Szatmári Balázs, Barabássy Ágota, Harsányi Judit, Laszlovszky István, Sebe Barbara, Gál Mónika, Shiragami Kazushi, Németh György
Department of Clinical Research, Gedeon Richter Plc., Budapest, Hungary.
Department of Medical Affairs, Gedeon Richter Plc, Budapest, Hungary.
Front Psychiatry. 2020 Mar 3;11:61. doi: 10.3389/fpsyt.2020.00061. eCollection 2020.
Schizophrenia is a life-long mental disorder, affecting young adolescents to elderly patients. Antipsychotic treatment is indicated for all patients with schizophrenia, including the very young and old as well. Developmental issues in the young and decline in organ functioning in the elderly could influence reactions to the drug, and require different dosing regimens. The aim of the present article was to examine the safety profile and dosing requirements in adolescent (13 to less than 18) and elderly (65 and above) patients treated with cariprazine. Data from two clinical studies (one pharmacokinetic pediatric study and one phase III clinical trial) on 49 adolescent patients and 17 elderly patients (65 years of age or above) treated with cariprazine was examined. Safety measures included assessment of adverse events (AEs), clinical laboratory values, physical examinations, extrapyramidal symptom (EPS)-, depression-, and suicidality rating scales. Safety parameters were summarized using descriptive statistics. Results indicate that cariprazine was generally safe and well tolerated. Adverse events in the marginal age populations were comparable to the adult population, except for less insomnia in the young and no reports of akathisia in the elderly. Laboratory parameters, vital sign values and EEG parameters were comparable to previously published data in the adult population. In conclusion, cariprazine in the approved adult dose-range of 1.5-6 mg might be a safe treatment option also in adolescent and elderly patients with schizophrenia. Further studies are need to verify these preliminary findings.
精神分裂症是一种终身性精神障碍，影响着青少年至老年患者。所有精神分裂症患者均需接受抗精神病药物治疗，包括非常年轻和年老的患者。年轻人的发育问题和老年人器官功能的衰退可能会影响对药物的反应，并且需要不同的给药方案。本文的目的是研究接受卡立哌嗪治疗的青少年（13至未满18岁）和老年人（65岁及以上）患者的安全性概况和给药要求。研究了两项关于49例接受卡立哌嗪治疗的青少年患者和17例老年患者（65岁及以上）的临床研究（一项药代动力学儿科研究和一项III期临床试验）的数据。安全措施包括评估不良事件（AE）、临床实验室值、体格检查、锥体外系症状（EPS）、抑郁和自杀倾向评定量表。使用描述性统计总结安全参数。结果表明，卡立哌嗪总体上安全且耐受性良好。边缘年龄人群中的不良事件与成人人群相当，只是年轻人失眠较少，老年人未报告有静坐不能。实验室参数、生命体征值和脑电图参数与先前发表的成人人群数据相当。总之，卡立哌嗪在1.5 - 6 mg的批准成人剂量范围内，对于患有精神分裂症的青少年和老年患者可能也是一种安全的治疗选择。需要进一步研究来验证这些初步发现。
