DM). Imeglimin is unique and different in action compared to other hypoglycaemic drugs. Imeglimin has been shown to have a beneficial effect on 3 key pathogenetic elements of T2DM, i.e.,

1. increased gluconeogenesis,

2. inadequate glucose-induced insulin secretion by beta cells,

3. peripheral insulin resistance.?

(Nowak M, Grzeszczak W. Imeglimin: a new antidiabetic drug with potential future in the treatment of patients with type 2 diabetes.?Endokrynol Pol. 2022;73(2):361-370. doi:10.5603/EP.a2022.0014 )

·???????On May 13, 2022, the U.S. Food and Drug Administration approved Mounjaro (Tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies.?

Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones involved in blood sugar control. Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control. Mounjaro is administered by injection under the skin once weekly, with the dose adjusted as tolerated to meet blood sugar goals.?

Three different doses of Mounjaro (5 milligrams, 10 milligrams and 15 milligrams) were evaluated in five clinical trials as either a stand-alone therapy or as an add-on to other diabetes medicines. The efficacy of Mounjaro was compared to placebo, a GLP-1 receptor agonist (semaglutide) and two long-acting insulin analogs.

(https://www.fda.gov/news-events/press-announcements/fda-approves-novel-dual-targeted-treatment-type-2-diabetes)

6.?????Predictive Analytics and Hypertension

·???????Often referred to as the "silent killer," hypertension or high blood pressure usually shows no symptoms while increasing the risk for serious health problems, including heart disease, heart failure, and stroke.

·???????Effective treatment options exist; however, many adults remain unaware that they have hypertension until they experience a significant health crisis.

·???????Using #machine learning (#ML), a type of #artificialintelligence (#AI), physicians are able to better select more effective medications, medication combinations, and dosages to improve control of hypertension.

·???????#AI also will allow physicians to predict cardiovascular morbidities and enable physicians to focus on interventions before they occur. #Predictiveanalytics equip providers with the key that could open the door to preventing hypertension and many other diseases.

7.?????Targeted Medication for Hypertrophic Cardiomyopathy

·???????For decades, clinicians have only been able to treat patients' hypertrophic cardiomyopathy(HCM) symptoms—using drugs developed to treat other heart conditions—with limited effectiveness.

·???????Currently, non-specific medications are prescribed to treat some of the symptoms that HCM shares with other cardiovascular diseases. These therapies include beta-blockers, anti-arrhythmic drugs, calcium channel blockers, and anticoagulants.

·???????A new treatment, however, works to reduce the root cause of the problem in many patients. A first-in-class medication specifically targets heart muscle to reduce abnormal contractions caused by genetic variants that put the heart into overdrive.

·???????By acting specifically on this mechanism in HCM patients, this novel treatment not only improves symptoms and quality of life but potentially could slow disease progression. It is the first medication explicitly dedicated to treating HCM and providing new hope to patients and physicians.

·???????On April 28 28, 2022, U.S. Food and Drug Administration approved Camzyos? (mavacamten), the first and only cardiac myosin inhibitor, for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms.

(https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-Approves-Camzyos-mavacamten-for-the-Treatment-of-Adults-With-Symptomatic-New-York-Heart-Association-Class-II-III-ObstructiveHypertrophic-Cardiomyopathy-HCM-to-Improve-Functional-Capacity-and-Symptoms/default.aspx)

·???????On 21st ?OCTOBER 2022, U.S. Food and Drug Administration (FDA) accepts Supplemental New Drug Application for CAMZYOS? (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy to Reduce the Need for Septal Reduction Therapy

(https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-FDA-Accepts-Supplemental-New-Drug-Application-for-CAMZYOS-mavacamten-in-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-to-Reduce-the-Need-for-Septal-Reduction-Therapy/default.aspx?linkId=186504191 )

8.?????Remote Cardiac Monitoring in Patients With Heart Failure

Remote cardiac monitoring is a promising approach to detect worsening heart failure early and intervene prior to an overt decompensation.

( Kennel PJ, Rosenblum H, Axsom KM, et al. Remote Cardiac Monitoring in Patients With Heart Failure: A Review.?JAMA Cardiol. 2022;7(5):556-564. doi:10.1001/jamacardio.2021.5090)

9.?????Innovations in the management of stroke:

On October 29, 2022, we celebrated the #WorldStrokeDay, an opportunity to highlight new advances in this disease management

·???????New technology providing good vibrations for stroke patients:

A new prototype device that delivers barely perceptible vibrations to the fingertips has led to improvements of between 20% – 40% in patients who have lost their sense of touch following an ischemic stroke.

(https://www.bioworld.com/topics/85-bioworld-medtech)

·???????Stroke suite dvekopment:

Medical imaging specialist?Avicenna.AI?announced a groundbreaking partnership with the MedTech company?deepc, offering one of the leading?radiology AI?platforms (deepcOS), to give healthcare providers access to their?stroke suite. This move facilitates a step change in patient management for?stroke, enabling rapid treatment decisions by combining a uniquely comprehensive stroke management technology with a platform that seamlessly integrates into radiologist’s clinical workflow.

Avicenna.AI’s CINA stroke suite provides a full range of tools powered by deep learning to automatically identify acute abnormalities and support the emergency imaging department. It comprises two FDA-cleared, CE-marked tools for automatic triage, and one CE-marked quantification tool:?

·???????CINA-LVO?is a triage tool that instantly flags suspected Large Vessel Occlusion (LVO) on CT angiography. Given that every minute of untreated LVO means two million neurons are lost, early diagnosis is critical.?

·???????Real-time trial tool CINA-ICH highlights suspected acute Intracranial Hemorrhage (ICH) on CT scans, efficiently prioritizing cases, drastically reducing the time to treatment. ICH affects over two million people worldwide with a 40-50%?mortality rate?within one month, so accurate early detection and treatment are vital.?

·???????CINA-ASPECTS is a quantification tool that automatically measures an ASPECT Score to assess ischemic changes in stroke. CINA-ASPECTS enables faster, more consistent, and more precise interpretations for assessing acute ischemic stroke.?

https://www.itnonline.com/content/avicennaai-partners-deepc-revolutionize-stroke-patient-care

·???????Potential treatment of post-stroke muscles stiffness:

A recent pilot study published in?Nature Scientific?Reports uses bi-exponential T1ρ mapping and shows how the enzyme hyaluronidase lessens muscle stiffness. The hyaluronidase injection reduced the amount of hyaluronan and released the water entrapped by the hyaluronan molecules in the muscles, allowing the muscles to relax and regain their shape. To confirm these findings, a phase II clinical trial is underway at Johns Hopkins to treat muscle stiffness after stroke using the injections.

( Menon, R.G., Raghavan, P. & Regatte, R.R. Pilot study quantifying muscle glycosaminoglycan using bi-exponential T1ρ?mapping in patients with muscle stiffness after stroke.?Sci Rep?11, 13951 (2021). https://doi.org/10.1038/s41598-021-93304-7 )

10.??Advances in the management of psoriasis:

On October 29, 2022, we celebrated the #WorldPsoriasisDay, an occasion to underline new innovations in this disease management,

·???????Sotyktu?(deucravacitinib):

In September 2022, the FDA approved Bristol Myers Squibb’s?Sotyktu?(deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The agent is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. The recommended dosage of the tablet is 6 mg once daily. The list price for a 30-day supply is $6,164.

·???????Spevigo?(spesolimab-sbzo) :

In September 2022, the FDA approved Boehringer Ingelheim’s?Spevigo?(spesolimab-sbzo) for the treatment of generalized pustular psoriasis flares in adults. The interleukin-36 receptor (IL-36R) antagonist is the first approved treatment for the condition. The FDA gave the drug breakthrough therapy designation for this indication. Dosing is 900 mg via a 90-minute intravenous infusion, with an additional dose possible one week later if flare symptoms persist.

·???????High-Concentration Hadlima

In August 2022, the FDA approved a citrate-free, high-concentration formulation of Samsung Bioepis Co., Ltd. and Organon & Co.’s?Hadlima?(adalimumab-bwwd) for all of its indications: the treatment of adults with moderately to severely active rheumatoid arthritis and ulcerative colitis; adults with active psoriatic arthritis and ankylosing spondylitis; people at least 2 years old with moderately to severely active polyarticular juvenile idiopathic arthritis; people at least 6 years old with moderately to severely active Crohn’s disease; and adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate. The agency initially approved a low-concentration formulation of the biosimilar of AbbVie Inc.’s Humira (adalimumab) onJuly 23rd, 2019. Dosing of the subcutaneous injectable varies according to the indication. Following the settlement of patent litigation with AbbVie, Hadlima is cleared to launch onJune 30th, 2023. Drugs.com lists the price of two kits of Humira, each containing two 40 mg/0.4 mL pens, as more than $6,759

https://www.mmitnetwork.com/aishealth/reality-check/mmit-reality-check-on-psoriasis-oct-2022/

Innovations in other fields of healthcare:

1.?????Next Generation of mRNA Vaccinology:

·???????Advancements in the generation, purification, and cellular delivery of RNA have enabled the development of mRNA vaccines across a broad array of applications, such as cancer and Zika virus infection. The technology is cost-effective, relatively simple to manufacture, and elicits immunity in a novel way. Furthermore, the emergence of the COVID-19 pandemic demonstrated that the world needed rapid development of a vaccine that was deployable around the globe.

·???????Because of previous research that laid the groundwork for this technology, an effective COVID-19 vaccine was developed, produced, approved, and deployed in less than a year. This landscape-changing technology has the potential to be used to manage some of healthcare's most challenging diseases quickly and efficiently.

2.?????Prostate-Specific Membrane Antigen (PSMA) -Targeted Therapy in Prostate Cancer:

·???????Each year, more than 200,000 American men receive a diagnosis of prostate cancer –making it the most commonly diagnosed cancer among men in the United States. Accurate imaging is critical for tumor localization, staging the disease, and detecting recurrences, an antigen found in high levels on the surface of prostate cancer cells, is a potential biomarker for the disease.

·???????PMSA PET scans use a radioactive tracer to attach to PSMA proteins, which are then combined with CT or MRI scans to visualize the location of prostate cancer cells.

In 2020, this technology received FDA approval based on phase III clinical trials, which showed substantially increased accuracy for detecting prostate cancer metastasis compared to conventional imaging with bone and CT scans

·???????When detected early by PSMAPET scans, recurrent prostate cancer can be treated through a targeted approach with stereotactic body radiation therapy, surgery, and/or systemic therapy in a personalized manner.

3.?????Breakthrough Treatment for Postpartum Depression

·???????Experts believe the rate of postpartum depression could be at least twice as high as what current statistics reveal because many cases go undiagnosed

·???????Currently, counseling and anti-depressant medications are the primary treatments, but some women do not respond to these therapies.

·???????On March 19 2019, the U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD. This novel therapy, administered around the clock for 60 hours, uses a neurosteroid to control the brain's response to stress. This treatment design is groundbreaking as it targets the signaling thought to be deficient in hormone-sensitive postpartum depression. Additionally, this treatment appears to show benefits very quickly, while traditional anti-depressants typically take two to four weeks to have a significant effect. This rapid treatment option would be a breakthrough for women with this often overlooked condition.

( https://newsroom.clevelandclinic.org/2022/02/16/cleveland-clinic-unveils-top-10-medical-innovations-for-2022/ )

#NationalInternalMedicineDay #IMProud #IMPhysician #InternalMedicine