Randomized clinical trial data showed continued long-term improvements in diabetes outcomes. bariatric surgery compared to medical/lifestyle interventions for people with the disease. type 2 diabetes Baseline BMI between 27 and 45 kg/m2.
The findings come from the Alliance for Randomized Trials of Medicine Versus Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D), a pooled analysis from four single-center randomized trials in the United States. Over seven years of follow-up, 193 people randomly assigned to one of three bariatric treatments lost weight. A1c They had higher levels of diabetes remission and higher remission rates than the 96 people randomized to medical/lifestyle interventions (usual guidance on diet and activity, some with medication).
Originally presented at the American Diabetes Association Annual Scientific Sessions in June 2023, it was reported that: Medscape Medical News at that time, Data published February 27, 2024 Japan Automobile Manufacturers Association By Anita P. Kourkoulas, MD, Director of the Minimally Invasive Bariatric Surgery Program at the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania, and colleagues.
said study co-author Dr. Ali Aminian, director of the Obesity and Metabolism Laboratory at the Cleveland Clinic in Cleveland, Ohio. Medscape Medical News“We have shown that the surgery is very durable in terms of diabetes management, need for diabetes medications, and weight loss. Other sources have shown durability of 25 to 30 years. However, they were not in the setting of a randomized clinical trial comparing surgery and medicine. ”
In an accompanying editorial, Dr. Thomas A. Wadden of the Department of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania, called the study “excellent” and “well-controlled,” calling it “an excellent study that provides “I will.” This is the most robust evidence to date of the long-term effectiveness of bariatric surgery to improve control of type 2 diabetes. ”
However, Wadden et al. noted that the four trials that make up ARMMS-T2D “started a long time ago.” Semaglutide and Tirzepatide Approved for type 2 diabetes, then obesity. These drugs have the potential to transform the management of both of these diseases,” he said, adding that the weight, diabetes and cardiovascular benefits achieved by these drugs are similar to those seen with bariatric surgery. I pointed out the data that shows this.
Dr. Aminian said, “This is like heart disease, where some patients are treated with drugs, some with lifestyle, and some with stents and open-heart surgery. “Everything is an option depending on the patient’s situation, severity of illness and response.” Transfer to other treatments is also possible. I think all are good options and patients should have access to them all. ”
The editorialists also noted that while the initial cost of surgery (which can reach $33,500) is generally considered cost-effective, drugs currently cost more than $1,000 per month for potential lifetime use. The cost of surgery can far exceed the cost of surgery, creating a challenge for insurance companies.
According to Aminian, “Eventually the cost of drugs will come down and drugs will become more available…But right now, in my experience, surgery is a one-time cost of about $15,000 to $25,000. This would be relatively expensive, similar to what it would cost to take these drugs for about 18 months at current prices. ”
Significant improvement in diabetes continues 7 to 12 years after bariatric surgery
At year 7 of ARMMS-T2D, A1c decreased non-significantly by 0.2 percentage points from baseline 8.2% in the medical/lifestyle group, but in the bariatric surgery group there was a significant decrease of 1.6 points from baseline 8.7%. there were. The difference between the groups was -1.4 points at 7 years (P < .001), and -1.1 for n = 166 for 12 years of data (P = .002).
At 1 year, diabetes remission was achieved in 50.8% with surgery versus 0.5% with conventional treatment. By 7 years, the remission rate was 18.2% with surgery and 6.2% with conventional treatment, but there was still a large difference (P = .02). The use of hypoglycemic drugs was also significantly lower in the surgical group: 16% vs. 56% in the surgical group. insulin When I was 7 years old (P < .001).
By year 12, there were no significant differences between the groups in terms of death or other serious adverse events, excluding fractures (13.3% vs. 5.2%). anemia (12% vs. 3.1%).
During follow-up, 25% of patients randomly assigned to the medical/lifestyle group decided to undergo bariatric surgery, but because the study design specified an intention-to-treat analysis, they remained in the original group. left behind. Therefore, Professor Aminian said, “Many of these patients had improved blood sugar levels, excess weight, and need for diabetes medication after crossing the border… So basically, the data we’re seeing at the medical group is actually “It means that things are getting better.”
Wadden et al. conclude, “Although clearly difficult to implement, long-term evaluations comparing bariatric surgery and new generation anti-obesity drugs with respect to safety, clinical and cost-effectiveness, patient acceptability, and quality of life are needed.” “Yes,” he concluded. It is important to consider the period of cost-effectiveness/savings and the patient subgroups that demonstrate cost-effectiveness. ”
Meanwhile, the editorial authors advised, “We encourage clinicians to consider the long-term benefits of bariatric surgery, an underutilized intervention for patients with type 2 diabetes that is not adequately controlled with medical and lifestyle therapy.” are doing.
The ARMMS-T2D collaboration was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Mr. Courcoulas reported that outside of the submitted work he has received grants from Allurion and Eli Lilly. Mr. Aminian reported receiving grants and personal fees from Medtronic, Eli Lilly, and Ethicon outside of the submitted work. Mr. Wadden reported that he serves on the advisory boards of Nordisk and WW (Weight Watchers).
Miriam E. Tucker is a freelance journalist based in the Washington, DC area. She is a regular contributor to her Medscape Medical News, as well as to the Washington Post, NPR’s Shots blog, and Diatribe. She belongs to her X: @MiriamETucker.