Real-World Data Shows Ozempic Continues Working for at Least 3 Years
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A new “real world” study shows that in people with type 2 diabetes, Ozempic (semaglutide) injections improved blood sugar control and weight loss during a study period of up to three years, which was comparable with what’s been reported in clinical trials. The results were presented October 2 at this year’s annual meeting of the European Association for the Study of Diabetes (EASD) in Hamburg, Germany.
“The most significant finding that was found in randomized controlled trials — the SUSTAIN phase 3 trials — was validated in this real-world analysis and is sustainable for up to three years,” says the lead author, Avraham Karasik, MD, of the Institute of Research and Innovation at Maccabi Health Services in Tel Aviv, Israel.
These findings support the use of semaglutide for the long-term management of type 2 diabetes (T2D), says Dr. Karasik. “The effect of the drug on glucose and weight is sustainable, and that with time there is no tolerance to the drug — if you continue to take the medication, the beneficial effects will continue.”
Injectable semaglutide, a glucagon-like peptide-1 (GLP-1) is prescribed for the treatment of T2D under the name Ozempic. The oral form for T2D is Rybelsus, and semaglutide for the treatment of obesity is marketed as Wegovy.
Type 2 diabetes is a chronic and progressive condition in which the body does not make or use insulin normally, leading to high levels of glucose in the blood. The condition tends to become more severe over time, and blood sugar levels become more difficult to manage. The condition can lead to other chronic issues, including heart disease and stroke, nerve damage, and damage to the eyes, kidneys, and other parts of the body, according to MedlinePlus.
The trial was funded by Novo Nordisk, a maker of semaglutide injections.
“This is encouraging, to have real-world data of longer-term use of semaglutide, showing safety, efficacy, and tolerability,” says Marilyn Tan, MD, an endocrinologist and internal medicine doctor who specializes in diabetes care at Stanford Health in California. “The majority of endocrinologists have witnessed this in their clinical practices, but this was a large patient population studied,” says Dr. Tan, who was not involved in the study.
Real-World Data Measures Up to What Was Found in Earlier Clinical Trials
While the effectiveness of once-weekly Ozempic to treat type 2 diabetes has been demonstrated in several randomized controlled trials (RCTs), long-term, large-scale, and real-world data have been lacking, according to the authors.
“Real world” data can provide additional insight to complement RCTs. “Patients in clinical trials and research studies frequently have better health outcomes due to a variety of reasons, such as adherence to medications and diet and more frequent check-ins, but this is based on real-world longer-term data, which is a strength,” says Tan.
Researchers identified more than 200,000 people from the Maccabi Health Services diabetes registry, the second-largest health maintenance organization in Israel, and found 23,442 eligible patients who had filled at least one prescription for weekly semaglutide subcutaneous injections (0.25, 0.5, and 1 milligram [mg]) between August 2019 and December 2022, and had one blood sugar control measurement (HbA1C) 12 months before, and six months after, treatment began.
Participants were 49 percent female, an average age of 62 years, had an average weight of 207.5 pounds, average BMI of 33.7, and average HbA1C of 7.6 percent. Adults with type 2 diabetes should aim for a target HbA1C of less than 7 percent, according to the authors.
Before being prescribed semaglutide, 30 percent of patients were treated with insulin and 31 percent were treated with another GLP-1 drug.
Those included in the analysis were evaluated for changes in HbA1C and weight for up to three years. Six months after starting on semaglutide, patients lowered their HbA1C by .77 percent, from 7.6 percent to 6.8 percent and reduced their body weight by an average of 10 pounds (lb), from 207 pounds to 197 lb. The percent reduction in weight and blood sugar was greater in those who had never taken semaglutide.
A follow-up after two years found HbA1C and body weight fell by an average of 0.77 percent and 13.3 lb respectively, while at three years they were down by 0.43 percent and 12.9 lb.
These findings mirror what Tan sees in her clinical practice: “Patients who start and stay on GLP-1 agonists can have significant benefits in terms of A1C reduction, weight reduction, and reduction in insulin requirements,” she says.
What Is Ozempic?
Ozempic works by helping the pancreas to release the right amount of insulin when blood sugar levels are high, according to MedlinePlus. It also slows the movement of food through the stomach and may decrease appetite and cause weight loss. It’s recommended that the medication be used together with diet and exercise.
The most common side effects of Ozempic are nausea, diarrhea, stomach pain, vomiting, and constipation. The drug also may cause serious side effects, including possible thyroid tumors.
People Who Stopped Taking Ozempic Didn’t Regain Weight Right Away
“Interestingly, in people that stopped taking the drug, no immediate increase in weight was observed,” says Karasik. But the researchers didn’t examine other factors that might influence that finding, such as whether those people started another weight loss medication after stopping Ozempic.
It’s been noted in multiple studies that patients need to stay on these medications to receive the benefits, says Fatima Cody Stanford, MD, MPH, an associate professor of medicine at Harvard Medical School and an obesity medicine physician scientist at Massachusetts General Hospital, both in Boston. “They are only effective if the patient is on the medication. As soon as they are withdrawn, they are no longer receiving the metabolic benefit that is conferred,” says Dr. Stanford, who was not involved in the study.
Tan agrees that “multiple studies have shown that stopping a GLP-1 agonist like semaglutide may lead to regaining of weight.”
The main way by which semaglutide reduces weight is by reducing caloric intake — not by affecting metabolism, she explains. “GLP-1 agonists slow stomach emptying to lead to earlier satiety (feeling of fullness) and target the hypothalamus to reduce appetite. In addition, there are multiple other mechanisms for glucose lowering,” she says.
That being said, some people might not notice a difference in appetite, hunger, and satiety after they stop taking a GLP-1 agonist. “The medication retrains their bodies and their habits, and they approach food and eating differently. For these patients, they can sometimes sustain the weight loss and metabolic benefits after semaglutide or other GLP1 agonists are stopped,” she says.
For people with T2D, once the GLP1 agonist is stopped, the glucose-lowering effects also wear off, so even in the absence of weight regain, there may be differences in blood sugars, says Tan.
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