Culpepper Larry, Vieta Eduard, Kelly Deanna L, Patel Mehul D, Szatmári Balázs, Hankinson Arlene, Earley Willie R
Boston University School of Medicine, Boston, MA, USA.
Hospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.
Neuropsychiatr Dis Treat. 2022 May 12;18:995-1011. doi: 10.2147/NDT.S348143. eCollection 2022.
Many medications used to treat schizophrenia and bipolar I disorder are linked to hyperprolactinemia. The effects of cariprazine, a dopamine D/D receptor partial agonist, on prolactin levels in patients with schizophrenia or bipolar I disorder were evaluated.
Effects on prolactin were evaluated using pooled data from randomized, double-blind, placebo-controlled studies in patients with schizophrenia (4 studies; 6-week duration; cariprazine 1.5-3 mg/d, 4.5-6 mg/d, and 9-12 mg/d), bipolar mania (3 studies; 3-week duration; cariprazine 3-6 and 9-12 mg/d), and bipolar depression (3 studies; 6- to 8-week duration; cariprazine 1.5 and 3 mg/d). Long-term effects were analyzed using open-label studies in patients with schizophrenia (2 studies; 48-week duration) and patients with bipolar mania (1 study; 16-week duration). Change in prolactin levels (ng/mL) from baseline to study endpoint was evaluated in subsets of sex and prior medication use.
In patients with schizophrenia (male, n = 1377; female, n = 558), median prolactin changes were -1.2 for males and -7.4 for females on placebo, and ranged from -4.2 to -3.6 for males and -12.4 to +0.2 for females in the cariprazine-treatment groups. In patients with bipolar mania (male, n = 570; female, n = 395), median prolactin changes were -0.2 for males and -1.1 for females on placebo and ranged from -2.1 to -3.0 for males and 0 to +1.8 for females in the cariprazine-treatment groups. Median decreases were also seen in the long-term studies of schizophrenia (range, -14.6 to -2.0) and bipolar mania (range, -0.8 to +1.9). In patients with bipolar depression (male, n = 485; female, n = 780), median prolactin changes were +0.3 for males and +0.7 for females on placebo and ranged from +0.4 to +0.5 for males and +3.0 to +3.1 for females in the cariprazine-treatment groups.
Treatment with cariprazine for schizophrenia or bipolar I disorder was associated with minimal effects on prolactin levels.
许多用于治疗精神分裂症和双相I型障碍的药物与高催乳素血症有关。评估了多巴胺D/D受体部分激动剂卡立普唑对精神分裂症或双相I型障碍患者催乳素水平的影响。
使用来自精神分裂症患者（4项研究；为期6周；卡立普唑1.5 - 3毫克/天、4.5 - 6毫克/天和9 - 12毫克/天）、双相躁狂症患者（3项研究；为期3周；卡立普唑3 - 6毫克/天和9 - 12毫克/天）以及双相抑郁症患者（3项研究；为期6至8周；卡立普唑1.5毫克/天和3毫克/天）的随机、双盲、安慰剂对照研究的汇总数据评估对催乳素的影响。使用对精神分裂症患者（2项研究；为期48周）和双相躁狂症患者（1项研究；为期16周）的开放标签研究分析长期影响。在按性别和既往用药情况划分的亚组中评估从基线到研究终点催乳素水平（纳克/毫升）的变化。
在精神分裂症患者中（男性，n = 1377；女性，n = 558），安慰剂组男性催乳素中位数变化为 - 1.2，女性为 - 7.4，卡立普唑治疗组男性变化范围为 - 4.2至 - 3.6，女性为 - 12.4至 + 0.2。在双相躁狂症患者中（男性，n = 570；女性，n = 395），安慰剂组男性催乳素中位数变化为 - 0.2，女性为 - 1.1，卡立普唑治疗组男性变化范围为 - 2.1至 - 3.0，女性为0至 + 1.8。在精神分裂症（范围为 - 14.6至 - 2.0）和双相躁狂症（范围为 - 0.8至 + 1.9）的长期研究中也观察到中位数下降。在双相抑郁症患者中（男性，n = 485；女性，n = 780），安慰剂组男性催乳素中位数变化为 + 0.3，女性为 + 0.7，卡立普唑治疗组男性变化范围为 + 0.4至 + 0.5，女性为 + 3.0至 + 3.1。
卡立普唑治疗精神分裂症或双相I型障碍对催乳素水平影响极小。
