Latest news with #GLP1RA
The Guardian
21 hours ago
- Business
- The Guardian
Weight loss drugs linked to higher risk of eye damage in diabetic patients
Weight loss drugs could at least double the risk of diabetic patients developing age-related macular degeneration, a large-scale study has found. Originally developed for diabetes patients, glucagon-like peptide-1 receptor agonist (GLP-1 RA) medicines have transformed how obesity is treated and there is growing evidence of wider health benefits. They help reduce blood sugar levels, slow digestion and reduce appetite. But a study by Canadian scientists published in Jama Ophthalmology has found that after six months of use GLP-1 RAs are associated with double the risk of older people with diabetes developing neovascular age-related macular degeneration compared with similar patients not taking the drugs. Academics at the University of Toronto examined medical data for more than 1 million Ontario residents with a diagnosis of diabetes and identified 46,334 patients with an average age of 66 who were prescribed GLP-1 RAs. Nearly all (97.5%) were taking semaglutide, while 2.5% were on lixisenatide. The study did not exclude any specific brand of drugs, but since Wegovy was only approved in Canada in November 2021, primarily for weight loss, it is likely the bulk of semaglutide users in the study were taking Ozempic, which is prescribed for diabetes. Each patient on semaglutide or lixisenatide was matched with two patients who also had diabetes but were not taking the drugs, who shared similar characteristics such as age, gender and health conditions. The researchers then compared how many patients developed neovascular age-related macular degeneration over three years. The study found that those who had been taking semaglutide or lixisenatide for at least six months had twice the risk of developing macular degeneration, compared with similar patients who were not taking the drugs. Patients who had been taking GLP-1s for more than 30 months had more than three times the risk. Diabetic patients who were older and/or had had a stroke had an even higher risk of developing macular degeneration if they were on these drugs, the authors found. Marko Popovic, a co-author of the study and physician in the department of ophthalmology and vision sciences at the University of Toronto, said: 'GLP-1 receptor agonists appear to have multiple effects on the eye, and in the case of neovascular age-related macular degeneration the overall impact may be harmful. 'Based on our data, I would advise exercising particular caution when prescribing GLP-1 receptor agonists to older [diabetic] patients or those with a history of stroke, as both groups were found to have an even higher risk of developing [the condition].' In an accompanying editorial, Brian VanderBeek, an associate professor of ophthalmology at the Hospital of the University of Pennsylvania, said the findings suggested that large numbers of patients could be affected. 'This suggests as many as one in 1,000 GLP-1 RA users could progress to new age-related macular degenaration over unexposed patients: if this risk was carried over millions of users, those affected could end up being a sizable group of patients,' he said. VanderBeek said work needed to be done to determine if this only affects patients with diabetes or if those taking these drugs for weight management or other indications are similarly at risk. 'While certainly not outweighing the good these medications offer, prescribing physicians need to keep in mind the real and serious ocular adverse events that may occur.' A spokesperson for Novo Nordisk, which manufactures Ozempic and Wegovy, said: 'Patient safety is our top priority and we take any report about an adverse event related to the use of our medicines very seriously. We work closely with authorities and regulatory bodies from around the world to continuously monitor the safety profile of our products. 'These medicines have been extensively examined in Novo Nordisk's robust clinical development programs, including randomised controlled trials, which to date have not shown any observable treatment difference compared to placebo for macular degeneration or age-related macular degeneration. Therefore, Novo Nordisk does not conclude a causal relationship between GLP-1 RA use, semaglutide and age-related macular degeneration at this time.' Dr Alison Cave, the chief safety officer of the MHRA, a UK watchdog, said: 'Macular degeneration is not currently listed as a potential side-effect of these medicines. However, we keep the safety of these medicines under close review, including emerging evidence from scientific publications, and will take appropriate action where necessary. On the basis of the current evidence, the benefits of GLP-1 RAs outweigh the potential risks when used for the licensed indications.'
Medscape
a day ago
- Health
- Medscape
GLP-1 RAs Linked to Doubled Risk for Macular Degeneration
Patients with diabetes using glucagon-like peptide 1 receptor agonists (GLP-1 RAs) may face more than twice the risk for developing neovascular age-related macular degeneration compared with those not using the medications, data from Canada showed. The risk appears to increase with longer exposure to the drugs. METHODOLOGY: Researchers conducted a population-based, retrospective cohort study using administrative data for 139,002 patients aged 66 years or older in Ontario, Canada, from January 2020 to November 2023. The researchers matched 46,334 patients who had received a GLP-1 agent (predominantly semaglutide) for at least 6 months 1:2 with patients who had not received this type of medication, based on factors such as age, gender, duration of diabetes, and comorbidities. They examined the incidence of new diagnoses of neovascular age-related macular degeneration during 3 years of follow-up. TAKEAWAY: Patients exposed to GLP-1 RAs showed a higher incidence of neovascular age-related macular degeneration than unexposed patients (0.2% vs 0.1%). Both unadjusted and adjusted Cox proportional hazard models estimated higher risk for neovascular age-related macular degeneration among patients exposed to GLP-1 medication (hazard ratio [HR], 2.11; 95% CI, 1.58-2.82; adjusted HR, 2.21; 95% CI, 1.65-2.96). In a sensitivity analysis, longer duration of exposure to a GLP-1 RA was associated with increased risk for neovascular age-related macular degeneration. IN PRACTICE: 'GLP-1 RAs have had a tremendous role in the care of patients with diabetes and now those needing additional help with weight management. However, the adage that 'there is no such thing as a free lunch' remains true,' wrote Brian L. VanderBeek, MD, MPH, with the Scheie Eye Institute at the University of Pennsylvania Perelman School of Medicine, Philadelphia, in an editorial accompanying the study. 'While certainly not outweighing the good these medications offer, prescribing physicians need to keep in mind the real and serious ocular adverse events that may occur.' SOURCE: Rajeev H. Muni, MD, with St. Michael's Hospital in Toronto, Ontario, was the corresponding author of the study, which was published online on June 5 in JAMA Ophthalmology . LIMITATIONS: The analysis did not stratify results by the type of GLP-1 RA prescribed or consider dose, route of administration, or frequency of administration. The researchers had limited information about variables like smoking and sun exposure. 'Further research is needed to determine if there is a true cause and effect relationship,' the study authors wrote. DISCLOSURES: Some of the researchers have received support from the Silver Target Foundation, the PSI Foundation, and Fighting Blindness Canada. Muni declared consulting for Alcon, Apellis, AbbVie, Bayer, Bausch Health, and Roche. His institution has received financial support from these companies.
Medscape
3 days ago
- Business
- Medscape
GLP-1 Less Frequent Dosing May Maintain Weight Loss
Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) administered at off-label reduced dosing maintained weight-loss benefits, with patients retaining the effects even with 2-4 weeks between doses. METHODOLOGY: GLP-1 RAs are transforming obesity treatment, but high costs and shortages limit patient access. Clinicians have suggested a less frequent dosing to maintain weight loss, but evidence supporting its effectiveness is lacking. Researchers used a combination of real-world case reports and mathematical modeling to examine the efficacy of a less frequent dosing of GLP-1 RAs for weight maintenance. They analyzed the data of two patients who used GLP-1 RAs at less frequent dosing schedules than recommended; patient 1 with obesity and prediabetes self-administered 7.5 mg tirzepatide every 10-14 days, whereas patient 2 with uncontrolled type 2 diabetes managed intermittent dosing of 15 mg tirzepatide due to supply shortages. A mathematical pharmacokinetic-pharmacodynamic model was used to simulate long-term changes in body weight of virtual patients administered semaglutide and tirzepatide at various dosing intervals. Simulations modeled semaglutide (2.4 mg) or tirzepatide (5 mg, 10 mg, or 15 mg) as a once-weekly dosing for 120 weeks, after which the 7-day dosing interval was increased to 10, 14, or 28 days or retained. TAKEAWAY: Patient 1 achieved an additional 13.7% body weight loss over 7 months and maintained it thereafter. Patient 2 lost 30% of her body weight and safely stopped insulin; even with intermittent dosing of tirzepatide, she retained a 22.8% body weight loss from baseline. Mathematical modeling predicted that switching from one dose per week to one dose every 2 weeks maintained 72% and 78% of the body weight loss achieved with 2.4 mg semaglutide and 15 mg tirzepatide, respectively. Even monthly dosing may have preserved half of the body weight loss achieved with weekly dosing, demonstrating that the reduction in efficacy was not proportional to the reduction in dosing frequency. IN PRACTICE: 'Future studies are needed to identify patient factors that predict a more favorable response to less frequent dosing of incretin mimetics and to examine the long-term clinical outcomes achieved through this approach compared with other off-ramping options (eg, switching to alternative AOMs [anti-obesity medications]),' the authors wrote. SOURCE: This study was led by Calvin C. Wu, Tono Health, Brooklyn, New York. It was published online in Obesity . LIMITATIONS: No limitations were provided for this study. DISCLOSURES: Two authors reported receiving funding from the National Science Foundation. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. Credit Lead image: KKfotostock/Dreamstime Medscape Medical News © 2025 WebMD, LLC Cite this: Edited by Javed Choudhury. GLP-1 Less Frequent Dosing May Maintain Weight Loss - Medscape - June 03, 2025.
Medscape
21-05-2025
- Health
- Medscape
New Data on GLP-1 RAs and Psychiatric Side Effects
Treatment with glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for weight loss or diabetes management doesn 't raise the risk for adverse psychiatric events and improves quality of life (QOL) in people with no history of mental illness, a large new review has found. The results, gleaned from placebo-controlled trials involving over 100,000 participants, are important given recent concerns about an increased risk for suicidality, self-injury, and psychiatric adverse events in people prescribed GLP-1 RAs. Toby Pillinger, PhD 'Our analysis of data from a large number of clinical trials shows that GLP-1 RAs are not only safe from a psychiatric perspective but may improve mental health outcomes. As the use of these medications continues to grow, our findings provide important reassurance to patients and clinicians alike that these treatments can support both body and mind,' investigator Toby Pillinger, PhD, clinical lecturer, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, England, told Medscape Medical News . However, patients with serous psychiatric diagnoses were excluded from reviewed studies, so the findings may not completely settle the question of whether GLP-1 RAs impact mental illness in all individuals, Pillinger added. The findings were published online on May 14 in JAMA Psychiatry . 'Reassuring' Findings GLP-1 RAs are highly effective in treating obesity and type 2 diabetes, and there's some evidence they're also beneficial for patients with type 1 diabetes. However, a few meta-analyses of randomized clinical trials have examined their psychiatric effects. The analysis included 107,860 adults (mean age, 60 years; 40% women) enrolled in 80 randomized double-blind controlled trials that compared mental health outcomes between those treated with a GLP-1 RA and those treated with a placebo. About 62% of the studies included patients with type 2 diabetes, while 29% of those had patients with overweight or obese, and 9% enrolled those with type 1 diabetes. The most studied drug was liraglutide (30% of studies), followed by semaglutide (24.7%). Studies that included participants with preexisting psychiatric or neurologic disorders such as Alzheimer's disease were excluded. The analysis found no significant difference in rates of serious psychiatric adverse events (log risk ratio [logRR], −0.02; 95% CI, −0.20 to 0.17; P = .90, with moderate certainty) or of nonserious psychiatric adverse events (logRR, −0.03; 95% CI, −0.21 to 0.16; P = .76, with low certainty) between GLP-1 RAs and placebo. GLP-1 RA treatment was associated with significantly improved restrained eating and reduced emotional eating. This finding, said the authors, was expected given the medications have known satiety-inducing effects leading to reduced food intake. 'Overall, our results provide reassurance regarding the psychiatric safety profile of GLP-1 RAs and suggest that GLP-1 RA treatment is associated with improved mental well-being, in addition to the known physical health improvements,' investigators wrote. Improved QOL The analysis also found GLP-1 RA treatment positively affected several aspects of QOL relative to placebo, including improved mental health ( P < .001), physical health ( P < .001), diabetes-related QOL ( P < .001), weight-related QOL ( P < .001), and overall QOL ( P = .01), all with moderate certainty. There were greater improvements in physical health–related QOL in women and younger patients. 'The reason for this is unclear, and these results should be interpreted cautiously,' said Pillinger, adding the analysis wasn't based on individual patient data, which limited the ability to explore the full range of contributing factors. Interestingly, the analysis didn't uncover a relationship between QOL and the amount of weight loss or degree of improved blood sugar control. Pillinger speculated that in addition to the impact losing weight or optimizing diabetes control can have on self-esteem and well-being, a neurobiological mechanism may also be at play. 'One possibility is that GLP-1 RAs exert direct effects on the brain, particularly within regions involved in mood and reward processing,' said Pillinger. 'These central pathways may influence emotional well-being independently of physical health improvements.' There was no clear evidence of an association between GLP-1 RA treatment and cognitive outcomes, likely owing to the small number of studies. Sensitivity analyses looking at different GLP-1 RA doses relative to placebo yielded results similar to the main analysis. This was also the case for an analysis excluding studies of patients with type 1 diabetes, although due to the limited number of related trials, it's impossible to draw firm conclusions concerning type 1 diabetes, said Pillinger. 'More research specifically in people with type 1 diabetes is needed to determine whether the psychiatric and quality-of-life effects of GLP-1 receptor agonists are consistent across diabetes subtypes,' he said. As researchers didn't perform separate meta-analyses for individual drugs, more head-to-head studies are needed to determine whether some GLP-1 RA agents are more beneficial than others. 'For now, the evidence supports a broadly reassuring psychiatric safety profile across commonly used GLP-1 RAs,' Pillinger said. While this new analysis found no relationship between GLP-1 RAs and adverse psychiatric outcomes, previous studies have. Pillinger explained that people living with obesity and diabetes already have a higher baseline risk for psychiatric symptoms, including depression and suicidal ideation. 'Previously observed signals of suicidality may reflect this underlying vulnerability in the patient population rather than an effect of the drug itself,' he said. Included studies didn't collect data on a broader range of psychiatric symptoms, such as changes in energy or activity levels, sleep, and obsessional symptoms. Another limitation was that mental health effects were secondary rather than primary outcomes of included studies. Questions Remain Reached for comment, Mahavir Agarwal, MD, PhD, associate professor, Department of Psychiatry, University of Toronto, and medical head of Clinical Research, Schizophrenia Division, Center for Addiction and Mental Health, both in Toronto, Ontario, Canada, said the review shows 'fairly well' that psychiatric issues 'are unlikely to be a common side effect' of GLP-1 RAs. However, Agarwal reiterated that studies that enroll people with diabetes or obesity, like those included in the review, typically exclude anyone with a severe mental illness, so the study cohorts are generally a relatively 'mentally healthy' population. Agarwal and his colleagues are conducting a study of these drugs in people with schizophrenia who have gained weight while taking antipsychotics. It is one of several such projects underway to investigate the effects of GLP-1 RAs in people with psychiatric illnesses and addiction. Importantly, said Agarwal, side effects and responses to these relatively new drugs may vary from patient to patient. 'What happens at an individual level is still unpredictable, and therefore, clinicians should still be on guard.' Indeed, there is some reported evidence of people with depression or anxiety actually experiencing worsening symptoms while on these weight-loss drugs, noted Paul Keedwell, MBChB, PhD, consultant psychiatrist and fellow of the Royal College of Psychiatrists, London, England, said in a statement from the nonprofit Science Media Centre. '(F)or most people, these drugs seem mentally safe, and may even help mood, but for those with a history of mental illness, there may be a risk,' Keedwell said. 'More research is needed, and anyone with past mental health issues should speak with a doctor before starting them.'
Yahoo
19-05-2025
- Business
- Yahoo
Novo Nordisk's CEO to step down as weight loss market share plummets
Novo Nordisk is parting ways with its CEO Lars Fruergaard Jørgensen after the two parties mutually agreed that a change of leadership was required amid fierce glucagon-like peptide 1 receptor agonists (GLP-1RA) market pressure from Eli Lilly. It is a significant moment for the Danish company, which has been a major catalyst for the growth in the weight loss and type 2 diabetes (T2D) drug markets with its popular products Wegovy (semaglutide) and Ozempic (semaglutide), respectively. Shares in the Copenhagen-listed company dropped 4.3% at market close in the aftermath of the announcement on 16 May. Stock was still down by Monday morning (19 May). Novo Nordisk did not provide a timeline for revealing its new CEO, saying only that the search for a successor is ongoing. Jørgensen will continue at the helm of the drugmaker to support a smooth transition to new leadership. Despite early success, however, Novo Nordisk has fallen behind in the GLP-1RA race, overtaken by Eli Lilly and its GLP-1RA asset tirzepatide, respectively sold under the brand names Zepbound and Mounjaro for weight loss and T2D. Novo Nordisk won the race as the first US Food and Drug Administration (FDA)-approved GLP-1RA with Ozempic in 2017, followed by Wegovy in 2021. Eli Lilly was never far behind, though, gaining approval for Mounjaro in 2022 and Zepbound in 2023. Whilst announcing Jørgensen's departure, Novo Nordisk pointed to a market squeeze by rivals, without mentioning Eli Lilly by name. 'The changes are made in light of the recent market challenges Novo Nordisk has been facing, and the development of the company's share price since mid-2024,' the company stated in a press release. During an eight-year tenure, Jørgensen had helped steer the company to be one of the biggest drugmakers in the world. Novo Nordisk even became Europe's largest company for a while, boasting a peak market cap of $604bn. However, dwindling share price meant the company lost its crown to German tech giant SAP in March 2025. Shares in Novo Nordisk have fallen more than 50% – down to $66.15 from a high of around $133 – over the past 12 months as tirzepatide continued to show better clinical data than semaglutide. In a head-to-head comparison between the two drugs, patients taking tirzepatide underwent 47% more relative weight loss than those taking semaglutide. It was a major win for Eli Lilly, giving the company a solid platform to advance into a dominant market position. Analysis by GlobalData in January 2025 demonstrated that tirzepatide was outpacing semaglutide in the obesity market, the former having a higher sales forecast by 2031. Last year, Eli Lilly's sales grew 32% compared to 26% for Novo Nordisk. 'Considering the recent market challenges, the share price decline, and the wish from the Novo Nordisk Foundation, the Novo Nordisk Board and Lars Fruergaard Jørgensen have jointly concluded that initiating a CEO succession is in the best interest of the company and its shareholders,' Novo Nordisk added in a statement. Novo Nordisk has also struggled with its next-generation GLP-1RA Cagrisema (cagrilintide/semaglutide), which produced disappointing Phase III data. The company has also slashed its 2025 forecast amid market challenges, both from Eli Lilly and the compounding sector. The company cut its sales growth to a range of 13%-21%, compared to earlier guidance of 16%-24%, as per its Q1 earnings report. Operating profit growth is forecast at 16%-24%, also down from a previous range of 19%-27%. "Novo Nordisk's CEO to step down as weight loss market share plummets" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
