Diabetes remission off medications is not a suitable endpoint for comparing bariatric/metabolic surgery with pharmacotherapy

Reconciliation of Type 2 Diabetes Remission Rates in Studies of Roux-en-Y Gastric Bypass

“…Several authors have argued for changing the standard definitions for remission after metabolic surgery to allow the use of metformin (18,20,21). Metformin therapy is now considered a standard of care for the prevention of diabetes (22) and, thus, could be considered consistent with complete remission.…”

Metabolic surgery for the treatment of type 2 diabetes in patients with BMI lower than 35 kg/m2: Why caution is still needed

“…We are aware that studies on this topic have used different criteria for diabetes remission, such as HbA1c levels lower than 6.0% or 6.5% to refer to complete or partial remission, respectively, but we will combine both definitions in this review for an easier understanding. Diabetes remission is a dichotomous variable and, thus, a clearly imperfect endpoint . For example, a patient with a baseline HbA1c level of 9.0% will definitely present clinical improvement after achieving a level of 6.2% while using metformin.…”

“…Based on this definition, patients in the medication arm of a particular study cannot be said to have achieved remission while on medication. An example of that is the CROSSROADS trial, in which the odds of achieving remission was 20 times higher in the surgical arm, despite a lack of difference in mean HbA1c levels with surgery versus lifestyle plus medical intervention . In this context, a more logical endpoint would be HbA1c values or fixed HbA1c values with or without medications.…”

Dealing with diabetes and pregnancy following bariatric surgery: a double-edged sword?

“…Recently, some cardiovascular safety trials with diabetes medications have demonstrated that these drugs offer cardiovascular protection (2); more data on hard outcomes are required to better assess not only the efficacy, but mainly the safety in very large series before endorsing the widespread indication of bariatric surgery in the subpopulation of type 2 diabetics with a BMI below 35 kg/m 2 . A significant proportion of individuals undergoing bariatric surgery experiment weight regain, residual diabetes or diabetes relapse (i.e., around one third of initial remitters over five years do not achieve remission or have diabetes recurrence), requiring to cope with the residual diabetes and emerging obesity (2,3) and also to deal with lifelong nutritional deficiencies and other potential long-term complications, such as vomiting, adhesions, strictures, gallstones, hernias, drinking problems, and small-bowel obstruction (4,5). In the scope under discussion, it is essential that the diagnosis of diabetes in patients undergoing bariatric surgery be reliable and safe.…”