Latest news with #semaglutide
Medscape
17 hours ago
- Health
- Medscape
ACC Revises Obesity Control Strategies in Heart Failure
A new Scientific Statement from the American College of Cardiology (ACC) has named two anti-obesity drugs as options for symptom control in patients with heart failure. The benefit for these incretin mimics, semaglutide and tirzepatide, is attributed to symptom control, according to the statement. The document, published on June 13 in the Journal of the American College of Cardiology , states that each medication has the potential to reduce cardiovascular (CV) events related to heart failure, but neither has yet done so on the basis of level 1 evidence. The new recommendation appl ies only to heart failure with preserved ejection fraction (HFpEF). The safety and efficacy of these drugs has yet to be established for heart failure with reduced ejection fraction (HFrEF), according to the ACC statement. The new anti-obesity drugs were approved initially for type 2 diabetes. On the basis of substantial weight loss and their relative safety, the FDA subsequently granted indications for obesity alone in patients with at least one additional obesity-related comorbidity, such as hypertension, dyslipidemia, or obstructive sleep apnea. Current Indications for Incretin Mimetics Semaglutide has an indication for patients with CV disease, but not heart failure specifically, and obesity on the basis of the 2023 SELECT trial. Tirzepatide has an indication for patients with sleep apnea and obesity in the absence of diabetes on the basis of the 2024 SURMOUNT-OSA trial. In the 2023 STEP-HFpEF trial with semaglutide and the 2025 SUMMIT trial with tirzepatide, each agent was associated with a reduction in symptoms of heart failure in patients with HFpEF. However, the study designs and outcomes differed. For one, the HFpEF entry criterion was a left ventricular ejection fraction ≥ 45% in STEP-HFpEF but ≥ 50% in the SUMMIT trial. In dual primary endpoints, both included changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ), but the first of the two trials evaluated weight change, while the second evaluated a composite endpoint of CV death and heart failure-related events. By listing semaglutide and tirzepatide as options within a comprehensive review of the treatment of obesity in heart failure, the new document steps in front of current regulatory guidance. In a table that juxtaposed FDA-approved indications for these drugs to evidence-based benefits as defined by the statement, only the latter identifies a role in heart failure. 'The intent of the Writing Committee in including this table was to highlight that there are no FDA-approved heart failure indications for the use of incretin-based anti-obesity medications to date,' said Michelle M. Kittleson, MD, PhD, director of Heart Failure Research at Cedars-Sinai Medical Center in Los Angeles, who chaired the committee. 'While clinicians might identify individuals with heart failure who meet the standard FDA-approved indications, it is important to also identify which of those patients also meet inclusion criteria for th e heart failure trials were benefit was shown,' Kittleson said. Semaglutide acts on the GLP-1 receptor alone. Tirzepatide is an agonist of both the GLP-1 receptor and glucose-dependent insulinotropic polypeptide. Both drugs are associated with strong signals of CV benefit overall and in heart failure specifically, even if the evidence in HFpEF is 'stronger,' according to the statement. Incretin drugs mimic hormones that downregulate appetite. They are considered third-generation anti-obesity agents on the basis of their targeted mechanism and a low relative risk for adverse events. More than a dozen such agents are now in various stages of development, according to the ACC statement. Semaglutide and Tirzepatide Trials Differ In the STEP-HFpEF trial, which like SUMMIT trial, was placebo controlled, the 7.8-point gain ( P <.0001) in the KCCQ on active therapy vs placebo was statistically significant, as was the percent body weight loss (-13.3% vs -2.6%; P < .001). The SUMMIT trial found a 6.9-point gain in the KCCQ score ( P < .001) relative to placebo, while the rate the composite event endpoint of CV death from events associated with heart failure was lower (9.9% vs 15.3%; P = .026), but CV deaths occurred in only 13 patients. Heart failure events were observed in 81 patients over 2 years of follow-up. In both studies, significant gains in the secondary endpoints of physical and exercise function were associated with the assigned weight-loss drug. On the evidence so far, the authors of the ACC statement concluded that despite the marginal benefit observed in the SUMMIT trial, no firm conclusions can be made about the ability of incretin therapies to protect patients with HFpEF against hard endpoints, Kittleson said. Until more data are available, she cautioned against the risk for 'indication creep,' the willingness to offer these drugs for potential benefits that have yet to be confirmed. Still, she added, 'the goal of the writing group was to strike a tone of cautious optimism guided by the available data.' Part of this optimism has been fueled by the 2023 SELECT trial, which enrolled more than 17,000 patients with overweight with CV disease but no diabetes. Relative to placebo, semaglutide was associated with a 20% reduction ( P < .001) in the composite primary endpoint of CV death, nonfatal myocardial infarction, and nonfatal stroke. Only 24% of patients in this study had heart failure, but the risk reduction in this group was consistent with that of the study population as a whole. Obesity is listed in most guidelines, including a 2024 ACC Expert Consensus Decision Pathway for Treatment of HFrEF, as a common comorbidity of heart failure and potentially treatable risk factor for symptoms and progression of the condition. However, the new statement differs from prior guidelines. Typically, lifestyle modifications are identified as a first step toward weight loss. 'Patients should not be required to try and fail lifestyle changes prior to initiating pharmacotherapy,' according to Olivia Gilbert, MD, a cardiologist specializing in advanced heart failure and transplantation at Atrium Wake Forest Baptist Medical Center, in Wake Forest, North Carolina. Although Gilbert was not part of the writing committee for the new document, she has been involved in developing clinical guidance statements for the ACC. The incretin therapies are more effective than lifestyle medications and safer than procedure-based weight-loss interventions, Gilbert said, providing a basis for suggesting they can be considered first line therapy for patients with symptomatic HFpEF. 'Lifestyle interventions should always be offered in conjunction with obesity medications,' she said.
Medscape
3 days ago
- Health
- Medscape
Blind Spots: Comparing the Vision Costs of Weight-Loss Drugs
While reviewing patient cases with residents one morning, Joseph F. Rizzo III, MD, mentioned he recently cared for a patient who had taken semaglutide and developed severe optic neuropathy. One resident reported that she had just seen a patient in the emergency room with a similar history, presenting with the same eye condition. A week later, Rizzo saw yet another one of these patients. 'It seemed improbable that it would just be a coincidence,' Rizzo, director of Neuro-Ophthalmology Service at Massachusetts Eye and Ear, a teaching hospital of Harvard Medical School in Boston, told Medscape Medical News . Eventually, Rizzo and several residents published research of patients at the clinic. It was the first study to show an association between the use of semaglutide and nonarteritic anterior ischemic optic neuropathy (NAION), according to the American Academy of Ophthalmology. Weight-loss drugs are known to affect vision in a small subset of patients. Labeling for GLP-1 receptor agonists such as semaglutide and tirzepatide include warnings about the increased risk for diabetic retinopathy in patients with type 2 diabetes. The label for the combination of phentermine and topiramate warns of a risk for acute myopia and secondary angle-closure glaucoma, and the label for the combination of naltrexone and bupropion lists the risk for angle-closure glaucoma. But which drug carries the lowest risk for vision complications remains a tricky question. 'Nobody has really done any true head-to-head comparisons of' the weight-loss drugs, said Mollie Cecil, MD, a spokesperson for the Obesity Medicine Association. All weight-loss drugs have the potential to change the shape of the eye lens, which can cause transient blurring of vision. They also can worsen diabetic retinopathy due to a dramatic drop in blood sugar and increase the risk for blindness from NAION, said Rahul N. Khurana, MD, a spokesperson for the American Academy of Ophthalmology and an ophthalmologist at Northern California Retina Vitreous Associates in Mountain View, California. 'I don't think we have enough data to say one drug is safer than the other,' he said. A Shifting Vision of GLP-1 Receptor Agonists Rizzo and his colleagues' study published in JAMA Ophthalmology in July 2024 included nearly 2000 patients with type 2 diabetes or obesity. Those who took semaglutide had a four to seven times higher risk for NAION than those who did not take GLP-1 receptor agonists. Rizzo said one limitation of the study was selection bias because patients were cared for at an eye hospital staffed by neuro-ophthalmologists, which was more likely to have patients with NAION. His team recently finished a nationwide study analyzing data on the same subject that has not yet been published, he said. Numerous studies published since then have shown conflicting results, including a lower or higher risk for NAION than that reported in Rizzo's research or no increase in risk. After Rizzo's study was published, the American Academy of Ophthalmology and other groups said further research was necessary to definitively say whether the drug causes NAION. The groups did not recommend that patients stop taking semaglutide unless they had a sudden loss of vision. The use of GLP-1 receptor agonists has also been associated with other vision problems. A recent study found patients with diabetes taking these drugs had a twofold higher risk for neovascular age-related macular degeneration than a matched cohort of patients who did not take a GLP-1 receptor agonist. But the newer class of drugs may be safer for other patients, such as those who have obesity and do not have diabetes. A retrospective cohort study published earlier this year in Ophthalmology found the risk for primary open-angle glaucoma and ocular hypertension was significantly lower in this population of patients taking GLP-1 receptor agonists than in those taking other weight-loss medications, such as the combination of phentermine and topiramate. 'I don't really think any of these are better for vision, although there is evidence that GLP-1 agents may be protective against glaucoma,' said Angelo Tanna, MD, vice chair of the Department of Ophthalmology at Northwestern University Feinberg School of Medicine in Chicago. Older Drug, New Insights Approved by the FDA in 1959 for the treatment of obesity, phentermine is the most commonly prescribed weight-loss drug in the US, according to a study published in January in JAMA Open Network . Katherine Talcott, MD, a vitreoretinal surgeon at the Cole Eye Institute at the Cleveland Clinic in Cleveland, said some data suggest GLP-1 receptor agonists can worsen diabetic retinopathy. She and her colleagues had not seen a study on the effect of phentermine having the same effect, so they set out to do so in patients with overweight and obesity. Their study found phentermine was associated with a decreased future risk for a new diagnosis of diabetic retinopathy or the need for intravitreal anti-VEGF injections. 'It's great that there's an additive protective effect by being on the medicine,' she said. However, phentermine is also associated with blurred vision and serious ocular side effects, with case reports of branch retinal artery occlusion, acute myopia and acute angle closure, and NAION. Topiramate and Angle Closure Tanna at Northwestern University said ocular adverse events associated with weight-loss drugs are rare but can have devastating consequences. Tanna co-authored a 2015 case report in the Journal of Glaucoma of bilateral angle closure in a woman who took the combination of phentermine and topiramate. He said he has seen a handful of cases of this rare reaction in patients taking topiramate, but this was the only case in which the drug was being used for weight loss. A study analyzing the FDA Adverse Event Reporting System (FAERS) database found that topiramate was 30% more likely to be associated with reports of vision impairment than semaglutide. Vision impairment included optic ischemic neuropathy, blindness, and reduced visual acuity. Another study, published last year in Ophthalmology Glaucoma , identified topiramate with the most reports of angle-closure glaucoma in the FAERS database over a 20-years period. A case report in 2014 also documented bilateral angle-closure glaucoma induced by topiramate several days after initiation of the drug. The combination of naltrexone and bupropion for weight loss also has been associated with this adverse event, along with bupropion alone for depression. Choosing a Drug Cecil said she considers several factors when deciding which weight-loss drug to prescribe, including a patient's preexisting eye health. 'If you have somebody who has not yet developed peripheral vascular disease or diabetes, without compelling evidence I think that all weight-loss drugs would have about the same safety,' she said. But insurance coverage and affordability are often the biggest drivers of her decisions. 'If I didn't have to worry about insurance, I really would lean on the GLP-1s for most patients because they are safe, they are effective, and we are discovering more and more secondary benefits to them all the time, including decrease in cardiovascular disease,' Cecil said. Rizzo said he does not discourage patients from taking semaglutide. But he urges caution for patients who have already lost vision for any reason. 'They have to make their own informed decision about whether they might be willing to accept what we believe is an increased risk,' he said. Cecil noted that for patients with complicated chronic diseases, clinicians must be careful not to blame a drug when a patient develops an eye condition that may be related to their disease state. 'That's one of the reasons why in obesity medicine, we talk so much about how important it is to really, truly have an individualized treatment plan,' she said. Rizzo reported being a consultant for Life Biosciences, machineMD, and Viridian Therapeutics. Tanna reported being a consultant for Alcon, Ivantis, and Zeiss. Other sources reported having no relevant financial conflicts of interest.
Yahoo
3 days ago
- Health
- Yahoo
Researchers Discover Drugs Like Ozempic Aren't as Effective Outside of Clinical Trials
Unless you've been living under a rock, you've probably heard the buzz about weight-loss drugs like Ozempic. Some people think they're a positive scientific breakthrough that can help folks with obesity; others are concerned about their side effects. No matter where you stand, you won't stop hearing about them any time soon. They're becoming a more common treatment for weight loss for everyone from celebrities to your neighbor down the street. But according to a new study from the Cleveland Clinic, semaglutides and tirzepatide—two of the most popular GLP-1 drugs—might not be as effective as scientists originally though, particularly when they're used outside research settings. The study, published in the Obesity Journal, found that people on GLP-1 medications tend to lose less weight outside of clinical trials, mostly because they don't stay on the drugs as long or use lower maintenance doses than those prescribed in research settings. 'Our study shows that patients treated for obesity with semaglutide or trizepatide lost less weight on average in a regular clinical setting compared to what is observed in randomized clinical trials," said lead author of the study Hamlet Gasoyan, Ph.D. "According to our data, this could be explained by higher rates of discontinuation and lower maintenance dosages used in clinical practice, compared to randomized clinical trial settings.' For the study, researchers looked at almost 8,000 adults with clinically-severe obesity, including over 1,300 with prediabetes. Between 2021 and 2023, all participants took either semaglutide or tirzepatide. Researchers tracked how long participants stayed on the medications as well as how much weight they 2024, the researchers broke the participants into two groups: those who discontinued treatment early (within three months of starting) or late (between three and 12 months of starting). Turns out, a lot of people didn't stick with the medication. More than 20 percent of participants stopped early, and another 32 percent stopped within a year. On top of that, over 80 percent of participants were taking lower-than-recommended maintenance doses. As you might've guessed, the longer people stayed on the drugs, the better the results. Those who ditched early lost just 3.6 percent of their body weight, while those who hung on a bit longer dropped about 6.8 percent in a year. But the real transformation came from patients who stuck with it—they lost around 11.9 percent. And when they combined that consistency with higher maintenance doses? Weight loss jumped to 13.7 percent with semaglutide and a hefty 18 percent with tirzepatide. Researchers didn't just look at weight loss either—they also tracked blood sugar levels in people who had prediabetes at the start of the study. And just like with weight, sticking with the meds for a longer period of time made a big difference. Only 33 percent of people who quit early saw their blood sugar return to normal. That went up to 41 percent for those who stayed on a bit longer. But for the people who stuck with treatment? Nearly 68 percent hit healthy blood sugar levels. 'Our findings about the real-world use patterns of these medications and associated clinical outcomes could inform the decisions of healthcare providers and their patients on the role of treatment discontinuation and maintenance dosage in achieving clinically meaningful weight reductions,' said Gasoyan. Researchers Discover Drugs Like Ozempic Aren't as Effective Outside of Clinical Trials first appeared on Men's Journal on Jun 17, 2025
Times
3 days ago
- Health
- Times
The expert guide to avoiding ‘Ozempic face'
Y ou're on the weight-loss jabs. You've turned the corner. Finally your trousers are falling off. The jabs work, hurrah! But then you look in the mirror and it dawns on you: the fat pads on your face have also handed in their resignation. Less hurrah. Welcome to Generation Ozempic Face. I am approaching this column with caution. Not because this subject is niche any more, but precisely because it's not. The list of people on semaglutide (Ozempic and Wegovy) and tirzepatide (Mounjaro) is growing by the day. Some are hush-hush about it. 'I'm just not that hungry,' one friend muttered, moving salad leaves around her plate. Whereas others are eyes-wide proud: 'Why are people talking about how skinny I am behind my back? It's my dream to be spoken about for being thin,' another chuckled.
Medscape
3 days ago
- Health
- Medscape
Bariatric Surgery Beats GLP-1 RAs for Sustained Weight Loss
Patients who underwent bariatric surgery experienced an approximately five times greater weight loss over 3 years than those who used weekly injections of GLP-1 receptor agonists (RAs) such as semaglutide and tirzepatide. METHODOLOGY: The use of GLP-1 RAs has surged over the years, but semaglutide and tirzepatide have rarely been directly compared with bariatric surgery, the gold standard for obesity and diabetes treatment. Researchers conducted a retrospective study using electronic health records to compare the weight-loss effects of injectable GLP-1 RAs (semaglutide or tirzepatide) with those of bariatric surgery on adults with BMI ≥ 35. They analyzed data of 38,545 patients who received GLP-1 RAs and 12,540 patients who underwent bariatric surgery via minimally invasive sleeve gastrectomy or Roux en-Y gastric bypass between 2018 and 2024. Percent total weight loss was compared over a 3-year follow-up period. TAKEAWAY: Patients who received GLP-1 RAs had significantly higher rates of diabetes, hyperlipemia, and chronic obstructive pulmonary disease than those who underwent surgery. After 3 years, patients who underwent bariatric surgery experienced a 23.3% total weight loss (95% CI, -23.5 to -23.1), whereas those who used GLP-1 RAs had a 4% total weight loss (95% CI, -4.1 to -3.8). Patients who used GLP-1 RAs continuously for 1 year lost 5.9% of their total weight, but weight loss was still significantly greater in those who underwent bariatric surgery (22.2%). IN PRACTICE: 'Clinical trials show weight loss between 15% to 21% for GLP-1s, but this study suggests that weight loss in the real world is considerably lower even for patients who have active prescriptions for an entire year. We know as many as 70% of patients may discontinue treatment within 1 year. GLP-1 patients may need to adjust their expectations, adhere more closely to treatment, or opt for metabolic and bariatric surgery to achieve desired results,' said the lead author in a news release. SOURCE: This study was led by Avery Brown, MD, a surgical resident at NYU Langone Health in New York City. It was presented on June 17, 2025, at the American Society for Metabolic and Bariatric Surgery 2025 Annual Scientific Meeting at the Gaylord National Resort & Convention Center in National Harbor, Maryland. LIMITATIONS: The authors did not report any specific limitations. DISCLOSURES: This study received support from a NYU Clinical and Translational Science Awards grant from the National Center for Advancing Translational Sciences and another grant from the National Institute of Allergy and Infectious Diseases.
