US FDA approves first GLP-1 oral drug to protect against heart attacks, stroke
PTC News Desk: The US Food and Drug Administration (FDA) has approved the first oral GLP-1 receptor agonist, Rybelsus (semaglutide), to help prevent heart attack and stroke in adults with type 2 diabetes and high cardiovascular risk.
The approval represents a significant broadening of Rybelsus’s use. Initially approved in 2019 for controlling blood sugar, the drug can now, based on new findings from the SOUL trial, be prescribed to lower the risk of major adverse cardiovascular events (MACE)—including cardiovascular death, nonfatal heart attack, and nonfatal stroke—even in patients without a prior history of such events.
The SOUL trial, published in the New England Journal of Medicine, tracked 9,650 adults with type 2 diabetes and elevated cardiovascular risk over nearly four years. Findings revealed that oral semaglutide lowered the risk of major adverse cardiovascular events (MACE) by 14%, mainly due to a reduction in nonfatal heart attacks. The positive effects were consistent across various patient groups, including those who had never experienced a prior cardiovascular event.
“Even without a history of heart attack or stroke, adults with type 2 diabetes face a higher risk of cardiovascular complications, highlighting the need for treatments that address more than just blood sugar,” said Dr. John B. Buse, Professor of Medicine at the University of North Carolina School of Medicine and co-chair of the SOUL steering committee.
Safety Profile and Side Effects
The safety results for Rybelsus in the SOUL trial were in line with previous studies. Serious adverse events—mostly heart-related issues and infections—occurred slightly less frequently in patients taking Rybelsus (47.9%) than in those on placebo (50.3%).
Gastrointestinal side effects such as nausea and vomiting were somewhat more common among Rybelsus users (5.0% versus 4.4%). Around 15.5% of participants stopped taking semaglutide due to side effects, compared with 11.6% in the placebo group.
Despite these tolerability challenges, researchers emphasized that the cardiovascular benefits significantly outweigh the mild risks, particularly for patients at high risk of heart disease. Previously, only injectable GLP-1 drugs like Ozempic, Wegovy, and Trulicity had demonstrated proven cardiovascular protection, reducing the likelihood of heart attack, stroke, and cardiovascular death in individuals with type 2 diabetes or obesity.
Rybelsus, which contains the same active ingredient as Ozempic (semaglutide), now offers these heart-protective benefits in a daily oral tablet—providing a first-of-its-kind option for patients who prefer to avoid injections.
- With inputs from agencies
