Abstract
Introduction
Overweight and obesity constitute a major concern among patients treated at forensic psychiatric departments. The present clinical feasibility study aimed at investigating the extent to which glucagon-like peptide 1 receptor agonist (GLP-1RA) treatment with once-daily liraglutide 3.0 mg could be a feasible pharmacological treatment of these conditions in patients with schizophrenia spectrum disorders hospitalised in forensic psychiatry.
Methods
The 26-week, open-label feasibility study included participants aged 18–65 years diagnosed with a severe mental illness and hospitalised at a forensic psychiatric department. At the time of inclusion, all participants fulfilled the indication for using liraglutide as a treatment for overweight and obesity. Participants' baseline examinations were followed by a 26-week treatment period with liraglutide injection once daily according to a fixed uptitration schedule of liraglutide, with a target dose of 3.0 mg. Each participant attended seven visits to evaluate the efficacy and adverse events. The primary endpoint was the number of “completers”, with adherence defined as >80% injections obtained in the period, weeks 12–26. Determining whether liraglutide is a feasible treatment was pre-defined to a minimum of 75% completers.
Results
Twenty-four participants were included in the study. Sex, male = 19 (79.2%). Mean age: 42.3 [25th and 75th percentiles: 39.1; 48.4] years; body mass index (BMI): 35.7 [31.7; 37.5] kg/m2; glycated haemoglobin (HbA1c): 37 [35; 39] mmol/mol. Eleven out of 24 participants (46%) completed the study. For the completers, the median net body weight loss after 26 weeks of participation was −11.4 kg [−15.4; −5.9]. The net difference in HbA1C and BMI was −2.0 mmol/mol [−4; −1] and −3.6 kg/m2 [−4.7; −1.8], respectively. The weight change and reduction in HbA1c and BMI were all statistically significant from baseline.
Conclusion
The study did not confirm our hypothesis that liraglutide is a feasible treatment for a minimum of 75% of the patients initiating treatment with liraglutide while hospitalised in a forensic psychiatric department. The high dropout rate may be due to the non-naturalistic setting of the clinical trial. For the proportion of patients compliant with the medication, liraglutide 3.0 mg was an efficient treatment for overweight.
Overweight and obesity constitute a major concern among patients treated at forensic psychiatric departments. The present clinical feasibility study aimed at investigating the extent to which glucagon-like peptide 1 receptor agonist (GLP-1RA) treatment with once-daily liraglutide 3.0 mg could be a feasible pharmacological treatment of these conditions in patients with schizophrenia spectrum disorders hospitalised in forensic psychiatry.
Methods
The 26-week, open-label feasibility study included participants aged 18–65 years diagnosed with a severe mental illness and hospitalised at a forensic psychiatric department. At the time of inclusion, all participants fulfilled the indication for using liraglutide as a treatment for overweight and obesity. Participants' baseline examinations were followed by a 26-week treatment period with liraglutide injection once daily according to a fixed uptitration schedule of liraglutide, with a target dose of 3.0 mg. Each participant attended seven visits to evaluate the efficacy and adverse events. The primary endpoint was the number of “completers”, with adherence defined as >80% injections obtained in the period, weeks 12–26. Determining whether liraglutide is a feasible treatment was pre-defined to a minimum of 75% completers.
Results
Twenty-four participants were included in the study. Sex, male = 19 (79.2%). Mean age: 42.3 [25th and 75th percentiles: 39.1; 48.4] years; body mass index (BMI): 35.7 [31.7; 37.5] kg/m2; glycated haemoglobin (HbA1c): 37 [35; 39] mmol/mol. Eleven out of 24 participants (46%) completed the study. For the completers, the median net body weight loss after 26 weeks of participation was −11.4 kg [−15.4; −5.9]. The net difference in HbA1C and BMI was −2.0 mmol/mol [−4; −1] and −3.6 kg/m2 [−4.7; −1.8], respectively. The weight change and reduction in HbA1c and BMI were all statistically significant from baseline.
Conclusion
The study did not confirm our hypothesis that liraglutide is a feasible treatment for a minimum of 75% of the patients initiating treatment with liraglutide while hospitalised in a forensic psychiatric department. The high dropout rate may be due to the non-naturalistic setting of the clinical trial. For the proportion of patients compliant with the medication, liraglutide 3.0 mg was an efficient treatment for overweight.
Originalsprog | Engelsk |
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Tidsskrift | Acta Psychiatrica Scandinavica |
Vol/bind | 150 |
Udgave nummer | 1 |
Sider (fra-til) | 35-47 |
Antal sider | 13 |
ISSN | 0001-690X |
DOI | |
Status | Udgivet - 2024 |