BOSTON – While about one-third of overweight patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) slimmed down after a weight-loss intervention, about 20% gained weight back within the next few years, according to results from a large, long-term observational cohort study.
Effectively, that meant about one-quarter of overweight subjects enrolled in the TARGET-NASH study were able to lose weight and keep it off, said investigator, a transplant hepatologist at Tampa General Hospital.
These findings illustrate how challenging lifestyle interventions can be for patients with NAFLD and NASH, and have clinical implications for identifying those individuals who are more or less likely to respond to weight-loss intervention as an initial treatment, Dr. Malespin said.
“I think we as providers need to better identify what are the barriers for weight loss for these patients, and try to use data, such as this data from TARGET-NASH, to help our clinical judgment and to learn strategies to be able to help these patients optimize their weight loss,” he added in an interview.
With no approved pharmacologic treatments for NAFLD and NASH, weight reduction remains one of the mainstays of treatment, Dr. Malespin said.
However, there are few studies evaluating structured programs designed to achieve such weight loss, and the long-term sustainability of this approach remains in question, according to Dr. Malespin, who presented findings of TARGET-NASH at the annual meeting of the American Association for the Study of Liver Diseases.
To date, more than 4,500 patients have been enrolled in TARGET-NASH at 59 U.S. centers. The present analysis, which Dr. Malespin described in an oral abstract presentation, included 2,037 patients with a body mass index of at least 25 kg/m2 and no decompensated cirrhosis, bariatric surgery, weight-loss medication use, or cancer diagnoses.
In sum, 34% of patients had 5% or more weight loss over about 3 years of follow-up, while about 10% had a 10% or greater weight loss, Dr. Malespin reported.
It took patients about 18 months, on average, to achieve 5% or greater weight loss. Those who achieved weight loss tended to be older, according to the investigator, and were about 1.5 times as likely to be obese class II or III, as opposed to just being overweight.
Patients were significantly more likely to lose weight, Dr. Malespin and coauthors found, if they had cirrhosis or comorbid medical conditions such as diabetes, osteoarthritis, or cardiovascular disease.
“All these factors essentially imply that these patients are hopefully being seen by multiple providers,” Dr. Malespin said, “so hopefully they’re getting the message [on the need for lifestyle modifications] from multiple different providers, and this is contributing to why we’re seeing some of this weight loss.”
However, weight loss did not persist in all patients, with 20.2% regaining weight back up to baseline or greater, according to the report. The median time to weight regain was 24-31 months, depending on initial weight class.
TARGET-NASH, sponsored by TARGET PharmaSolutions, is a 5-year longitudinal observational study with an enrollment goal of 15,000 patients with NAFLD or NASH and an estimated study completion date of 2021, according to a ClinicalTrials.gov listing.
Dr. Malespin reported disclosures with Gilead (speaker board), Intercept (speaker board, advisory committee), and TARGET PharmaSolutions (research grant paid to institution).
SOURCE: Malespin MH et al. The Liver Meeting 2019, .