Two types of bariatric metabolic surgery were shown to be more effective than lifestyle changes and best medical care in treating nonalcoholic steatohepatitis (NASH) in an Italian randomized trial .
In over 200 patients with obesity and biopsy-confirmed NASH who completed the study, the primary endpoint of histological resolution of NASH (no fibrosis worsening) was %, achieved in 57% of randomized patients. Her Geltrude Mingrone, MD, PhD, and her colleagues at King’s College London reported having had a sleeve gastrectomy compared with only 16% of her participants undergoing lifestyle changes. bottom.
NASH resolution was 3.60 times more likely (95% CI 2.19-5.92, P.<0.0001) 3.67-fold in the Roux-en-Y group (95% CI 2.23-6.02, P.<0.0001) Authors' notes for the sleeve gastrectomy group compared to the lifestyle change group lancet.
The secondary endpoint of the trial was at least one-grade improvement in fibrosis without worsening NASH. This was observed in 37% of patients in the Roux-en-Y gastric bypass group, 39% of patients in the sleeve gastrectomy group, and 23% of participants in the lifestyle modification group.
Previous studies have found that at least 10% weight loss is required to achieve a clinically significant NASH resolution rate.
“The ability of surgery to control and even ameliorate fibrosis associated with NASH is particularly important given the fact that fibrosis is a major predictor of hepatic complications and cardiovascular mortality and morbidity in NASH. “It is clinically relevant,” the authors said. “These findings further support the use of bariatric metabolic surgery in people with metabolic disorders.”
Lifestyle modifications through physical activity and weight-loss strategies are the “mainstay” of NASH treatment, said Sarah Magob and Philip N. Newsom, M.D., Ph.D., of the Institute of Immunology and Immunotherapy at the University of Birmingham, UK. The study’s commentary added that aerobic exercise and resistance training “have been shown to reduce fatty liver and NAFLD-related cardiovascular risks.”
NASH is an advanced form of nonalcoholic fatty liver disease (NAFLD) and is the most common cause of chronic liver disease. NAFLD affects 75% of obese people and 55% of people with type 2 diabetes. NAFLD is becoming a public health problem and is expected to be the leading cause of liver transplants and liver cancer, said Mahgoub and Newsome. “is seldom achieved by lifestyle changes, let alone long-term maintenance”.
The study, called BRAVES, was a 52-week, open-label, multicenter trial comparing lifestyle changes and best practice with two types of bariatric metabolic surgery, conducted in three hospitals in Italy. According to the authors, similar studies do not appear to have been done before. Her 288 patients with biopsy-proven obesity and her NASH were included and randomized to either Roux-en-Y gastric bypass, sleeve gastrectomy, lifestyle modifications and best medical care. was assigned to 236 participants completed the trial.
To participate in this study, participants must have a body mass index (BMI) between 30 and 55, with or without type 2 diabetes, histologically confirmed NASH, a NAFLD activity score of at least 1, and other There should have been no signs of morphology. of liver disease.
The level of fibrosis was measured by the NAFLD fibrosis score. All participants with a NAFLD fibrosis score > -1.455 were considered suitable candidates for liver biopsy for histologic confirmation.
There were no deaths or life-threatening complications in this study. Of the patients who underwent surgery, he had 10 serious adverse events and none required repeat surgery. These serious adverse events were resolved medically or endoscopically.
Disclosure
Mingrone reported relationships with Fracty, GHP Scientific, Jemyll, Keyron, Metadeq, Novo Nordisk, and Recor. Co-authors reported relationships with Ethicon, GHP Scientific, GI Dynamics, Keyron, Metadeq, Medtronic, and Novo Nordisk.
Mahgoub reported no disclosures. Newsom, on behalf of the University of Birmingham, reported on his affiliations with AstraZeneca, Boehringer He Ingelheim, Bristol-Myers Squibb, Gilead, GSK, The Intercept, Madrigal, Novo Nordisk, Pfizer and Sun His Pharma. He was supported by the Research Biomedical Research Center for Health and Care at Birmingham National Laboratory.
Primary information
lancet
Source: Verrastro O, et al. Bariatric Metabolic Surgery and Lifestyle Interventions and Best Medical Care in Nonalcoholic Steatohepatitis (BRAVES): A Multicenter, Open-label, Randomized Trial. Lancet 2023; DOI: 10.1016/S0140-6736(23)00634-7.
secondary source
lancet
Source reference: Mahgoub S, Newsome PN “Bariatric metabolic surgery and lifestyle interventions in non-alcoholic steatohepatitis” Lancet 2023; DOI: 10.1016/S0140-6736(23)00773-0.