Health & Wellness
Once-Weekly Insulin Icodec Bests Day-to-day Insulin Alternate choices for Kind 2 Diabetes
Published
1 year agoon
— Superior to as soon as-a-day insulin glargine U100 and degludec
by
Kristen Monaco, Senior Workers Author, MedPage This day
June 25, 2023
SAN DIEGO — Investigational as soon as-weekly insulin icodec outperformed as soon as-day to day insulin glargine U100 when it came to glycemic regulate in sort 2 diabetes, the fragment IIIa ONWARDS 1 trial discovered.
Over the direction of 52 weeks, of us with sort 2 diabetes noticed a increased moderate reduction in HbA1c with icodec when put next with glargine U100 (estimated between-neighborhood difference -0.19%, 95% CI -0.36% to -0.03%), reported Julio Rosenstock, MD, of Dash Scientific Analysis at Medical Metropolis in Dallas, and colleagues.
Reaching the trial’s important endpoint, this difference in HbA1c confirmed both non-inferiority and superiority of icodec. These on icodec scream a fall from 8.50% to 6.93% while those on glargine U100 noticed a fall from 8.44% to 7.12% throughout the year.
The findings private been presented at the American Diabetes Association (ADA) Scientific Classes and concurrently published in the Contemporary England Journal of Medication.
“I in actual fact feel that weekly insulins private the aptitude to turn into transformational as most well-appreciated alternatives for basal insulin change in of us with sort 2 diabetes in want of initiation of insulin therapy,” Rosenstock said throughout an ADA presentation. “I accept as true with that basal insulin analogues Twenty years previously, 22 years previously, private been transformational on deal with sort 2 diabetes with as soon as-day to day glargine or degludec, etc.”
“I accept as true with that right here’s déjà vu all around the assign over again,” he added. “20, 25 years later we private made a mammoth step forward in the management of sort 2 diabetes.”
This glycemic regulate became maintained throughout an extension fragment of the trial as effectively, which continued for one other 26 weeks. At the finish of the 78th week since randomization, icodec-handled sufferers had a HbA1c of 6.92 while glargine U100 sufferers had an A1c of seven.03.
By the finish of the 52-week period, 57.6% of icodec sufferers executed an HbA1c beneath 7% versus Forty five.4% of glargine sufferers.
That being said, both treatment groups had similar adjustments in fasting plasma glucose (-60.32 mg/dL for icodec vs -60.08 mg/dL for glargine).
All over weeks forty eight-52 of treatment, sufferers on icodec furthermore spent on moderate 4.27% (71.9% vs 66.9%) extra of time in glycemic fluctuate — 70 to 180 mg/dL — achieving superiority. This translated to about 1 hour and 1 minute longer per day spent in target fluctuate. This advantage became furthermore sustained in the extension fragment, as icodec sufferers spent 4.41% extra time (1 hr 4 min longer) in target fluctuate throughout weeks 74-78.
These on icodec furthermore spent a great deal less time in hyperglycemia (glucose levels over 180 mg/dL) when put next with glargine U100 (-4.58%, 1 hr 6 min less time).
Icodec sufferers noticed a miniature, but statistically insignificant greater rates of clinically significant or severe hypoglycemia: 0.30 events per particular person-year of exposure with icodec and nil.16 events per particular person-year of exposure with glargine U100 at week 52 (estimated charge ratio 1.64, 95% CI 0.98-2.75). Total, the rates of adversarial events private been similar between the 2 insulin groups.
“Insulin is insulin,” said Rosenstock. “After we spend insulin, there continually would possibly be hypoglycemia, but we very finest had less than one tournament per year.”
The 143-situation open-trace trial contain 492 contributors in both groups, all of whom had sort 2 diabetes (baseline HbA1c between 7-11%) and private been by no method previously handled with insulin. The trendy age became 59 and most private been male. Nearly all private been furthermore on metformin, over a third private been furthermore on an SGLT2 inhibitor and/or DPP-4 inhibitor, and about 18% private been on a GLP-1 receptor agonist. Nearly half of private been taking sulfonylureas, but sulfonylureas and glinides private been the true treatments discontinued at randomization. All other antidiabetic treatments private been continued all the method thru the trial.
The trendy weekly insulin dose became 214 U per week (about 31 U per day) in the icodec neighborhood and 222 U per week (about 32 U per day) in the glargine U100 neighborhood throughout the important fragment of the trial.
Also Superior to Degludec
Adding to the 78-week trial findings private been 26-week findings from the double-blind fragment IIIa ONWARDS 3 trial, presented at ADA and concurrently published in JAMA. Right here, similar findings private been seen amongst a 588-participant neighborhood evaluating as soon as-weekly icodec to as soon as-day to day insulin degludec in insulin-naïve sufferers with sort 2 diabetes.
After 26 weeks, icodec sufferers noticed a fall in HbA1c from 8.6% to 7.0% versus a fall from 8.5% to 7.2% in the degludec neighborhood (estimated treatment difference -0.2, 95% CI -0.3 to -0.1%). Equal to the ONWARDS 1 trial, icodec furthermore achieving non-inferiority and superiority right here.
Likewise, there private been no significant differences between the icodec and degludec groups with regards to fasting plasma glucose adjustments or physique weight.
However, icodec sufferers did compare a a great deal greater charge of stage 2 or 3 hypoglycemic events throughout the 26-week period (0.35 vs 0.12 events per patient-year exposure, P=0.01).
“I accept as true with most importantly, of us handled with icodec will very finest private to grab one shot every week as in opposition to one shot each day,” said Ildiko Lingvay, MD, of the College of Texas Southwestern Medical Heart in Dallas, throughout an ADA presentation.
Developer Novo Nordisk announced it submitted a biologics license application to the FDA in April for as soon as-weekly insulin icodec for the treatment of diabetes, with a name expected April 2024.
“If authorised, insulin icodec will symbolize the important and intensely finest as soon as-weekly basal insulin option for adults with diabetes, addressing an unmet want in treatment vs. a day to day basal insulin option,” in step with a reveal from Novo Nordisk.
-
Kristen Monaco is a senior workers writer, focusing on endocrinology, psychiatry, and nephrology info. Based completely mostly out of the Contemporary York Metropolis repute of industrial, she’s labored at the firm since 2015.
Disclosures
The trials private been supported by Novo Nordisk.
Rosenstock and Lingvay disclosed extra than one relationships with alternate in conjunction with Novo Nordisk.
Main Source
Contemporary England Journal of Medication
Source Reference: Rosenstock J, et al “Weekly Icodec versus day to day glargine U100 in sort 2 diabetes without outdated insulin” N Engl J Med 2023; DOI: 10.1056/NEJMoa2303208.
Secondary Source
JAMA
Source Reference: Lingvay I, et al “Once-weekly insulin icodec vs as soon as-day to day insulin degludec in adults with insulin-naive sort 2 diabetes” JAMA 2023; DOI: 10.1001/jama.2023.11313.
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Why 2024 Was the Year of Whiskey: A Musical and Cultural Phenomenon
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The surge in whiskey-themed music can be traced to more than just creative expression—2024 marked a time when whiskey was more than a drink; it was a moment of reflection and release. With the world facing challenges like economic instability, global conflicts, and social shifts, whiskey became the cultural antidote. These musical hits reflected the times, with whiskey as a symbol of both sorrow and celebration.
In parallel, celebrity involvement in the whiskey industry reached new heights in 2024. High-profile figures in the entertainment industry, such as Matthew McConaughey with his Longbranch whiskey, Nick Offerman’s Lagavulin, and other notable stars, introduced their own brands, driving the whiskey market to unprecedented levels of popularity. These collaborations further embedded whiskey into mainstream culture and helped shape it as one of the top spirits of the year.
The rise of whiskey can also be tied to World Whiskey Day, which is celebrated every year on the third Saturday of May. In 2024, this day of celebration on May 18th coincided with the whiskey music explosion, adding to the cultural momentum. Whiskey, a spirit deeply tied to tradition and history, took on new layers of meaning in 2024, both as a drink to savor and as a symbol of defiance, release, and indulgence.
Top Whiskeys to Try in 2024
- Heaven’s Door Whiskey: A premium whiskey from the legendary Bob Dylan, offering a rich, complex flavor that has won multiple awards. Its different variations, including straight bourbon and rye, continue to be crowd favorites.
- Kikori Whiskey: This Japanese whiskey, made from 100% rice, stands out for its smooth taste, aged in a variety of casks, including French oak and sherry. It’s one of the first whiskeys crafted by an Asian American woman.
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A Sublime Creation: Tory Burch’s Latest Fragrance
When you think of Tory Burch, you likely envision timeless elegance, bold designs, and an effortless sense of style. Her new scent is no different, perfectly capturing the essence of what her brand represents. The fragrance is a sublime fusion of floral and woody notes, creating a sophisticated yet warm aroma that’s as inviting as it is memorable.
This sublime fragrance is designed to evoke a sense of confidence and femininity, with an underlying warmth that makes it suitable for both day and night wear. Its blend of unique ingredients ensures that it lasts throughout the day, leaving a lingering presence that captivates those around you.
Kendall Jenner: The Face of Tory Burch’s New Scent
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How to Wear Tory Burch’s New Scent
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A Journey of Leadership and Transformation
Daniel Brock’s professional foundation at D. Brock & Associates was built in law enforcement, where he served with dedication and integrity, eventually becoming an instructor at the New Mexico Department of Public Safety’s police academy. This role honed his leadership skills, adaptability, and ability to work under pressure.
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The Distinct Mindset for Multi-Unit Management
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Wellness Industry Trends: The Future Outlook
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The Business Case for Prioritizing Mental Health
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Published
3 months agoon
September 19, 2024Health experts have discovered that certain blockbuster weight-loss drugs could significantly reduce the risk of heart attacks, offering new hope for broader cardiovascular protection. Certain blockbuster weight-loss drugs have been found to offer significant protection to the heart, and new research indicates that the cardiovascular benefits of these drugs may extend to a much broader set of patients than clinical trial data has previously shown. This new insight suggests that these drugs, specifically GLP-1 receptor agonists, could prevent tens of thousands of heart attacks and strokes in the United States each year. These findings could mark a substantial shift in how these drugs are viewed, moving beyond their use for weight loss to potentially becoming critical tools in preventing cardiovascular events on a much larger scale.Clinical trial data from Novo Nordisk, the pharmaceutical company behind Wegovy, showed that people who used the drug had a 20% lower risk of experiencing a cardiac event, such as a heart attack or stroke, compared to those who were given a placebo. This data prompted the U.S. Food and Drug Administration (FDA) in March to approve an update to Wegovy’s label, making it the first weight-loss medication officially approved to reduce the risk of heart attack, stroke, or heart-related death in individuals who are at a higher risk of these conditions. Wegovy belongs to a class of drugs known as GLP-1 receptor agonists, and its active ingredient, semaglutide, is also available as Ozempic for the treatment of type 2 diabetes. Novo Nordisk’s clinical trial, however, was limited to people who were living with obesity and had already experienced a previous cardiovascular event, such as a heart attack or stroke, or those with symptoms of peripheral artery disease, which includes conditions like clogged arteries in the limbs. This group is at higher risk of future heart problems, and the trial focused on whether Wegovy could help prevent subsequent events in this population.
Now, new research from Dandelion Health, a health platform leveraging real-world data and artificial intelligence (AI) to advance personalized care, suggests that GLP-1 drugs could also be highly effective as a primary prevention method. This means that these drugs might significantly reduce the risk of heart attacks and strokes even for people who have mild or moderate cardiovascular disease but have not yet suffered a major cardiovascular event. The implications of this research are profound, as it suggests that GLP-1 receptor agonists could benefit an even larger group of people than previously thought, extending beyond those with a history of heart disease.
The researchers at Dandelion Health used AI to analyze real-world medical records of patients who shared similarities with those in the Novo Nordisk clinical trial but had no history of major cardiovascular events. By tracking years of medical data, particularly focusing on electrocardiogram readings (which measure the heart’s electrical activity), the AI model predicted the potential benefits of GLP-1 drugs in reducing the risk of heart attacks and strokes. The AI-driven predictions were then validated against actual patient outcomes.
What the researchers found was striking: GLP-1 receptor agonists reduced the risk of heart attack or stroke by 15% to 20%—a result that mirrors the findings of the clinical trial but for a much broader population. Based on these results, the researchers estimate that if everyone in this larger group of potentially eligible patients took GLP-1 drugs, it could prevent around 34,000 heart attacks and strokes in the U.S. each year. This could transform the way cardiovascular disease is managed in millions of people, marking a shift toward using GLP-1 drugs as a cornerstone in heart disease prevention.
“In clinical research, you take the moderate to severe patients because you require fewer patients to prove out the efficacy. But there’s this huge danger that you will consistently miss the impact of medication on broader populations because you just can’t afford the time or money to study them. This is just a natural flaw of clinical research,” explained Elliott Green, co-founder and CEO of Dandelion Health. He emphasised that broadening the scope of research through the use of AI can help capture data on patients who might otherwise be overlooked in traditional clinical trials—those he referred to as the “clinically silent” group.
The potential for GLP-1 drugs to reshape cardiovascular care has already been transformative. Many experts now consider these drugs not merely as weight-loss solutions but as powerful tools that promote overall health, particularly heart health. Dr. Harlan Krumholz, a cardiologist and scientist at Yale University and Yale New Haven Hospital, who was not involved in the Dandelion Health analysis, sees the growing evidence of the cardiovascular benefits of GLP-1s as potentially game-changing. “We could reframe the discussion,” Krumholz said, explaining that instead of focusing solely on the weight-loss effects of these drugs, the conversation could shift to how they help reduce cardiovascular risk and promote longer, healthier lives. This added evidence of heart health benefits may help persuade more people to consider the use of GLP-1 drugs.
Dr. Brendan Everett, a cardiologist at Brigham and Women’s Hospital and associate professor at Harvard Medical School, is among the physicians who have already begun prescribing GLP-1 drugs for their cardiovascular benefits. “I am a preventive cardiologist who wants people to be well and has watched this epidemic of obesity and what we call cardiometabolic disease consume the United States over the past two or three decades,” he said. Everett highlighted that GLP-1 drugs have created an “absolute paradigm shift” in the way cardiovascular disease is treated. He believes that expanding the use of these drugs to patients with mild or moderate cardiovascular disease could provide even greater benefits, as long as the costs and prevention goals are clearly understood.
However, the cost of GLP-1 drugs remains a critical consideration. A recent analysis published in *Health Affairs* suggested that if Medicare were to cover weight-loss drugs like Wegovy, Part D spending could increase by $3 billion annually, even if only 5% of eligible patients were prescribed the drug. However, preventing costly heart attacks and strokes through the use of GLP-1 drugs could potentially offset these costs in other areas of healthcare. For example, research from last year found that each heart attack costs hospitals an average of about $19,000.
While clinical trials with randomized controls, such as those conducted by Novo Nordisk, remain the gold standard for determining the safety and efficacy of medications, AI-driven research like that from Dandelion Health offers valuable insights. This new research also had some advantages over the Novo Nordisk trial. For instance, the Dandelion Health analysis included a more diverse patient population, with a more balanced ratio of men and women and nearly three times the number of non-white patients. Additionally, the AI model was able to identify the decreased cardiovascular risk in less than two years, whereas the Novo Nordisk clinical trial took over three years to complete.
As heart disease remains the leading cause of death in the United States and stroke is the fifth leading cause, the opportunities to improve cardiovascular health through the use of GLP-1 drugs are significant. With the growing popularity of these medications, additional data from real-world analyses and clinical trials could help healthcare providers better allocate the currently limited supply to those who would benefit the most.
Health & Wellness
Weight loss drug liraglutide shows promise for younger children with obesity, study finds
Published
3 months agoon
September 12, 2024In a recent study, children who used the weight loss drug liraglutide experienced a significant reduction in weight compared to those who received a placebo. This groundbreaking research sheds light on a potential new treatment avenue for younger children struggling with obesity, a group that has traditionally relied on non-pharmaceutical interventions such as diet and exercise.
Managing obesity is challenging for individuals of all ages, but it is particularly difficult for children. While adults and adolescents aged 12 and older have access to GLP-1 receptor agonists, a class of medications effective for weight management, younger children typically rely solely on lifestyle modifications. These include dietary changes, increased physical activity, and behavioral counseling. Despite these efforts, substantial weight loss in younger children has often proven elusive, with most interventions yielding only modest results.
Liraglutide, known commercially as Saxenda and Victoza, was initially approved by the US Food and Drug Administration (FDA) in 2014 for weight loss in adults. Its approval was expanded in 2020 to include children aged 12 to 17. The recent study, published in the New England Journal of Medicine and presented at the annual European Association for the Study of Diabetes conference, represents the first investigation into liraglutide’s effects on children aged 6 to 12 with high BMI.
Conducted by Dr. Claudia Fox, a pediatrician at the Center for Pediatric Obesity Medicine at the University of Minnesota Medical School in Minneapolis, the study involved 82 children. These participants were divided into two groups: 56 children received daily liraglutide injections, while 26 received a placebo. All participants also received counseling designed to promote healthier eating habits and an increase in physical activity, specifically moderate to high-intensity exercise for at least an hour each day.
The results were notable. After just over a year, children in the liraglutide group experienced a 5.8% reduction in BMI, compared to a 1.6% increase in the placebo group. This represents a 7.4 percentage point difference in BMI between the two groups. These findings align with previous studies involving teenagers but were even more pronounced in the younger children studied.
Liraglutide was generally well-tolerated by the participants, though some adverse effects were reported. Both the liraglutide and placebo groups experienced gastrointestinal issues, such as nausea, diarrhea, and vomiting, with these symptoms being more prevalent among those receiving the medication. However, these side effects were mostly transient and did not result in a high dropout rate.
The study has several important implications but also some limitations. One key unanswered question is the long-term effectiveness and safety of liraglutide for younger children. The trial did not explore how long children would need to remain on the medication or the long-term effects of discontinuing it. After the study period ended and medication and counseling stopped, BMI levels among participants began to increase again, although the rise was less pronounced compared to previous studies involving teenagers. This suggests that early intervention with liraglutide might offer more durable results, but additional research is needed to confirm this.
Obesity is a prevalent and serious health issue among children in the United States, affecting nearly 20% of the population. This condition often persists into adulthood, leading to various health problems such as type 2 diabetes, cardiovascular disease, and other serious conditions. Effective treatments for childhood obesity are crucial not only for managing weight but also for preventing long-term health complications.
Developing and implementing weight loss medications for children is complex due to their ongoing growth and development. It is crucial to ensure that such treatments do not negatively impact physical growth or developmental milestones. Although the study did not indicate any adverse effects on growth or puberty, further research is essential to verify that liraglutide does not interfere with these important developmental processes.
The potential benefits of weight loss medications like liraglutide must be weighed against their costs and long-term effects. While the current research is promising, more studies are needed to fully understand the implications of such treatments for young children. These studies should focus on long-term safety, potential impacts on growth and development, and the overall efficacy of maintaining weight loss over time.
In summary, the study on liraglutide offers a promising new option for managing obesity in younger children. With significant weight loss observed and a generally acceptable safety profile, liraglutide could become a valuable tool in treating childhood obesity. However, further research is needed to fully understand its long-term impact and to ensure its safe and effective use in the younger population.
Health
How a Weekend Nap Might Boost Your Heart Health, New Research Reveals
Published
3 months agoon
September 6, 2024When a demanding week disrupts your regular sleep routine, catching up on sleep over the weekend often seems like a sensible remedy. However, new research suggests that this approach might offer more than just temporary relief—it could actually benefit your heart health. Set to be presented at the European Society of Cardiology’s annual congress on September 1, the study indicates that making up for lost sleep on weekends is linked to a significantly lower risk of developing heart disease.
This research, based on data from the UK Biobank study involving over 90,000 participants, reveals intriguing findings. Those who used weekends to compensate for lost sleep showed a 19% lower risk of heart disease compared to individuals who didn’t catch up as much. The benefit was notably greater for those who regularly faced inadequate sleep during the workweek. Over an average follow-up period of nearly 14 years, participants who averaged the most additional sleep on weekends were less likely to develop serious cardiovascular conditions, such as heart disease, heart failure, atrial fibrillation, and stroke.
For people suffering from chronic sleep deprivation—defined as getting less than seven hours of sleep per night—this research found that catching up on sleep over the weekend reduced the risk of heart disease by 20%. This suggests that even intermittent sleep recovery can have a protective effect on cardiovascular health.
Despite these promising results, experts stress the importance of maintaining a consistent sleep schedule throughout the entire week. Irregular sleep patterns, often referred to as “social jet lag,” can have detrimental effects on heart health, undermining the benefits of weekend sleep recovery. For instance, excessive weekend sleep might not fully mitigate the adverse effects of insufficient sleep during the week.
The research, while compelling, remains in abstract form and has some limitations. It primarily reflects the UK population, and the study’s methodology does not yet account for all potential risk factors for heart disease or variations in individual sleep needs. Further research is needed to determine the optimal amount of daily sleep and whether there are thresholds beyond which additional weekend sleep offers no further benefit.
Dr. Nieca Goldberg, medical director of Atria New York City and a clinical associate professor of medicine at New York University’s Grossman School of Medicine, emphasizes the broader implications of the findings. She points out that chronic sleep deprivation is known to contribute to various cardiovascular issues, including high blood pressure, high cholesterol, obesity, diabetes, and stroke. Therefore, while catching up on sleep can be beneficial, it is crucial to aim for a consistent sleep routine to maximize heart health.
Other experts, like Dr. Nour Makarem from Columbia University’s Mailman School of Public Health, highlight that maintaining regular sleep patterns every day is likely the best strategy for long-term health. They also suggest discussing sleep issues with healthcare providers to address any underlying problems and ensure the most effective approach to improving sleep and overall cardiovascular health.
In summary, while making up for lost sleep on weekends appears to offer heart health benefits, the ideal approach is to maintain a consistent and adequate sleep schedule throughout the week. Further research will be needed to refine these findings and provide more specific guidelines for optimizing sleep for heart health.
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