Prime Highlights
- The FDA approved Rybelsus, the first oral diabetes medication shown to manage blood sugar and reduce the risk of heart attacks and strokes.
- The approval offers a convenient alternative to injections, helping millions worldwide manage both diabetes and cardiovascular risk.
Key Facts
- The approval was based on the SOUL trial, which showed a 14% lower risk of major cardiovascular eventsover four years in patients taking 14 mg daily of Rybelsus.
- Rybelsus is a GLP-1 receptor agonistthat also aids weight loss, lowers LDL cholesterol, and reduces blood pressure, with mild gastrointestinal side effects reported.
Background
The US Food and Drug Administration (FDA) approved Rybelsus, a semaglutide pill, to help people with Type 2 diabetes prevent heart attacks and strokes. This marks the first time an oral diabetes medication has been approved for both blood sugar management and cardiovascular protection.
Rybelsus is a GLP-1 receptor agonist (GLP-1 RA), which copies a natural hormone that increases insulin and lowers blood sugar. It also helps with weight loss by reducing appetite. The FDA’s decision was based on results from the SOUL trial, published in the New England Journal of Medicine, involving 9,650 adults with Type 2 diabetes and high cardiovascular risk.
Over four years, patients who took a 14 mg daily dose of Rybelsus had a 14% lower risk of major cardiovascular events (MACE) such as heart attacks and strokes, compared with those on placebo. The safety profile remained consistent with earlier studies, though mild gastrointestinal effects like nausea and vomiting were reported slightly more often.
Dr. V. Mohan, Chairman of Dr. Mohan’s Diabetes Specialities Centre, Chennai, said the approval is “a major step for India,” where diabetes and heart disease are widespread. He noted that Rybelsus not only helps reduce blood sugar and weight but also lowers LDL cholesterol and blood pressure.
Doctors recommend starting Rybelsus at a low dose to minimize side effects. The tablet should be taken on an empty stomach with 50–100 ml of water. Wait 30 minutes before eating or taking any other medicine.
Experts say this approval could help millions worldwide by providing a convenient pill instead of weekly injections to manage diabetes and heart health.
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