Lixisenatide

London: Adding Roche's immunotherapy drug Tecentriq to chemotherapy after surgery in certain patients whose colon cancer had spread to the lymph nodes led to a 50 per cent reduction in cancer recurrence and death compared to chemotherapy alone, according to trial data presented at recent medical meeting. Patients in the study had tumors with a genetic defect known as deficient DNA mismatch repair, or dMMR. About 15 per cent of colon cancer patients have dMMR tumors , which do not respond well to chemotherapy. "The findings from our study represent a major advance in the adjuvant treatment of dMMR stage 3 colon cancer and will now change the treatment for this type of cancer," study leader Dr. Frank Sinicrope of the Mayo Clinic in Rochester, Minnesota said in a statement. The data were presented at the ASCO meeting that concluded earlier this week. The trial enrolled 712 patients with dMMR stage 3 colon cancer that had been surgically removed and who had cancer cells in their lymph nodes. Half of the study participants received chemotherapy along with Tecentriq, which activates the immune system to attack and kill cancer cells, for six months, followed by the immunotherapy alone for another six months. The other half of the patients received chemotherapy for 12 months. The benefit of Tecentriq was seen even in the oldest patients and those at particularly high-risk. "It's extremely rewarding to be able to offer our patients a new treatment regimen that can reduce the risk of recurrence and improve their chances of survival," Sinicrope said. ASPIRIN MAY NOT BE BEST LONG-TERM OPTION AFTER HEART PROCEDURE As patients recover after a minimally invasive heart procedure, they might be better off continuing to take a certain type of blood-thinning drug to help prevent a heart attack or stroke, instead of continuing with the traditional aspirin, a new study suggests. Early after percutaneous coronary intervention (PCI) - a procedure to prop open blocked arteries either after a heart attack, or to prevent one - patients often receive dual anti-clotting therapy with both a P2Y12 inhibitor such as clopidogrel, the generic version of Plavix, or AstraZeneca's Brilinta (ticagrelor), and aspirin. After several months, patients are usually switched from dual therapy to lifelong daily aspirin use. But pooled data looking at patients who took part in five earlier clinical trials found that continuing to prescribe the P2Y12 inhibitors and stopping the aspirin was associated with lower rates of death, heart attack and stroke compared with continuing the aspirin, with no increased risk of major bleeding, researchers reported in The BMJ. Overall, the trials involved 16,117 patients who received either a P2Y12 inhibitor or aspirin after completing dual therapy following PCI. After an average follow-up period of around 4 years, P2Y12 inhibitor therapy was associated with a 23% lower risk of a composite of heart-related death, heart attack, or stroke, compared with aspirin, with no significant difference in major bleeding. That translates into one prevented cardiovascular death, heart attack, or stroke for every 46 patients taking a P2Y12 inhibitor instead of aspirin after dual therapy. Overall, the findings suggest that P2Y12 inhibitor drugs should be preferred over aspirin "due to reductions in major adverse cardiac and cerebrovascular events without increasing major bleeding in the medium term," according to an editorial published with the study. But the editorial said that since patients are advised to continue the post-PCI therapy for life, large trials directly comparing the different strategies with longer follow up are needed. LONG-TERM GLP-1 USE LINKED TO HIGHER RISK OF AGE-RELATED EYE DISEASE Some diabetes and weight-loss drugs from the class known as GLP-1 agonists were linked with a small but elevated risk for an age-related eye disease in patients with diabetes, according to a study published on Thursday in JAMA Ophthalmology. In 139,000 patients with diabetes, including 46,334 who had been using the GLP-1 drugs semaglutide or lixisenatide, researchers identified 181 new cases of neovascular age-related macular degeneration, also known as wet AMD. Wet AMD is a degenerative eye disease marked by the abnormal growth of blood vessels under the retina that leak fluid or blood and can lead to blindness. The risk of developing AMD during up to three years of follow-up was low, at 0.2% in GLP-1 users versus 0.1% in non-users. Still, the researchers point out, after accounting for patients' individual risk factors, the odds of AMD were doubled with at least six months of GLP-1 use and tripled in patients with the longest duration of use. Semaglutide is the active ingredient in the widely used Novo Nordisk drugs Ozempic and Wegovy, while lixisenatide is the main ingredient in Sanofi's discontinued Adlyxin. GLP-1 drugs have also been associated with higher risks for an eye condition known as nonarteritic anterior ischemic optic neuropathy, or NAION. Researchers did not have information about the dose, route of administration, or frequency of administration of the medications used in the study. Even with that information, the study could not have proved cause and effect. At least one earlier study with longer follow up reported that GLP-1 use was linked with a lower, rather than higher, risk for AMD. "Our findings are not directly contradictory" with that earlier report, said study leader Dr. Reut Shor of the University of Toronto. "Factors such as timing and duration of exposure, disease stage, and patient characteristics may all influence outcomes," Shor said. "Our results add another layer to the emerging understanding of this complex relationship and emphasize the need for further research to clarify these trends." (To receive the full newsletter in your inbox for free sign up here) (Reporting by Nancy Lapid; additional reporting by Shawana Alleyne-Morris; editing by Bill Berkrot)

New findings come after a previous study linked GLP-1 use to a potential risk of developing nonarteritic anterior ischemic optic neuropathy. Researchers have zeroed in on yet another possible ocular concern for diabetes patients who take popular GLP-1 therapies.A recent study, published in JAMA Ophthalmology and conducted by University of Toronto researchers, found that diabetes patients who use GLP-1 drugs were twice as likely to develop neovascular age-related macular degeneration (nAMD) compared to their peers who don’t take the meds.AMD is a leading cause of irreversible blindness in older adults, affecting some 196 million people as of 2020, the study authors said. While atrophic AMD, also known as dry AMD, is more common, the neovascular form of the disease (the “wet” form) is more severe and often leads to rapid, permanent vision loss.  The findings were collected after researchers evaluated the health data of 139,002 diabetes patients in Canada, all of whom were 66 years or older and either used a GLP-1 drug for more than six months or not at all.  The patients were sorted into a 1:2 matched cohort, with researchers analyzing more than 46,000 patients who had used GLP-1s and more than 92,668 who hadn’t.Over three years of follow-up between 2020 and 2023, 0.2% (93 patients) of those in the GLP-1 user group were diagnosed with nAMD, as were 0.1% (88 patients) in the contrasting group.Of the GLP-1 group, 97.5% of patients were on Novo Nordisk’s popular diabetes and obesity GLP-1 semaglutide—sold as Wegovy, Ozempic and in oral form as Rybelsus—while 2.5% took Sanofi’s lixisenatide.As it turns out, the risk of developing nAMD was quite low regardless of GLP-1 usage, the study authors acknowledged. Still, the risk became even higher for those who were on GLP-1s the longest. Other risk nAMD risk factors noted in the study include advanced age and a history or cerebrovascular accident.“These findings expand upon the growing body of literature raising concerns regarding the potential ocular safety of systemic GLP-1 RA use in patients with diabetes,” researchers wrote, although the findings importantly speak to “associations, rather than cause and effect." Another previously noted ocular-related concern of the popular drugs is a potential risk factor for nonarteritic anterior ischemic optic neuropathy (NAION), a serious eye condition that causes vision loss due to decreased blood supply to the optic nerve. After a study published in JAMA Ophthalmology last summer found that people taking Novo’s semaglutide for diabetes or weight loss were four to nearly eight times as likely to end up with NAION, the European Medicines Agency (EMA) took its own look at the possible safety risk.On June 6, the EMA’s safety committee recommended that the product information for semaglutide be updated to include NAION as a “very rare” side effect that could affect up to 1 in 10,000 people.The agency came to the conclusion after evaluating results from several large studies, and will now send its recommendation over to the Committee for Medicinal Products for Human Use (CHMP) before the European Commission makes its legally binding decision.