Liraglutide 3.0 mg once daily for the treatment of overweight and obesity in patients hospitalised at a forensic psychiatric department: A 26-week open-label feasibility study

IF 5.3 2区 医学 Q1 PSYCHIATRY Acta Psychiatrica Scandinavica Pub Date : 2024-04-17 DOI:10.1111/acps.13690
Marie Reeberg Sass, Anne Mette Brandt Christensen, Margit Lykke Christensen, Ema Gruber, Helle Nerdrum, Lone Marianne Pedersen, Maximilian Resch, Troels Højsgaard Jørgensen, Claus T. Ekstrøm, Jimmi Nielsen, Tina Vilsbøll, Anders Fink-Jensen
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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.

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利拉鲁肽 3.0 毫克,每日一次,用于治疗法医精神病科住院患者的超重和肥胖症:为期26周的开放标签可行性研究
导言:超重和肥胖是法医精神病科治疗患者的一个主要问题。本临床可行性研究旨在调查每日一次使用利拉鲁肽 3.0 毫克的胰高血糖素样肽 1 受体激动剂(GLP-1RA)治疗精神分裂症谱系障碍法医精神病科住院患者超重和肥胖的可行药物治疗程度。在纳入研究时,所有参与者均符合使用利拉鲁肽治疗超重和肥胖症的适应症。在对参与者进行基线检查后,将按照利拉鲁肽的固定剂量方案进行为期26周的治疗,每天注射一次利拉鲁肽,目标剂量为3.0毫克。每位受试者接受了七次访视,以评估疗效和不良反应。主要终点是 "完成者 "的人数,完成者的定义是在第12-26周期间有80%的人完成了注射。确定利拉鲁肽是否是一种可行的治疗方法的前提是至少有 75% 的完成者。性别:男性=19(79.2%)。平均年龄:42.3 [第 25 和第 75 百分位数:39.1;48.4] 岁;体重指数 (BMI):35.7 [31.7; 37.5] kg/m2;糖化血红蛋白 (HbA1c):37 [35; 39] mmol/m2:37 [35; 39] mmol/mol。24 名参与者中有 11 人(46%)完成了研究。在完成研究的参与者中,参与研究 26 周后体重净减的中位数为-11.4 千克 [-15.4; -5.9]。HbA1C 和 BMI 的净差异分别为 -2.0 mmol/mol [-4; -1] 和 -3.6 kg/m2 [-4.7; -1.8] 。结论该研究并未证实我们的假设,即至少75%的法医精神病科住院患者在开始接受利拉鲁肽治疗时,利拉鲁肽是一种可行的治疗方法。高辍学率可能是由于临床试验的非自然环境所致。就符合用药要求的患者比例而言,利拉鲁肽3.0毫克是治疗超重的有效药物。
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来源期刊
Acta Psychiatrica Scandinavica
Acta Psychiatrica Scandinavica 医学-精神病学
CiteScore
11.20
自引率
3.00%
发文量
135
审稿时长
6-12 weeks
期刊介绍: Acta Psychiatrica Scandinavica acts as an international forum for the dissemination of information advancing the science and practice of psychiatry. In particular we focus on communicating frontline research to clinical psychiatrists and psychiatric researchers. Acta Psychiatrica Scandinavica has traditionally been and remains a journal focusing predominantly on clinical psychiatry, but translational psychiatry is a topic of growing importance to our readers. Therefore, the journal welcomes submission of manuscripts based on both clinical- and more translational (e.g. preclinical and epidemiological) research. When preparing manuscripts based on translational studies for submission to Acta Psychiatrica Scandinavica, the authors should place emphasis on the clinical significance of the research question and the findings. Manuscripts based solely on preclinical research (e.g. animal models) are normally not considered for publication in the Journal.
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