Alkermes, Inc., 825 Winter St., Waltham, MA, 02451-1420, USA.
OMI, Inc., Boston, MA, USA.
BMC Psychiatry. 2022 Feb 14;22(1):114. doi: 10.1186/s12888-022-03758-w.
Many second-generation antipsychotics (SGAs) are associated with weight gain and cardiometabolic effects. Antipsychotic-associated weight gain is linked to treatment interruptions, potentially increasing risk of relapse and hospitalization. This retrospective study assessed clinically significant weight gain (CSWG), treatment interruptions, and development of cardiometabolic conditions in patients with schizophrenia (SZ) or bipolar I disorder (BD-I) following initiation of oral SGAs with moderate to high weight gain risk.
Patients with no prior use of moderate to high weight gain risk oral SGAs were identified from patient-level medical/pharmacy claims and electronic medical records (January 2013-February 2020; OM1 Real-World Data Cloud). Those with ≥ 1 weight measurement in both the 12 months preceding and 3 months after SGA initiation (index date) were analyzed for continuous changes in weight, CSWG (≥ 7% and ≥ 10% increases from baseline), treatment interruptions (switches/discontinuations), and development of cardiometabolic conditions.
Median follow-up times in the SZ (n = 8174) and BD-I (n = 9142) cohorts were 153.4 and 159.4 weeks, respectively; 45.5% and 50.7% were obese at baseline. Mean (SD) percent weight increase during treatment was 3.3% (7.2) and 3.7% (7.0) for patients with SZ and BD-I, respectively, and was highest for underweight/normal weight patients (SZ: 4.8% [8.1]; BD-I: 5.5% [8.7]). More than 96% had treatment interruptions during follow-up, primarily discontinuations. CSWG and treatment interruptions occurred within a median of 13 and 14 weeks after treatment initiation, respectively. Of patients with CSWG and treatment interruptions, approximately 75% did not return to baseline weight during follow-up. Among those without baseline cardiometabolic conditions, 14.7% and 11.3% of patients with SZ or BD-I, respectively, developed ≥ 1 condition over 12 months post-index. Incidence was generally highest among those who were overweight/obese at baseline and those who experienced CSWG.
In this analysis of real-world data, both weight gain and treatment interruptions occurred early in treatment for patients with SZ or BD-I. Treatment-associated weight gain persisted despite switching or discontinuing index treatment. Additionally, cardiometabolic morbidity increased within 12 months of treatment initiation. Patients with SZ or BD-I are at greater risk than the general population for cardiometabolic conditions; weight gain associated with SGAs may exacerbate these health risks.
许多第二代抗精神病药物（SGAs）与体重增加和心血管代谢效应有关。抗精神病药相关的体重增加与治疗中断有关，这可能会增加复发和住院的风险。这项回顾性研究评估了精神分裂症（SZ）或双相 I 障碍（BD-I）患者在开始使用具有中度至高度体重增加风险的口服 SGA 后，体重显著增加（CSWG）、治疗中断和心血管代谢状况的发展。
从患者层面的医疗/药房索赔和电子病历中确定了没有使用过具有中度至高度体重增加风险的口服 SGA 的患者（2013 年 1 月至 2020 年 2 月；OM1 真实世界数据云）。那些在 SGA 开始前 12 个月和开始后 3 个月内（索引日期）有≥1 次体重测量的患者，分析了体重的连续变化、CSWG（基线增加≥7%和≥10%）、治疗中断（转换/停药）和心血管代谢状况的发展。
SZ（n=8174）和 BD-I（n=9142）队列的中位随访时间分别为 153.4 和 159.4 周，基线时分别有 45.5%和 50.7%的患者肥胖。治疗期间体重平均（SD）百分比增加分别为 SZ 患者的 3.3%（7.2）和 BD-I 患者的 3.7%（7.0），体重增加最高的是体重不足/正常的患者（SZ：4.8%[8.1]；BD-I：5.5%[8.7]）。超过 96%的患者在随访期间有治疗中断，主要是停药。CSWG 和治疗中断分别在治疗开始后 13 周和 14 周内发生。在有 CSWG 和治疗中断的患者中，约有 75%的患者在随访期间没有恢复到基线体重。在没有基线心血管代谢疾病的患者中，SZ 或 BD-I 患者分别有 14.7%和 11.3%在索引后 12 个月内出现≥1 种疾病。在基线时超重/肥胖的患者和经历过 CSWG 的患者中，发病率通常最高。
在这项真实世界数据的分析中，SZ 或 BD-I 患者的体重增加和治疗中断都发生在治疗早期。尽管进行了药物转换或停药，治疗相关的体重增加仍在持续。此外，心血管代谢发病率在治疗开始后 12 个月内增加。SZ 或 BD-I 患者比一般人群患心血管代谢疾病的风险更高；SGA 相关的体重增加可能会加剧这些健康风险。
