Nasrallah Henry A, Aquila Ralph, Stanford Arielle D, Jamal Hasan H, Weiden Peter J, Risinger Robert
Dr. Nasrallah, MD, Department of Psychiatry & Behavioral Neuroscience, Saint Louis School of Medicine, St Louis, MO, USA; Dr. Aquila, MD, Fountain House, New York City, NY, USA; Drs. Stanford, MD, Jamal, MSc, Weiden, MD, Risinger, MD, Clinical Development and Medical Affairs, Alkermes, Inc., Waltham, MA, USA; Dr. Jamal, MSc, Previously at Alkermes, Inc., Waltham, MA, USA; Dr. Risinger, MD, NeuroRx Pharmaceuticals, Wilmington, DE, USA.
Psychopharmacol Bull. 2017 Aug 1;47(3):35-43.
We assessed long-term metabolic and endocrine profiles of outpatients with schizophrenia participating in a one-year open-label extension study of monthly aripiprazole lauroxil (AL), a long-acting injectable antipsychotic.
Patients (N = 478) were enrolled in a 52-week, open-label extension study of AL monotherapy administered by intramuscular injection every 4 weeks. Of these, most (368) received AL 882 mg and the remainder AL 441 mg as their fixed-dose regimen. Among the patients entering the long-term study, 181 (38%) had already received three prior AL injections. The baseline values for this analysis were obtained from the visit before the first AL injection. Patients were followed for the full year of the extension study unless they discontinued early. Changes in metabolic parameters (weight, fasting blood sugar, lipids) and serum prolactin were assessed over the duration of AL exposure, which could extend to a total of 16 AL injections. Data presented are last observation carried forward from baseline to last visit.
Most patients remained for most of the follow-up period, with 409 (86%) remaining at 6 months and 326 (68%) completing the one-year treatment period. The mean (standard deviation) changes from baseline in the overall population were: +1.1 (27.5) mg/dL for glucose, +0.07 (0.6)% for glycated hemoglobin (HbA), -3.3 (35.8) mg/dL for total cholesterol and -5.3 (101.9) mg/dL for triglycerides. Prolactin change from baseline was -8.7 ng/mL (14.7) for men and -14.9 (43.4) ng/mL for women. Overall, the mean weight change was +0.8 (5.9) kg. In terms of categorical weight change, 88 patients (18%) gained ≥7% body weight, and 59 (12%) lost ≥7% body weight. Overall, there was no clinically meaningful difference between any of these variables and AL dose.
Long-term treatment with AL in outpatients with schizophrenia was associated with a modest lowering of serum prolactin for both genders and relatively modest changes in average weight, fasting glucose, and HbA values. There appeared to be little net change in lipid parameters. This presentation extends a recently published report on the short-term metabolic and endocrine effects of AL over a period of 12 weeks. The present study increased the follow-up period to more than a year and was careful to use the first exposure to AL as the baseline. Limitations include lack of a comparison group and difficulty disentangling effects of medication treatment versus factors. Overall, the metabolic, weight, and endocrine effects reported here are consistent with other long-term effects of oral aripiprazole treatment. This study was funded by Alkermes, Inc.
我们评估了参与阿立哌唑月桂酸盐（AL）（一种长效注射用抗精神病药物）为期一年的开放标签扩展研究的精神分裂症门诊患者的长期代谢和内分泌特征。
患者（N = 478）参加了一项为期52周的开放标签扩展研究，该研究为每4周肌肉注射一次AL单药治疗。其中，大多数患者（368例）接受882 mg的AL作为固定剂量方案，其余患者接受441 mg的AL。在进入长期研究的患者中，181例（38%）此前已接受过三次AL注射。该分析的基线值来自首次AL注射前的访视。患者在扩展研究的一整年中接受随访，除非提前停药。在AL暴露期间评估代谢参数（体重、空腹血糖、血脂）和血清催乳素的变化，AL暴露可能总共持续16次注射。所呈现的数据是从基线到最后一次访视的末次观察值向前结转。
大多数患者在大部分随访期内持续参与研究，409例（86%）在6个月时仍参与研究，326例（68%）完成了一年的治疗期。总体人群中与基线相比的平均（标准差）变化为：血糖升高+1.1（27.5）mg/dL，糖化血红蛋白（HbA）升高+0.07（0.6）%，总胆固醇降低-3.3（35.
