Correll Christoph U, Cutler Andrew J, Laliberté François, Germain Guillaume, MacKnight Sean D, Boudreau Julien, Wade Sally W, Nabulsi Nadia, Nguyen Huy-Binh, Parikh Mousam
Department of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
Department of Psychiatry, Psychiatry Research, The Zucker Hillside Hospital, Northwell Health, 75-59 263rd Street, Glen Oaks, NY, 11004, USA.
Ann Gen Psychiatry. 2025 Jan 27;24(1):5. doi: 10.1186/s12991-024-00542-w.
Atypical antipsychotics are a common treatment for serious mental illness, but many are associated with adverse effects, including weight gain and cardiovascular issues, and real-world experience may differ from clinical trial data. Cariprazine has previously demonstrated a favorable safety and tolerability profile in clinical trials. Here, we evaluated the effects of cariprazine on body weight and blood pressure for bipolar I disorder (BP-I), schizophrenia, or as adjunctive treatment for major depressive disorder (MDD) using real-world data.
Symphony Health's Integrated Dataverse® with electronic medical record access (3/1/2015-10/31/2018) was used to identify adults (≥ 18 years) diagnosed with BP-I depression, BP-I mania/mixed, schizophrenia, or MDD, with ≥ 2 cariprazine dispensings (first dispensing = index) and continuous clinical activity for ≥ 12 months pre-index (baseline) and ≥ 3 months post-index. The on-treatment period spanned from index to cariprazine discontinuation, exposure to another atypical or long-acting injectable antipsychotic, or end of clinical activity/data availability. Outcomes included estimated annual linear trajectories for weight, body mass index (BMI), systolic blood pressure (SBP), and diastolic blood pressure (DBP) during baseline and on treatment. Changes were estimated using linear mixed-effects models fitted over measurements pre-index and on treatment; 95% CIs were derived from nonparametric bootstrap procedures.
The body weight analysis included 612 patients (BP-I, n = 331 [BP-I depression, n = 172; BP-I mania/mixed, n = 159]; schizophrenia, n = 75; MDD, n = 206). The mean patient age was 43.4 years, 75.2% were female, and the mean (SD) on-treatment period was 219 (185) days. Among patients with measurements before and during cariprazine treatment, estimated annual weight trajectories were + 3.55 (95% CI 2.38, 4.59) kg/year before cariprazine initiation and + 0.91 (- 1.17, 2.82) kg/year during cariprazine treatment. Additionally, annual linear trajectories evaluated across the on-treatment period were + 0.31 (- 0.42, 1.01) kg/m/year for BMI, - 2.38 (- 4.27, - 0.76) mmHg/year for SBP, and - 0.57 (- 1.75, 0.61) mmHg/year for DBP.
In this real-world analysis, cariprazine was associated with an estimated weight gain of + 0.91 kg/year and had minimal impact on BMI and blood pressure when evaluated up to 12 months.
非典型抗精神病药物是治疗严重精神疾病的常用药物，但许多药物都伴有不良反应，包括体重增加和心血管问题，而实际应用中的情况可能与临床试验数据有所不同。卡立哌嗪此前在临床试验中已显示出良好的安全性和耐受性。在此，我们使用实际应用数据评估了卡立哌嗪对双相I型障碍（BP-I）、精神分裂症患者的体重和血压的影响，以及作为重度抑郁症（MDD）辅助治疗的效果。
利用Symphony Health的综合数据集®并获取电子病历（2015年3月1日至2018年10月31日），以识别年龄≥18岁、被诊断为BP-I型抑郁症、BP-I型躁狂/混合发作、精神分裂症或MDD的成年人，且至少有2次卡立哌嗪配药记录（首次配药=索引），并在索引前（基线）至少有12个月的持续临床活动以及索引后至少3个月的持续临床活动。治疗期从索引开始至卡立哌嗪停药、改用另一种非典型或长效注射用抗精神病药物，或临床活动/数据可获取期结束。观察指标包括基线期和治疗期体重、体重指数（BMI）、收缩压（SBP）和舒张压（DBP）的估计年度线性轨迹。使用基于索引前和治疗期测量值拟合的线性混合效应模型估计变化；95%置信区间来自非参数自助法。
体重分析纳入了612例患者（BP-I型，n = 331 [BP-I型抑郁症，n = 172；BP-I型躁狂/混合发作，n = 159]；精神分裂症，n = 75；MDD，n = 206）。患者平均年龄为43.4岁，75.2%为女性，平均（标准差）治疗期为219（185）天。在有卡立哌嗪治疗前和治疗期间测量值的患者中，卡立哌嗪开始治疗前估计年度体重轨迹为+3.55（95%置信区间2.38，4.59）kg/年，卡立哌嗪治疗期间为+0.91（-1.17，2.82）kg/年。此外，在整个治疗期评估的年度线性轨迹中，BMI为+0.31（-0.42，1.01）kg/m/年，SBP为-2.38（-4.27，-0.76）mmHg/年，DBP为-0.57（-1.75，0.61）mmHg/年。
在这项实际应用分析中，卡立哌嗪与估计每年体重增加0.91 kg相关，在长达12个月的评估中对BMI和血压影响极小。
