Gastric bypass surgery is significantly more effective than the best pharmacotherapy in achieving remission of early-stage chronic kidney disease (CKD), according to the first randomized clinical trial comparing the two treatments in patients with type 2 diabetes and obesity (BMI 30 to 35).1 The Ethicon*-supported study, recently published online in JAMA Surgery, is the latest to demonstrate the superiority of bariatric surgery over medical therapy alone in treating common diseases associated with obesity.
In the MOMS (Microvascular Outcomes after Metabolic Surgery) study,100 patients were randomly assigned to receive Roux-en-Y gastric bypass surgery (RYGB) or best medical treatment. At the two-year follow-up period, 82% of surgical patients achieved remission early-stage CKD versus a remission rate of 48% in patients only receiving pharmacotherapy. There were no differences in serious complications between the two treatment groups (13% each).
“These findings point to a new treatment paradigm to reverse or prevent early chronic kidney disease progression in patients with diabetes and obesity,” said lead study author Ricardo Cohen, MD, Oswaldo Cruz German Hospital in Sao Paulo, Brazil.^ “Both patients, and the physicians who treat them for these diseases, should consider metabolic surgery together with medical management as a potentially better option than medical management alone.”
Coauthor Prof. Carel le Roux from University College Dublin in Ireland#, further commented that “by treating chronic kidney disease with a metabolic surgery approach we are also able to often place type 2 diabetes and hypertension in remission while allowing patients to maintain 25% weight loss in the long term.”
The medical community has long known that bariatric surgery is the most effective treatment for obesity. But three landmark randomized clinical trials – MOMS, STAMPEDE and GATEWAY – all sponsored by Ethicon over the last three years, have helped to further establish surgery as an effective treatment for type 2 diabetes, hypertension and most recently, kidney disease. While previous studies have had similar findings, none were randomized clinical trials, considered the “gold standard” for research because they produce the highest level of evidence in assessing the effectiveness of treatment.
“Randomized clinical trials remain the cornerstone of evidence-based medicine, and along with real-world clinical studies, provide the basis for determining the standard of care for healthcare professionals and guiding coverage decisions made by health insurers and policymakers,” said Raymond Fryrear, MD, VP & Integrated Leader, Pre-Clinical, Clinical and Medical Affairs, Johnson & Johnson. “Ethicon has made a major investment in these kinds of studies as we strive to make bariatric surgery available to all patients who could benefit.”
Randomized Clinical Trials on Diabetes and Hypertension
In STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently), Cleveland Clinic researchers found bariatric surgery and intensive medical therapy is a better long-term treatment than intensive medical therapy alone for patients with obesity and type 2 diabetes.2 In the five-year study, over 88% of surgical patients maintained healthy blood glucose levels without the use of insulin and more than a quarter achieved and maintained normal blood glucose levels, compared to just 5% of those on medication alone. The study was published in The New England Journal of Medicine in 2017.
That same year, GATEWAY (GAstric bypass to Treat obEse patients With steAdy hYpertension) was published in Circulation. This study found that bariatric surgery and medical therapy are superior to medical therapy alone in improving or resolving hypertension in patients with obesity.3 Within a month of surgery, 83.7% of gastric bypass patients achieved blood pressure control with at least 30% fewer medications, and within a year, more than half showed remission and required no medications at all. The medical therapy group was not as successful with only 12.8% reducing their use of high blood pressure drugs by 30% and none achieving remission over 12 months.
According to World Health Organization (WHO) about 650 million people had obesity in 2016.4 Data suggests bariatric surgery has the greatest impact on the complications of obesity of any treatment option,5 yet less than 1 percent of eligible patients have bariatric surgery in any given year.6 Obesity complications such as high cholesterol, stroke, type 2 diabetes, heart disease, cancer and arthritis increase healthcare costs and significantly reduce quality of life.7Bariatric surgery now has the evidence base to support the conclusion that it effectively reduces the complications of obesity.
5 Kaplan LM, et al. Bariatric- Times. 2012;9(9 suppl C):C12_C13
7 Kaplan L. J Gastrointest Surg. 2003;7(4) proceeding;443_451.