Diabetes Weight Loss Drugs – Sold under the brand names Ozempic and Rybelsus, the drug approved for the treatment of type 2 diabetes may lead to a solution for safe and sustainable weight loss, a new study suggests.
A drug approved to treat type 2 diabetes can help people with obesity lose 10 to 15 percent of their body weight — an amount that health care professionals say could help lower their risk of developing the disease. severe chronic.
Diabetes Weight Loss Drugs
Semaglutide, sold under the brand names Ozempic and Rybelsus, helped most obese people in a clinical trial lose at least 10 percent of their body weight, and more than half of them reduced their weight by at least 15 percent. percent, according to the results of the study. , which were published in February 2021 in the New England Journal of Medicine.
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The study focused on a once-weekly injection of semaglutide at a higher dose than is approved for the treatment of type 2 diabetes. The drug’s maker, Novo Nordisk, is now seeking approval from the US Food and Drug Administration- (FDA) to sell a weekly injectable version of the drug as a weight loss aid.
The new study findings provide fresh evidence that medications can be used to manage obesity in the same way that drugs are used for other chronic health issues, says senior study author Robert Kushner, MD, of Northwestern University Feinberg School of Medicine. in Chicago.
“Obesity management drugs are approved for weight loss and maintenance of weight loss,” says Dr. Kushner. “They should be considered the same way we think about medications taken for diabetes or hypertension — two other chronic diseases that need long-term management.”
The trial included 1,961 adults with a body mass index (BMI) of 30 or higher — the threshold for diagnosing obesity — or with a BMI of 27 or higher and at least one weight-related medical problem. None of the participants had type 2 diabetes at the start of the trial, but some had prediabetes, or slightly high blood sugar levels.
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All trial participants received nutritional advice and were advised to do at least 150 minutes of physical activity per week. People who received semaglutide in addition to this support to promote lifestyle changes lost an average of 33.7 pounds by the end of the 68-week trial, compared with an average of just 5.7 pounds in the group that received a placebo.
People taking semaglutide also experienced greater improvements in cardiovascular risk factors such as BMI, waist circumference, blood pressure and blood sugar than participants given a placebo.
The most common side effects of semaglutide were gastrointestinal problems, including nausea, vomiting and constipation, which were experienced by almost half of those taking the drug. However, most participants stayed with the trial, with only about 4.5 percent of people on semaglutide and 0.8 percent of people on placebo stopping treatment because of gastrointestinal problems.
Many drugs that have been approved for weight loss in the past have been withdrawn because of serious and potentially life-threatening side effects, according to an editorial published about the new study in the New England Journal of Medicine. These include some addictive amphetamines; fenfluramine, which caused damage to heart valves; and lorcaserin, which increase the risk of cancer.
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Semaglutide is in a family of medicines known as GLP1 agonists, which mimic the action of a hormone that makes people feel full. A similar drug, liraglutide, is already approved for weight loss in addition to type 2 diabetes.
“Semaglutide appears to be as safe as other drugs in its class like liraglutide,” says Beverly Tchang, MD, an assistant professor at Weill Cornell Medicine who was not involved in the semaglutide trial.
“And at the 2.4 milligram dose, semaglutide has shown the greatest amount of weight loss among all other currently approved obesity medications,” adds Dr. Chang.
Several other approved weight-loss medications have not achieved results as dramatic as those seen with semaglutide in the current trial, according to a review of obesity treatments published in January 2021 in Current Obesity Reports. In an attempt to isolate the effect of the weight-loss drugs alone, the researchers subtracted the weight lost in the placebo group, which followed only the lifestyle interventions, from the amount of weight lost in the study group, which followed the lifestyle interventions. life and received medication.
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They found that participants lost an average of 6.8 percent of their body weight on phentermine/topiramate, followed by 5.4 percent on liraglutide, 4.0 percent on naltrexone/bupropion, and 2.9 percent on orlistat.
In contrast, people on semaglutide in the current trial lost 12.4 percent of their body weight after the researchers performed the same calculation.
None of these weight-loss medications are as effective as surgical weight loss, which can help people lose about 30 percent of their body weight, says Frank Greenway, MD, director of the Center’s outpatient research clinic. Pennington Biomedical Research Institute in Baton Rouge, Louisiana. .
However, not all patients are good candidates for surgery, and the results of the current trial suggest that semaglutide may be a safe and effective intervention for long-term weight management, says Dr. Greenway, who was not involved in the clinical trial.
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“The FDA has always set the safety bar high for anti-obesity drugs, and there has been a quick push to withdraw them when unexpected side effects are identified,” says Greenway. “Semaglutide is less likely to have this problem than other really new drugs.”
That’s because drugs in the same family of medicine, GLP1 agonists, have already been on the market for years, limiting the potential for unexpected safety issues to arise if the drug wins approval as a weight-loss treatment, Greenway says.
The safety and effectiveness seen with semaglutide in the current trial are reassuring, agrees Tchang, especially because patients can stay on the drug for the rest of their lives.
“Obesity is a disease just like high blood pressure or high cholesterol, and you don’t stop taking your blood pressure medication when your blood pressure is normal, because when you stop, your blood pressure goes back up,” says Tchang . “Similarly, when patients stop an anti-obesity drug that was helping them lose weight, their weight may also gain back.”
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The US Food and Drug Administration (FDA) has approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes (T2D) as an adjunct to diet and exercise. The drug, made by Eli Lilly, improved blood sugar more effectively than other diabetes therapies that were included in the clinical studies that were the basis for its approval, according to the FDA statement released on May 13.
It is estimated that more than 37 million people in the United States have type 2 diabetes, according to the Centers for Disease Control and Prevention (CDC). People with T2D are twice as likely to have heart disease or stroke compared to someone without diabetes and at a younger age, according to the agency.
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“Given the challenges many patients experience in achieving their blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” said Patrick Archdeacon, MD, associate director of the division of diabetes, lipid disorders and obesity at the FDA’s Center for Drug Evaluation and Research, in the statement.
The drug is the first drug approved to target the two main natural incretin hormones, GIP and GLP-1. Incretins are metabolic hormones that stimulate the lowering of blood glucose levels.
The approval was based on results from the phase 3 SURPASS program, which included head-to-head comparisons with Ozempic (semaglutide) 1 milligram (mg) injectable, as well as comparisons with the long-acting insulin analogs Lantus (insulin glargine) and Tresiba ( insulin degludec). At the end of seven different phase 3 trials lasting between 40 and 52 weeks, Mounjaro produced superior A1C reductions against all comparators.
Mounjaro “appears to represent an advance over current GLP-1 analogs, providing enhanced glycemic and weight benefits without an increased penalty in terms of gastrointestinal side effects,” said a comment response published in July 2021 in The Lancet after publication of one of the phase 3 trials.
Medication & Treatments
Mounjaro has not been studied in patients with a history of pancreatitis and is not indicated for use in patients with type 1 diabetes mellitus.
Many of the participants in Mounjaro’s trials were also overweight or obese; Median BMI was 32 to 34 at the time of trial enrollment. A BMI of 30 or higher is in the obesity range, according to the CDC.
While the drug is not indicated for weight loss, mean change in body weight was a secondary endpoint in all SURPASS studies, and participants lost an average of 12 to 25 pounds.
Eli Lilly is seeking approval for tirzepatide for weight loss, and the company recently announced results from a phase 3 trial. Participants (all overweight or obese,
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