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  • Sotagliflozin rejected by FDA; new lifestyle intervention guidelines

    Sotagliflozin rejected by FDA; new lifestyle intervention guidelines

    November 06, 2024

    2 min read


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    Sotagliflozin was not recommended for approval by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for glucose control as an adjunct to insulin in adults with type 1 diabetes and chronic kidney disease.

    The committee voted 11-3 that the risks of sotagliflozin (Zynquista, Lexicon), especially for diabetic ketoacidosis, did not outweigh the benefits of glucose control it offered.



    FDA sign

    Sotagliflozin was not recommended for approval by an FDA committee. Image: Adobe Stock

    “I really feel like we need a prospective trial,” Cecilia C. Low Wang, MD, professor of medicine at University of Colorado Anschutz Medical Campus and member of the Glucose Management Team at University of Colorado Hospital, and chairperson of the committee, who voted no, said during the hearing.

    “I have a really hard time voting to approve a drug when there are so little relevant data,” she added. “I feel like it does my patients a disservice.”

    It was the top story in endocrinology last week.

    In another top story, a novel clinical practice outline from the American College of Lifestyle Medicine outlines and recommends lifestyle interventions as the first line of defense for treating patients with prediabetes and type 2 diabetes.

    Read these and more top stories in endocrinology below:

    FDA panel votes against sotagliflozin for glucose control in type 1 diabetes, CKD

    The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended not approving sotagliflozin for glucose control as an adjunct to insulin in adults with type 1 diabetes and chronic kidney disease. Read more.

    ‘This is the foundation’: New guideline emphasizes lifestyle-first approach to diabetes

    A first-ever clinical practice guideline from the American College of Lifestyle Medicine outlines practical recommendations for lifestyle interventions as first-line therapy for people with prediabetes or type 2 diabetes. Read more.

    Continuous glucose monitor sensors now approved to be worn during imaging procedures

    Abbott announced that the FDA has removed the contraindication for its continuous glucose monitoring sensors to be used during imaging procedures. Read more.

    Approaches to holistic obesity treatment and identifying healthful behaviors

    Behavioral modification with diet and exercise demonstrated similar weight-loss benefits vs. other pharmaceutical and surgical approaches to obesity management, but patients must remain adherent, a speaker at the Cardiometabolic Health Congress reported. Read more.

    GLP-1 use before weight-loss surgery rising, not linked to harmful outcomes

    Among patients with obesity undergoing bariatric surgery, the proportion taking a GLP-1 receptor agonist in the year before their procedure rose sharply between 2018 and 2023, researchers reported. Read more.


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  • EXPERT PITCH: WVU neurologist addresses updated guidelines suggesting screenings, lifestyle changes are keys to preventing first strokes | WVU Today

    EXPERT PITCH: WVU neurologist addresses updated guidelines suggesting screenings, lifestyle changes are keys to preventing first strokes | WVU Today

    This week, the American Stroke Association released new guidelines designed to reduce risks of first strokes. WVU School of Medicine Stroke Program Medical Director Dr. Muhammad Alvi is available to discuss what that will mean for patients.
    (WVU Photo)

    A West Virginia University stroke expert says new guidelines from the American Stroke Association that are designed to reduce the risk of a first stroke for patients provide a more comprehensive approach to early detection and prevention and, because of that, could lead to fewer stroke cases. 

    Dr. Muhammad Alvi is the medical director for the WVU School of Medicine Stroke Program. His work as a board-certified neurologist with the WVU Rockefeller Neuroscience Institute involves leading an interdisciplinary stroke team of specialists.

    On Oct. 21, the American Stroke Association, a division of the American Heart Association, updated its clinical recommendations.

    The new guidelines state healthy lifestyle behaviors, such as good nutrition, smoking cessation and being physically active, along with routine health screenings and managing risk factors for cardiovascular disease and stroke, can help keep people from having initial strokes.

    Quotes:

    “As providers, we are able to recommend behavioral and healthy lifestyle changes, including medications for some patients, by reviewing a patient’s physical exam and blood tests. When we address risk factors like high blood pressure, elevated cholesterol and elevated blood sugar, we can increase the likelihood of preventing a first stroke.

    “Decreasing sedentary lifestyles and increasing physical activity is key to reducing the risk of stroke. Increased physical activity can help regulate blood pressure, cholesterol, inflammatory markers, insulin resistance, endothelial function and weight.

    “Many adults can decrease their risk of stroke by following a Mediterranean dietary pattern. Mediterranean dietary programs focus on plant-based foods and healthy fats. Vegetables, fruits, whole grains and extra virgin olive oil play key roles in this dietary lifestyle. 

    “Obesity and weight continue to be a factor for many stroke patients, and this new guideline explores using FDA-approved glucagon-like protein-1 (GLP-1) receptor agonist medications, like semaglutide or trizepatide, for patients with this risk factor and Type 2 diabetes.” — Dr. Muhammad Alvi, associate professor, WVU School of Medicine, medical director, WVU Stroke Program, and neurologist, WVU Rockefeller Neuroscience Institute

    -WVU-

    ct/10/24/24

    MEDIA CONTACT: Cassie Thomas
    Director of Communications and Marketing
    WVU School of Medicine
    304-293-3412; Cassie.Thomas@hsc.wvu.edu

    Call 1-855-WVU-NEWS for the latest West Virginia University news and information from WVUToday.

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  • EXPERT PITCH: WVU neurologist addresses updated guidelines suggesting screenings, lifestyle changes are keys to preventing first strokes | WVU Today

    EXPERT PITCH: WVU neurologist addresses updated guidelines suggesting screenings, lifestyle changes are keys to preventing first strokes | WVU Today

    This week, the American Stroke Association released new guidelines designed to reduce risks of first strokes. WVU School of Medicine Stroke Program Medical Director Dr. Muhammad Alvi is available to discuss what that will mean for patients.
    (WVU Photo)

    A West Virginia University stroke expert says new guidelines from the American Stroke Association that are designed to reduce the risk of a first stroke for patients provide a more comprehensive approach to early detection and prevention and, because of that, could lead to fewer stroke cases. 

    Dr. Muhammad Alvi is the medical director for the WVU School of Medicine Stroke Program. His work as a board-certified neurologist with the WVU Rockefeller Neuroscience Institute involves leading an interdisciplinary stroke team of specialists.

    On Oct. 21, the American Stroke Association, a division of the American Heart Association, updated its clinical recommendations.

    The new guidelines state healthy lifestyle behaviors, such as good nutrition, smoking cessation and being physically active, along with routine health screenings and managing risk factors for cardiovascular disease and stroke, can help keep people from having initial strokes.

    Quotes:

    “As providers, we are able to recommend behavioral and healthy lifestyle changes, including medications for some patients, by reviewing a patient’s physical exam and blood tests. When we address risk factors like high blood pressure, elevated cholesterol and elevated blood sugar, we can increase the likelihood of preventing a first stroke.

    “Decreasing sedentary lifestyles and increasing physical activity is key to reducing the risk of stroke. Increased physical activity can help regulate blood pressure, cholesterol, inflammatory markers, insulin resistance, endothelial function and weight.

    “Many adults can decrease their risk of stroke by following a Mediterranean dietary pattern. Mediterranean dietary programs focus on plant-based foods and healthy fats. Vegetables, fruits, whole grains and extra virgin olive oil play key roles in this dietary lifestyle. 

    “Obesity and weight continue to be a factor for many stroke patients, and this new guideline explores using FDA-approved glucagon-like protein-1 (GLP-1) receptor agonist medications, like semaglutide or trizepatide, for patients with this risk factor and Type 2 diabetes.” — Dr. Muhammad Alvi, associate professor, WVU School of Medicine, medical director, WVU Stroke Program, and neurologist, WVU Rockefeller Neuroscience Institute

    -WVU-

    ct/10/24/24

    MEDIA CONTACT: Cassie Thomas
    Director of Communications and Marketing
    WVU School of Medicine
    304-293-3412; Cassie.Thomas@hsc.wvu.edu

    Call 1-855-WVU-NEWS for the latest West Virginia University news and information from WVUToday.

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  • New stroke guidelines stress prevention through diet and blood pressure

    The American Stroke Association, a part of the American Heart Association, released updated guidelines on Monday, indicating that up to 80% of strokes can be prevented through healthy lifestyle choices, better blood pressure management, and other medical interventions.

    The recommendations emphasize a Mediterranean diet, regular physical activity, and closer monitoring of high-risk groups, including women and transgender individuals.

    Stroke, the third leading cause of death in Israel, impacts around 20,000 people annually, often resulting in severe disability or death. According to the updated guidelines, which are the first major revision in a decade, most strokes can be avoided with preventive actions.

    A stroke occurs when blood flow to the brain is suddenly interrupted, usually due to a blood clot or hemorrhage. This lack of oxygen and nutrients causes rapid brain cell death, making immediate medical attention crucial.

    Symptoms include sudden weakness or paralysis, often on one side of the body, difficulty speaking, vision loss, loss of balance, and severe headaches. In such cases, it’s vital to contact Magen David Adom at 101 and rush to the hospital for a CT scan and urgent treatment.

    Stroke (illustrative) (credit: INGIMAGE)

    The new guidelines stress that most strokes are preventable through lifestyle changes. “These guidelines are a crucial update based on recent studies that identified key factors for reducing stroke risk,” says Prof. Ronen Leker, Chair of the Israeli Stroke Society and Director of the Stroke Center at Hadassah Medical Center.

    They recommend adopting a Mediterranean diet rich in nuts and olive oil, shown to lower stroke risk, along with regular physical activity to counteract sedentary lifestyles common in Western countries.

    The silent killer

    Managing high blood pressure is another critical factor. Studies indicate that a single blood pressure medication only helps about 30% of patients reach their target. Most patients require a combination of two or three medications to achieve the desired results. Based on this data, the guidelines recommend using at least two drugs for most patients needing hypertension treatment.

    Specific recommendations are also made for women, particularly those who are pregnant, have experienced early menopause, or suffer from endometriosis, as these conditions increase the risk of stroke. For transgender women, the guidelines highlight that hormone therapy containing estrogen increases stroke risk, warranting close medical supervision.

    “Rapid treatment, such as performing a CT scan within 25 minutes of the patient’s arrival, followed by clot-dissolving medication or brain catheterization, has been proven to save lives and reduce disability,” Prof. Leker adds. “However, these new guidelines focus on prevention, aiming to prevent strokes altogether through proactive care that family physicians need to prioritize.”





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  • 2024 Fantasy Football Draft Guidelines for the Cincinnati Bengals

    2024 Fantasy Football Draft Guidelines for the Cincinnati Bengals

    With the regular season quickly approaching, exactly a week away, fantasy football season is upon us.

    It’s time to strategize for your draft. Depending on your league settings, you will have to approach your draft with certain guidelines, such as the best positions for each round and the number of players in each position.

    There are several different types of fantasy leagues, but I’ve only been involved in two types in the last several years, both Points Per Reception (PPR). You have a traditional league with a regular lineup, including D/ST and a K, but you also have leagues with a flex player and a super flex player, and this is where you have to pay attention early in the draft.

    So, the question is, where should you draft different Cincinnati Bengals players?

    Traditional

    Joe Burrow – Rounds 4-6. In traditional leagues, most quarterbacks aren’t drafted until the middle rounds, but Burrow is an obvious starter.

    Ja’Marr Chase – Rounds 1-3. The only reason I give multiple rounds for Uno is simply due to the current situation. Unfortunately, do we know if he’s going to play in Week 1 or further? No. If he does play, he’s an obvious round 1 choice.

    Tee Higgins – Rounds 2-3. Higgins signed his franchise tag, and he has reported and played. He will be playing this season, and he will make an impact like normal.

    Andre Iosivas – Rounds 6-8. You could draft him earlier, but Yoshi is not a big name yet, so you could very easily steal him in a later round. I’m expecting a big year for Yoshi as he fills the role of Boyd.

    Jermaine Burton – Rounds 8+. It’s been obvious that Burton is a very talented receiver, but there are simply too many starters ahead of him. He could be a potential late-round pickup.

    Evan McPherson – Rounds 9+. McPherson is an elite kicker, and he can put up points. You have to be careful drafting kickers too early or too late. You don’t want to skip over solid players to get a kicker, but you also don’t want to wait too long to get a kicker.

    D/ST – Rounds 8+. The defense and special teams is similar to the kicker. You can’t draft them too early, but you definitely can’t draft too late. I think the Bengals are a top-10 defense, and I believe they will put up points with turnovers.

    Chase Brown – Rounds 3-5. You have to remember there are still some teams with one primary back who will get 95% of the carries. Those players will be your round 1-3 players. But Brown is a versatile player, and he is a dual threat on the ground and receiving.

    Zack Moss – Rounds 3-5. I would put him and Brown in the same rounds. I think he and Brown will both capitalize this year and put up points.

    Mike Gesicki – Rounds 7-9. I don’t think he will be picked early by many people, but if you look at tight ends track records with Burrow, it’s very positive. This is Gesicki’s third team, and I believe he will surprise some people in the red zone. He will be a good late-round tight end.

    FLEX/SUPER FLEX:

    Not much changes for the Bengals switching to a flex league, simply because the Bengals are a multi-tool team. They use everyone versus some teams that primarily use just a few players. I may change one player.

    Burrow – Rounds 3-5. I’m keeping Burrow in about the same area, but you can pick him a round or two earlier. Burrow is on a revenge tour and he has weapons, he will put up points.

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