Abstract：
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.
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.
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.
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.
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.
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.
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.
摘要：
背景：超重和肥胖是法医精神科治疗患者的主要问题。本临床可行性研究旨在调查胰高血糖素样肽1受体激动剂（GLP-1RA）每日一次利拉鲁肽3.0mg治疗在法医精神病学住院的精神分裂症谱系障碍患者中这些疾病的可行药物治疗程度。
方法：26周，开放标签可行性研究包括18-65岁被诊断患有严重精神疾病并在法医精神科住院的参与者。在包容的时候，所有参与者均符合使用利拉鲁肽治疗超重和肥胖的适应症.根据利拉鲁肽固定的向上滴定时间表，参与者进行基线检查，然后进行为期26周的治疗期，每天一次注射利拉鲁肽。目标剂量为3.0mg。每位参与者参加了7次访问以评估疗效和不良事件。主端点是“完成者”的数量，依从性定义为在此期间获得>80%的注射，12-26周。确定利拉鲁肽是否是可行的治疗方法预先定义为至少75%的完成者。
结果：24名参与者被纳入研究。性,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/mol。24名参与者中有11人(46%)完成了这项研究。对于完成者来说，参与26周后的中位净体重减轻为-11.4kg[-15.4;-5.9].HbA1C和BMI的净差异为-2.0mmol/mol[-4;-1]和-3.6kg/m2[-4.7;-1.8]，分别。与基线相比，体重变化和HbA1c和BMI的降低均具有统计学意义。
结论：这项研究没有证实我们的假设，即对于至少75%在法医精神科住院期间开始使用利拉鲁肽治疗的患者，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主义背景。对于依从药物治疗的患者比例，利拉鲁肽3.0mg是超重的有效治疗方法.
方法：26周，开放标签可行性研究包括18-65岁被诊断患有严重精神疾病并在法医精神科住院的参与者。在包容的时候，所有参与者均符合使用利拉鲁肽治疗超重和肥胖的适应症.根据利拉鲁肽固定的向上滴定时间表，参与者进行基线检查，然后进行为期26周的治疗期，每天一次注射利拉鲁肽。目标剂量为3.0mg。每位参与者参加了7次访问以评估疗效和不良事件。主端点是“完成者”的数量，依从性定义为在此期间获得>80%的注射，12-26周。确定利拉鲁肽是否是可行的治疗方法预先定义为至少75%的完成者。
结果：24名参与者被纳入研究。性,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/mol。24名参与者中有11人(46%)完成了这项研究。对于完成者来说，参与26周后的中位净体重减轻为-11.4kg[-15.4;-5.9].HbA1C和BMI的净差异为-2.0mmol/mol[-4;-1]和-3.6kg/m2[-4.7;-1.8]，分别。与基线相比，体重变化和HbA1c和BMI的降低均具有统计学意义。
结论：这项研究没有证实我们的假设，即对于至少75%在法医精神科住院期间开始使用利拉鲁肽治疗的患者，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主义背景。对于依从药物治疗的患者比例，利拉鲁肽3.0mg是超重的有效治疗方法.
