First to Compare Bypass Surgery and Medical Treatment for 5 Years
The open-label, randomized controlled trial is the first to compare gastric-bypass or biliopancreatic-diversion surgery with medical therapy with follow-up of 5 years.
Previous trials with gastric-bypass surgery and another bariatric surgical procedure that is rapidly gaining ground, laparoscopic sleeve gastrectomy, have shown that there is benefit in type 2 diabetes, but only to 3 years maximum.
However, a recent retrospective analysis of sleeve-gastrectomy procedures has revealed weight regain and a decrease in remission rates for type 2 diabetes at 5 years' follow-up.
"The 5-year mark is important because it provides a measure of durability of remission while also allowing a look at other aspects that are not assessable over the short term — for example, quality of life or disease-related complications," explained Dr Rubino.
The current single-center study was carried out at Catholic University, Rome, Italy. Participants had a body mass index (BMI) of at least 35 kg/m2, were aged 30 to 60 years, had a history of type 2 diabetes lasting at least 5 years, and an HbA1cconcentration of 7.0% or more (≥53 mmol/mol). The majority of patients had previously received medical treatment, with many on insulin.
Of the 60 patients included in the study, 20 were randomly assigned to receive medical therapy (glucose-lowering drugs, insulin, and glucagonlike peptide-1 [GLP-1] agonists); 20 to Roux-en-Y gastric-bypass surgery; and 20 to the biliopancreatic-diversion procedure. The vast majority (88%) completed 5 years of follow-up.
The primary end point was the rate of diabetes remission at 2 years, defined as a fasting glucose concentration of 5.6 mmol/L or less and HbA1c concentration of 6.5% or less (≤47.5 mmol/mol). Importantly, patients were required to achieve this without active drug treatment for at least 1 year (2009 ADA definition of remission).
Patients were assessed annually for durability of diabetes remission (up to 5 years), overall glycemic and metabolic control, cardiovascular risk, medication use, quality of life, diabetes-related complications, and long-term surgical complications.
Five-Year Remission Postsurgery Is 50%, but Long-Term Follow-up Key
Diabetes remission at 5 years was seen in 19/38 (50%) of the surgical patients without any medication. Of these patients, seven of 19 [37%] were in the gastric-bypass group and 12 of 19 [63%] in the bilipancreatic-diversion group.
None of the 15 patients in the medical-treatment group achieved remission at 5 years.
And of those patients who received only metformin to achieve an HbA1c concentration below 7.0%, the proportion of surgical patients with major improvement of diabetes from baseline rose to over 80%, according to Dr Rubino.
"Remarkably, while almost 50% (47%) of surgical patients required insulin prior to surgery, alone or in combination with multiple other agents, all but one did not require insulin 5 years after surgery," he added.
A total of 15/34 (44%) patients (53% of gastric-bypass and 37% of biliopancreatic-diversion patients) who achieved 2-year remission with surgery later relapsed with hyperglycemia, but they maintained a mean HbA1c of 6.7% at 5 years with just diet and either metformin or no medication.
"The relapse of hyperglycemia, albeit mild, in almost half of the patients with initial remission, underscores the need for continued long-term monitoring of glycemia in all patients after surgery," stressed Dr Rubino.
Two patients on medical therapy, unable to achieve adequate control of glycemia despite taking multiple drugs and/or insulin for over 2 years, requested crossover to surgery, following which they immediately entered remission.
Dr Rubino pointed out the dramatic reduction in the total number of antidiabetes and cardiovascular medications in the surgical patients over the total 5 years, adding, "This has implications for cost-effectiveness."
In surgically treated patients, there was also a greater improvement in quality of life compared with the medically treated group, and the rate of diabetes-related complications was also lower.
"Five major diabetes-specific complications were observed in the medical group, including one death from heart attack, compared with only one in the gastric-bypass group and none in the biliopancreatic-diversion group," he noted.
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Reference information:
www.medscape.com
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