FDA Rybelsus: The US Food and Drug Administration has expanded the label for Rybelsus, the once-daily oral form of semaglutide, to include prevention of major cardiovascular events, heart attack and stroke, in adults with Type 2 diabetes. It is the first oral diabetes medicine approved both to manage blood sugar and to lower cardiac risk.
Semaglutide is a GLP-1 receptor agonist that mimics a gut hormone released after meals, prompting more insulin release, lowering glucose, and, at higher doses, reducing appetite. Rybelsus has been available since 2019 for glycemic control (and in India since 2022). The new indication follows results from the SOUL trial showing a meaningful reduction in cardiovascular events.
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Published in the New England Journal of Medicine, SOUL tracked 9,650 adults with Type 2 diabetes at high cardiovascular risk for nearly four years. Participants received either 14 mg oral semaglutide or a placebo on top of standard diabetes and heart medications. The semaglutide group saw a 14% relative reduction in major adverse cardiovascular events (MACE), with benefits consistent across subgroups, including those without prior events. Serious cardiac events occurred less often with semaglutide (47.9%) than with placebo (50.3%). Gastrointestinal side effects, nausea and vomiting. were slightly more common (5.0% vs 4.4%), in line with the GLP-1 class.
Indian experts say the decision is especially relevant given the country’s high burden of early heart disease and diabetes. “An oral drug to control both can make a huge difference,” said Dr V. Mohan of Dr Mohan’s Diabetes Specialities Centre, noting benefits on HbA1c, body weight, and now cardiovascular outcomes, The Indian Express reported. Cardiologist Dr M. Sudhakar Rao added that GLP-1 therapies may reduce inflammation, improve endothelial function, lower LDL cholesterol, and modestly aid blood pressure and heart failure through diuretic effects.
Clinicians advise starting low and titrating slowly to limit GI upset. Rybelsus should be taken once daily on an empty stomach with 50–100 ml of water, with no food or other medicines for 30 minutes afterwards to ensure absorption. Unlike weekly injectable GLP-1 drugs, the oral form requires daily dosing because of lower bioavailability.