Rybelsus (semaglutide) is an oral medication primarily prescribed to improve blood sugar control in adults aged 18 and over with type 2 diabetes. It is also used to reduce the risk of cardiovascular events in people with type 2 diabetes who are at high risk for such events. While not specifically approved for weight loss, Rybelsus has demonstrated weight loss effects in clinical trials, leading to off-label use for weight management. This article delves into the details of Rybelsus, including its uses, how it works, potential side effects, and its role in weight loss.
What is Rybelsus?
Rybelsus is a prescription medication containing semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It was approved by the Food and Drug Administration (FDA) in 2019 as the first oral GLP-1 diabetes medication, making it available in pill form rather than through injections. Novo Nordisk, the manufacturer of Rybelsus, also produces Ozempic and Wegovy, all of which share semaglutide as their active ingredient.
How Rybelsus Works
Semaglutide, the active ingredient in Rybelsus, mimics the action of GLP-1, a hormone naturally produced in the intestines in response to food intake. When you eat, your intestines release GLP-1, signaling the pancreas to release insulin. Insulin helps the body absorb glucose (sugar) from the blood into cells for energy or storage. GLP-1 ensures insulin is released when needed, especially after meals when blood glucose levels tend to rise.
Additionally, GLP-1 reduces the secretion of another pancreatic hormone called glucagon, which has the opposite effect of insulin by increasing blood sugar levels. By inhibiting glucagon, GLP-1 helps prevent excessive release of glucose from the liver, which can lead to high blood sugar levels.
GLP-1 agonists like Rybelsus may also slow down the emptying of the stomach (gastric emptying). This helps regulate the rate at which nutrients from your meal enter the bloodstream, preventing sudden spikes in blood sugar levels after eating. Slower stomach emptying can also make you feel full for longer, potentially reducing your overall calorie intake.
Read also: Using Rybelsus for Weight Loss: A Guide
Rybelsus and Weight Loss
Although Rybelsus is not FDA-approved for weight loss, it has been shown to lead to weight loss in patients when coupled with a healthy diet and regular exercise. Because 90% of adults with type 2 diabetes also have obesity or are overweight, the benefits of Rybelsus affect both conditions. Weight losses of 2kg to 4kg may occur in people taking Rybelsus for type 2 diabetes.
Mechanisms of Weight Loss with Rybelsus
Rybelsus may result in weight loss through two primary actions: blood sugar management and appetite reduction.
Blood Sugar Management
Semaglutide encourages the pancreas to release insulin, which helps move glucose (sugar) from the blood into cells for energy. This action stabilizes blood sugar levels and reduces the chance of sudden energy swings that can make you crave high-calorie foods.
Also, semaglutide effectively stops the production of glucagon, another hormone that raises blood sugar levels, by telling the liver to release stored glucose into the blood. By controlling glucagon, Rybelsus keeps blood sugar levels steady and prevents excessive hunger caused by low blood sugar.
Appetite Reduction
Rybelsus's impact extends beyond blood sugar control; it also regulates appetite.GLP-1 receptors in the brain, especially in the hypothalamus, control our hunger and fullness. When GLP-1 binds to these receptors, it tells the brain to reduce appetite and cravings. This means you'll feel less hungry and more satisfied with smaller meals.
Read also: Rybelsus: A Weight Loss Option?
Rybelsus also slows down how quickly the stomach empties its contents into the small intestine. Slower stomach emptying means food stays in your stomach longer after you eat, making you feel full for a longer time and reducing the urge to eat more.
Rybelsus is prescribed alongside lifestyle changes like eating fewer calories and exercising more. It's not meant to be the only treatment for obesity.
Clinical Trial Evidence
Novo Nordisk has released key findings from the OASIS 1 phase 3a trial, part of the global OASIS program. The 68-week trial involved 667 adults who were overweight or obese with weight-related health issues. It compared a once-daily 50 mg dose of Rybelsus, alongside lifestyle changes, to a placebo for weight management. The trial successfully met its primary goal, showing that oral semaglutide 50 mg led to significant and superior weight loss compared to the placebo.
Specifically, participants taking the oral medication achieved a substantial 17.4% weight loss after 68 weeks, while those on the placebo experienced only a 1.8% reduction. Furthermore, 89.2% of the oral semaglutide group achieved a weight loss of 5% or more, compared to only 24.5% in the placebo group.
When considering treatment adherence, those on oral semaglutide 50 mg dose still achieved a significant 15.1% weight loss compared to a 2.4% reduction in the placebo group. Additionally, 84.9% of the oral semaglutide group reached a 5% or more weight loss, compared to 25.8% with placebo.
Read also: Rybelsus and Its Effects
Off-Label Use for Weight Loss
In sum, Rybelsus is not specifically approved for weight loss. Currently, it is only indicated to treat type 2 diabetes. However, it has been shown to yield significant weight loss in patients who take it along with lifestyle changes. This off-label effect is why it is sometimes prescribed for weight loss or used for weight loss in patients who also have type 2 diabetes.
Dosage and Administration
For type 2 diabetes, Rybelsus is available in 3 mg, 7 mg, and 14 mg tablets. The recommended dosage of Rybelsus will vary depending on the individual and their specific needs. Your healthcare provider will start you at a lower dosage for 30 days. After 30 days, this dosage may increase depending on your condition and how well you tolerate the medication.
Usually, Rybelsus is taken orally once daily. You should take the tablet 30 minutes before you eat, drink, or take any other medications.
Important Dosage Instructions
- Take Rybelsus by mouth once per day, at least 30 minutes before your first meal of the day.
- Take Rybelsus with no more than 4 ounces of plain water.
- Do not take Rybelsus with food, beverages (besides water), or other medications that are taken by mouth.
Dosage Adjustment
Your doctor will start you on the lowest dose of Rybelsus for the first 30 days of treatment. After 30 days, your doctor will likely raise your dose to help you achieve your blood sugar goals. If you haven’t reached your goals after another 30 days, your doctor may raise your Rybelsus dose again.
The dose you take will depend on the formulation your doctor recommends. If your doctor prescribes formulation R1, you’ll take a dose of 3 mg once per day for the first 30 days. Then you’ll take 7 mg once per day. After another 30 days, if your blood sugar isn’t well-managed, your doctor may increase your daily dose to 14 mg.
Likewise, if your doctor prescribes formulation R2, you’ll take 1.5 mg once per day for 30 days, followed by 4 mg once per day. If needed, they may raise your dose again to 9 mg once per day.
The formulations of Rybelsus aren’t interchangeable. If your doctor recommends switching between formulations, they will give you instructions on how to do so.
Rybelsus vs. Other Medications
Rybelsus vs. Ozempic and Wegovy
Rybelsus, Ozempic, and Wegovy are all medications made by the pharmaceutical company Novo Nordisk, and they serve different purposes in managing health.
- Rybelsus is used to help control blood sugar levels in people with type 2 diabetes. It comes in a convenient pill form that you take by mouth. Rybelsus helps your body process sugar more effectively and supports weight loss.
- Ozempic is also used to manage blood sugar levels in type 2 diabetes but is given as an injection under the skin. It's typically taken once a week and can help lower blood sugar, promote weight loss, and reduce the risk of cardiovascular problems in people with diabetes.
- Wegovy is a medication designed for weight management in people who are overweight or obese, whether they have diabetes or not. It's given as a weekly injection and can help you lose weight by making you feel less hungry and more satisfied with smaller meals.
In summary, Rybelsus is for controlling blood sugar and weight in people with type 2 diabetes, Ozempic is primarily for managing blood sugar and promoting weight loss in those with diabetes, and Wegovy is specifically for weight management in people who are overweight or obese. These medications have different forms of administration (pill or injection) and target various aspects of health. Your healthcare provider can help determine which is right for you based on your health needs and goals.
Rybelsus vs. Metformin
Rybelsus is a brand-name medication that contains the active ingredient semaglutide. Metformin is an active ingredient that comes as a generic medication.
Both drugs help manage blood sugar in adults with type 2 diabetes as part of a treatment plan that includes healthy eating and exercise habits. Unlike Rybelsus, metformin is also approved for this use in some children.
Rybelsus and metformin come as tablets that you swallow. (Metformin also comes in other oral forms.)
It’s possible to take metformin with Rybelsus. Your doctor can discuss whether taking both or one of these drugs might be the right treatment for you.
Alternatives to Rybelsus
Rybelsus is not FDA-approved for weight loss. The decision to prescribe Rybelsus is at the discretion of your healthcare provider. If you are curious about alternatives to Rybelsus, discuss these options with your provider:
- Tirzepatide (available as Mounjaro or Zepbound): Tirzepatide is a medication used for both type 2 diabetes and obesity management. It aids in regulating blood sugar levels, reducing appetite, and slowing stomach emptying. The brand name Zepbound, containing tirzepatide, is specifically approved for obesity treatment in patients without type 2 diabetes.
- Liraglutide (available as Saxenda): Liraglutide, a GLP-1 receptor agonist, holds FDA approval for treating obesity in adults and adolescents aged 12 and above. It accomplishes this by lowering blood sugar levels, suppressing appetite, and delaying stomach emptying.
- Metformin: Metformin, a prescription diabetes medication, can lead to weight loss in some individuals. This is achieved by regulating blood sugar levels and enhancing insulin sensitivity, which reduces the amount of sugar circulating in the bloodstream.
- Topiramate (available as Topamax): Topiramate, an anticonvulsant drug, has demonstrated weight loss effects in certain patients. Its exact mechanism of action is not entirely understood, but it is believed to reduce calorie intake through appetite suppression, prevent excess fat storage, lower specific fat and cholesterol levels, and potentially impact the brain's reward system to reduce binge eating. It's important to note that while Topiramate is not FDA-approved as a weight loss medication, clinical trials have shown significant weight loss in individuals taking it compared to those on a placebo.
- Contrave (bupropion/naltrexone): Contrave is a combination drug composed of two active ingredients, bupropion and naltrexone, each with distinct mechanisms contributing to its weight loss effects. Primarily, Contrave acts on the brain to control appetite and reduce cravings for high-calorie foods. It's essential to be aware that Contrave may have serious side effects, including the potential for suicidal thoughts.
Side Effects and Precautions
Rybelsus was approved by the FDA in 2019 as the first oral semaglutide medication. The approval is based on data from 10 clinical trials involving 9,543 participants, including comparisons with other diabetes medications and placebo control groups. Rybelsus® was shown to reduce A1C levels, along with a reduction in body weight.
Overall, Rybelsus was found to be safe and well-tolerated. However, it may cause side effects in some people.
Common Side Effects
The most common side effects of Rybelsus are gastrointestinal issues that include nausea, vomiting, diarrhea, constipation, heartburn, and abdominal pain.
Serious Side Effects
More serious side effects may occur, but they are uncommon. Some serious adverse effects of Rybelsus use include:
- Increased heart rate
- Low blood sugar (hypoglycemia)
- Allergic Reactions: Rash, swelling, breathing difficulties
- Pancreatitis (inflammation of the pancreas)
- Gallbladder problems, including gallstones
- Increased risk of thyroid cancer
If you experience any side effects while taking Rybelsus, seek medical attention from a licensed healthcare provider.
Precautions
While Rybelsus is safe and effective for most patients, it can cause side effects in some people. It may also interact with certain medical conditions or substances in the body, causing adverse reactions.
Before starting treatment with any prescription medication, you should tell your doctor about any medical conditions you have, any prescription drugs or supplements you are taking, and any allergies you may have. This information will help reduce the risk of any drug interactions or severe side effects.
Inform your doctor if you have a history of:
- Pancreatitis
- Gallbladder problems
- Kidney problems
- Personal or family history of medullary thyroid carcinoma (MTC) (thyroid tumors)
- Multiple endocrine neoplasia syndrome type 2 (MEN2)
- Diabetic retinopathy (eye problems)
- Any digestive disorders
Rybelsus may not be prescribed to pregnant women, women who are trying to conceive, or women who are breastfeeding.
Who Should Consider Rybelsus for Weight Loss?
Rybelsus is FDA-approved to regulate blood sugar levels in patients managing type 2 diabetes. It is not approved to treat type 1 diabetes. Its use as a weight loss aid is off-label, meaning that weight loss is not the primary use of this drug.
Some patients may be prescribed Rybelsus for its off-label weight loss effects. It may be used by health care in adults with obesity (with a body mass index- BMI-of 30 kg/m2 or greater) or overweight adults (a BMI of 27 kg/m2 or greater) who also have weight-related health conditions such as hypertension (high blood pressure), high cholesterol, or obstructive sleep apnea.
Note that the use of Rybelsus as a weight loss medication is strictly at the discretion of the prescribing provider.
Obtaining Rybelsus
Rybelsus is a prescription drug, meaning that you must have a written order from a licensed healthcare provider to get it. It cannot be purchased over the counter. Rybelsus is available under its brand name. There are no generic versions of Rybelsus currently available.
Weight loss drugs are prescribed to individuals with obesity or individuals who are overweight and managing a weight-related health condition. If you are curious about Rybelsus or any other weight loss drug, talk to your healthcare provider about whether or not these treatment options are right for you. You should also discuss the cost, potential side effects, and any concerns you may have.
Important Considerations
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects. Tell your doctor if you are pregnant or planning to become pregnant. Do not use this medicine for at least 2 months before you plan to become pregnant. It is very important to carefully follow any instructions from your health care team about:
- Alcohol: Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines: Do not take other medicines during the time you are using semaglutide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling: Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
- Travel: Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
In case of emergency, there may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
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