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.
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.