Liraglutide warrants further investigation in obese people with severe mental illness
medwireNews: Findings from a pilot study suggest that the glucagon-like peptide (GLP)-1 receptor agonist liraglutide might be beneficial for the management of obesity in people with schizophrenia, schizoaffective disorder, or first-episode psychosis.
“People with severe mental illness are 2-3 times more likely to be overweight and obese than the general population and this is associated with significant morbidity and premature mortality,” say the study authors.
For the study, 47 adults (mean age 43.9 years, 49% women) from mental health and primary care centers were randomly assigned to receive liraglutide 3.0 mg or placebo once daily for 6 months. All participants had been prescribed antipsychotic medication for at least 1 month and were obese or overweight, with at least one weight-related comorbidity such as dysglycemia, hypertension, or dyslipidemia. The average bodyweight at baseline was 111.4 kg in the liraglutide arm and 117.7 kg in the placebo group.
Richard Holt (Southampton General Hospital, UK) and fellow investigators say that “[r]ecruitment for this trial proved more challenging than initially expected,” and the study was terminated “for pragmatic reasons” when 47 participants had been randomized.
Nevertheless, they found that after recruitment, “retention and adherence to medication were in line with expectations.” The completion rate was 78%, with 17 individuals in the liraglutide group and 20 in the placebo group finishing the study. In all, 25 participants stayed on trial medication from baseline to the final visit.
In an exploratory efficacy analysis, Holt et al found that after 6 months, individuals in the liraglutide group lost a mean of 5.7 kg in bodyweight (4.5%) while those in the placebo group gained an average of 0.3 kg (0.0%), giving an estimated treatment difference between groups of 6.0 kg.
There were also statistically significant improvements in BMI, Brief Psychiatric Rating Scale, and glycated hemoglobin among participants treated with liraglutide versus placebo, reports the team in Diabetes, Obesity and Metabolism.
No serious adverse reactions were observed over the duration of the trial. In line with the known safety profile of liraglutide, the most frequent adverse events were gastrointestinal, most commonly dyspepsia, affecting 17% of people in the liraglutide group and none of those given placebo.
The researchers conclude: “This study supports the need for a larger definitive randomised controlled trial to evaluate the use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness.”
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