Latest news with #JohnBuse
Medscape
26-06-2025
- Health
- Medscape
Mifepristone Improves A1C in T2D With Hypercortisolism
CHICAGO — Mifepristone treatment improved glycemic control and led to weight loss and a reduction of waist circumference in patients with poorly controlled type 2 diabetes (T2D) and hypercortisolism, according to new data from the CATALYST trial. Results from the prevalence phase of the study, presented last year, indicated that 24% (253) of the 1055 patients enrolled had hypercortisolism, as determined by dexamethasone suppression test. The figure was surprising, as the expected prevalence was 8%. The current data were presented at the American Diabetes Association (ADA) 85th Scientific Sessions and simultaneously published in Diabetes Care . 'These findings demonstrate a potentially promising treatment solution' for these patients, who are often frustrated with their diabetes care, said study author John Buse, MD, PhD, Verne S. Caviness Distinguished Professor of Medicine at the University of North Carolina School of Medicine, Chapel Hill, North Carolina, in a press release. The CATALYST Trial: Latest Results In the second phase of CATALYST, individuals who had abnormal cortisol suppression were offered the opportunity to take part in a randomized trial of mifepristone, a medication that reduces the effects of cortisol. It is currently FDA approved for the treatment of elevated blood glucose in patients with hypercortisolism and prediabetes or T2D. The trial took place at 36 sites in the US. A total of 136 patients with T2D (A1c of 7.5%-11.5%, who were on multiple medications) and hypercortisolism were randomized 2:1 to mifepristone (300-900 mg once daily; 91 patients) or placebo (45 patients) for 24 weeks, with stratification by presence/absence of an adrenal imaging abnormality. Almost 40% of the patients were women, and the mean age was 63 years. The mean A1c was 8.55%, and mean BMI was 33.3. Twenty-eight percent of participants had adrenal imaging abnormalities. The medication reduced A1c by 1.5% (95% CI, -1.79 to -1.14). For those taking placebo, A1c declined 0.2% from 8.41% to 8.36% (95% CI, -0.56 to 0.27). Within the first 12 weeks, 30% of those taking mifepristone reduced or discontinued fast-acting insulin compared to 11% of those taking placebo. And half reduced or discontinued long-acting insulin compared to 13% of those taking placebo. 'As their A1c came down, they didn't need the insulin,' Buse told reporters at a press conference at the meeting. Patients taking mifepristone also lost 4.4 kg of body weight and had a 5.2 cm (2.05 in) reduction in waist circumference from baseline. However, almost 50% of those taking mifepristone discontinued due to adverse events compared to just 18% of those taking placebo. A total of 62% of patients on mifepristone reported having treatment-related adverse events, said Buse, adding that people on mifepristone primarily experience glucocorticoid withdrawal syndrome or hypokalemia. Mifepristone 'is a challenging drug to use,' he said, and 'it's important to set expectations appropriately with patients about steroid withdrawal symptoms and how to manage them.' CATALYST already demonstrated that hypercortisolism was likely a culprit in almost a quarter of patients with poorly controlled diabetes, and screening with a dexamethasone suppression test is relatively easy, said Buse. The treatment phase of CATALYST showed 'that identifying and addressing hypercortisolism is a novel path to improving diabetes care in millions of people worldwide,' he added. The CATALYST investigators 'believe that there's sufficient evidence now to suggest guideline changes at the American Diabetes Association and other international health organizations.' This study was funded by Corcept Therapeutics. Buse disclosed serving on an advisory panel/as a consultant for Altimmune, Antag Therapeutics, Amgen, APstem Therapeutics, Aqua Medical, AstraZeneca, Boehringer Ingelheim, CeQur, Corcept Therapeutics, Dexcom, Eli Lilly, embecta, GentiBio, Glyscend, Insulet, Medtronic MiniMed, Mellitus Health, Metsera, Novo Nordisk, Pendulum Therapeutics, Praetego, Stability Health, Tandem Diabetes Care, Terns Pharmaceuticals, Vertex Pharmaceuticals, and Zealand Pharma; and having stocks/shares in Glyscend, Mellitus Health, Metsera, Pendulum Therapeutics, Praetego, and Stability Health.
Yahoo
23-06-2025
- Health
- Yahoo
Mifepristone Shown to Reduce A1C in Patients with Difficult-to-Control Type 2 Diabetes and Hypercortisolism
Study Results Signal Paradigm Shift in Diabetes Care for Patients with Difficult-to-Control Type 2 Diabetes CHICAGO, June 23, 2025 /PRNewswire/ -- New findings from the CATALYST study show that the use of mifepristone resulted in improved blood glucose (blood sugar) control and weight reduction in patients with difficult-to-control type 2 diabetes and hypercortisolism. The results of the largest prospective trial of its kind were presented as a late-breaking symposium at the 85th Scientific Sessions of the American Diabetes Association® (ADA) in Chicago, and simultaneously published in Diabetes Care®. Among patients with type 2 diabetes, more than half do not achieve blood glucose targets as assessed by the hemoglobin A1C test, despite substantial lifestyle efforts and multiple medications. The CATALYST study explored whether hypercortisolism is a contributing factor in people with difficulty achieving A1C targets despite multiple medications. Hypercortisolism is a condition where the body produces too much cortisol, which can raise blood glucose. Part 1 of the CATALYST study, presented at the 84th Scientific Sessions, revealed that hypercortisolism may be a significant contributing factor in one in four patients with difficult-to-control diabetes. Patients with hypercortisolism presenting as uncontrolled type 2 diabetes physically appear the same as those without hypercortisolism, but they do seem to require more medications and have more complications. Part 2 of the CATALYST study was a randomized, prospective, placebo-controlled, double-blind multi-center trial designed to assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism who have difficult-to-control type 2 diabetes. 136 participants with hypercortisolism received either mifepristone or placebo over a 24-week period to assess the impact on glycemic control and other metabolic parameters. Mifepristone is a medication that reduces the effects of cortisol and is FDA approved for the treatment of elevated blood glucose in patients with hypercortisolism and prediabetes or type 2 diabetes. Mifepristone reduced A1C by 1.5% as compared to a reduction of 0.2% with placebo. The A1C reductions occurred even as many patients decreased or stopped other diabetes medications, including insulin. In addition, treatment of hypercortisolism with mifepristone was associated with nearly 10 pounds of weight loss and a reduction in waist circumference of more than two inches. "These findings demonstrate a potentially promising treatment solution for patients with difficult-to-treat type 2 diabetes and hypercortisolism, a patient population frustrated with poor results of their diabetes care," said John Buse, MD, PhD, from the University of North Carolina School of Medicine and one of the authors of the study. "By treating the root cause—excess cortisol—we saw meaningful improvements in both blood glucose and weight which could be game changing when it comes to managing type 2 diabetes." The authors note that results may translate to expanded screening for hypercortisolism in patients with type 2 diabetes. Future research is needed to understand whether patients with less advanced type 2 diabetes may experience similar benefits, if other cortisol-directed therapies offer similar results, and whether long-term treatment will provide benefits in preventing complications associated with inadequately controlled type 2 diabetes. Research presentation details:Dr. Buse will present the findings at the following symposium along with Drs. Ralph DeFronzo, Vanita Aroda, and Vivian Fonseca: Symposium: Treatment of Hypercortisolism in People with Difficult-to-Control Type 2 Diabetes—Final Results of the CATALYST Trial Presented on Monday, June 23 at 3:15 p.m. CT About the ADA's Scientific SessionsThe ADA's 85th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention, and care, will be held in Chicago, IL on June 20-23. Thousands of leading physicians, scientists, and health care professionals from around the world are expected to convene both in person and virtually to unveil cutting-edge research, treatment recommendations, and advances toward a cure for diabetes. Attendees will receive exclusive access to thousands of original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Join the Scientific Sessions conversation on social media using #ADASciSessions. About the American Diabetes Association The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to end diabetes and helping people thrive. This year, the ADA celebrates 85 years of driving discovery and research to prevent, manage, treat, and ultimately cure—and we're not stopping. There are 136 million Americans living with diabetes or prediabetes. Through advocacy, program development, and education, we're fighting for them all. To learn more or to get involved, visit us at or call 1-800-DIABETES (800-342-2383). Join us in the fight on Facebook (American Diabetes Association), Spanish Facebook (Asociación Americana de la Diabetes), LinkedIn (American Diabetes Association), and Instagram (@AmDiabetesAssn). To learn more about how we are advocating for everyone affected by diabetes, visit us on X (@AmDiabetesAssn). Media Contact: MCarmody@ View original content to download multimedia: SOURCE American Diabetes Association
Reuters
02-04-2025
- Health
- Reuters
Health Rounds: Semaglutide pill Rybelsus matches heart benefits of injectable versions
April 2 (Reuters) - (To receive the full newsletter in your inbox for free sign up here) Novo Nordisk's ( opens new tab diabetes medicine Rybelsus, an oral form of the GLP-1 drug semaglutide, provides similar cardiovascular benefits as the injectable forms of the drug, researchers reported at the American College of Cardiology scientific meeting in Chicago. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. In a trial of 9,650 patients with type 2 diabetes, who had clogged heart arteries and/or chronic kidney disease, those taking Rybelsus were overall 14% less likely to experience heart-related death, heart attack or stroke than those who received a placebo after an average follow-up of four years. The researchers saw a 26% reduction in non-fatal heart attacks with oral semaglutide and a 12% reduction in non-fatal strokes, both of which 'are among the most common and devastating complications of diabetes,' study coauthor Dr. John Buse of the University of North Carolina School of Medicine said in a statement. There was also a 7% lower rate of cardiovascular death with Rybelsus. This level of risk reduction is in line with results from eight previous trials involving injectable GLP-1s, such as Novo's Ozempic and Eli Lilly's (LLY.N), opens new tab Trulicity, said study leader Dr. Darren McGuire of UT Southwestern Medical Center and Parkland Health in Dallas. 'The same cardiovascular benefits can be derived from the tablet that we've seen from the injectables before,' McGuire said in a statement. Although the exact mechanism through which the drugs reduce cardiovascular risk is not known, their anti-inflammatory activity is thought to play a role. The most common side effects reported in the study that was also published in The New England Journal of Medicine, opens new tab were gastrointestinal problems such as nausea, diarrhea, constipation and gas, which are also the most common side effects of injectable semaglutide. 'Semaglutide has been a mainstay of our efforts to reduce heart attack and stroke in people with diabetes,' Buse said. 'Having an oral option to deliver this highly effective therapy is a big advance.' HEART FAILURE PATIENTS CAN STOP LIMITING FLUIDS Heart failure patients do not benefit from restricted fluid intake, according to findings that may contradict current practice. U.S. and European medical guidelines have long advised heart failure patients to limit their daily fluid intake to about six cups (1,500 milliliters), to help reduce fluid buildup in the lungs and extremities, but without much evidence to support this practice, researchers said at the ACC meeting. In the trial of 504 patients with mild to moderate heart failure, there was no difference in health status after three months between individuals with unrestricted fluid intake compared with patients assigned to fluid restriction. Nor were there any differences in safety outcomes, such as swelling or shortness of breath due to congestion from fluid overload in the body that occurs when the heart is too stiff or too weak to effectively pump blood, according to a report of the study published in Nature Medicine, opens new tab. Patients in the fluid restriction group reported more problems with thirst, however. There was a trend toward better health at three months among those with unrestricted fluid intake, but the difference between groups was not statistically significant and so could be due to chance. 'Our conclusion is that in patients with stable heart failure there is no need for fluid restriction,' study leader Dr. Roland van Kimmenade of Radboud University Medical Center in Nijmegen, Netherlands said in a statement. MINIMALLY INVASIVE HEART PROCEDURES IMPROVING IN LOW-RISK PATIENTS Physically fit patients who need heart procedures are traditionally referred for major surgery, but the benefits of minimally invasive procedures are starting to outweigh the disadvantages in these individuals, researchers reported at the ACC meeting. In a trial called FAME 3, 1,500 relatively healthy patients with blockages in three coronary arteries, but not in the left main artery known as the 'widow maker', were recruited between 2014 and 2019. They underwent either a percutaneous coronary intervention via a small incision through the skin, or coronary artery bypass grafting (CABG) surgery, which involves sawing through the breastbone and stopping the heart and requires weeks or months of recovery. None of the patients was at particularly high risk for complications from open-heart surgery. Researchers had earlier reported that one year into the study, the combined rate of death, stroke, heart attack, or need for a repeat procedure to reopen the arteries was higher in the minimally invasive group, suggesting the major surgery was still the best option for these patients. But now, five years out, there is no significant difference in the composite of death, stroke, or heart attack between the two groups, the researchers say. 'This is the only study to compare CABG and PCI as they are currently used in cardiology – incorporating recent advances in surgical and minimally invasive techniques as well as in medical therapy – in patients with triple-vessel disease,' study leader Dr. William Fearon of Stanford University School of Medicine in California said in a statement. Looking at the endpoints individually, rates of death and stroke were similar in the two groups, but PCI patients had higher risks for heart attack (8% vs 5%) and repeat revascularization (16% vs 8%) than the CABG group. The narrowing of the outcomes difference between the two approaches is likely due to improved stent technology, the routine use of new techniques for selecting which arteries to treat with PCI, and greater patient adherence to medical therapy, Fearon's team said in The Lancet, opens new tab. In a separate trial involving 1,478 relatively healthy patients who needed aortic valve replacement, rates of death or disabling stroke at five years were similar whether the valve was replaced through a small incision in the arm or via standard open-heart surgery, Dr. Michael Reardon of Houston Methodist Hospital and colleagues reported at the meeting and in the Journal of the American College of Cardiology, opens new tab. However, in a third study of 1,618 patients who were at intermediate or high risk for surgical complications – also reported at the meeting and in the Journal of the American College of Cardiology, opens new tab - five-year outcomes were significantly better after minimally invasive procedures than after surgery, Reardon's team said.
