Patient Reported Outcomes After Metabolic Surgery Versus Medical Therapy For Diabetes: Insights From The STAMPEDE Randomized Trial
*Ali Aminian1, *Sangeeta R Kashyap1, *Kathy Wolski1, Stacy A Brethauer2, *John P Kirwan3, *Steven E Nissen1, *Deepak L Bhatt4, Philip R Schauer3
1Cleveland Clinic, Cleveland, OH;2Ohio State University Wexner Medical Center, Columbus, OH;3Pennington Biomedical Research Center, Baton Rouge, LA;4Harvard Medical School, Boston, MA
OBJECTIVE(S): Robust data on patient-reported outcomes (PROs) from randomized trials comparing medical and surgical treatments for type 2 diabetes (T2D) are lacking. The Surgical Treatment And Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial showed that 5-years after randomization, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) were superior to intensive medical therapy (IMT) alone in achieving glycemic control in T2D. We investigated the long-term effects of different T2D treatments on PROs.
METHODS: 104 patients participating in the STAMPEDE trial were administered two general quality-of-life questionnaires (RAND-36 and EQ-5D-3L) and a diabetes-specific instrument at baseline and then on an annual basis up to 5-years after randomization.
RESULTS: RYGB and SG significantly improved the general health perception (Fig.1A), energy/fatigue (Fig.1B), and diabetes-related quality-of-life (Fig.1C) compared with IMT alone on longitudinal analyses. None of the quality-of-life components improved significantly from baseline in the IMT group. No significant differences were observed among the study groups in measures of psychological and social aspects of quality-of-life. On multivariable analysis, independent factors associated with improved general health perception at long-term were baseline general health (p<0.001), not taking insulin at 5-years (p=0.005), RYGB versus IMT (p=0.005), and SG versus IMT (p=0.034). Positive changes after RYGB and SG were comparable.
CONCLUSIONS:In patients with T2D, bariatric surgery is associated with long-term favorable changes in certain PROs compared with IMT, mainly on physical health and diabetes-related domains.
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