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SearchSPLENDOR study suggests bariatric surgery as the first effective treatment for advanced fatty liver disease
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A Cleveland Clinic study shows that patients with obesity and advanced fatty liver disease who had bariatric weight loss surgery significantly lowered their future risk of liver disease complications and serious cardiovascular disease compared with patients who did not have surgery.
More specifically, at the end of the study period, bariatric surgery was associated with 88% lower risk of progression of fatty liver to cirrhosis, liver cancer, or liver-related death. Bariatric surgery also was associated with 70% lower risk of developing serious cardiovascular diseases, such as heart attack and stroke in these patients. The results were published online in JAMA.
“There is currently no FDA-approved medication for fatty liver,” said Ali Aminian, M.D., director of Cleveland Clinic’s Bariatric & Metabolic Institute and lead investigator of the study. “The striking findings of this study provide strong evidence that bariatric surgery should be considered as an effective therapeutic option for patients with advanced fatty liver and obesity.”
Obesity is a major risk factor for developing an advanced form of fatty liver disease known as nonalcoholic steatohepatitis (NASH). The accumulation of fat in the liver causes inflammation and damages the organ. As the liver disease progresses, scar tissues form in the liver, preventing the liver from functioning properly. A liver that is permanently damaged has cirrhosis, which increases the risk for liver cancer and may require a liver transplant to survive.
In addition to complications related to liver disease, fatty liver and NASH are strongly linked with diabetes and cardiovascular diseases, such as heart attack and heart failure.
Initially, individuals with fatty liver may not experience noticeable symptoms. A liver biopsy is needed in certain patients to accurately diagnose the disease and assess its severity. To manage NASH, a multidisciplinary approach is needed to prevent further liver injury and minimize the future risk of serious cardiovascular events. However, there are currently no approved medical treatments for NASH and no therapy has been shown to reduce the risk of serious cardiovascular events or liver disease progression in patients with NASH.
The aim of the SPLENDOR (Surgical Procedures and Long-term Effectiveness in NASH Disease and Obesity Risk) study was to investigate the long-term relationship between bariatric surgery and future risk of progression to cirrhosis and development of serious cardiovascular events in patients with NASH and obesity.
Researchers studied 1,158 adult patients with biopsy-proven NASH who had their liver biopsy between 2004 and 2016 at Cleveland Clinic and were followed through March 2021. A bariatric surgery group of 650 patients were compared with a control group of 508 nonsurgical patients. Study participants had similar characteristics such as severity of liver disease at their baseline liver biopsy.
Ten years after enrollment, advanced liver disease (progression to cirrhosis, liver cancer, need for liver transplant, or death from liver disease) occurred in 2.3% in the surgical group versus 9.6% in the control group. In addition, at the end of the study, 8.5% in the surgical group and 15.7% in the nonsurgical group developed major adverse cardiovascular events such as heart attack, heart failure, stroke or death from heart disease.
At 10 years, body weight was reduced by 22.4% in the surgical group and by 4.6% in the nonsurgical group. Bariatric surgery also was associated with a significant reduction in blood sugar levels in patients with diabetes. Those findings confirm the durability of health benefits of bariatric surgery, as shown in the Cleveland Clinic-led STAMPEDE clinical trial.
“The SPLENDOR study shows that in patients with obesity and NASH, substantial and sustained weight loss achieved with bariatric surgery can simultaneously protect the heart and decrease the risk of progression to end-stage liver disease,” said the study’s senior investigator, Steven Nissen, M.D., Chief Academic Officer of the Heart, Vascular and Thoracic Institute at Cleveland Clinic. “This is the first study in the medical field reporting a treatment modality that is associated with decreased risk of major adverse events in patients with biopsy-proven NASH.”
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. Cleveland Clinic is consistently recognized in the U.S. and throughout the world for its expertise and care. Among Cleveland Clinic’s 81,000 employees worldwide are more than 5,743 salaried physicians and researchers, and 20,160 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,690-bed health system that includes a 173-acre main campus near downtown Cleveland, 23 hospitals, 276 outpatient facilities, including locations in northeast Ohio; Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2023, there were 13.7 million outpatient encounters, 323,000 hospital admissions and observations, and 301,000 surgeries and procedures throughout Cleveland Clinic’s health system. Patients came for treatment from every state and 132 countries. Visit us at clevelandclinic.org. Follow us at twitter.com/CleClinicNews. News and resources available at newsroom.clevelandclinic.org.
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