medwireNews: Long-term follow-up of the STAMPEDE trial shows that improvements in body mass index (BMI) and glycemic control are maintained 5 years after metabolic surgery in patients with type 2 diabetes.
The study is the second such trial to report 5-year outcomes, and the first that includes patients with BMIs as low as 27 kg/m2.
Speaking to medwireNews, Francesco Rubino (King’s College London, UK), who was an author on the previous study, said that the randomized trial findings are consistent with the even longer-term results of nonrandomized studies.
“In the aggregate, I think it’s reassuring evidence that there is really value in considering surgical options in treating type 2 diabetes,” he said.
And he believes that the advent of surgery for type 2 diabetes, recently enshrined in guidelines and endorsed by multiple medical and surgical societies, will have knock-on benefits for diabetes care as a whole. By providing another means to escalate treatment, metabolic surgery “will push the entire diabetes care towards a more rational approach whereby patients who are not responding are obviously patients who need something else,” he said.
“There’s too much inertia in conventional diabetes care,” said Rubino. “Everything should happen earlier than it does.”
But now he believes “we will probably make more emphasis and more attention to utilising conventional therapies earlier and in the proper fashion before we move on and advise for surgery, so I think the addition of surgery to the spectrum of therapies is great news because it will, in my opinion, improve the care of diabetes patients – even of those who will never be candidates for surgery.”
The latest STAMPEDE findings, which are published in The New England Journal of Medicine, include 134 patients who completed 5 years of follow-up. At this point, 29% of 49 patients who underwent gastric bypass and 23% of 47 who underwent sleeve gastrectomy met the primary endpoint of a glycated hemoglobin (HbA1c) level of 6.0% or less, with or without use of antidiabetic drugs.
By comparison, just 5% of the 38 patients who received standard medical care achieved this goal, report Philip Schauer (Cleveland Clinic, Ohio, USA) and colleagues.
Average bodyweight was 23.2 kg lower at 5 years than at baseline in the gastric surgery group and 18.6 kg lower in the sleeve gastrectomy group, compared with just 5.3 kg lower in the medical therapy group.
The best improvements in terms of BMI and glycemic control occurred within the first 2 years after surgery, with BMI and HbA1c tending to drift upwards thereafter. However, Rubino stressed that, although some patients technically relapsed, their blood sugar levels “would still be in a range that anybody would consider excellent control of diabetes by conventional standards,” but requiring far fewer medications than at baseline.
Indeed, the proportion of patients requiring no antidiabetic medications was 0–2% at baseline compared with 45% in the gastric bypass group and 25% in the sleeve gastrectomy group at 5 years, with no change in the control group. Likewise, the proportion using insulin was significantly lower at 5 years than at baseline in the surgical groups, but not the medical therapy group.
“Now you can imagine the impact that this could have in terms of quality of life, cost of treatment, and […] also long-term complications of diabetes,” said Rubino. He also stressed that 5 years of diabetes remission in 20–30% of patients is in itself “a remarkable finding, because it really challenges what we’ve always thought about diabetes.”
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