What Is Rybelsus, and Why Does It Matter?
Rybelsus (semaglutide) is a once-daily pill used to help lower blood sugar in adults with type 2 diabetes (T2D). It belongs to a group of medicines called GLP-1 receptor agonists. The FDA has now approved this medicine to help lower the risk of major cardiovascular events (MACE) – such as heart attacks, strokes, or heart-related deaths – in adults with type 2 diabetes who face a high risk of heart problems. This includes people with or without a history of heart disease.
MACE is a leading cause of death among people with T2D because diabetes can damage blood vessels and speed up atherosclerosis (the buildup of plaque in arteries). This risk exists even for those who have never had a previous heart attack or stroke, making protection of the heart and blood vessels an important part of diabetes care.
This approval is important because Rybelsus is the first oral medicine in its class to be approved for reducing MACE risk. It works by mimicking a natural hormone in your body that helps control appetite and blood sugar levels, along with body weight and inflammation – all important things that contribute to heart disease. First approved in 2019 to lower blood sugar levels in T2D, Rybelsus may help in both primary prevention (preventing first-time heart problems) and secondary prevention (reducing the risk of another event in those who've already had one) of MACE.
Because it's taken by mouth, Rybelsus may be a good option for people who prefer not to get shots. Having a pill that helps manage both blood sugar and heart risk may also make it easier to stay on schedule with treatment.
Why Was It Approved?
The FDA's decision was based on results from a large clinical trial that showed Rybelsus helped lower the risk of MACE in people with T2D who have a high risk of heart problems.
The study included 9,650 patients who took either Rybelsus 14 mg once daily or a placebo, along with their usual care, and were followed up for about four years.
About 12.0% of people taking Rybelsus had a major heart-related event – such as a heart attack, stroke, or heart-related death – compared to 13.8% of those taking a placebo. This means Rybelsus reduced the risk of MACE by 14%.
The most common side effects were stomach-related, such as nausea, vomiting, diarrhea, and constipation. Some people also had more serious side effects, including inflammation of the pancreas, eye problems related to diabetes, low blood sugar (especially if taken with insulin or sulfonylureas), kidney issues from dehydration, and gallbladder problems.
What Do I Need to Know?
You take this medicine once a day by mouth. Take it first thing in the morning on an empty stomach with no more than 4 ounces of water. After taking it, wait at least 30 minutes before eating, drinking, or taking any other oral medicine. Swallow the tablet whole – don't split, crush, or chew it.
Rybelsus 7 mg and 14 mg tablets are approved to help reduce the risk of MACE. Your health care provider will find out the best dose for you and may adjust it over time based on how you respond to treatment.
This medicine is not recommended if you or someone in your family has had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have a rare condition called multiple endocrine neoplasia syndrome type 2 (MEN2). These risks are based on findings from animal studies and past reports with similar medicines.
You should tell your health care provider if you have problems with your kidneys or pancreas, T2D-related eye problems, or are allergic to semaglutide or any of the ingredients in Rybelsus before starting your treatment. It is important to let your health care provider know if you are taking Rybelsus before any surgery or deep sedation because of a risk of lung problems caused by breathing in stomach contents.
This medicine may slow down how your stomach empties, which can affect how other medicines are absorbed. Be sure to tell your health care provider about all the medicines you take, including over-the-counter products and supplements. Rybelsus can harm an unborn baby and may enter breast milk. Let your health care provider know if you are pregnant or are breastfeeding. You should stop using Rybelsus for at least two months before trying to get pregnant. You should not breastfeed during the treatment
If you take insulin or a sulfonylurea, your provider may need to lower your dose to help prevent low blood sugar. Always talk to your health care provider if you notice new symptoms or have concerns about side effects.